Application of composition in preparing health care product or medicine for preventing and treating leukopenia caused by radiotherapy and chemotherapy

Abstract

The present invention relates to use of a composition in the manufacture of a health care product or medicament for preventing and treating leucopenia induced by radiotherapy or chemotherapy. The composition is made from raw materials comprising 5 to 200 parts by weight of Ganoderma, 5 to 150 parts by weight of Radix Panacis Quinquefolii or Radix Et Rhizoma Ginseng, 1 to 90 parts by weight of fermented Cordyceps sinensis powder and/or 1 to 120 parts by weight of Cordyceps, or is a composition consisting of water and/or alcohol extracts of the above raw materials as active components.

Claims

1. A method of treating or reducing the incidence of leucopenia induced by radiotherapy or chemotherapy, comprising the step of administering to a subject in need thereof a composition made from raw materials comprising as sole active ingredients: (i) Ganoderma, Radix Panacis Quinquefolii or Radix Et Rhizoma Ginseng, fermented Cordyceps sinensis powder and/or Cordyceps, and (ii) one or more of Flos Rosae Rugosae in an amount of 5 to 90 parts, Ganoderma spore powder in an amount of 5 to 150 parts, Ganoderma spore oil in an amount of 1 to 90 parts, Radix Pseudostellariae in an amount of 10 to 400 parts, Folium Ginseng in an amount of 1 to 120 parts, Radix Codonopsis in an amount of 3 to 400 parts, and Radix Astragali in an amount of 3 to 400 parts, or any combination thereof.

2. The method of claim 1, characterized in that the raw materials comprise one or more of 10 to 60 parts of Flos Rosae Rugosae, 10 to 120 parts of Ganoderma spore powder, 10 to 60 parts of Ganoderma spore oil, 20 to 200 parts of Radix Pseudostellariae, 20 to 90 parts of Folium Ginseng, 20 to 200 parts of Radix Codonopsis, and 20 to 200 parts of Radix Astragali, or any combination thereof.

3. The method of claim 2, characterized in that the raw materials comprise one or more of 30 parts of Flos Rosae Rugosae, 30 parts of Ganoderma spore powder, 20 parts of Ganoderma spore oil, 40 parts of Radix Pseudostellariae, 30 parts of Folium Ginseng, 40 parts of Radix Codonopsis, and 40 parts of Radix Astragali, or any combination thereof.

4. The method of claim 1, characterized in that the raw materials comprise 5 to 200 parts of Ganoderma, 5 to 150 parts of Radix Panacis Quinquefolii or Radix Et Rhizoma Ginseng, 1 to 90 parts of fermented Cordyceps sinensis powder and/or 1 to 120 parts of Cordyceps, and 5 to 90 parts of Flos Rosae Rugosae.

5. The method of claim 4, characterized in that the raw materials comprise 20 to 120 parts of Ganoderma, 10 to 90 parts of Radix Panacis Quinquefolii or Radix Et Rhizoma Ginseng, 3 to 60 parts of fermented Cordyceps sinensis powder and/or 3 to 90 parts of Cordyceps, and 10 to 60 parts of Flos Rosae Rugosae.

6. The method of claim 5, characterized in that the raw materials comprise 40 parts of Ganoderma, 30 parts of Radix Panacis Quinquefolii or Radix Et Rhizoma Ginseng, 20 parts of fermented Cordyceps sinensis powder and/or 6.7 parts of Cordyceps, and 30 parts of Flos Rosae Rugosae.

7. The method of claim 1, characterized in that the raw materials comprise: 5 to 200 parts of Ganoderma, 5 to 150 parts of Radix Panacis Quinquefolii or Radix Et Rhizoma Ginseng, 1 to 90 parts of fermented Cordyceps sinensis powder and/or 1 to 120 parts of Cordyceps, and 5 to 90 parts of Flos Rosae Rugosae, and one or more of 5 to 150 parts of Ganoderma spore powder, 1 to 90 parts of Ganoderma spore oil, 10 to 400 parts of Radix Pseudostellariae, 1 to 120 parts of Folium Ginseng, 3 to 400 parts of Radix Codonopsis, and 3 to 400 parts of Radix Astragali, or any combination thereof.

8. The method of claim 1, characterized in that the species to which the fermented Cordyceps sinensis powder belongs is one of or any combination of: Paecilomyces hepialli Chen et Dai, sp.nov, Mortiscrslla hepialid C.T.&B.liu, Synnematium sinensis Yin & Shen, Gliocladium roseum (link)Thom, Mortierella sp., Cephalosporium sinensis Chen sp.nov, or Hirsutella sinensis Liu, Guo, Yu-et Zeng, sp.nov.

9. The method of claim 1, wherein the Ganoderma spore powder is sporoderm-broken Ganoderma spore powder.

10. The method of claim 1, further comprising the step of adding thereto auxiliary agent(s) or excipient(s) which is/are acceptable in health care products and/or in medicaments.

11. The method of claim 10, characterized in that the dosage form of the composition is any one of a tablet, an oral liquid, a granule, a capsule, an electuary, a dripping pill, a pill, powder, a lozenge, a fluid extract, an extract, an injection, and a syrup.

12. The method of claim 1, characterized in that the composition made from the raw materials is prepared by mixing the raw materials; or by mixing the raw materials and extracting them with water and/or alcohol to obtain the composition; or by extracting one or more of the raw materials with water and/or alcohol and using the extract as the active ingredient to prepare the composition.

13. The method of claim 12, characterized in that the composition made from the raw materials is prepared by the following steps: 1) weighing out traditional Chinese drugs as the raw materials; and 2) extracting the raw materials under reflux with alcohol or water, so as to obtain a liquid extract as the active ingredient, and adding auxiliary agent(s) to prepare various dosage forms.

14. The method of claim 12, characterized in that the composition made from the raw materials is prepared by the following steps: 1) weighing out traditional Chinese drugs as the raw materials, adding methanol or ethanol thereto to carry out extraction, recovering methanol or ethanol from the extraction liquid, to obtain Extract I; 2) evaporating methanol or ethanol from the residual drugs, adding water to carry out extraction, to obtain Extract II; and 3) combining Extract I and Extract II, carrying out filtration, concentrating the filtrate to an appropriate amount, adding pharmaceutically conventional auxiliary agent(s) to prepare a desired formulation by a pharmaceutically conventional process.

15. The method of claim 12, characterized in that the composition made from the raw materials is prepared by the following steps: 1) raw material preparation: weighing out traditional Chinese drugs as the raw materials; 2) extraction and concentration: soaking the Chinese drug raw materials processed in step 1) in water, then decocting several times by heating, combining the liquid extracts to carry out filtration, concentrating the filtrate to an appropriate amount, cooling the concentrate and subjecting it to high-speed centrifugation to remove impurities, and reserving the product until use; and 3) formulation preparation: preparing the concentrate obtained in step 2), alone or together with medicinally acceptable auxiliary agent(s), into a desired formulation by a pharmaceutically conventional process.

16. The method of claim 15, characterized in that, in step 2), the soaking time is 20 to 60 min, and after soaking, decocting is carried out 1 to 3 times by heating, with each decoction lasting for 1 to 2 h and having a 6 to 13-fold amount of water added.

17. The method of claim 12, characterized in that the alcohol is methanol or ethanol.

18. The method of claim 14, characterized in that the concentration of the methanol is 5% to 95%, and the concentration of the ethanol is 5% to 95%.

Description

DETAILED DESCRIPTION

Example 1

(1) 1.5 kg Radix Panacis Quinquefolii, 2.0 kg Ganoderma, and 0.33 kg Cordyceps were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced. The Cordyceps was pulverized and then put in a cloth bag. The above three drugs were soaked in water for 30 min, and decocted 3 times by heating. The first decoction lasted for 2 h with a 13-fold amount of water added, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered. The filtrate was concentrated to produce a clear paste, which was then spray-dried to prepare a composite powder. The composition obtained, designated as Composition 1, was used in the efficacy experiments as below.

Example 2

(2) 1.5 kg Radix Panacis Quinquefolii, 2.0 kg Ganoderma, and 1.0 kg fermented Cordyceps sinensis powder were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced and the fermented Cordyceps sinensis powder was put in a cloth bag. The above three drugs were soaked in water for 30 min, and decocted 3 times by heating. The first decoction lasted for 2 h with a 13-fold amount of water added, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered. The filtrate was concentrated to produce a clear paste, which was then spray-dried to prepare a composite powder. The composition obtained, Composition 2, was used in the efficacy experiments as below.

Example 3

(3) 1.5 kg Radix Panacis Quinquefolii, 2.0 kg Ganoderma, 1.0 kg fermented Cordyceps sinensis powder and 0.33 kg Cordyceps were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced and the fermented Cordyceps sinensis powder was put in a cloth bag. The Cordyceps was pulverized and then put in a cloth bag. The above four drugs were soaked in water for 30 min, and decocted 3 times by heating. The first decoction lasted for 2 h with a 13-fold amount of water added, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered. The filtrate was concentrated to produce a clear paste, which was then spray-dried to prepare a composite powder. The composition obtained, Composition 3, was used in the efficacy experiments as below.

Example 4

(4) 1.5 kg Radix Panacis Quinquefolii, 2.0 kg Ganoderma, 0.33 kg Cordyceps, and 1.5 kg Flos Rosae Rugosae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced. The Cordyceps was pulverized and then put in a cloth bag. The above four drugs were soaked in water for 30 min, and decocted 3 times by heating. The first decoction lasted for 2 h with a 13-fold amount of water added, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered. The filtrate was concentrated to produce a clear paste, which was then spray-dried to prepare a composite powder. The composition obtained, Composition 4, was used in the efficacy experiments as below.

Example 5

(5) 1.5 kg Radix Panacis Quinquefolii, 2.0 kg Ganoderma, 1.0 kg fermented Cordyceps sinensis powder, and 1.5 kg Flos Rosae Rugosae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced and the fermented Cordyceps sinensis powder was put in a cloth bag. The above four drugs were soaked in water for 30 min, and decocted 3 times by heating. The first decoction lasted for 2 h with a 13-fold amount of water added, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered. The filtrate was concentrated to produce a clear paste, which was then spray-dried to prepare a composite powder. The composition obtained, Composition 5, was used in the efficacy experiments as below.

Example 6

(6) 1.5 kg Radix Panacis Quinquefolii, 2.0 kg Ganoderma, 1.0 kg fermented Cordyceps sinensis powder, 0.33 kg Cordyceps and 1.5 kg Flos Rosae Rugosae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced and the fermented Cordyceps sinensis powder was put in a cloth bag. The Cordyceps was pulverized and then put in a cloth bag. The above five drugs were soaked in water for 30 min, and decocted 3 times by heating. The first decoction lasted for 2 h with a 13-fold amount of water added, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered. The filtrate was concentrated to produce a clear paste, which was then spray-dried to prepare a composite powder. The composition obtained, Composition 6, was used in the efficacy experiments as below.

Example 7

(7) 300 g Radix Panacis Quinquefolii, 400 g Ganoderma, 200 g fermented Cordyceps sinensis powder (Hirsutella sinensis Liu, Guo, Yu-et Zeng, sp.nov), and 300 g Flos Rosae Rugosae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the fermented Cordyceps sinensis powder was put in a cloth bag. The above four drugs were soaked in water for 20 min, and decocted 3 times by heating. Each decoction lasted for 1 h with a 10-fold amount of water added. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 8

(8) 300 g Radix Panacis Quinquefolii, 400 g Ganoderma, 67 g Cordyceps, 200 g fermented Cordyceps sinensis powder (Paecilomyces hepialli Chen et Dai, sp.nov), and 300 g Flos Rosae Rugosae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the fermented Cordyceps sinensis powder was put in a cloth bag. The Cordyceps was pulverized and then put in a cloth bag. The above five drugs were soaked in water for 1 h, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for tablets were added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for tablets.

