Chinese herbal medicine composition having a function of reducing uric acid

Abstract

Herbal composition having an effect of reducing uric acid, which is made from the following herbal materials in specified portions by weight: 4-30 portions of Glabrous greenbrier rhizome, 2-15 portions of Chicory, 2-15 portions of Herba Plantaginis, 2-20 portions of Coix seed, and 2-10 portions of Kudzuvine Root. The composition may be used in combination with modern Western medicines to achieve optimal effects.

Claims

1. An herbal composition having an effect of reducing uric acid, comprising therapeutically effective amounts of the following herbal ingredients in specified weight portions: 4-30 portions of Glabrous greenbrier rhizome, 2-15 portions of Chicory, 2-15 portions of Herba Plantaginis, 2-20 portions of Coix seed, and 2-10 portions of Kudzuvine Root.

2. The herbal composition of claim 1, wherein said ingredients are in following specified weight portions: 10-25 portions of Glabrous greenbrier rhizome, 5-12 portions of Chicory, 3-12 portions of Herba Plantaginis, 6-18 portions of Coix seed, and 4-8 portions of Kudzuvine Root.

3. The herbal composition of claim 2, wherein said ingredients are in following specified weight portions: 20 portions of Glabrous greenbrier rhizome, 15 portions of Chicory, 8 portions of Herba Plantaginis, 12 portions of Coix seed, and 8 portions of Kudzuvine Root .

4. A healthcare dietary product, comprising therapeutically effective amounts of extracts from following herbal ingredients in specified weight portions: 4-30 portions of Glabrous greenbrier rhizome, 2-15 portions of Chicory, 2-15 portions of Herba Plantaginis, 2- 20 portions of Coix seed, and 2-10 portions of Kudzuvine Root.

5. The healthcare dietary product of claim 4, wherein wherein said ingredients are in following specified weight portions: 10-25 portions of Glabrous greenbrier rhizome, 5-12 portions of Chicory, 3-12 portions of Herba Plantaginis, 6-18 portions of Coix seed, and 4-8 portions of Kudzuvine Root.

6. The healthcare dietary product of claim 4, wherein 20 portions of Glabrous greenbrier rhizome, 15 portions of Chicory, 8 portions of Herba Plantaginis, 12 portions of Coix seed, and 8 portions of Kudzuvine Root .

7. The healthcare dietary product of claim 4, which is formulated into a dosage form selected from the group consisting of oral liquid, capsule, tablet, powder and granule.

8. The healthcare dietary product of claim 5, which is formulated into a dosage form selected from the group consisting of oral liquid, capsule, tablet, powder and granule.

9. The healthcare dietary product of claim 6, which is formulated into a dosage form selected from the group consisting of oral liquid, capsule, tablet, powder and granule.

Description

DETAILED DESCRIPTION OF PARTICULAR EMBODIMENTS OF THE INVENTION

(1) The present invention is described in connection with some specific embodiments illustrated as follows. It is understood that the following specific examples are only intended to further illustrate the present invention and shall not be deemed to limite the protection scope of the present invention. Some non-substantial modifications and adjustments made by the others according to the spirit of the present invention shall fall into the scope of the invention.

Example 1

(2) The health-care dietary product of Example 1 of the present invention, is prepared from the components in the following portions by weight: 20 portions of Glabrous greenbrier rhizome, 15 portions of Chicory, 8 portions of Herba Plantaginis, 12 portions of Coix seed, and 8 portions of Kudzuvine Root.

Example 2

(3) The health-care dietary product of Example 2 of the present invention, is prepared from the components in the following portions by weight: 8 portions of Glabrous greenbrier rhizome, 15 portions of Chicory, 15 portions of Herba Plantaginis, 10 portions of Coix seed, and 10 portions of Kudzuvine Root.

Example 3

(4) The health-care dietary product of Example 3 of the present invention, is prepared from the components in the following portions by weight: 20 portions of Glabrous greenbrier rhizome, 15 portions of Chicory, 13 portions of Herba Plantaginis, 10 portions of Coix seed, and 8 portions of Kudzuvine Root.

Example 4

(5) The health-care dietary product of Example 4 of the present invention, is prepared from the components in the following portions by weight: 18 portions of Glabrous greenbrier rhizome, 13 portions of Chicory, 10 portions of Herba Plantaginis, 17 portions of Coix seed, and 7 portions of Kudzuvine Root.

Example 5

(6) The health-care dietary product of Example 5 of the present invention, is prepared from the components in the following portions by weight: 15 portions of Glabrous greenbrier rhizome, 10 portions of Chicory, 8 portions of Herba Plantaginis, 15 portions of Coix seed, and 5 portions of Kudzuvine Root.

Example 6

(7) The health-care dietary product of Example 6 of the present invention, is prepared from the components in the following portions by weight: 25 portions of Glabrous greenbrier rhizome, 12 portions of Chicory, 12 portions of Herba Plantaginis, 15 portions of Coix seed, and 6 portions of Kudzuvine Root.

