MULTI-COMPONENT INJECTION

Abstract

The invention relates to the technical field of medicines, and particularly relates to a multi-component injection and preparation processes and applications thereof. In the present invention, the effective ingredients of safflower Carthamus, Red Paeony Root, Ligusticum wallichii, radix salvia miltiorrhizae and Angelica sinensis are analyzed and a multi-component injection is prepared via the modem pharmaceutical preparation technology. The study proves that the multi-component injection of the invention has therapeutic effects on Sepsis.

Claims

1.-10. (canceled)

11. A method for treating sepsis in a subject in need thereof comprising administering to the subject a multi-component injection, wherein the multi-component injection comprises albiflorin std, paeoniflorin, Oxypaeoniflorin, Benzoylpaeoniflorin, Benzoyloxypaeoniflorin, Mudanpioside J, galloylpaeoniflorin, Mudanpioside C, benzoic acid, gallic acid, ethyl gallate, catechin, Kaempferol-3-0-glucoside, scutellarin, quercetin-3-0-glucoside, Kaempferol-3-0-rutinoside, Kaempferol-3-0-sophoroside, quercetin-3-0-rutinoside, Hydroxysafflor yellow A, uracil, adenine, phenylalanine, uridine, adenosine, guanosine, butanedioic acid, p-hydroxybenzoic acid, p-coumaric acid, caffeic acid, chlorogenic acid, senkyunolide I (42), senkyunolide H, senkyunolide N, open-loop senkyunolide I, senkyunolide G, 3-hydroxyl-3-butylphthalide, senkyunolide A, and ferulaic acid.

12. The method according to claim 11, wherein the multi-component injection comprises 8.66-35.26 parts of albiflorin std, 1000.0-1700.0 parts of paeoniflorin, 11.13-68.07 parts of Oxypaeoniflorin, 12.20-52.98 parts of Benzoylpaeoniflorin, 0.667-1.617 parts of Benzoyloxypaeoniflorin, 1.915-3.202 parts of Mudanpioside J, 10.63-20.13 parts of galloylpaeoniflorin, 0.804-1.338 parts of Mudanpioside C, 10.0-200.0 parts of benzoic acid, 0.21-15.88 parts of gallic acid, 0.2396-0.6860 parts of ethyl gallate, 1.31-12.60 parts of catechin, 1.232-3.547 parts of Kaempferol-3-0-glucoside, 0.0500-0.4184 parts of scutellarin, 0.755-2.570 parts of quercetin-3-0-glucoside, 8.42-29.40 parts of Kaempferol-3-0-rutinoside, 4.036-7.695 parts of Kaempferol-3-0-sophoroside, 1.517-5.598 parts of quercetin-3-0-rutinoside, 200.0-500.0 parts of Hydroxysafflor yellow A, 0.316-0.774 parts of uracil, 13.77-30.56 parts of adenine, 20.50-44.99 parts of phenylalanine, 11.44-27.13 parts of uridine, 5.07-12.63 parts of adenosine, 8.00-24.11 parts of guanosine, 4.96-16.86 parts of butanedioic acid, 2.384-5.404 parts of p-hydroxybenzoic acid, 3.00-17.98 parts of p-coumaric acid, 4.837-7.806 parts of caffeic acid, 3.83-8.59 parts of chlorogenic acid, 6.51-69.39 parts of senkyunolide 1 (42), 1.55-18.27 parts of senkyunolide H, 4.30-14.22 parts of senkyunolide N, 2.460-5.648 parts of open-loop senkyunolide I, 1.55-10.74 parts of senkyunolide G, 1.43-8.67 parts of 3-hydroxyl-3-butylphthalide, 0.10-0.961 parts of senkyunolide A, and 7.66-47.15 parts of ferulaic acid.

13. The method according to claim 11, wherein the multi-component injection is obtained from safflower carthamus, Red Paeony Root, Ligusticum wallichii, and Angelica sinensis.

14. The method according to claim 13, the multi-component injection is obtained from equal amounts in weight of safflower carthamus, Red Paeony Root, Ligusticum wallichii, and Angelica sinensis.