Example 9

(9) 150 g Radix Panacis Quinquefolii, 90 g fermented Cordyceps sinensis powder (Hirsutella hepialid Chen et Shen), 120 g Cordyceps, 200 g Ganoderma, and 90 g Flos Rosae Rugosae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the fermented Cordyceps sinensis powder was put in a cloth bag. The above four drugs were soaked in water for 1 h, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 10

(10) 500 g Radix Et Rhizoma Ginseng, 100 g fermented Cordyceps sinensis powder (Synnematium sinensis Yin & Shen), 500 g Ganoderma, and 500 g Flos Rosae Rugosae were weighed out. The Radix Et Rhizoma Ginseng and Ganoderma were sliced, and the fermented Cordyceps sinensis powder and Flos Rosae Rugosae were put in a cloth bag. The above four drugs were soaked in water for 30 min, and decocted 3 times by heating. The first decoction lasted for 2 h with a 15-fold amount of water added, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 11

(11) 500 g Radix Panacis Quinquefolii, 100 g fermented Cordyceps sinensis powder (Hirsutella sinensis Liu, Guo, Yu-et Zeng, sp.nov), 500 g Ganoderma, and 500 g Flos Rosae Rugosae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the fermented Cordyceps sinensis powder and Flos Rosae Rugosae were put in a cloth bag. The above four drugs were soaked in water for 20 min, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 12

(12) 150 g Radix Panacis Quinquefolii, 120 g Cordyceps, 200 g Ganoderma, and 90 g Flos Rosae Rugosae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced. The Cordyceps was pulverized and then put in a cloth bag. The above four drugs were soaked in water for 40 min, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 13

(13) 150 g Radix Et Rhizoma Ginseng, 90 g fermented Cordyceps sinensis powder (Gliocladium roseum (link) Thom), 200 g Ganoderma, and 90 g Flos Rosae Rugosae were weighed out. The Radix Et Rhizoma Ginseng and Ganoderma were sliced, and the fermented Cordyceps sinensis powder was put in a cloth bag. The above four drugs were soaked in water for 1 h, and decocted twice by heating. The first decoction lasted for 2 h with a 15-fold amount of water added, and the second decoction lasted for 1.5 h with a 10-fold amount of water added. The two liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 14

(14) 150 g Radix Panacis Quinquefolii, 90 g fermented Cordyceps sinensis powder (Hirsutella hepialid Chen et Shen), 120 g Cordyceps, 200 g Ganoderma, and 90 g Flos Rosae Rugosae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the fermented Cordyceps sinensis powder was put in a cloth bag. The above four drugs were soaked in water for 1 h, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 15

(15) 100 g Radix Panacis Quinquefolii, 30 g Cordyceps, 200 g Ganoderma, and 100 g Flos Rosae Rugosae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced. The Cordyceps was pulverized and then put in a cloth bag. The above four drugs were soaked in water for 30 min, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 16

(16) 150 g Radix Panacis Quinquefolii, 30 g fermented Cordyceps sinensis powder (Hirsutella sinensis Liu, Guo, Yu-et Zeng, sp.nov), 200 g Ganoderma, and 100 g Flos Rosae Rugosae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the fermented Cordyceps sinensis powder was put in a cloth bag. The above four drugs were soaked in water for 1 h, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 17

(17) 90 g Radix Panacis Quinquefolii, 90 g Cordyceps, 120 g Ganoderma, and 60 g Flos Rosae Rugosae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced. The Cordyceps was pulverized and then put in a cloth bag. The above four drugs were soaked in water for 20 min, and decocted 3 times by heating. Each decoction lasted for 1 h with a 10-fold amount of water added for each. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 18

(18) 90 g Radix Et Rhizoma Ginseng, 90 g Cordyceps, 120 g Ganoderma, and 60 g Flos Rosae Rugosae were weighed out. The Radix Et Rhizoma Ginseng and Ganoderma were sliced. The Cordyceps was pulverized and then put in a cloth bag. The above four drugs were soaked in water for 30 min, and decocted 3 times by heating. Each decoction lasted for 1 h with a 10-fold amount of water added for each. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 19

(19) 90 g Radix Panacis Quinquefolii, 60 g fermented Cordyceps sinensis powder (Cephalosporium sinensis Chen sp.nov), 120 g Ganoderma, and 60 g Flos Rosae Rugosae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the fermented Cordyceps sinensis powder was put in a cloth bag. The above four drugs were soaked in water for 20 min, and decocted 3 times by heating. Each decoction lasted for 1 h with a 10-fold amount of water added for each. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 20

(20) 300 g Radix Panacis Quinquefolii, 400 g Ganoderma, 67 g Cordyceps, and 300 g Flos Rosae Rugosae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced. The Cordyceps was pulverized and then put in a cloth bag. The above four drugs were soaked in water for 1 h, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for tablets were added thereto and uniformly mixed; and various types of tablets were prepared by conventional processes for tablets.

Example 21

(21) 300 g Radix Panacis Quinquefolii, 400 g Ganoderma, 200 g fermented Cordyceps sinensis powder (Paecilomyces hepialli Chen et Dai, sp.nov), and 300 g Flos Rosae Rugosae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the fermented Cordyceps sinensis powder was put in a cloth bag. The above four drugs were soaked in water for 20 min, and decocted 3 times by heating. Each decoction lasted for 1 h with a 10-fold amount of water added for each. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 22

(22) 500 g Radix Panacis Quinquefolii, 100 g Cordyceps, 500 g Ganoderma, 500 g Flos Rosae Rugosae and 500 g sporoderm-broken Ganoderma spore powder were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced. The Cordyceps was pulverized and then put in a cloth bag. The above four drugs were soaked in water for 20 min, and decocted 3 times by heating. The first decoction lasted for 2 h with a 15-fold amount of water added, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for tablets and the sporoderm-broken Ganoderma spore powder were added thereto and uniformly mixed; and various types of tablets were prepared by conventional processes for tablets.

Example 23

(23) 500 g Radix Et Rhizoma Ginseng, 100 g fermented Cordyceps sinensis powder (Paecilomyces sinensis Chen, Xiao et Shi, sp.nov), 500 g Ganoderma, 500 g Flos Rosae Rugosae and 500 g sporoderm-broken Ganoderma spore powder were weighed out. The Radix Et Rhizoma Ginseng and Ganoderma were sliced, and the fermented Cordyceps sinensis powder and the sporoderm-broken Ganoderma spore powder were put in a cloth bag. The above five drugs were soaked in water for 20 min, and decocted 3 times by heating. The first decoction lasted for 2 h with a 15-fold amount of water added, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for granules were added thereto and uniformly mixed; and granules were prepared by conventional processes for granules.

Example 24

(24) 150 g Radix Panacis Quinquefolii, 90 g fermented Cordyceps sinensis powder (Tolypocladium sinensis C.lan Li), 200 g Ganoderma, 90 g Flos Rosae Rugosae and 150 g sporoderm-broken Ganoderma spore powder were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the fermented Cordyceps sinensis powder was put in a cloth bag. The above four drugs were soaked in water for 20 min, and decocted 3 times by heating. The first decoction lasted for 2 h with a 15-fold amount of water added, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for tablets and the Ganoderma spore powder were added thereto and uniformly mixed; and various types of tablets were prepared by conventional processes for tablets.

Example 25

(25) 500 g Radix Panacis Quinquefolii, 100 g Cordyceps, 500 g Ganoderma, 500 g Flos Rosae Rugosae and 100 g Ganoderma spore oil were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the Cordyceps was pulverized. Upon addition of 80% ethanol, the above four drugs were extracted twice under reflux, with each extraction lasting for 2 h, and then filtered. Ethanol was recovered from the liquid filtrate until no ethanol odor could be smelled. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for dripping pills and the Ganoderma spore oil were added thereto and uniformly mixed; and dripping pills were prepared by conventional processes for dripping pills.

Example 26

(26) 500 g Radix Panacis Quinquefolii, 100 g fermented Cordyceps sinensis powder (Synnematium sinensis Yin & Shen), 500 g Ganoderma, 500 g Flos Rosae Rugosae, 500 g sporoderm-broken Ganoderma spore powder, 100 g Ganoderma spore oil and 100 g Folium Ginseng were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the fermented Cordyceps sinensis powder was put in a cloth bag. The above drugs were soaked in water for 40 min, and decocted 3 times by heating. The first decoction lasted for 2 h and the following decoctions each lasted for 1 h, with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for granules, the sporoderm-broken Ganoderma spore powder and the Ganoderma spore oil were added thereto and uniformly mixed; and granules were prepared by conventional processes for granules.

Example 27

(27) 150 g Radix Panacis Quinquefolii, 90 g fermented Cordyceps sinensis powder (Hirsutella hepialid Chen et Shen), 200 g Ganoderma, 90 g Flos Rosae Rugosae and 400 g Radix Codonopsis were weighed out. The Radix Panacis Quinquefolii, Ganoderma and Radix Codonopsis were sliced, and the fermented Cordyceps sinensis powder was put in a cloth bag. The above five drugs were soaked in water for 40 min, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for tablets were added thereto and uniformly mixed; and various types of tablets were prepared by conventional processes for tablets.

Example 28

(28) 150 g Radix Panacis Quinquefolii, 120 g Cordyceps, 200 g Ganoderma, 90 g Flos Rosae Rugosae and 400 g Radix Astragali were weighed out. The Radix Panacis Quinquefolii, Ganoderma and Radix Astragali were sliced. The Cordyceps was pulverized and then put in a cloth bag. The above five drugs were soaked in water for 20 min, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 14-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agents frequently used for lozenges were added thereto and uniformly mixed, and lozenges were prepared by conventional processes for lozenges.

Example 29

(29) 500 g Radix Panacis Quinquefolii, 50 g fermented Cordyceps sinensis powder (Paecilomyces hepialli Chen et Dai, sp.nov), 50 g fermented Cordyceps sinensis powder (Hirsutella sinensis Liu, Guo, Yu-et Zeng, sp.nov), 500 g Ganoderma, 500 g Flos Rosae Rugosae and 300 g Radix Codonopsis were weighed out. The Radix Panacis Quinquefolii, Ganoderma and Radix Codonopsis were sliced, and the fermented Cordyceps sinensis powders were put in a cloth bag. The above five drugs were soaked in water for 1 h, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for powder were added thereto and uniformly mixed; and powder was prepared by conventional processes for powder.

Example 30

(30) 500 g Radix Panacis Quinquefolii, 100 g Cordyceps, 500 g Ganoderma, 500 g Flos Rosae Rugosae and 300 g Radix Astragali were weighed out. The Radix Panacis Quinquefolii, Ganoderma and Radix Astragali were sliced. The Cordyceps was pulverized and then put in a cloth bag. The above five drugs were soaked in water for 20 min, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 14-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 31

(31) 100 g Radix Panacis Quinquefolii, 200 g Ganoderma, 30 g Cordyceps, 3 g fermented Cordyceps sinensis powder (Cs-C-Q80 Hirsutella sinensis Liu, Guo, Yu-et Zeng, sp.nov), 100 g Flos Rosae Rugosae and 100 g Ganoderma spore powder were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the Cordyceps was pulverized and put in a cloth bag together with the Ganoderma spore powder. The above five drugs were soaked in water for 20 min, and decocted 3 times by heating. The first decoction lasted for 2 h with a 15-fold amount of water added, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for tablets were added thereto and uniformly mixed; and various types of tablets were prepared by conventional processes for tablets.

Example 32

(32) 100 g Radix Panacis Quinquefolii, 200 g Ganoderma, 30 g fermented Cordyceps sinensis powder (Mortiscrslla hepialid C.T.& B.liu), 100 g Flos Rosae Rugosae and 100 g Ganoderma spore powder were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the fermented Cordyceps sinensis powder and the Ganoderma spore powder were put in a cloth bag. The above five drugs were soaked in water for 20 min, and decocted 3 times by heating. The first decoction lasted for 2 h with a 15-fold amount of water added, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for pills were added thereto and uniformly mixed; and various types of pills were prepared by conventional processes for pills.

Example 33

(33) 90 g Radix Panacis Quinquefolii, 120 g Ganoderma, 90 g Cordyceps, 60 g Flos Rosae Rugosae and 90 g Ganoderma spore oil were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced. The Cordyceps was pulverized and then put in a cloth bag. The above four drugs were soaked in water for 30 min, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for granules and the Ganoderma spore oil were added thereto and uniformly mixed; and granules were prepared by conventional processes for granules.

Example 34

(34) 100 g Radix Panacis Quinquefolii, 200 g Ganoderma, 30 g Cordyceps, 100 g Flos Rosae Rugosae and 200 g Radix Pseudostellariae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the Cordyceps was pulverized and then put in a cloth bag. The above five drugs were soaked in water for 40 min, and decocted 3 times by heating. The first decoction lasted for 2 h with a 15-fold amount of water added, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, auxiliary agents frequently used for soft extracts were added thereto and uniformly mixed, and a soft extract was prepared by conventional processes for soft extracts.