Example 7

(8) The health-care dietary product of Example 7 of the present invention, is prepared from the components in the following portions by weight: 15 portions of Glabrous greenbrier rhizome, 8 portions of Chicory, 10 portions of Herba Plantaginis, 18 portions of Coix seed, and 8 portions of Kudzuvine Root.

(9) All herbal ingredients in the aforesaid examples are off the shelf commercial products, prepared in various forms through conventional formulation techniques (such as water extraction and alcohol extraction, etc.), and formulated into many pharmaceutical dosage forms, such as oral liquid, capsule, tablet, powder or granule, etc.

(10) Pharmacodynamic Studies

(11) Using the composition of Example 1, in the form of an oral liquid formulation (the testing sample) prepared by the conventional water extraction method, the efficacy was demonstrated in a way described as follows:

(12) 1. Experimental Site

(13) Department of Pharmacology & Toxicology, School of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou, China.

(14) 2. Experimental Purpose

(15) Examine the effect of the Chinese herbal composition of the present invention for reducing uric acid in the rat model of hyperuricemia.

(16) 3. Laboratory Animals

(17) 3.1 Grade and germ line: SPF-Grade SD Rat

(18) 3.2 Animal management: the animals were fed and looked after by the staff having a qualification certificate for laboratory animal management.

(19) 3.3 Purchase date: Jul. 10, 2012, of an age around 6-week.

(20) 3.4 Body weight, number, and gender at purchase: 50 males with body weights in the range of 130-150 grams.

(21) 3.5 Breeding site: the Laboratory Animal Center of Guangzhou University of Chinese Medicine (Laboratory Animal Production License No is SCXK(YUE) 2008-0020). The Laboratory Animal Quality Certificate No. is 0110322.

(22) 3.6 Immunization: immunized rats were examined for 3 days, during which, indicators such as the appearance, activities, excrement character, weight and diet of the animal are observed.

(23) 3.7 Reason for selecting rats as the test animals: Rats are strong in fertility, easily fed, with a size suitable for easy administration, and are convenient for sampling and quantification, making them suitable for this study.

(24) 3.8 Animal-labeling: Dots are painted on different sites of hair on the body surface of animals, with saturated picric acid solution, to indicate different number references.

(25) 3.9 Cage-labeling: The filled label card (indicating experiment title, special person in charge, animal's germ line, gender, numbering, grouping, prescription start date, etc.,) is hung on the front surface of the rat cage.

(26) 4. Feeding and Management of Animals

(27) Feeding Room: Barrier animal facilities on 2nd floor, Laboratory Animal Center (Northern Campus), Sun Yat-Sen University. Laboratory animal Usage License No. SYXK (YUE) 2007-0081.

(28) Temperature: 2025 C.; Humidity: 40%70%

(29) Aeration times: more than 10 times/hour

(30) Feeding density: 5/cage

(31) Illumination Duration: 12 hrs (turn on at 7am, turn off at 7pm)

(32) 5. Feedstuff

(33) Type: Sterile feedstuff for SPF-grade rats, manufactured by Guangdong Medical Lab Animal Center, address: Huang Qi BoYang Road No. 119, Nanhai District, Foshan City, Production License No. is SCXK (YUE) 2008-0002.

(34) Feeding method: Freely ingested

(35) Conventional nutritional component index of feedstuff: as determined by Guangdong Laboratory Animals Monitoring Institute (Referring to National Standard of the People's Republic of China GB14924.3-2010), inspection frequency: twice yearly.

(36) Storage of feedstuff: stored in a particular storeroom, keep ventilated, clean, dry.

(37) 6. Drinking Water

(38) Type: sterile water sterilized under 121 C. (1.0kg/cm.sup.2) for 30 min, complying with Water quality standard for fine drinking water (CJ94-2005).

(39) Administration method: Freely ingested through animal drinking bottles.

(40) 7. Equipment and Reagents

(41) Equipment

(42) Electric balance: PUT, manufactured by Shenzhen Amput Electronic Technology Co., Ltd;

(43) Electric balance: mettler Toledo, Type: p1303;

(44) Table-top centrifuge: LDZ5-2 centrifuge, manufactured by Beijing medical centrifuge factory;

(45) DK-80 type electric heating water bath, manufactured by electric heating water bath, manufactured by Guangdong Huankai Microbial Sci. & Tech. Co. Ltd.;

(46) W-80A votex, manufactured by Shanghai Medical University Instrument Factory; BECKMAN Synchron CX5 Chemistry Analyzer (USA);

(47) Miscellaneous: Fixing cage, capillary blood-sampling tube, centrifuge tube, syringe etc.

(48) Reagents

(49) Uric Acid Test Kit (enzymatic colorimetry): Lot number: T20120310, manufactured by Fenghui (S.H.) Medical Science & Tech. Company Ltd.

(50) 8. Experimental Design

(51) Animal grouping

(52) Animals were assigned randomly into: Blank control group, Sample control group, Model control group, Test group, and Positive control group. Each group consisted of 10 animals.

(53) Administration

(54) Administration route and reason: orally intragastrical administration, as it is similar to clinical administration route.

(55) Administration frequency: once daily.