15. The method according to claim 14, wherein the multi-component injection is prepared by a method according to the following: providing 100 g of safflower carthamus decoction pieces; leaching the safflower carthamus decoction pieces for 8 hours to obtain a leach liquor with 30% ethanol, wherein the 30% ethanol is in an amount of 8 times the weight of the safflower carthamus decoction pieces; filtering the leach liquor to obtain a liquid medicine of 4-6 times the weight of the safflower carthamus decoction pieces; adding 95% ethanol to the liquid medicine to obtain an ethanol-containing liquid medicine having an ethanol volume content of 70%; storing the ethanol-containing liquid medicine under cooling conditions for 48 hours to obtain a cool ethanol-containing liquid medicine; filtering the cool ethanol-containing liquid medicine to obtain a first filtrate; concentrating the first filtrate under reduced pressure to obtain a concentrate of 100 ml; adding 95% ethanol to the concentrate to obtain an ethanol-containing concentrate having an ethanol volume content of 80%; storing the ethanol-containing concentrate under cooling conditions for 48 hours to obtain a cool ethanol-containing concentrate; filtering the cool ethanol-containing concentrate to obtain a second filtrate; recycling ethanol from the second filtrate to obtain an ethanol-reduced filtrate; concentrating and vacuum drying the ethanol-reduced filtrate to obtain a safflower carthamus dry paste; providing 100 g of Red Paeony Root decoction pieces; heating and boiling the Red Paeony Root decoction pieces with water to obtain a first decoction after 2 hours of slight boiling, wherein the water is in an amount of 10 times the weight of the Red Paeony Root decoction pieces; filtering the first decoction to obtain filtrate I and a first dreg; boiling the first dreg with water of 8 times the weight of the first dreg to obtain a second decoction after 1 hour of slight boiling; filtering the second decoction to obtain filtrate II and a second dreg; mixing filtrate I and filtrate II to obtain a mixture; concentrating the mixture to obtain a first concentrate of 100 ml; adding a gelatin solution to the first concentrate under stirring to obtain a gelatin-containing first concentrate; adding 95% ethanol to the gelatin-containing first concentrate to obtain an ethanol-containing first concentrate having an ethanol volume content of 70%; storing the ethanol-containing first concentrate under cooling conditions for 24 hours to obtain a cool ethanol-containing first concentrate; filtering and concentrating the cool ethanol-containing first concentrate to obtain a second concentrate of 100 ml; extracting the second concentrate with water-saturated n-butanol for 4 times and using 50 ml water-saturated n-butanol for each time; combining extract liquors of the 4 times extraction to obtain a combined extract liquor; recycling n-butanol from the combined extract liquor to obtain a n-butanol-reduced extract liquor without alcohol taste; and vacuum drying the n-butanol-reduced extract liquor to obtain a Red Paeony Root dry paste; providing 100 g of Ligusticum wallichii decoction pieces and 100 g of Angelica sinensis decoction pieces; treating the Ligusticum wallichii decoction pieces and Angelica sinensis decoction pieces with a same treatment process as the Red Paeony Root decoction pieces except for keeping 300 ml of a second concentrate instead of 100 mL every time and extracting with 150 ml of water-saturated n-butanol each time, to obtain a third dry paste; providing the safflower carthamus dry paste, the Red Paeony Root dry paste and the third dry paste; dissolving the three dry pastes in injection water to obtain a dilute of 200 ml; storing the dilute under cooling conditions to obtain a first cool liquid; adding glucosum anhydricum in an amount that is 4.5% of the weight of the multi-component injection and adding injection water to the first cool liquid to obtain a 1000 ml liquid; adjusting the pH value of the 1000 ml liquid to 5.5-7.0 with a sodium hydroxide solution of 10% mass fraction to obtain a pH adjusted liquid; storing the pH adjusted liquid under cooling conditions to obtain a second cool liquid; subjecting the second cool liquid to ultrafiltration to obtain an ultrafiltrate; adding solubilizing auxiliary materials, which are dissolved in injection water into the ultrafiltrate to obtain a solubilizing auxiliary materials-containing ultrafiltrate; adjusting the pH value of the solubilizing auxiliary materials-containing ultrafiltrate to 5.5-7.0 using the sodium hydroxide solution of 10% mass fraction to obtain a pH adjusted ultrafiltrate; filtering the pH adjusted ultrafiltrate to obtain a filtrate; encapsulating and sterilizing the filtrate to obtain the multi-component injection.

16. The method according to claim 11, wherein the multi-component injection further comprises a solubilizing auxiliary material.

17. The method according to claim 16, wherein the multi-component injection has a pH value of 5.5-7.0.

18. The method according to claim 17, wherein the multi-component injection is suitable for administration via an intramuscular injection, a subcutaneous injection, or an intravenous injection.

19. The method according to claim 12, wherein the multi-component injection further comprises a solubilizing auxiliary material.

20. The method according to claim 19, wherein the multi-component injection has a pH value of 5.5-7.0.

21. The method according to claim 20, wherein the multi-component injection is suitable for administration via an intramuscular injection, a subcutaneous injection, or an intravenous injection.