Example 35

(35) 100 g Radix Panacis Quinquefolii, 200 g Ganoderma, 30 g Cordyceps, 100 g Flos Rosae Rugosae and 200 g Folium Ginseng were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the Cordyceps was pulverized and then put in a cloth bag. The above five drugs were soaked in water for 40 min, and decocted 3 times by heating. The first decoction lasted for 2 h with a 15-fold amount of water added, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agents frequently used for syrups were added thereto and uniformly mixed, and a syrup was prepared by conventional processes for syrups.

Example 36

(36) 100 g Radix Panacis Quinquefolii, 200 g Ganoderma, 30 g fermented Cordyceps sinensis powder (Mortierella sp.), 100 g Flos Rosae Rugosae and 200 g Radix Codonopsis were weighed out. The Radix Panacis Quinquefolii, Ganoderma and Radix Codonopsis were sliced, and the fermented Cordyceps sinensis powder was put in a cloth bag. The above five drugs were soaked in water for 40 min, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fined particles were made by spray drying; auxiliary agents frequently used for tablets were added thereto and uniformly mixed; and various types of tablets were prepared by conventional processes for tablets.

Example 37

(37) 100 g Radix Panacis Quinquefolii, 200 g Ganoderma, 30 g fermented Cordyceps sinensis powder (Verticillium sinens Wamg sp.nov), 100 g Flos Rosae Rugosae and 200 g Radix Astragali were weighed out. The Radix Panacis Quinquefolii, Ganoderma and Radix Astragali were sliced, and the fermented Cordyceps sinensis powder was put in a cloth bag. The above five drugs were soaked in water for 40 min, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for capsules were added thereto and uniformly mixed; and capsules were prepared by conventional processes for capsules.

Example 38

(38) 90 g Radix Panacis Quinquefolii, 120 g Ganoderma, 30 g fermented Cordyceps sinensis powder (Cephalosporium sinensis Chen sp.nov), 30 g fermented Cordyceps sinensis powder (Synnematium sinensis Yin & Shen), 60 g Flos Rosae Rugosae and 60 g Ganoderma spore oil were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the fermented Cordyceps sinensis powders were put in a cloth bag. The above four drugs were soaked in water for 1 h, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 13-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for pills and the Ganoderma spore oil were added thereto and uniformly mixed; and various types of pills were prepared by conventional processes for pills.

Example 39

(39) 90 g Radix Panacis Quinquefolii, 120 g Ganoderma, 90 g Cordyceps, 60 g Flos Rosae Rugosae, 200 g Radix Astragali, and 10 g Ganoderma spore oil were weighed out. The Radix Panacis Quinquefolii, Ganoderma and Radix Astragali were sliced, and the Cordyceps was pulverized and then put in a cloth bag. The above five drugs were soaked in water for 40 min, and decocted 3 times by heating. The first decoction lasted for 2 h with a 15-fold amount of water added, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agents frequently used for syrups were added thereto and uniformly mixed, and a syrup was prepared by conventional processes for syrups.

Example 40

(40) 300 g Radix Panacis Quinquefolii, 400 g Ganoderma, 200 g fermented Cordyceps sinensis powder (Scytalidium hepialii C.L.Li), 300 g Flos Rosae Rugosae and 400 g Ganoderma spore powder were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the Cordyceps was pulverized and then put in a cloth bag. The above four drugs were soaked in water for 20 min, and decocted 3 times by heating. The first decoction lasted for 2 h with a 15-fold amount of water added, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for tablets and the Ganoderma spore powder were added thereto and uniformly mixed; and various types of tablets were prepared by conventional processes for tablets.

Example 41

(41) 300 g Radix Panacis Quinquefolii, 400 g Ganoderma, 67 g Cordyceps, 300 g Flos Rosae Rugosae and 20 g Ganoderma spore oil were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the Cordyceps was pulverized and then put in a cloth bag. The above four drugs were soaked in water for 30 min, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for granules and the Ganoderma spore oil were added thereto and uniformly mixed; and granules were prepared by conventional processes for granules.

Example 42

(42) 300 g Radix Panacis Quinquefolii, 400 g Ganoderma, 200 g fermented Cordyceps sinensis powder (Cephalosporium sinens Chen sp.nov), 300 g Flos Rosae Rugosae and 400 g Radix Pseudostellariae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the fermented Cordyceps sinensis powder was put in a cloth bag. The above five drugs were soaked in water for 40 min, and decocted 3 times by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fined particles were made by spray drying; auxiliary agents frequently used for tablets were added thereto and uniformly mixed; and various types of tablets were prepared by conventional processes for tablets.

Example 43

(43) 300 g Radix Panacis Quinquefolii, 400 g Ganoderma, 67 g Cordyceps, 300 g Flos Rosae Rugosae and 400 g Radix Pseudostellariae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the Cordyceps was pulverized and then put in a cloth bag. The above five drugs were soaked in water for 40 min, and decocted 3 times by heating. The first decoction lasted for 2 h with a 15-fold amount of water added, and the following decoctions each lasted for 1 h with a 10-fold amount of water added for each decoction. The three liquid extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agents frequently used for syrups were added thereto and uniformly mixed, and a syrup was prepared by conventional processes for syrups.

Example 44

(44) 300 g Radix Panacis Quinquefolii, 400 g Ganoderma, 100 g fermented Cordyceps sinensis powder (Chrysosporium sinens Z.Q.liang), 100 g fermented Cordyceps sinensis powder (Hirsutella sinensis Liu, Guo, Yu-et Zeng, sp.nov), and 300 g Flos Rosae Rugosae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the fermented Cordyceps sinensis powders were put in a cloth bag. Upon addition of 5% methanol, the drugs were extracted twice under reflux, with each extraction lasting for 1 h. Then the liquid extracts were combined, and methanol was recovered to obtain an alcohol extract. The residual drugs were further decocted twice in water by heating. The first decoction lasted for 2 h, and the following decoction lasted for 1 h, with a 10-fold amount of water added for each decoction. The alcohol extract and water extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for granules were added thereto and uniformly mixed; and granules were prepared by conventional processes for granules.

Example 45

(45) 300 g Radix Panacis Quinquefolii, 400 g Ganoderma, 67 g Cordyceps, 20 g fermented Cordyceps sinensis powder (Hirsutella sinensis Liu, Guo, Yu-et Zeng, sp.nov), and 300 g Flos Rosae Rugosae were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the Cordyceps was pulverized and then put in a cloth bag. Upon addition of 75% ethanol, the drugs were extracted for 2 h under reflux, and ethanol was recovered to obtain an alcohol extract. The residual drugs were further decocted three times in water by heating, with each decoction lasting for 2 h. The alcohol extract and water extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 46

(46) 300 g Radix Et Rhizoma Ginseng, 400 g Ganoderma, 200 g fermented Cordyceps sinensis powder (Cephalosporium acremonium Corda, Icones Fungorum), 300 g Flos Rosae Rugosae and 400 g Radix Codonopsis were weighed out. The Radix Et Rhizoma Ginseng, Ganoderma and Radix Codonopsis were sliced, and the fermented Cordyceps sinensis powder was put in a cloth bag. Upon addition of 95% methanol, the drugs were extracted twice under reflux, with each extraction lasting for 1 h. Then the liquid extracts were combined, and methanol was recovered to obtain an alcohol extract. The residual drugs were further decocted 3 times in water by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 10-fold amount of water added for each decoction. The alcohol extract and water extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for granules were added thereto and uniformly mixed; and granules were prepared by conventional processes for granules.

Example 47

(47) 300 g Radix Et Rhizoma Ginseng, 400 g Ganoderma, 200 g fermented Cordyceps sinensis powder (Sporothrix insectorum de Hong & H. C. Evans), 300 g Flos Rosae Rugosae and 400 g Radix Codonopsis were weighed out. The Radix Et Rhizoma Ginseng and Ganoderma were sliced, and the Cordyceps was pulverized and put in a cloth bag. Upon addition of 95% ethanol, the drugs were extracted under reflux for 2 h, and ethanol was recovered to obtain an alcohol extract. The residual drugs were further decocted 3 times in water by heating, with each decoction lasting for 2 h. The alcohol extract and water extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 48

(48) 300 g Radix Et Rhizoma Ginseng, 400 g Ganoderma, 67 g Cordyceps, 300 g Flos Rosae Rugosae, 300 Ganoderma spore powder and 400 g Radix Astragali were weighed out. The Radix Et Rhizoma Ginseng and Ganoderma were sliced, and the Cordyceps was pulverized and then put in a cloth bag. Upon addition of 5% ethanol, the drugs were extracted under reflux for 2 h, and ethanol was recovered to obtain an alcohol extract. The residual drugs were further decocted twice in water by heating, with each decoction lasting for 2 h. The alcohol extract and water extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 49

(49) 300 g Radix Panacis Quinquefolii, 400 g Ganoderma, 200 g fermented Cordyceps sinensis powder (Isaria farinose (Holmsk.) Fr. Systema Mycologicum), 300 g Flos Rosae Rugosae and 400 g Radix Astragali were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the fermented Cordyceps sinensis powder was put in a cloth bag. Upon addition of 95% methanol, the drugs were extracted twice under reflux for 2 h, with each extraction lasting for 1 h. Then the liquid extracts were combined, and methanol was recovered to obtain an alcohol extract. The residual drugs were further decocted 3 times in water by heating. The first decoction lasted for 2 h, and the following decoctions each lasted for 1 h, with a 10-fold amount of water added for each decoction. The alcohol extract and water extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, and the impurities therein were then removed by high-speed centrifugation. A paste was made by further concentration under reduced pressure, or fine particles were made by spray drying; auxiliary agents frequently used for granules were added thereto and uniformly mixed; and granules were prepared by conventional processes for granules.

Example 50

(50) 300 g Radix Panacis Quinquefolii, 400 g Ganoderma, 67 g Cordyceps, 300 g Flos Rosae Rugosae, and 90 g Folium Ginseng were weighed out. The Radix Panacis Quinquefolii and Ganoderma were sliced, and the Cordyceps was pulverized and then put in a cloth bag. Upon addition of 5% ethanol, the drugs were extracted under reflux for 2 h, and ethanol was recovered to obtain an alcohol extract. The residual drugs were further decocted 3 times in water by heating, with each decoction lasting for 2 h. The alcohol extract and water extracts were combined and filtered, the liquid filtrate was concentrated to an appropriate level, the liquid concentrate was left to cool down, the impurities therein were then removed by high-speed centrifugation, auxiliary agent(s) frequently used for oral liquid was added thereto and uniformly mixed, and a 20,000 ml oral liquid was prepared by conventional processes for oral liquid.

Example 51. Animal Experiment Report of Composition 1 of Example 1 in Prevention and Treatment of Leucopenia Induced by Radiotherapy or Chemotherapy

(51) 1. Materials and Methods

(52) 1.1 Sources of Samples

(53) The test drug was Composition 1 (Radix Panacis Quinquefolii, Ganoderma, and Cordyceps) provided by Jiangzhong Pharmaceutical Co. Ltd. as composite powder. 1 g dry composite powder was equivalent to 10.97 g total crude drugs.

(54) 1.2 Laboratory Animals

(55) Male and female mice of Kunming breed, each weighing 18 to 22 g, were provided by the Laboratory Animal Center, Jiangxi University of Traditional Chinese Medicine (Animal Certification Number: SCXK (Jiangxi) 2005-0001).

(56) 1.3 Primary Reagents

(57) Drug for positive control, batyl alcohol (100 mg/kg), was obtained from Shanghai Sine Yanan Pharmaceutical Co., Ltd. (batch No. 20080723). Cyclophosphamide was manufactured by Jiangsu Hengrui Medicine Co., Ltd. (batch No. 08110621). Cytarabine was manufactured by Shanghai Hualian Pharmaceuticals (batch No. 0512048). EDTA-K.sub.2 was manufactured by Sinopharm Chemical Reagent Co., Ltd. (batch No. F20080423).

(58) 1.4 Primary Instruments

(59) Sysmex-2000iV blood cell analyzer (Sysmex Corporation, Japan), AR1140/C eletronic analytic balance (Ohaus (Shanghai) Corp.), microscope (Olympus), pipets (Gilson), and ELx800 Absorbance reader for ELISA (BioTek, US).

(60) 2. Experimental Methods

(61) 2.1 Effect of Composition 1 on Leucocyte Reduction in Mice Induced by Cyclophosphamide.sup.[1]

(62) 2.1.1 Grouping, Modeling and Dosage Regime

(63) Mice were randomly divided into 6 groups with 10 animals per group, i.e., normal control group, model control group, positive control group, and groups on low, medium and high doses of Composition 1. The low-, medium- and high-dose groups were intragastrically given Composition 1 at a dose of 2.0 g crude drug/kg, 4.0 g crude drug/kg, and 12.0 g crude drug/kg, respectively; the positive control group was intragastrically given batyl alcohol (100 mg/kg) at a dose of 0.1 ml/10 g body weight; the normal control group and the model control group were intragastrically given an equivalent volume of distilled water; and the dosage regime lasted for 15 days with one dose per day. From day 9 of intragastrical administration, all mice in each group, except the normal control group, were given cyclophosphamide at a dose of 40 mg/kg each day via subcutaneous injection for 3 consecutive days. One hour after the intragastrical administration on day 15, blood and femurs were harvested for tests.

(64) 2.1.2 Peripheral Leucocyte Assay

(65) 40 μL blood was drawn from the tail vein of the mice and transferred into a EDTA-K.sub.2 anticoagulative tube, into which 160 μL dilution liquid was added, and then assayed in an automatic blood cell analyzer.

(66) 2.1.3 Bone Marrow Nucleated Cell Count (BMC)

(67) Mice were sacrificed by cervical dislocation. The left femur was removed and flushed with a 10 ml solution of 3% acetic acid to obtain the cells in the bone marrow. The number of cells in 4 large grids on a hemacytometer was counted, and the number was multiplied by 2.5×10.sup.4 to obtain the BMC in one femur.

(68) 2.1.4 Bone Marrow DNA Content Determination

(69) A 7 mm section was dissected from the middle of the right femur. The whole bone marrow was flushed into a centrifuge tube with a 10 mL solution of 0.005 mol/L CaCl.sub.2, placed in a refrigerator at 4° C. for 30 min, and then centrifuged at 2500 r/min for 15 min. The supernatant was discarded, and a 5 ml solution of 0.2 mol/L HClO.sub.4 was added to the precipitate and uniformly mixed. The mixture was heated in a water bath at 90° C. for 15 min, then kept in a refrigerator overnight, and centrifuged at 2500 r/min for 10 min. The supernatant was removed and its absorbance at 268 nm was measured.

(70) 2.2 Effect of Composition 1 on Leucocyte Reduction in Mice Induced by Cytarabine.sup.[2]

(71) 2.2.1 Grouping, Modeling and Dosage Regime

(72) The grouping and dosage regime were the same as those in 2.1.1, except that, from day 7 of intragastrical administration, all animals in each group, except the normal control group, were given cytarabine at a dose of 100 mg/kg via peritoneal injection for 2 consecutive days, and from the next day the dose was switched to 50 mg/kg which was continued for another 3 consecutive days. One hour after the intragastrical administration on day 15, blood and femurs were harvested for tests.

(73) 2.2.2 Peripheral Leucocyte Assay, Bone Marrow Nucleated Cell Count, and Bone Marrow DNA Content Determination

(74) All the same as in 2.1.

(75) 2.3 Effect of Composition 1 on Leucocyte Reduction in Mice Induced by X-Ray Radiation.sup.[3]

(76) 2.3.1 Grouping, Modeling and Dosage Regime

(77) The grouping and dosage regime were the same as those in 2.1.1 except that all groups other than the normal group were subjected to systematic radiation once under low-energy X ray from a medical linear accelerator to establish models, wherein the skin-to-source distance was 100 cm, the radiation dose was 4.0 Gy/min and the radiation duration was 4 min One hour after the intragastrical administration on day 8 and day 15, blood and femurs were harvested for tests.

(78) 2.3.2 Peripheral Leucocyte Assay, Bone Marrow Nucleated Cell Count, and Bone Marrow DNA Content Determination

(79) All the same as in 2.1.

(80) 2.4 Statistic Method

(81) Data was processed by SPSS15.0 using a one-way ANOVA analysis. P<0.05 is considered as significant difference. P<0.01 is considered as highly significant difference.

(82) 3. Results

(83) 3.1 Effect of Composition 1 on Leucocyte Reduction in Mice Induced by Cyclophosphamide

(84) Test results are shown in Tables 1 and 2. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 1 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 1 low-dose group, indicating that Composition 1 can resist leucocyte reduction in mice induced by cyclophosphamide and improve the hematopoietic function of the bone marrow thereof.

(85) TABLE-US-00001 TABLE 1 Effect of Composition 1 on peripheral leucocyte reduction in mice induced by cyclophosphamide (x ± s, ×10.sup.9) Dose (g crude Number of WBC before WBC after WBC after Groups drug/kg) animals modeling modeling treatment Normal control group 0.0 10 8.19 ± 1.96 8.37 ± 1.54 8.28 ± 1.77 Model control group 0.0 10 8.08 ± 1.58 3.46 ± 1.09** 4.25 ± 1.41** Positive control group 100 mg 10 8.20 ± 2.19 3.55 ± 1.21** 6.20 ± 1.82.sup..box-tangle-solidup. Test drug low-dose group 2.0 10 8.22 ± 1.54 3.48 ± 1.36** 5.15 ± 1.62 Test drug medium-dose group 4.0 10 8.32 ± 1.73 3.50 ± 1.02** 6.40 ± 1.92.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 8.42 ± 1.89 3.29 ± 1.13** 6.92 ± 1.87.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(86) TABLE-US-00002 TABLE 2 Effect of Composition 1 on the contents of bone marrow BCM and DNA in mice injected with cyclophosphamide (x ± s) Dose (g crude Number of Bone marrow BCM Bone marrow Groups drug/kg) animals (×10.sup.6) DNA Normal control group 0.0 10 16.01 ± 2.42 0.913 ± 0.276 Model control group 0.0 10  10.9 ± 2.63** 0.422 ± 0.108** Positive control group 100 mg 10 13.44 ± 2.36.sup..box-tangle-solidup. 0.610 ± 0.138.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group 2.0 10 12.18 ± 1.97 0.523 ± 0.142 Test drug medium-dose group 4.0 10 13.56 ± 2.78.sup..box-tangle-solidup. 0.602 ± 0.157.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 14.49 ± 2.95.sup..box-tangle-solidup..box-tangle-solidup. 0.680 ± 0.176.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
3.2 Effect of Composition 1 on Leucocyte Reduction in Mice Induced by Cytarabine

(87) Test results are shown in Tables 3 and 4. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 1 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 1 low-dose group, indicating that Composition 1 can resist leucocyte induction in mice induced by cytarabine and improve the hematopoietic function of the bone marrow thereof.

(88) TABLE-US-00003 TABLE 3 Effect of Composition 1 on peripheral leucocyte reduction in mice induced by cytarabine (x ± s, ×10.sup.9) Dose (g crude Number of WBC before WBC after WBC after Groups drug/kg) animals modeling modeling treatment Normal control group 0.0 10 8.45 ± 1.87 8.59 ± 1.90 8.74 ± 2.13 Model control group 0.0 10 8.62 ± 1.92 3.67 ± 1.20** 4.47 ± 1.26** Positive control group 100 mg 10 8.50 ± 2.32 3.80 ± 1.03** 6.54 ± 1.93.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group 2.0 10 8.33 ± 1.69 3.54 ± 1.21** 5.44 ± 1.09 Test drug medium-dose group 4.0 10 8.45 ± 1.85 3.76 ± 1.09** 6.07 ± 1.23.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 8.29 ± 2.08 3.48 ± 1.03** 6.87 ± 1.50.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(89) TABLE-US-00004 TABLE 4 Effect of Composition 1 on the contents of bone marrow BCM and DNA in mice injected with cytarabine (x ± s) Dose (g crude Number of Bone marrow BCM Bone marrow Groups drug/kg) animals (×10.sup.6) DNA Normal control group 0.0 10 15.38 ± 2.60 0.945 ± 0.292 Model control group 0.0 10  9.86 ± 2.17** 0.460 ± 0.127** Positive control group 100 mg 10 12.53 ± 2.24.sup..box-tangle-solidup. 0.634 ± 0.130.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group 2.0 10 11.36 ± 1.85 0.544 ± 0.153 Test drug medium-dose group 4.0 10 12.49 ± 2.52.sup..box-tangle-solidup. 0.627 ± 0.136.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 13.26 ± 2.88.sup..box-tangle-solidup..box-tangle-solidup. 0.709 ± 0.190.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
3.3 Effect of Composition 1 on Leucocyte Reduction in Mice Induced by X-Ray Radiation

(90) Test results are shown in Tables 5 and 6. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 1 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 1 low-dose group, indicating that Composition 1 can resist leucocyte induction in mice induced by X-ray radiation and improve the hematopoietic function of the bone marrow thereof.

(91) TABLE-US-00005 TABLE 5 Effect of Composition 1 on peripheral leucocyte reduction in mice induced by X-ray radiation (x ± s, ×10.sup.9) Dose (g crude Number of WBC before WBC on day 8 WBC on day 15 Groups drug/kg) animals modeling after treatment after treatment Normal control group 0.0 10 8.92 ± 2.05 9.05 ± 2.54 9.12 ± 2.30 Model control group 0.0 10 8.85 ± 1.80 3.89 ± 1.14** 5.08 ± 1.60** Positive control group 100 mg 10 8.74 ± 2.21 3.66 ± 1.05** 6.92 ± 1.98.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group 2.0 10 8.90 ± 1.94 3.82 ± 1.12** 5.75 ± 1.44 Test drug medium-dose group 4.0 10 8.68 ± 1.80 3.91 ± 1.30** 6.73 ± 1.29.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 8.79 ± 1.78 3.76 ± 1.22** 7.47 ± 1.41.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(92) TABLE-US-00006 TABLE 6 Effect of Composition 1 on the contents of bone marrow BCM and DNA in mice after X-ray radiation (x ± s) Dose (g crude Number of Bone marrow BCM Bone marrow Groups drug/kg) animals (×10.sup.6) DNA Normal control group 0.0 10 15.85 ± 2.60 0.978 ± 0.285 Model control group 0.0 10 10.42 ± 2.31** 0.480 ± 0.124** Positive control group 100 mg 10 13.20 ± 2.02.sup..box-tangle-solidup. 0.637 ± 0.150.sup..box-tangle-solidup. Test drug low-dose group 2.0 10 11.94 ± 1.67 0.563 ± 0.121 Test drug medium-dose group 4.0 10 13.08 ± 2.62.sup..box-tangle-solidup..box-tangle-solidup. 0.653 ± 0.140.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 14.15 ± 2.76.sup..box-tangle-solidup..box-tangle-solidup. 0.701 ± 0.192.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
4. Conclusion

(93) The animal experiments demonstrate that Composition 1 obtained in Example 1 can resist leucocyte reduction in mice induced by cyclophosphamide, cytarabine and X-ray radiation and can improve the hematopoietic function of the bone marrow thereof, indicating that Composition 1 may be effective in preventing and treating leucopenia induced by radiotherapy and chemotherapy.

Example 52. Animal Experiment Report of Composition 2 Obtained in Example 2 in Prevention and Treatment of Leucopenia Induced by Radiotherapy or Chemotherapy

(94) 1. Materials and Methods

(95) 1.1 Sources of Samples

(96) The test drug was Composition 2 (Radix Panacis Quinquefolii, Ganoderma, and fermented Cordyceps sinensis powder) provided by Jiangzhong Pharmaceutical Co. Ltd. as composite powder. 1 g dry composite powder was equivalent to 11.41 g total crude drugs.

(97) 1.2 Laboratory Animals

(98) The same as in Example 51.

(99) 1.3 Primary Reagents

(100) The same as in Example 51.

(101) 1.4 Primary Instruments

(102) The same as in Example 51.

(103) 2. Experimental Methods

(104) 2.1 Effect of Composition 2 on Leucocyte Reduction in Mice Induced by Cyclophosphamide.sup.[1]

(105) 2.1.1 Grouping, Modeling and Dosage Regime

(106) Mice were randomly divided into 6 groups with 10 animals per group, i.e., normal control group, model control group, positive control group, and groups on low, medium and high doses of Composition 2. The low-, medium- and high-dose groups were intragastrically given Composition 2 at a dose of 2.0 g crude drug/kg, 4.0 g crude drug/kg, and 12.0 g crude drug/kg, respectively; the positive control group was intragastrically given batyl alcohol (100 mg/kg) at a dose of 0.1 ml/10 g body weight; the normal control group and the model control group were intragastrically given an equivalent volume of distilled water; and the dosage regime lasted for 15 days with one dose per day. From day 9 of intragastrical administration, all mice in each group, except the normal control group, were given cyclophosphamide at a dose of 40 mg/kg each day via subcutaneous injection for 3 consecutive days. One hour after the intragastrical administration on day 15, blood and femurs were harvested for tests.