22. A method for treating sepsis in a subject in need thereof comprising administering to the subject a multi-component injection, wherein the multi-component injection comprises: an extract from safflower carthamus treated with aquaous ethanol, an extract from Red Paeony Root treated with boiling water, an extract from Ligusticum wallichii and Angelica sinensis treated with boiling water, wherein the safflower carthamus, Red Paeony Root, Ligusticum wallichii, and Angelica sinensis are provided in equal amounts in weight.

23. The method according to claim 22, wherein the multi-component injection further comprises a solubilizing auxiliary material.

24. The method according to claim 23, wherein the multi-component injection has a pH value of 5.5-7.0.

25. The method according to claim 24, wherein the multi-component injection is suitable for administration via an intramuscular injection, a subcutaneous injection, or an intravenous injection.

26. A method for treating sepsis in a subject in need thereof comprising administering to the subject a multi-component injection comprising extracts from equal amounts in weight of safflower carthamus, Red Paeony Root, Ligusticum wallichii, and Angelica sinensis, and a solubilizing auxiliary material, wherein the multi-component injection has a pH value of 5.5-7.0.

Description

IV. DESCRIPTION OF THE DRAWINGS

[0105] FIG. 1 Comparison of survival rates of endotoxin induced Sepsis mice among groups

[0106] Note: compared with the model group, the experimental groups 1-12 have the significant statistical difference (p<0.05).

[0107] FIG. 2 Comparison of the survival rates of cecal ligation and puncture mediated Sepsis mice among groups

[0108] Note: compared with the model group, the experimental groups 7-12 have the significant statistical difference (p<0.05).

V. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0109] There is a further description to the invention via the following specific embodiments, which is not used as limits.

[0110] Embodiment 1 Testing Method for Effective Ingredients in Injection

[0111] Method 1: Chromatographic Separation Conditions for Analyzing Ingredients of Safflower Carthamus and Red Paeony Root

[0112] Chromatographic column: Waters HSS T3 UPLC C18 Chromatographic column (100 mm×2.1 mm; 1.8 μM, Waters, USA);

[0113] Column Temperature: 45° C.;

[0114] Mobile phase: A: H.sub.2O (containing 25 mM HCOOH, B: MeOH (containing 25 mM HCOOH);

[0115] Gradient elute is shown in Table 6; flow velocity: 0.35 mL/min; injection volume: 5 μL; analysis time: 13 min.

TABLE-US-00009 TABLE 6 Liquid-phase gradient elute conditions of ingredients of safflower carthamus and Red Paeony Root Time (min) Solvent A Solvent B 0.0 98%  2% 8.0 30% 70% 11.0  2% 98% 13.0 98%  2%

[0116] Method 2: Chromatographic Separation Conditions for Analyzing Ingredients of Radix Salviae Miltiorrhizae

[0117] Chromatographic column: Waters HSS T3 UPLC C18 Chromatographic column (100 mm×2.1 mm; 1.8 μM, Waters, USA);

[0118] Column temperature: 45° C.;

[0119] Mobile phase: A: H.sub.2O (containing 25 mM HCOOH), B: MeOH (containing 25 mM HCOOH);

[0120] Gradient elute is shown in Table 7; flow velocity: 0.35 mL/min; injection volume: 5 μL; analysis time: 20 min.

TABLE-US-00010 TABLE 7 Liquid-phase gradient elute conditions of ingredients of radix salviae miltiorrhizae Time (min) Solvent A Solvent B 0.0 98% 2% 1.0 98% 2% 15.0 30% 70%  17.0  2% 98%  20.0 98% 2%

[0121] Method 3: Chromatographic Separation Conditions for Analyzing Ingredients of Ligusticum wallichii and Angelica sinensis, Adenine and Adenosine

[0122] Chromatographic column: Waters HSS T3 UPLC C18 Chromatographic column (100 mm×2.1 mm; 1.8 μM, Waters, USA);

[0123] Column temperature: 45° C.;

[0124] Mobile phase: A: MeOH-H.sub.2O (v/v, 1:99), including 1 mM HCOOH and 25 μM, CH3COOLi; B:

[0125] MeOH-H.sub.2O (v/v, 99:1), including 1 mM HCOOH and 25 μM, CH3COOLi;

[0126] Gradient elute is shown in Table 8; flow velocity: 0.35 mL/min; injection volume: 5 μL; analysis time: 8 min.