(107) 2.1.2 Peripheral Leucocyte Assay

(108) The same as in Example 51.

(109) 2.1.3 Bone Marrow Nucleated Cell Count (BMC)

(110) The same as in Example 51.

(111) 2.1.4 Bone Marrow DNA Content Determination

(112) The same as in Example 51.

(113) 2.2 Effect of Composition 2 on Leucocyte Reduction in Mice Induced by Cytarabine.sup.[2]

(114) 2.2.1 Grouping, Modeling and Dosage Regime

(115) The same as in Example 51.

(116) 2.2.2 Peripheral Leucocyte Assay, Bone Marrow Nucleated Cell Count, and Bone Marrow DNA Content Determination

(117) The same as in 2.1.

(118) 2.3 Effect of Composition 2 on Leucocyte Reduction in Mice Induced by X-Ray Radiation.sup.[3]

(119) 2.3.1 Grouping, Modeling and Dosage Regime

(120) The same as in Example 51.

(121) 2.3.2 Peripheral Leucocyte Assay, Bone Marrow Nucleated Cell Count, and Bone Marrow DNA Content Determination

(122) The same as in 2.1.

(123) 2.4 Statistic Method

(124) The same as in Example 51.

(125) 3. Results

(126) 3.1 Effect of Composition 2 on Leucocyte Reduction in Mice Induced by Cyclophosphamide

(127) Test results are shown in Tables 1 and 2. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 2 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 2 low-dose group, indicating that Composition 2 can resist leucocyte reduction in mice induced by cyclophosphamide and improve the hematopoietic function of the bone marrow thereof.

(128) TABLE-US-00007 TABLE 1 Effect of Composition 2 on peripheral leucocyte reduction in mice induced by cyclophosphamide (x ± s, ×10.sup.9) Dose (g Number crude of WBC before WBC after WBC after Groups drug/kg) animals modeling modeling treatment Normal control group 0.0 10 9.21 ± 1.75 9.44 ± 1.72 9.35 ± 1.94 Model control group 0.0 10 9.33 ± 2.30 4.75 ± 1.22** 5.26 ± 1.72** Positive control group 100 mg 10 9.42 ± 2.12 4.64 ± 1.30** 7.34 ± 1.59.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group 2.0 10 9.20 ± 1.89 4.60 ± 1.41** 6.24 ± 1.88 Test drug medium-dose group 4.0 10 9.26 ± 1.96 4.55 ± 1.25** 7.21 ± 1.62.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 9.06 ± 1.64 4.39 ± 1.32** 7.81 ± 1.90.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(129) TABLE-US-00008 TABLE 2 Effect of Composition 2 on the contents of bone marrow BCM and DNA in mice injected with cyclophosphamide (x ± s) Dose (g crude Number of Bone marrow BCM Bone marrow Groups drug/kg) animals (×10.sup.6) DNA Normal control group 0.0 10 14.39 ± 2.46 0.928 ± 0.264 Model control group 0.0 10  9.60 ± 2.72** 0.440 ± 0.125** Positive control group 100 mg 10 11.87 ± 2.08.sup..box-tangle-solidup..box-tangle-solidup. 0.629 ± 0.150.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group 2.0 10 10.95 ± 2.14 0.537 ± 0.132 Test drug medium-dose group 4.0 10 12.62 ± 2.45.sup..box-tangle-solidup. 0.624 ± 0.166.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 13.42 ± 2.80.sup..box-tangle-solidup..box-tangle-solidup. 0.699 ± 0.169.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
3.2 Effect of Composition 2 on Leucocyte Reduction in Mice Induced by Cytarabine

(130) Test results are shown in Tables 3 and 4. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 2 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 2 low-dose group, indicating that Composition 2 can resist leucocyte induction in mice induced by cytarabine and improve the hematopoietic function of the bone marrow thereof.

(131) TABLE-US-00009 TABLE 3 Effect of Composition 2 on peripheral leucocyte reduction in mice induced by cytarabine (x ± s, ×10.sup.9) Dose (g crude Number of WBC before WBC after WBC after Groups drug/kg) animals modeling modeling treatment Normal control group 0.0 10 8.70 ± 1.76 8.90 ± 1.44 8.94 ± 2.20 Model control group 0.0 10 8.92 ± 1.88 4.58 ± 1.36** 4.70 ± 1.16** Positive control group 100 mg 10 8.68 ± 2.03 4.67 ± 1.27** 6.85 ± 1.70.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group 2.0 10 8.78 ± 1.96 4.80 ± 1.08** 5.73 ± 1.23 Test drug medium-dose group 4.0 10 8.85 ± 2.13 4.38 ± 1.14** 6.17 ± 1.23.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 8.69 ± 2.01 4.62 ± 1.18** 7.38 ± 2.44.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(132) TABLE-US-00010 TABLE 4 Effect of Composition 2 on the contents of bone marrow BCM and DNA in mice injected with cytarabine (x ± s) Dose (g crude Number of Bone marrow BCM Bone marrow Groups drug/kg) animals (×10.sup.6) DNA Normal control group 0.0 10 15.92 ± 2.60 0.993 ± 0.267 Model control group 0.0 10 10.61 ± 2.82** 0.503 ± 0.161** Positive control group 100 mg 10 13.95 ± 2.77.sup..box-tangle-solidup. 0.684 ± 0.152.sup..box-tangle-solidup. Test drug low-dose group 2.0 10 11.90 ± 2.20 0.590 ± 0.142 Test drug medium-dose group 4.0 10 13.44 ± 2.70.sup..box-tangle-solidup. 0.676 ± 0.128.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 14.08 ± 1.92.sup..box-tangle-solidup..box-tangle-solidup. 0.733 ± 0.181.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
3.3 Effect of Composition 2 on Leucocyte Reduction in Mice Induced by X-Ray Radiation

(133) Test results are shown in Tables 5 and 6. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 2 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 2 low-dose group, indicating that Composition 2 can resist leucocyte induction in mice induced by X-ray radiation and improve the hematopoietic function of the bone marrow thereof.

(134) TABLE-US-00011 TABLE 5 Effect of Composition 2 on peripheral leucocyte reduction in mice induced by X-ray radiation (x ± s, ×10.sup.9) Dose (g Number crude of WBC before WBC on day 8 WBC on day 15 Groups drug/kg) animals modeling after treatment after treatment Normal control group 0.0 10 10.24 ± 2.05 10.02 ± 2.32 10.12 ± 2.41 Model control group 0.0 10 10.47 ± 2.14  5.38 ± 1.33**  5.16 ± 1.44** Positive control group 100 mg 10 10.16 ± 2.30  5.60 ± 1.28**  7.04 ± 1.87.sup..box-tangle-solidup. Test drug low-dose group 2.0 10 10.58 ± 1.89  5.52 ± 1.19**  6.28 ± 1.50 Test drug medium-dose group 4.0 10 10.32 ± 1.62  5.24 ± 1.21**  6.94 ± 1.66.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 10.27 ± 1.33  5.46 ± 1.20**  7.26 ± 1.48.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(135) TABLE-US-00012 TABLE 6 Effect of Composition 2 on the contents of bone marrow BCM and DNA in mice after X-ray radiation (x ± s) Groups Dose (g crude Number of Bone marrow BCM Bone marrow drug/kg) animals (×10.sup.6) DNA Normal control group 0.0 10 14.32 ± 2.78 0.916 ± 0.274 Model control group 0.0 10  9.15 ± 2.07** 0.425 ± 0.108** Positive control group 100 mg 10 12.43 ± 2.29.sup..box-tangle-solidup. 0.589 ± 0.123.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group 2.0 10 11.03 ± 1.90 0.514 ± 0.119 Test drug medium-dose group 4.0 10 12.20 ± 2.82.sup..box-tangle-solidup..box-tangle-solidup. 0.609 ± 0.126.sup..box-tangle-solidup..box-tangle-solidup. Test drug high-dose group 12.0 10 13.09 ± 2.55.sup..box-tangle-solidup..box-tangle-solidup. 0.685 ± 0.187.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
4. Conclusion

(136) The animal experiments demonstrate that Composition 2 obtained in Example 2 can resist leucocyte reduction in mice induced by cyclophosphamide, cytarabine and X-ray radiation and can improve the hematopoietic function of the bone marrow thereof, indicating that Composition 2 may be effective in preventing and treating leucopenia induced by radiotherapy and chemotherapy.

Example 53. Animal Experiment Report of Composition 3 Obtained in Example 3 in Prevention and Treatment of Leucopenia Induced by Radiotherapy or Chemotherapy

(137) 1. Materials and Methods

(138) 1.1 Sources of Samples

(139) The test drug was Composition 3 (Radix Panacis Quinquefolii, Ganoderma, fermented Cordyceps sinensis powder and Cordyceps) provided by Jiangzhong Pharmaceutical Co. Ltd. as composite powder. 1 g dry composite powder was equivalent to 12.39 g total crude drugs.

(140) 1.2 Laboratory Animals

(141) The same as in Example 51.

(142) 1.3 Primary Reagents

(143) The same as in Example 51.

(144) 1.4 Primary Instruments

(145) The same as in Example 51.

(146) 2. Experimental Methods

(147) 2.1 Effect of Composition 3 on Leucocyte Reduction in Mice Induced by Cyclophosphamide.sup.[1]

(148) 2.1.1 Grouping, Modeling and Dosage Regime

(149) Mice were randomly divided into 6 groups with 10 animals per group, i.e., normal control group, model control group, positive control group, and groups on low, medium and high doses of Composition 3. The low-, medium- and high-dose groups were intragastrically given Composition 3 at a dose of 2.0 g crude drug/kg, 4.0 g crude drug/kg, and 12.0 g crude drug/kg, respectively; the positive control group was intragastrically given batyl alcohol (100 mg/kg) at a dose of 0.1 ml/10 g body weight; the normal control group and the model control group were intragastrically given an equivalent volume of distilled water; and the dosage regime lasted for 15 days with one dose per day. From day 9 of intragastrical administration, all mice in each group, except the normal control group, were given cyclophosphamide at a dose of 40 mg/kg each day via subcutaneous injection for 3 consecutive days. One hour after the intragastrical administration on day 15, blood and femurs were harvested for tests.

(150) 2.1.2 Peripheral Leucocyte Assay

(151) The same as in Example 51.

(152) 2.1.3 Bone Marrow Nucleated Cell Count (BMC)

(153) The same as in Example 51.

(154) 2.1.4 Bone Marrow DNA Content Determination

(155) The same as in Example 51.

(156) 2.2 Effect of Composition 3 on Leucocyte Reduction in Mice Induced by Cytarabine.sup.[2]

(157) 2.2.1 Grouping, Modeling and Dosage Regime

(158) The same as in Example 51.

(159) 2.2.2 Peripheral Leucocyte Assay, Bone Marrow Nucleated Cell Count, and Bone Marrow DNA Content Determination

(160) The same as in 2.1.

(161) 2.3 Effect of Composition 3 on Leucocyte Reduction in Mice Induced by X-Ray Radiation.sup.[3]

(162) 2.3.1 Grouping, Modeling and Dosage Regime

(163) The same as in Example 51.

(164) 2.3.2 Peripheral Leucocyte Assay, Bone Marrow Nucleated Cell Count, and Bone Marrow DNA Content Determination

(165) The same as in 2.1.

(166) 2.4 Statistic Method

(167) The same as in Example 51.

(168) 3. Results

(169) 3.1 Effect of Composition 3 on Leucocyte Reduction in Mice Induced by Cyclophosphamide

(170) Test results are shown in Tables 1 and 2. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 3 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 3 low-dose group, indicating that Composition 3 can resist leucocyte reduction in mice induced by cyclophosphamide and improve the hematopoietic function of the bone marrow thereof.

(171) TABLE-US-00013 TABLE 1 Effect of Composition 3 on peripheral leucocyte reduction in mice induced by cyclophosphamide (x ± s, ×10.sup.9) Dose (g crude Number of WBC before WBC after WBC after Groups drug/kg) animals modeling modeling treatment Normal control group 0.0 10 9.55 ± 1.90 9.82 ± 2.04 9.69 ± 1.77 Model control group 0.0 10 9.70 ± 2.04 5.03 ± 1.28** 5.20 ± 1.76** Positive control group 100 mg 10 9.27 ± 2.21 5.25 ± 1.30** 7.56 ± 1.80.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group 2.0 10 9.80 ± 1.96 5.18 ± 1.41** 6.50 ± 1.62 Test drug medium-dose group 4.0 10 9.64 ± 1.88 5.23 ± 1.25** 7.24 ± 1.88.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 9.55 ± 1.79 5.40 ± 1.32** 7.94 ± 1.94.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(172) TABLE-US-00014 TABLE 2 Effect of Composition 3 on the contents of bone marrow BCM and DNA in mice injected with cyclophosphamide (x ± s) Dose (g crude Number of Bone marrow BCM Bone marrow Groups drug/kg) animals (×10.sup.6) DNA Normal control group 0.0 10 15.42 ± 2.86 0.877 ± 0.212 Model control group 0.0 10 10.88 ± 2.13** 0.438 ± 0.107** Positive control group 100 mg 10 13.65 ± 2.42.sup..box-tangle-solidup. 0.625 ± 0.162.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group 2.0 10 12.80 ± 2.33 0.584 ± 0.140 Test drug medium-dose group 4.0 10 13.23 ± 2.72.sup..box-tangle-solidup. 0.635 ± 0.172.sup..box-tangle-solidup..box-tangle-solidup. Test drug high-dose group 12.0 10 13.99 ± 1.93.sup..box-tangle-solidup..box-tangle-solidup. 0.684 ± 0.155.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
3.2 Effect of Composition 3 on Leucocyte Reduction in Mice Induced by Cytarabine

(173) Test results are shown in Tables 3 and 4. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 3 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 3 low-dose group, indicating that Composition 3 can resist leucocyte induction in mice induced by cytarabine and improve the hematopoietic function of the bone marrow thereof.

(174) TABLE-US-00015 TABLE 3 Effect of Composition 3 on peripheral leucocyte reduction in mice induced by cytarabine (x ± s, ×10.sup.9) Dose (g crude Number of WBC before WBC after WBC after Groups drug/kg) animals modeling modeling treatment Normal control group 0.0 10 9.22 ± 1.80 9.30 ± 1.86 9.51 ± 2.26 Model control group 0.0 10 9.45 ± 1.92 4.83 ± 1.51** 4.73 ± 1.34** Positive control group 100 mg 10 9.30 ± 2.14 4.90 ± 1.43** 7.10 ± 1.88.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group 2.0 10 9.26 ± 1.54 4.84 ± 1.26** 5.66 ± 1.45 Test drug medium-dose group 4.0 10 9.17 ± 2.07 4.64 ± 1.33** 6.52 ± 1.48.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 9.23 ± 2.21 4.91 ± 1.27** 7.29 ± 1.90.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(175) TABLE-US-00016 TABLE 4 Effect of Composition 3 on the contents of bone marrow BCM and DNA in mice injected with cytarabine (x ± s) Dose (g crude Number of Bone marrow BCM Bone marrow Groups drug/kg) animals (×10.sup.6) DNA Normal control group 0.0 10 15.60 ± 2.72 0.980 ± 0.209 Model control group 0.0 10 10.37 ± 2.43** 0.524 ± 0.142** Positive control group 100 mg 10 13.64 ± 2.19.sup..box-tangle-solidup. 0.713 ± 0.138.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group 2.0 10 11.53 ± 2.34 0.621 ± 0.151 Test drug medium-dose group 4.0 10 13.10 ± 2.56.sup..box-tangle-solidup. 0.693 ± 0.136.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 14.21 ± 2.80.sup..box-tangle-solidup..box-tangle-solidup. 0.748 ± 0.175.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
3.3 Effect of Composition 3 on Leucocyte Reduction in Mice Induced by X-Ray Radiation

(176) Test results are shown in Tables 5 and 6. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 3 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 3 low-dose group, indicating that Composition 3 can resist leucocyte induction in mice induced by X-ray radiation and improve the hematopoietic function of the bone marrow thereof.

(177) TABLE-US-00017 TABLE 5 Effect of Composition 3 on peripheral leucocyte reduction in mice induced by X-ray radiation (x ± s, ×10.sup.9) Dose (g Number Groups crude of WBC before WBC on day 8 WBC on day 15 drug/kg) animals modeling after treatment after treatment Normal control group 0.0 10 10.54 ± 2.18 10.16 ± 2.05 10.43 ± 2.35 Model control group 0.0 10 10.60 ± 2.09  5.92 ± 1.38**  5.88 ± 1.70** Positive control group 100 mg 10 10.88 ± 2.24  5.87 ± 1.62**  7.49 ± 1.52.sup..box-tangle-solidup. Test drug low-dose group 2.0 10 10.27 ± 1.92  5.65 ± 1.40**  6.89 ± 1.33 Test drug medium-dose group 4.0 10 10.58 ± 2.30  5.80 ± 1.53**  7.61 ± 1.53.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 10.37 ± 2.33  5.74 ± 1.38**  8.22 ± 1.60.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(178) TABLE-US-00018 TABLE 6 Effect of Composition 3 on the contents of bone marrow BCM and DNA in mice after X-ray radiation (x ± s) Dose (g crude Number of Bone marrow BCM Bone marrow Groups drug/kg) animals (×10.sup.6) DNA Normal control group 0.0 10 16.50 ± 2.80 0.998 ± 0.258 Model control group 0.0 10 11.27 ± 2.34** 0.520 ± 0.120** Positive control group 100 mg 10 13.69 ± 2.65.sup..box-tangle-solidup. 0.723 ± 0.135.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group 2.0 10 13.22 ± 2.18 0.626 ± 0.127 Test drug medium-dose group 4.0 10 14.40 ± 2.43.sup..box-tangle-solidup..box-tangle-solidup. 0.734 ± 0.178.sup..box-tangle-solidup..box-tangle-solidup. Test drug high-dose group 12.0 10 15.17 ± 2.26.sup..box-tangle-solidup..box-tangle-solidup. 0.765 ± 0.166.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
4. Conclusion

(179) The animal experiments demonstrate that Composition 3 obtained in Example 3 can resist leucocyte reduction in mice induced by cyclophosphamide, cytarabine and X-ray radiation and can improve the hematopoietic function of the bone marrow thereof, indicating that Composition 3 may be effective in preventing and treating leucopenia induced by radiotherapy and chemotherapy.

Example 54. Animal Experiment Report of Composition 4 Obtained in Example 4 in Prevention and Treatment of Leucopenia Induced by Radiotherapy or Chemotherapy

(180) 1. Materials and Methods

(181) 1.1 Sources of Samples

(182) The test drug was Composition 4 (Radix Panacis Quinquefolii, Ganoderma, Cordyceps, and Flos Rosae Rugosae) provided by Jiangzhong Pharmaceutical Co. Ltd. as composite powder. 1 g dry composite powder was equivalent to 12.19 g total crude drugs.

(183) 1.2 Laboratory Animals

(184) The same as in Example 51.

(185) 1.3 Primary Reagents

(186) The same as in Example 51.

(187) 1.4 Primary Instruments

(188) The same as in Example 51.

(189) 2. Experimental Methods

(190) 2.1 Effect of Composition 4 on Leucocyte Reduction in Mice Induced by Cyclophosphamide.sup.[1]

(191) 2.1.1 Grouping, Modeling and Dosage Regime

(192) Mice were randomly divided into 6 groups with 10 animals per group, i.e., normal control group, model control group, positive control group, and groups on low, medium and high doses of Composition 4. The low-, medium- and high-dose groups were intragastrically given Composition 4 at a dose of 2.0 g crude drug/kg, 4.0 g crude drug/kg, and 12.0 g crude drug/kg, respectively; the positive control group was intragastrically given batyl alcohol (100 mg/kg) at a dose of 0.1 ml/10 g body weight; the normal control group and the model control group were intragastrically given an equivalent volume of distilled water; and the dosage regime lasted for 15 days with one dose per day. From day 9 of intragastrical administration, all mice in each group, except the normal control group, were given cyclophosphamide at a dose of 40 mg/kg each day via subcutaneous injection for 3 consecutive days. One hour after the intragastrical administration on day 15, blood and femurs were harvested for tests.

(193) 2.1.2 Peripheral Leucocyte Assay

(194) The same as in Example 51.

(195) 2.1.3 Bone Marrow Nucleated Cell Count (BMC)

(196) The same as in Example 51.

(197) 2.1.4 Bone Marrow DNA Content Determination

(198) The same as in Example 51.

(199) 2.2 Effect of Composition 4 on Leucocyte Reduction in Mice Induced by Cytarabine.sup.[2]

(200) 2.2.1 Grouping, Modeling and Dosage Regime

(201) The same as in Example 51.

(202) 2.2.2 Peripheral Leucocyte Assay, Bone Marrow Nucleated Cell Count, and Bone Marrow DNA Content Determination

(203) The same as in 2.1.

(204) 2.3 Effect of Composition 4 on Leucocyte Reduction in Mice Induced by X-Ray Radiation.sup.[3]

(205) 2.3.1 Grouping, Modeling and Dosage Regime

(206) The same as in Example 51.

(207) 2.3.2 Peripheral Leucocyte Assay, Bone Marrow Nucleated Cell Count, and Bone Marrow DNA Content Determination

(208) The same as in 2.1.

(209) 2.4 Statistic Method

(210) The same as in Example 51.

(211) 3. Results

(212) 3.1 Effect of Composition 4 on Leucocyte Reduction in Mice Induced by Cyclophosphamide

(213) Test results are shown in Tables 1 and 2. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 4 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 4 low-dose group, indicating that Composition 4 can resist leucocyte reduction in mice induced by cyclophosphamide and improve the hematopoietic function of the bone marrow thereof.

(214) TABLE-US-00019 TABLE 1 Effect of Composition 4 on peripheral leucocyte reduction in mice induced by cyclophosphamide (x ± s, ×10.sup.9) Dose (g crude Number of WBC before WBC after WBC after Groups drug/kg) animals modeling modeling treatment Normal control group 0.0 10 10.43 ± 1.88 10.81 ± 2.61 10.60 ± 2.32 Model control group 0.0 10 10.56 ± 2.14  5.77 ± 1.62**  5.96 ± 1.78** Positive control group 100 mg 10 10.29 ± 2.30  6.13 ± 1.47**  8.23 ± 1.54.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group 2.0 10 10.74 ± 2.11  5.86 ± 1.38**  7.48 ± 1.86 Test drug medium-dose group 4.0 10 10.27 ± 2.26  6.08 ± 1.62**  8.10 ± 2.03.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 10.50 ± 2.09  5.94 ± 1.55**  8.52 ± 1.90.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(215) TABLE-US-00020 TABLE 2 Effect of Composition 4 on the contents of bone marrow BCM and DNA in mice injected with cyclophosphamide (x ± s) Dose (g crude Number of Bone marrow BCM Bone marrow Groups drug/kg) animals (×10.sup.6) DNA Normal control group 0.0 10 16.60 ± 2.92 0.956 ± 0.233 Model control group 0.0 10 11.86 ± 2.21** 0.544 ± 0.132** Positive control group 100 mg 10 14.73 ± 2.04.sup..box-tangle-solidup. 0.730 ± 0.150.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group 2.0 10 13.93 ± 2.26 0.660 ± 0.138 Test drug medium-dose group 4.0 10 14.35 ± 2.51.sup..box-tangle-solidup. 0.752 ± 0.169.sup..box-tangle-solidup..box-tangle-solidup. Test drug high-dose group 12.0 10 14.90 ± 1.88.sup..box-tangle-solidup..box-tangle-solidup. 0.786 ± 0.172.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
3.2 Effect of Composition 4 on Leucocyte Reduction in Mice Induced by Cytarabine

(216) Test results are shown in Tables 3 and 4. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 4 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 4 low-dose group, indicating that Composition 4 can resist leucocyte induction in mice induced by cytarabine and improve the hematopoietic function of the bone marrow thereof.