TABLE-US-00011 TABLE 8 Liquid-phase gradient elute conditions of ingredients of Ligusticum wallichii and Angelica sinensis, adenine and adenosine Time (min) Solvent A Solvent B 0.0 94% 6% 7.0  5% 95%  8.0 94% 6%

[0127] Embodiment 2 Preparation of Multi-Component Injection

[0128] providing 100 g of Red Paeony Root decoction pieces; heating and boiling the Red Paeony Root decoction pieces with process water of 10 times the weight of the Red Paeony Root decoction pieces to obtain a first decoction after 2 hours slight boiling; filtering the first decoction to obtain filtrate I and a first dreg; boiling the first dreg with process water of 8 times the weight of the first dreg to obtain a second decoction after 1 hour slight boiling; filtering the second decoction to obtain filtrate II and a second dreg; mixing filtrate I and filtrate II to obtain a mixture; concentrating the mixture to obtain a first concentrate of 100 ml; adding a proper amount of gelatin solution to the first concentrate under stirring to obtain a gelatin-containing first concentrate; adding 95% ethanol to the gelatin-containing first concentrate to obtain an ethanol-containing first concentrate having an ethanol volume content of 70%; storing the ethanol-containing first concentrate under cooling condition for 24 hours to obtain a cool ethanol-containing first concentrate; filtering and concentrating the cool ethanol-containing first concentrate to obtain a second concentrate of 100 ml; extracting the second concentrate with water-saturated n-butanol for 4 times and using water-saturated n-butanol of 50 ml for each time; combining extract liquors of the 4 times extraction to obtain a combined extract liquor; recycling n-butanol from the combined extract liquor to obtain a n-butanol-reduced extract liquor without alcohol taste; and vacuum drying the n-butanol-reduced extract liquor to obtain a Red Paeony Root dry paste;

[0129] providing a proper amount of the Red Paeony Root dry paste; dissolving the Red Paeony Root dry paste in injection water to obtain a dilute of 200 ml; storing the dilute under cooling condition to obtain a first cool liquid; adding glucosum anhydricum of an amount in accordance with 4.5% mass fraction of the multi-component injection and injection water to the first cool liquid to obtain a 1000 ml liquid; adjusting the pH value of the 1000 ml liquid to 5.5-7.0 with a sodium hydroxide solution of 10% mass fraction to obtain a pH adjusted liquid; storing the pH adjusted liquid under cooling condition to obtain a second cool liquid; subjecting the second cool liquid to ultrafiltration to obtain an ultrafiltrate; adding a proper amount of solubilizing auxiliary materials which are dissolved in a proper amount of injection water into the ultrafiltrate to obtain a solubilizing auxiliary materials-containing ultrafiltrate; adjusting the pH value of the solubilizing auxiliary materials-containing ultrafiltrate to 5.5-7.0 using the sodium hydroxide solution of 10% mass fraction to obtain a pH adjusted ultrafiltrate; filtering the pH adjusted ultrafiltrate to obtain a filtrate; encapsulating and sterilizing the filtrate to obtain the multi-component injection.

[0130] Three batches of injections are prepared in accordance with the process, and the testing results of the effective ingredients are as below:

TABLE-US-00012 Effective ingredient The First The Second The Third (Unit ug/ml) batch batch batch Albiflorin std 8.66 9.51 11.98 Paeoniflorin 1000.0 1010.7 1051.6 Oxypaeoniflorin 11.13 14.43 14.45 Benzoylpaeoniflorin 12.20 15.48 18.09 Benzoyloxypaeoniflorin 0.667 0.711 0.753 Mudanpioside J 1.915 1.934 1.960 Galloylpaeoniflorin 10.63 11.03 11.15 Mudanpioside C 0.804 0.805 0.941 Benzoic acid 10.0 20.4 30.1 Gallic acid 0.21 0.73 0.77 Ethyl gallate 0.2396 0.2428 0.2526 Catechin 1.31 1.91 1.60

[0131] Embodiment 3 Preparation Process of Multi-Component Injection

[0132] providing 100 g of safflower carthamus decoction pieces; leaching the safflower carthamus decoction pieces with 30% ethanol of 8 times the weight of the safflower carthamus decoction pieces for 8 hours to obtain a leach liquor; filtering the leach liquor to obtain a liquid medicine of 4-6 times the weight of the safflower carthamus decoction pieces; adding 95% ethanol to the liquid medicine to obtain an ethanol-containing liquid medicine having an ethanol volume content of 70%; storing the ethanol-containing liquid medicine under cooling condition for 48 hours to obtain a cool ethanol-containing liquid medicine; filtering the cool ethanol-containing liquid medicine to obtain a first filtrate; concentrating the first filtrate under reduced pressure to obtain a concentrate of 100 ml; adding 95% ethanol to the concentrate to obtain an ethanol-containing concentrate having an ethanol volume content of 80%; storing the ethanol-containing concentrate under cooling condition for 48 hours to obtain a cool ethanol-containing concentrate; filtering the cool ethanol-containing concentrate to obtain a second filtrate; recycling ethanol from the second filtrate to obtain an ethanol-reduced filtrate; concentrating and vacuum drying the ethanol-reduced filtrate to obtain a safflower carthamus dry paste;