(217) TABLE-US-00021 TABLE 3 Effect of Composition 4 on peripheral leucocyte reduction in mice induced by cytarabine (x ± s, ×10.sup.9) Dose (g crude Number of WBC before WBC after WBC after Groups drug/kg) animals modeling modeling treatment Normal control group 0.0 10 8.16 ± 1.76 8.36 ± 1.58 8.47 ± 1.95 Model control group 0.0 10 8.50 ± 1.54 4.51 ± 1.61** 4.48 ± 1.58** Positive control group 100 mg 10 8.28 ± 1.62 4.16 ± 1.09** 7.26 ± 1.90.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group 2.0 10 8.53 ± 2.08 4.66 ± 1.17** 5.54 ± 1.75 Test drug medium-dose group 4.0 10 8.60 ± 2.11 4.35 ± 1.25** 6.71 ± 1.98.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 8.29 ± 1.65 4.27 ± 1.41** 7.16 ± 1.22.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(218) TABLE-US-00022 TABLE 4 Effect of Composition 4 on the contents of bone marrow BCM and DNA in mice injected with cytarabine (x ± s) Dose (g crude Number of Bone marrow BCM Bone marrow Groups drug/kg) animals (×10.sup.6) DNA Normal control group  0.0 10 17.21 ± 2.96 1.052 ± 0.226 Model control group  0.0 10 11.16 ± 2.88** 0.673 ± 0.145** Positive control group 100 mg 10 14.32 ± 2.65.sup..box-tangle-solidup. 0.879 ± 0.169.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group  2.0 10 13.66 ± 2.78 0.802 ± 0.184 Test drug medium-dose group  4.0 10 14.50 ± 2.90.sup..box-tangle-solidup. 0.868 ± 0.166.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 15.63 ± 2.67.sup..box-tangle-solidup..box-tangle-solidup. 0.944 ± 0.190.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
3.3 Effect of Composition 4 on Leucocyte Reduction in Mice Induced by X-Ray Radiation

(219) Test results are shown in Tables 5 and 6. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 4 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 4 low-dose group, indicating that Composition 4 can resist leucocyte induction in mice induced by X-ray radiation and improve the hematopoietic function of the bone marrow thereof.

(220) TABLE-US-00023 TABLE 5 Effect of Composition 4 on peripheral leucocyte reduction in mice induced by X-ray radiation (x ± s, ×10.sup.9) WBC WBC Dose Number WBC on day 8 on day 15 (g crude of before after after Groups drug/kg) animals modeling treatment treatment Normal control group  0.0 10 9.67 ± 2.26 9.33 ± 2.15 9.46 ± 2.20 Model control group  0.0 10 9.36 ± 2.17 5.71 ± 1.20** 5.60 ± 1.45** Positive control group 100 mg 10 9.42 ± 2.05 5.80 ± 1.44** 7.88 ± 1.61.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group  2.0 10 9.57 ± 1.77 5.24 ± 1.07** 6.76 ± 1.22 Test drug medium-dose group  4.0 10 9.83 ± 2.08 5.33 ± 1.18** 7.40 ± 1.48.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 9.47 ± 2.19 5.52 ± 1.24** 8.36 ± 1.55.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(221) TABLE-US-00024 TABLE 6 Effect of Composition 4 on the contents of bone marrow BCM and DNA in mice after X-ray radiation (x ± s) Dose (g crude Number of Bone marrow BCM Bone marrow Groups drug/kg) animals (×10.sup.6) DNA Normal control group  0.0 10 17.06 ± 2.96 0.972 ± 0.224 Model control group  0.0 10 12.11 ± 2.03** 0.541 ± 0.109** Positive control group 100 mg 10 14.57 ± 2.57.sup..box-tangle-solidup. 0.760 ± 0.147.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group  2.0 10 14.06 ± 2.42 0.644 ± 0.122 Test drug medium-dose group  4.0 10 15.31 ± 2.60.sup..box-tangle-solidup..box-tangle-solidup. 0.752 ± 0.103.sup..box-tangle-solidup..box-tangle-solidup. Test drug high-dose group 12.0 10 16.02 ± 2.33.sup..box-tangle-solidup..box-tangle-solidup. 0.786 ± 0.148.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
4. Conclusion

(222) The animal experiments demonstrate that Composition 4 obtained in Example 4 can resist leucocyte reduction in mice induced by cyclophosphamide, cytarabine and X-ray radiation and can improve the hematopoietic function of the bone marrow thereof, indicating that Composition 4 may be effective in preventing and treating leucopenia induced by radiotherapy and chemotherapy.

Example 55. Animal Experiment Report of Composition 5 Obtained in Example 5 in Prevention and Treatment of Leucopenia Induced by Radiotherapy or Chemotherapy

(223) 1. Materials and Methods

(224) 1.1 Sources of Samples

(225) The test drug was Composition 5 (Radix Panacis Quinquefolii, Ganoderma, fermented Cordyceps sinensis powder, and Flos Rosae Rugosae) provided by Jiangzhong Pharmaceutical Co. Ltd. as composite powder. 1 g dry composite powder was equivalent to 12.56 g total crude drugs.

(226) 1.2 Laboratory Animals

(227) The same as in Example 51.

(228) 1.3 Primary Reagents

(229) The same as in Example 51.

(230) 1.4 Primary Instruments

(231) The same as in Example 51.

(232) 2. Experimental Methods

(233) 2.1 Effect of Composition 5 on Leucocyte Reduction in Mice Induced by Cyclophosphamide.sup.[1]

(234) 2.1.1 Grouping, Modeling and Dosage Regime

(235) Mice were randomly divided into 6 groups with 10 animals per group, i.e., normal control group, model control group, positive control group, and groups on low, medium and high doses of Composition 5. The low-, medium- and high-dose groups were intragastrically given Composition 5 at a dose of 2.0 g crude drug/kg, 4.0 g crude drug/kg, and 12.0 g crude drug/kg, respectively; the positive control group was intragastrically given batyl alcohol (100 mg/kg) at a dose of 0.1 ml/10 g body weight; the normal control group and the model control group were intragastrically given an equivalent volume of distilled water; and the dosage regime lasted for 15 days with one dose per day. From day 9 of intragastrical administration, all mice in each group, except the normal control group, were given cyclophosphamide at a dose of 40 mg/kg each day via subcutaneous injection for 3 consecutive days. One hour after the intragastrical administration on day 15, blood and femurs were harvested for tests.

(236) 2.1.2 Peripheral Leucocyte Assay

(237) The same as in Example 51.

(238) 2.1.3 Bone Marrow Nucleated Cell Count (BMC)

(239) The same as in Example 51.

(240) 2.1.4 Bone Marrow DNA Content Determination

(241) The same as in Example 51.

(242) 2.2 Effect of Composition 5 on Leucocyte Reduction in Mice Induced by Cytarabine.sup.[2]

(243) 2.2.1 Grouping, Modeling and Dosage Regime

(244) The same as in Example 51.

(245) 2.2.2 Peripheral Leucocyte Assay, Bone Marrow Nucleated Cell Count, and Bone Marrow DNA Content Determination

(246) The same as in 2.1.

(247) 2.3 Effect of Composition 5 on Leucocyte Reduction in Mice Induced by X-Ray Radiation.sup.[3]

(248) 2.3.1 Grouping, Modeling and Dosage Regime

(249) The same as in Example 51.

(250) 2.3.2 Peripheral Leucocyte Assay, Bone Marrow Nucleated Cell Count, and Bone Marrow DNA Content Determination

(251) The same as in 2.1.

(252) 2.4 Statistic Method

(253) The same as in Example 51.

(254) 3. Results

(255) 3.1 Effect of Composition 5 on Leucocyte Reduction in Mice Induced by Cyclophosphamide

(256) Test results are shown in Tables 1 and 2. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 5 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 5 low-dose group, indicating that Composition 5 can resist leucocyte reduction in mice induced by cyclophosphamide and improve the hematopoietic function of the bone marrow thereof.

(257) TABLE-US-00025 TABLE 1 Effect of Composition 5 on peripheral leucocyte reduction in mice induced by cyclophosphamide (x ± s, ×10.sup.9) Dose (g crude Number of WBC before WBC after WBC after Groups drug/kg) animals modeling modeling treatment Normal control group  0.0 10 9.10 ± 1.77 9.39 ± 2.08 9.55 ± 2.20 Model control group  0.0 10 9.23 ± 2.03 5.52 ± 1.54** 5.88 ± 1.42** Positive control group 100 mg 10 9.52 ± 2.16 5.73 ± 1.60** 7.89 ± 1.60.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group  2.0 10 9.44 ± 2.20 5.29 ± 1.53** 7.30 ± 1.75 Test drug medium-dose group  4.0 10 9.09 ± 2.05 5.37 ± 1.72** 7.64 ± 2.12.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 9.31 ± 2.17 5.67 ± 1.80** 8.23 ± 1.76.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(258) TABLE-US-00026 TABLE 2 Effect of Composition 5 on the contents of bone marrow BCM and DNA in mice injected with cyclophosphamide (x ± s) Dose (g crude Number of Bone marrow BCM Bone marrow Groups drug/kg) animals (×10.sup.6) DNA Normal control group  0.0 10 16.95 ± 2.67 0.985 ± 0.225 Model control group  0.0 10 12.03 ± 2.40** 0.570 ± 0.147** Positive control group 100 mg 10 14.86 ± 2.28.sup..box-tangle-solidup. 0.755 ± 0.128.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group  2.0 10 13.78 ± 2.17 0.681 ± 0.133 Test drug medium-dose group  4.0 10 14.56 ± 2.23.sup..box-tangle-solidup. 0.779 ± 0.151.sup..box-tangle-solidup..box-tangle-solidup. Test drug high-dose group 12.0 10 15.13 ± 1.99.sup..box-tangle-solidup..box-tangle-solidup. 0.780 ± 0.165.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
3.2 Effect of Composition 5 on Leucocyte Reduction in Mice Induced by Cytarabine

(259) Test results are shown in Tables 3 and 4. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 5 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 5 low-dose group, indicating that Composition 5 can resist leucocyte induction in mice induced by cytarabine and improve the hematopoietic function of the bone marrow thereof.

(260) TABLE-US-00027 TABLE 3 Effect of Composition 5 on peripheral leucocyte reduction in mice induced by cytarabine (x ± s, ×10.sup.9) Dose (g crude Number of WBC before WBC after WBC after Groups drug/kg) animals modeling modeling treatment Normal control group  0.0 10 8.77 ± 1.88 8.90 ± 1.74 8.86 ± 1.69 Model control group  0.0 10 8.59 ± 1.61 4.77 ± 1.80** 4.89 ± 1.38** Positive control group 100 mg 10 8.44 ± 1.74 4.53 ± 1.28** 7.54 ± 1.62.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group  2.0 10 8.76 ± 1.83 4.61 ± 1.63** 5.90 ± 1.34 Test drug medium-dose group  4.0 10 8.81 ± 1.75 4.82 ± 1.36** 7.23 ± 1.45.sup..box-tangle-solidup..box-tangle-solidup. Test drug high-dose group 12.0 10 8.65 ± 1.60 4.74 ± 1.53** 7.62 ± 1.50.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(261) TABLE-US-00028 TABLE 4 Effect of Composition 5 on the contents of bone marrow BCM and DNA in mice injected with cytarabine (x ± s) Dose (g crude Number of Bone marrow BCM Bone marrow Groups drug/kg) animals (×10.sup.6) DNA Normal control group  0.0 10 16.24 ± 2.70 1.029 ± 0.218 Model control group  0.0 10 10.05 ± 2.64** 0.654 ± 0.139** Positive control group 100 mg 10 13.25 ± 2.31.sup..box-tangle-solidup. 0.856 ± 0.150.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group  2.0 10 12.58 ± 2.28 0.788 ± 0.177 Test drug medium-dose group  4.0 10 13.61 ± 2.65.sup..box-tangle-solidup. 0.845 ± 0.158.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 14.52 ± 2.53.sup..box-tangle-solidup..box-tangle-solidup. 0.921 ± 0.172.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
3.3 Effect of Composition 5 on Leucocyte Reduction in Mice Induced by X-Ray Radiation

(262) Test results are shown in Tables 5 and 6. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 5 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 5 low-dose group, indicating that Composition 5 can resist leucocyte induction in mice induced by X-ray radiation and improve the hematopoietic function of the bone marrow thereof.