[0133] providing 100 g of Red Paeony Root decoction pieces; heating and boiling the Red Paeony Root decoction pieces with process water of 10 times the weight of the Red Paeony Root decoction pieces to obtain a first decoction after 2 hours slight boiling; filtering the first decoction to obtain filtrate I and a first dreg; boiling the first dreg with process water of 8 times the weight of the first dreg to obtain a second decoction after 1 hour slight boiling; filtering the second decoction to obtain filtrate II and a second dreg; mixing filtrate I and filtrate II to obtain a mixture; concentrating the mixture to obtain a first concentrate of 100 ml; adding a proper amount of gelatin solution to the first concentrate under stirring to obtain a gelatin-containing first concentrate; adding 95% ethanol to the gelatin-containing first concentrate to obtain an ethanol-containing first concentrate having an ethanol volume content of 70%; storing the ethanol-containing first concentrate under cooling condition for 24 hours to obtain a cool ethanol-containing first concentrate; filtering and concentrating the cool ethanol-containing first concentrate to obtain a second concentrate of 100 ml; extracting the second concentrate with water-saturated n-butanol for 4 times and using 50 ml water-saturated n-butanol for each time; combining extract liquors of the 4 times extraction to obtain a combined extract liquor; recycling n-butanol from the combined extract liquor to obtain a n-butanol-reduced extract liquor without alcohol taste; and vacuum drying the n-butanol-reduced extract liquor to obtain a Red Paeony Root dry paste;

[0134] providing the safflower carthamus dry paste and the Red Paeony Root dry paste each of a proper amount; dissolving the two dry pastes in injection water to obtain a dilute of 200 ml; storing the dilute under cooling condition to obtain a first cool liquid; adding glucosum anhydricum of an amount in accordance with 4.5% mass fraction of the multi-component injection and injection water to the first cool liquid to obtain a 1000 ml liquid; adjusting the pH value of the 1000 ml liquid to 5.5-7.0 with a sodium hydroxide solution of 10% mass fraction to obtain a pH adjusted liquid; storing the pH adjusted liquid under cooling condition to obtain a second cool liquid; subjecting the second cool liquid to ultrafiltration to obtain an ultrafiltrate; adding a proper amount of solubilizing auxiliary materials which are dissolved in a proper amount of injection water into the ultrafiltrate to obtain a solubilizing auxiliary materials-containing ultrafiltrate; adjusting the pH value of the solubilizing auxiliary materials-containing ultrafiltrate to 5.5-7.0 using the sodium hydroxide solution of 10% mass fraction to obtain a pH adjusted ultrafiltrate; filtering the pH adjusted ultrafiltrate to obtain a filtrate; encapsulating and sterilizing the filtrate to obtain the multi-component injection.

[0135] Three batches of injections are prepared in accordance with the above process, and the testing results of the effective ingredients are as below:

TABLE-US-00013 Effective ingredient The First The Second The Third (Unit ug/ml) batch batch batch Albiflorin std 13.58 15.46 15.01 Paeoniflorin 1119.7 1139.7 1209.5 Oxypaeoniflorin 21.45 24.17 24.24 Benzoylpaeoniflorin 21.20 21.55 24.19 Benzoyloxypaeoniflorin 0.820 0.844 0.904 Mudanpioside J 2.083 2.463 2.480 Galloylpaeoniflorin 11.48 11.81 13.96 Mudanpioside C 0.942 1.031 1.048 Benzoic acid 84.8 85.8 100.2 Gallic acid 6.68 5.72 8.41 Ethyl gallate 0.3083 0.3967 0.4453 Catechin 4.01 5.86 5.97 Kaempferol-3-0-glucoside 1.232 1.440 1.506 Scutellarin 0.0500 0.0570 0.1033 Quercetin-3-0-glucoside 0.755 0.859 0.973 Kaempferol-3-0-rutinoside 8.42 11.02 12.59 Kaempferol-3-0-sophoroside 4.036 4.369 4.954 Quercetin-3-0-rutinoside 1.517 1.529 1.774 Hydroxysafflor yellow A 200.0 225.5 229.8 Uracil 0.316 0.338 0.424 Adenine 13.77 14.31 16.45 Phenylalanine 20.50 24.22 36.02 Uridine 11.44 13.25 14.26 Adenosine 5.07 5.59 5.70 Guanosine 8.00 9.06 10.02 Butanedioic acid 4.96 5.67 8.23 p-hydroxybenzoic acid 2.384 2.997 3.040 p-coumaric acid 3.00 3.23 3.79 Caffeic acid 4.837 5.298 5.584 Chlorogenic acid 3.83 3.86 4.28

[0136] Embodiment 4 Preparation Process of Multi-Component Injection

[0137] providing 100 g of safflower carthamus decoction pieces; leaching the safflower carthamus decoction pieces with 30% ethanol of 8 times the weight of the safflower carthamus decoction pieces for 8 hours to obtain a leach liquor; filtering the leach liquor to obtain a liquid medicine of 4-6 times the weight of the safflower carthamus decoction pieces; adding 95% ethanol to the liquid medicine to obtain an ethanol-containing liquid medicine having an ethanol volume content of 70%; storing the ethanol-containing liquid medicine under cooling condition for 48 hours to obtain a cool ethanol-containing liquid medicine; filtering the cool ethanol-containing liquid medicine to obtain a first filtrate; concentrating the first filtrate under reduced pressure to obtain a concentrate of 100 ml; adding 95% ethanol to the concentrate to obtain an ethanol-containing concentrate having an ethanol volume content of 80%; storing the ethanol-containing concentrate under cooling condition for 48 hours to obtain a cool ethanol-containing concentrate; filtering the cool ethanol-containing concentrate to obtain a second filtrate; recycling ethanol from the second filtrate to obtain an ethanol-reduced filtrate; concentrating and vacuum drying the ethanol-reduced filtrate to obtain a safflower carthamus dry paste;

[0138] providing 100 g of Red Paeony Root decoction pieces; heating and boiling the Red Paeony Root decoction pieces with process water of 10 times the weight of the Red Paeony Root decoction pieces to obtain a first decoction after 2 hours slight boiling; filtering the first decoction to obtain filtrate I and a first dreg; boiling the first dreg with process water of 8 times the weight of the first dreg to obtain a second decoction after 1 hour slight boiling; filtering the second decoction to obtain filtrate II and a second dreg; mixing filtrate I and filtrate II to obtain a mixture; concentrating the mixture to obtain a first concentrate of 100 ml; adding a proper amount of gelatin solution to the first concentrate under stirring to obtain a gelatin-containing first concentrate; adding 95% ethanol to the gelatin-containing first concentrate to obtain an ethanol-containing first concentrate having an ethanol volume content of 70%; storing the ethanol-containing first concentrate under cooling condition for 24 hours to obtain a cool ethanol-containing first concentrate; filtering and concentrating the cool ethanol-containing first concentrate to obtain a second concentrate of 100 ml; extracting the second concentrate with water-saturated n-butanol for 4 times and using 50 ml water-saturated n-butanol for each time; combining extract liquors of the 4 times extraction to obtain a combined extract liquor; recycling n-butanol from the combined extract liquor to obtain a n-butanol-reduced extract liquor without alcohol taste; and vacuum drying the n-butanol-reduced extract liquor to obtain a Red Paeony Root dry paste;

[0139] providing 100 g of Ligusticum wallichii decoction pieces and 100 g of Angelica sinensis decoction pieces; treating the Ligusticum wallichii decoction pieces and Angelica sinensis decoction pieces with a same treatment process as the Red Paeony Root decoction pieces except for keeping 300 ml of concentrate every time and extracting with 150 ml of water-saturated n-butanol each time, to obtain a third dry paste;

[0140] providing the safflower carthamus dry paste, the Red Paeony Root dry paste and the third dry paste each of a proper amount; dissolving the three dry pastes in injection water to obtain a dilute of 200 ml; storing the dilute under cooling condition to obtain a first cool liquid; adding glucosum anhydricum of an amount in accordance with 4.5% mass fraction of the multi-component injection and injection water to the first cool liquid to obtain a 1000 ml liquid; adjusting the pH value of the 1000 ml liquid to 5.5-7.0 with a sodium hydroxide solution of 10% mass fraction to obtain a pH adjusted liquid; storing the pH adjusted liquid under cooling condition to obtain a second cool liquid; subjecting the second cool liquid to ultrafiltration to obtain an ultrafiltrate; adding a proper amount of solubilizing auxiliary materials which are dissolved in a proper amount of injection water into the ultrafiltrate to obtain a solubilizing auxiliary materials-containing ultrafiltrate; adjusting the pH value of the solubilizing auxiliary materials-containing ultrafiltrate to 5.5-7.0 using the sodium hydroxide solution of 10% mass fraction to obtain a pH adjusted ultrafiltrate; filtering the pH adjusted ultrafiltrate to obtain a filtrate; encapsulating and sterilizing the filtrate to obtain the multi-component injection.