(263) TABLE-US-00029 TABLE 5 Effect of Composition 5 on peripheral leucocyte reduction in mice induced by X-ray radiation (x ± s, ×10.sup.9) Dose (g crude Number of WBC before WBC on day 8 WBC on day 15 Groups drug/kg) animals modeling after treatment after treatment Normal control group  0.0 10 9.04 ± 2.10 9.24 ± 1.76 9.18 ± 2.02 Model control group  0.0 10 9.13 ± 2.25 5.56 ± 1.31** 5.72 ± 1.66** Positive control group 100 mg 10 9.09 ± 2.08 5.32 ± 1.54** 7.80 ± 1.43.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group  2.0 10 9.21 ± 1.90 5.62 ± 1.26** 6.90 ± 1.45 Test drug medium-dose group  4.0 10 9.08 ± 2.12 5.61 ± 1.30** 7.53 ± 1.28.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 9.26 ± 2.33 5.48 ± 1.29** 8.10 ± 1.47.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(264) TABLE-US-00030 TABLE 6 Effect of Composition 5 on the contents of bone marrow BCM and DNA in mice after X-ray radiation (x ± s) Dose (g crude Number of Bone marrow Bone marrow Groups drug/kg) animals BCM (×10.sup.6) DNA Normal control group  0.0 10 16.53 ± 2.96 0.105 ± 0.201 Model control group  0.0 10 11.66 ± 2.03** 0.570 ± 0.118** Positive control group 100 mg 10 13.92 ± 2.57.sup..box-tangle-solidup. 0.795 ± 0.127.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group  2.0 10 13.50 ± 2.42 0.678 ± 0.145 Test drug medium-dose group  4.0 10 14.71 ± 2.60.sup..box-tangle-solidup..box-tangle-solidup. 0.786 ± 0.132.sup..box-tangle-solidup..box-tangle-solidup. Test drug high-dose group 12.0 10 15.02 ± 2.33.sup..box-tangle-solidup..box-tangle-solidup. 0.810 ± 0.135.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
4. Conclusion

(265) The animal experiments demonstrate that Composition 5 obtained in Example 5 can resist leucocyte reduction in mice induced by cyclophosphamide, cytarabine and X-ray radiation and can improve the hematopoietic function of the bone marrow thereof, indicating that Composition 5 may be effective in preventing and treating leucopenia induced by radiotherapy and chemotherapy.

Example 56. Animal Experiment Report of Composition 6 Obtained in Example 6 in Prevention and Treatment of Leucopenia Induced by Radiotherapy or Chemotherapy

(266) 1. Materials and Methods

(267) 1.1 Sources of Samples

(268) The test drug was Composition 6 (Radix Panacis Quinquefolii, Ganoderma, fermented Cordyceps sinensis powder, Cordyceps, and Flos Rosae Rugosae) provided by Jiangzhong Pharmaceutical Co. Ltd. as composite powder. 1 g dry composite powder was equivalent to 13.78 g total crude drugs.

(269) 1.2 Laboratory Animals

(270) The same as in Example 51.

(271) 1.3 Primary Reagents

(272) The same as in Example 51.

(273) 1.4 Primary Instruments

(274) The same as in Example 51.

(275) 2. Experimental Methods

(276) 2.1 Effect of Composition 6 on Leucocyte Reduction in Mice Induced by Cyclophosphamide.sup.[1]

(277) 2.1.1 Grouping, Modeling and Dosage Regime

(278) Mice were randomly divided into 6 groups with 10 animals per group, i.e., normal control group, model control group, positive control group, and groups on low, medium and high doses of Composition 6. The low-, medium- and high-dose groups were intragastrically given Composition 6 at a dose of 2.0 g crude drug/kg, 4.0 g crude drug/kg, and 12.0 g crude drug/kg, respectively; the positive control group was intragastrically given batyl alcohol (100 mg/kg) at a dose of 0.1 ml/10 g body weight; the normal control group and the model control group were intragastrically given an equivalent volume of distilled water; and the dosage regime lasted for 15 days with one dose per day. From day 9 of intragastrical administration, all mice in each group, except the normal control group, were given cyclophosphamide at a dose of 40 mg/kg each day via subcutaneous injection for 3 consecutive days. One hour after the intragastrical administration on day 15, blood and femurs were harvested for tests.

(279) 2.1.2 Peripheral Leucocyte Assay

(280) The same as in Example 51.

(281) 2.1.3 Bone Marrow Nucleated Cell Count (BMC)

(282) The same as in Example 51.

(283) 2.1.4 Bone Marrow DNA Content Determination

(284) The same as in Example 51.

(285) 2.2 Effect of Composition 6 on Leucocyte Reduction in Mice Induced by Cytarabine.sup.[2]

(286) 2.2.1 Grouping, Modeling and Dosage Regime

(287) The same as in Example 51.

(288) 2.2.2 Peripheral Leucocyte Assay, Bone Marrow Nucleated Cell Count, and Bone Marrow DNA Content Determination

(289) The same as in 2.1.

(290) 2.3 Effect of Composition 6 on Leucocyte Reduction in Mice Induced by X-Ray Radiation.sup.[3]

(291) 2.3.1 Grouping, Modeling and Dosage Regime

(292) The same as in Example 51.

(293) 2.3.2 Peripheral Leucocyte Assay, Bone Marrow Nucleated Cell Count, and Bone Marrow DNA Content Determination

(294) The same as in 2.1.

(295) 2.4 Statistic Method

(296) The same as in Example 51.

(297) 3. Results

(298) 3.1 Effect of Composition 6 on Leucocyte Reduction in Mice Induced by Cyclophosphamide

(299) Test results are shown in Tables 1 and 2. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 6 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 6 low-dose group, indicating that Composition 6 can resist leucocyte reduction in mice induced by cyclophosphamide and improve the hematopoietic function of the bone marrow thereof.

(300) TABLE-US-00031 TABLE 1 Effect of Composition 6 on peripheral leucocyte reduction in mice induced by cyclophosphamide (x ± s, ×10.sup.9) Dose (g crude Number of WBC before WBC after WBC after Groups drug/kg) animals modeling modeling treatment Normal control group  0.0 10 10.60 ± 1.95 10.42 ± 2.30 10.54 ± 2.27 Model control group  0.0 10 10.44 ± 2.23  6.08 ± 1.88**  6.31 ± 1.67** Positive control group 100 mg 10 10.58 ± 2.34  6.25 ± 1.76**  8.96 ± 1.93.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group  2.0 10 10.72 ± 2.28  6.16 ± 1.93**  7.58 ± 1.75 Test drug medium-dose group  4.0 10 10.28 ± 2.19  6.40 ± 1.97**  8.22 ± 1.76.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 10.47 ± 2.23  6.27 ± 1.73**  9.40 ± 1.94.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(301) TABLE-US-00032 TABLE 2 Effect of Composition 6 on the contents of bone marrow BCM and DNA in mice injected with cyclophosphamide (x ± s) Dose (g crude Number of Bone marrow BCM Bone marrow Groups drug/kg) animals (×10.sup.6) DNA Normal control group  0.0 10 17.58 ± 2.81 0.116 ± 0.212 Model control group  0.0 10 12.67 ± 2.52** 0.745 ± 0.156** Positive control group 100 mg 10 15.72 ± 2.34.sup..box-tangle-solidup. 0.958 ± 0.138.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group  2.0 10 14.33 ± 2.76 0.842 ± 0.147 Test drug medium-dose group  4.0 10 15.28 ± 2.19.sup..box-tangle-solidup. 0.915 ± 0.165.sup..box-tangle-solidup..box-tangle-solidup. Test drug high-dose group 12.0 10 16.20 ± 2.59.sup..box-tangle-solidup..box-tangle-solidup. 0.969 ± 0.173.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
3.2 Effect of Composition 6 on Leucocyte Reduction in Mice Induced by Cytarabine

(302) Test results are shown in Tables 3 and 4. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 6 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 6 low-dose group, indicating that Composition 6 can resist leucocyte induction in mice induced by cytarabine and improve the hematopoietic function of the bone marrow thereof.

(303) TABLE-US-00033 TABLE 3 Effect of Composition 6 on peripheral leucocyte reduction in mice induced by cytarabine (x ± s, ×10.sup.9) Dose (g crude Number of WBC before WBC after WBC after Groups drug/kg) animals modeling modeling treatment Normal control group  0.0 10 10.14 ± 2.20 10.32 ± 2.66 10.44 ± 2.70 Model control group  0.0 10 10.25 ± 2.25  6.45 ± 1.39**  6.15 ± 1.34** Positive control group 100 mg 10 10.10 ± 2.40  6.62 ± 1.52**  8.52 ± 1.55.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group  2.0 10 10.33 ± 2.18  6.77 ± 1.70**  7.48 ± 1.70 Test drug medium-dose group  4.0 10 10.51 ± 2.23  6.38 ± 1.54**  8.45 ± 1.66.sup..box-tangle-solidup..box-tangle-solidup. Test drug high-dose group 12.0 10 10.44 ± 2.16  6.50 ± 1.61**  8.62 ± 1.47.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(304) TABLE-US-00034 TABLE 4 Effect of Composition 6 on the contents of bone marrow BCM and DNA in mice injected with cytarabine (x ± s) Dose (g crude Number of Bone marrow BCM Bone marrow Groups drug/kg) animals (×10.sup.6) DNA Normal control group  0.0 10 15.89 ± 2.70 0.973 ± 0.209 Model control group  0.0 10  9.66 ± 2.05** 0.625 ± 0.143** Positive control group 100 mg 10 13.58 ± 2.17.sup..box-tangle-solidup. 0.830 ± 0.116.sup..box-tangle-solidup. Test drug low-dose group  2.0 10 11.87 ± 2.64 0.756 ± 0.170 Test drug medium-dose group  4.0 10 12.30 ± 2.38.sup..box-tangle-solidup. 0.818 ± 0.180.sup..box-tangle-solidup. Test drug high-dose group 12.0 10 14.19 ± 2.49.sup..box-tangle-solidup..box-tangle-solidup. 0.900 ± 0.166.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
3.3 Effect of Composition 6 on Leucocyte Reduction in Mice Induced by X-Ray Radiation

(305) Test results are shown in Tables 5 and 6. The number of peripheral WBC and the contents of bone marrow nucleated cells and DNA in the model control group decreased as compared to those in the normal control group, suggesting a successful modeling. Compared to the model control group, the number of peripheral WBC and the contents of bone marrow nucleated cells and DNA significantly increased in the Composition 6 high- and medium-dose groups and in the positive control group, and also showed a tendency to increase in the Composition 6 low-dose group, indicating that Composition 6 can resist leucocyte induction in mice induced by X-ray radiation and improve the hematopoietic function of the bone marrow thereof.

(306) TABLE-US-00035 TABLE 5 Effect of Composition 6 on peripheral leucocyte reduction in mice induced by X-ray radiation (x ± s, ×10.sup.9) Dose (g Number WBC WBC on WBC on crude of before day 8 after day 15 after Groups drug/kg) animals modeling treatment treatment Normal control group  0.0 10 9.88 ± 2.16 9.66 ± 1.76 9.78 ± 2.43 Model control group  0.0 10 9.72 ± 2.09 5.90 ± 1.55** 5.70 ± 1.82** Positive control group 100 mg 10 9.65 ± 2.22 5.53 ± 1.28** 8.03 ± 1.59.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group  2.0 10 9.84 ± 1.70 5.76 ± 1.44** 7.24 ± 1.60 Test drug medium-dose group  4.0 10 9.73 ± 2.26 5.81 ± 1.39** 7.90 ± 1.44.sup..box-tangle-solidup..box-tangle-solidup. Test drug high-dose group 12.0 10 9.55 ± 2.01 5.72 ± 1.70** 8.34 ± 1.75.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.

(307) TABLE-US-00036 TABLE 6 Effect of Composition 6 on the contents of bone marrow BCM and DNA in mice after X-ray radiation (x ± s) Dose (g crude Number of Bone marrow BCM Bone marrow Groups drug/kg) animals (×10.sup.6) DNA Normal control group  0.0 10 16.26 ± 2.78 0.996 ± 0.222 Model control group  0.0 10 11.41 ± 2.62** 0.563 ± 0.121** Positive control group 100 mg 10 14.78 ± 2.44.sup..box-tangle-solidup..box-tangle-solidup. 0.780 ± 0.135.sup..box-tangle-solidup..box-tangle-solidup. Test drug low-dose group  2.0 10 13.02 ± 2.55 0.665 ± 0.160 Test drug medium-dose group  4.0 10 14.35 ± 2.32.sup..box-tangle-solidup..box-tangle-solidup. 0.772 ± 0.144.sup..box-tangle-solidup..box-tangle-solidup. Test drug high-dose group 12.0 10 14.66 ± 2.09.sup..box-tangle-solidup..box-tangle-solidup. 0.801 ± 0.127.sup..box-tangle-solidup..box-tangle-solidup. *P < 0.05, **P < 0.01 vs. normal control group; .sup..box-tangle-solidup.P < 0.05, .sup..box-tangle-solidup..box-tangle-solidup.P < 0.01 vs. model control group.
4. Conclusion

(308) The animal experiments demonstrate that Composition 6 obtained in Example 6 can resist leucocyte reduction in mice induced by cyclophosphamide, cytarabine and X-ray radiation and can improve the hematopoietic function of the bone marrow thereof, indicating that Composition 6 may be effective in preventing and treating leucopenia induced by radiotherapy and chemotherapy.