[0141] Three batches of injections are prepared in accordance with the process, and the testing results of the effective ingredients are as below:

TABLE-US-00014 Effective ingredient The First The Second The Third (Unit ug/ml) batch batch batch Albiflorin std 19.06 22.10 22.27 Paeoniflorin 1227.3 1263.2 1286.0 Oxypaeoniflorin 40.38 43.28 43.69 Benzoylpaeoniflorin 32.04 34.49 35.72 Benzoyloxypaeoniflorin 1.364 1.396 1.436 Mudanpioside J 2.516 2.729 2.773 Galloylpaeoniflorin 15.07 15.71 16.16 Mudanpioside C 1.060 1.074 1.170 Benzoic acid 153.4 165.4 176.3 Gallic acid 8.80 10.12 13.70 Ethyl gallate 0.5517 0.5527 0.5863 Catechin 9.95 10.37 10.45 Kaempferol-3-0-glucoside 1.646 1.723 1.898 Scutellarin 0.1236 0.1307 0.1766 Quercetin-3-0-glucoside 1.482 1.775 1.918 Kaempferol-3-0-rutinoside 13.87 14.82 14.93 Kaempferol-3-0-sophoroside 5.321 5.542 5.619 Quercetin-3-0-rutinoside 2.669 2.788 3.150 Hydroxysafflor yellow A 250.4 311.5 329.9 Uracil 0.440 0.476 0.477 Adenine 16.56 17.27 19.82 Phenylalanine 31.17 31.85 32.93 Uridine 14.78 15.23 19.32 Adenosine 6.66 6.72 7.24 Guanosine 10.07 10.81 11.95 Butanedioic acid 9.51 9.78 10.04 p-hydroxybenzoic acid 3.054 3.447 3.712 p-coumaric acid 10.61 12.46 12.55 Caffeic acid 5.627 5.971 6.212 Chlorogenic acid 4.32 4.53 4.68 Senkyunolide I 6.51 7.72 8.06 Senkyunolide H 1.55 2.93 2.51 Senkyunolide N 4.30 4.86 6.17 Open-loop senkyunolide I 2.460 3.037 3.132 Senkyunolide G 1.55 2.06 2.12 3-hydroxy-3-Butylphthalide 1.43 1.7 2.38 Senkyunolide A 0.10 0.183 0.203 Ferulaic acid 7.66 8.41 10.23

[0142] Embodiment 5 Preparation Process of Multi-Component Injection

[0143] providing 100 g of safflower carthamus decoction pieces; leaching the safflower carthamus decoction pieces with 30% ethanol of 8 times the weight of the safflower carthamus decoction pieces for 8 hours to obtain a leach liquor; filtering the leach liquor to obtain a liquid medicine of 4-6 times the weight of the safflower carthamus decoction pieces; adding 95% ethanol to the liquid medicine to obtain an ethanol-containing liquid medicine having an ethanol volume content of 70%; storing the ethanol-containing liquid medicine under cooling condition for 48 hours to obtain a cool ethanol-containing liquid medicine; filtering the cool ethanol-containing liquid medicine to obtain a first filtrate; concentrating the first filtrate under reduced pressure to obtain a concentrate of 100 ml; adding 95% ethanol to the concentrate to obtain an ethanol-containing concentrate having an ethanol volume content of 80%; storing the ethanol-containing concentrate under cooling condition for 48 hours to obtain a cool ethanol-containing concentrate; filtering the cool ethanol-containing concentrate to obtain a second filtrate; recycling ethanol from the second filtrate to obtain an ethanol-reduced filtrate; concentrating and vacuum drying the ethanol-reduced filtrate to obtain a safflower carthamus dry paste;

[0144] providing 100 g of Red Paeony Root decoction pieces; heating and boiling the Red Paeony Root decoction pieces with process water of 10 times the weight of the Red Paeony Root decoction pieces to obtain a first decoction after 2 hours slight boiling; filtering the first decoction to obtain filtrate I and a first dreg; boiling the first dreg with process water of 8 times the weight of the first dreg to obtain a second decoction after 1 hour slight boiling; filtering the second decoction to obtain filtrate II and a second dreg; mixing filtrate I and filtrate II to obtain a mixture; concentrating the mixture to obtain a first concentrate of 100 ml; adding a proper amount of gelatin solution to the first concentrate under stirring to obtain a gelatin-containing first concentrate; adding 95% ethanol to the gelatin-containing first concentrate to obtain an ethanol-containing first concentrate having an ethanol volume content of 70%; storing the ethanol-containing first concentrate under cooling condition for 24 hours to obtain a cool ethanol-containing first concentrate; filtering and concentrating the cool ethanol-containing first concentrate to obtain a second concentrate of 100 ml; extracting the second concentrate with water-saturated n-butanol for 4 times and using 50 ml water-saturated n-butanol for each time; combining extract liquors of the 4 times extraction to obtain a combined extract liquor; recycling n-butanol from the combined extract liquor to obtain a n-butanol-reduced extract liquor without alcohol taste; and vacuum drying the n-butanol-reduced extract liquor to obtain a Red Paeony Root dry paste;

[0145] providing 100 g of Ligusticum wallichii decoction pieces, 100 g of radix salviae miltiorrhizae and 100 g of Angelica sinensis decoction pieces; treating the three decoction pieces with a same treatment process as the Red Paeony Root decoction pieces except for keeping 300 ml of concentrate every time and extracting with 150 ml of water-saturated n-butanol each time, to obtain a third dry paste;

[0146] providing the safflower carthamus dry paste, the Red Paeony Root dry paste and the third dry paste each of a proper amount; dissolving the three dry pastes in injection water to obtain a dilute of 200 ml; storing the dilute under cooling condition to obtain a first cool liquid; adding glucosum anhydricum of an amount in accordance with 4.5% mass fraction of the multi-component injection and injection water to the first cool liquid to obtain a 1000 ml liquid; adjusting the pH value of the 1000 ml liquid to 5.5-7.0 with a sodium hydroxide solution of 10% mass fraction to obtain a pH adjusted liquid; storing the pH adjusted liquid under cooling condition to obtain a second cool liquid; subjecting the second cool liquid to ultrafiltration to obtain an ultrafiltrate; adding a proper amount of solubilizing auxiliary materials which are dissolved in a proper amount of injection water into the ultrafiltrate to obtain a solubilizing auxiliary materials-containing ultrafiltrate; adjusting the pH value of the solubilizing auxiliary materials-containing ultrafiltrate to 5.5-7.0 using the sodium hydroxide solution of 10% mass fraction to obtain a pH adjusted ultrafiltrate; filtering the pH adjusted ultrafiltrate to obtain a filtrate; encapsulating and sterilizing the filtrate to obtain the multi-component injection.

[0147] Three batches of injections are prepared in accordance with the process, and the testing results of the effective ingredients are as below:

TABLE-US-00015 Effective ingredient The First The Second The Third (Unit ug/ml) batch batch batch Albiflorin std 34.94 32.30 35.26 Paeoniflorin 1588.2 1677.0 1700.0 Oxypaeoniflorin 59.42 64.52 68.07 Benzoylpaeoniflorin 47.98 48.27 52.98 Benzoyloxypaeoniflorin 1.452 1.551 1.617 Mudanpioside J 2.775 3.030 3.202 Galloylpaeoniflorin 18.37 19.71 20.13 Mudanpioside C 1.225 1.277 1.338 Benzoic acid 186.2 191.9 200.0 Gallic acid 13.85 15.40 15.88 Ethyl gallate 0.6277 0.6633 0.6860 Catechin 11.48 11.94 12.60 Kaempferol-3-0-glucoside 2.859 3.328 3.547 Scutellarin 0.2824 0.3620 0.4184 Quercetin-3-0-glucoside 2.295 2.263 2.570 Kaempferol-3-0-rutinoside 22.90 26.66 29.40 Kaempferol-3-0-sophoroside 7.384 7.667 7.695 Quercetin-3-0-rutinoside 4.420 5.288 5.598 Hydroxysafflor yellow A 422.4 476.9 500.0 Uracil 0.723 0.758 0.774 Adenine 24.44 28.49 30.56 Phenylalanine 38.44 40.78 44.99 Uridine 23.22 26.86 27.13 Adenosine 10.34 12.28 12.63 Guanosine 20.68 22.95 24.11 Butanedioic acid 15.29 15.44 16.86 p-hydroxybenzoic acid 4.690 5.363 5.404 p-coumaric acid 15.63 17.92 17.98 Caffeic acid 6.909 7.774 7.806 Chlorogenic acid 7.74 8.48 8.59 Senkyunolide I 60.32 63.21 69.39 Senkyunolide H 15.76 17.29 18.27 Senkyunolide N 13.36 14.18 14.22 Open-loop senkyunolide I 5.126 5.190 5.648 Senkyunolide G 10.31 10.68 10.74 3-hydroxy-3-Butylphthalide 7.02 7.08 8.67 Senkyunolide A 0.656 0.938 0.961 Ferulaic acid 35.62 42.68 47.15 Protocatechualdehyde 1.435 8.511 17.25 Protocatechuic acid 2.361 2.469 4.030 Tanshinol 2.776 4.150 6.845 Rosmarinic acid 5.07 9.57 12.78 Salvianolic acid D 0.0697 0.2892 0.4005 Salvianolic acid C 1.123 2.185 4.732 Salvianolic acid A 0.366 1.508 2.505 Alkannic acid 0.429 0.480 0.945 Salvianolic acid B 4.00 8.96 11.00