(56) Dosage of intragastrical sample: administrated in the amount 30 folds of human body's recommended dosage (20 g/d of raw material), the equivalent dosage for rat (calculated as concentrated solution) 50603023=16.67(ml/kg/d), is about 17 ml/kg/d.

(57) Administration amount: 1.7 ml/100 g rat.

(58) 9. Experimental Methods

(59) 50 healthy male SD rats, body weights in the range of 130-150 g, were observed for 3 days in the experimental environment upon normal feeding and immunization. They were randomly assigned into 5 groups, each group consisting of 10 animals, the body weight distribution of each group of rats is similar. These groups were Blank control group (distilled water-17 ml/kg), Sample control group (17 ml/kg), Model control group (distilled water-17 ml/kg), Test group (test sample-17 ml/kg), Positive control group (allopurinol), respectively. Blank control group was administrated with 17 ml/kg of distilled water intragastrically every afternoon, Sample control group was administrated with 17 ml/kg of test sample intragastrically every afternoon, Model control group was administrated with distilled water intragastrically in the afternoon, Positive control group was administrated with allopurinol intragastrically in the afternoon, and Test group was administrated with 17 ml/kg of test sample intragastrically in the afternoon. Additionally, for Model control group, Positive control group and Test group, each group was administrated with Oteracil potassium intragastrically every morning. The administration was conducted daily for 30 days. Prior to experiments, the rats were fastened for 12 h (but water was provided) and then about 1 ml of blood were taken from orbital veniplex with glass capillary tube. Sera were separated for measuring the pre-testing level of uric acid. On day 30, blood were taken in the same manner and sera were separated for measuring the serum levels of uric acid, creatinine, and urea nitrogen.

(60) Modeling principle: Rats were intragastrically administrated with Oteracil potassium, a chemical inhibitor of uricase, to inhibit the activity of uricase in the body of rats, rendering uric acid in the body of rats unable to breakdown, causing the accumulation of uric acid produced in the serum, so as to produce a rat model of hyperuricemia.

(61) Animal grouping and administration

(62) Blank control group: 17 ml/kg*d of distilled water was administrated intragastrically, once daily for 30 days;

(63) Sample control group: 17 ml/kg*d of test sample was administrated intragastrically, once daily for 30 days;

(64) Model control group: 17 ml/kg*d of distilled water was administrated intragastrically, once daily for 30 days;

(65) Test sample prevention group: 17 ml/kg*d of test sample was administrated intragastrically, once daily for 30 days;

(66) Positive control group: 17 ml/kg*d of positive control allopurinolis administrated intragastrically, once daily for 30 days.

(67) 10. Observation Indicators

(68) General status observation: The status of animals (appearance, activities, excrement character, diet conditions etc) were observed daily.

(69) Observation of Body weight: The growing condition of animals were observed by weighing prior to administration and on Day 30 of administration.

(70) Observation of relevant metabolism indicators:

(71) Blood were taken prior to administration and on Day 30 of administration to measure uric acid, creatinine, urea nitrogen, to calculate the changing rate of uric acid level in serum.

(72) The changing rate of uric acid in serum=(uric acid value in serum after experiment-uric acid value in serum prior to experiment)/uric acid value in serum prior to experimentx100%

(73) 11. Data Processing

(74) ANOVA (analysis of variance) was used. Firstly, homogeneous variance test was carried out, and F values were calculated. If F value<F.sub.0.05, it indicated that the means of each group had no significant difference; if F valueF.sub.0.05, P0.05, the mean of each experimental group and control group were compared for statistical analysis; for non-normal or heterogeneous variance data, appropriate variant transformation was processed, when normal or homogeneous variance requirement was satisfied, the transformed data was processed for statistical analysis; if normal or homogeneous variance requirement could not satisfied after variant transformation, Rank sum test was used for statistical analysis.

(75) 12. Experimental Results

(76) 12.1 General status observation

(77) In comparison with Blank control group, all other groups of animals showed less smooth hair, but had no significant difference in other appearance signs, activities, and excrement characters etc. In comparison with Model control group, Test group and Positive control group had no significant difference in appearance, activities, and excrement characters etc.

(78) 12.2 Observation of body weight

(79) As shown in Table 1, the serum levels of uric acid (UA), urea nitrogen (BUN), and creatinine (CR) of each group of rats prior to modeling (i.e., prior to administration) were essentially similar, and they had no significant difference between groups (comparing with Blank control group or Model control group, each p>0.05). It meant that each group of rats have similar levels of relevant metabolism indicators in serum prior to modeling (prior to administration).

(80) TABLE-US-00001 TABLE 1 UA, BUN, CR contents in the sera of rats prior to administration (X S) BUN CR UA UA Grouping n (mol/L) (mmol/L) (mol/L) Reduction (%) Blank control 10 8.01 2.17 29.40 7.10 48.20 14.43 group Sample control 10 6.19 1.88 24.60 11.22 54.30 14.97 / group Model control 10 9.68 2.13 33.10 8.20 54.00 14.82 / group Test sample 10 10.41 2.58 31.70 10.28 53.30 15.70 / prevention group Positive control 10 8.82 2.72 28.90 5.17 51.10 9.21 / group Notes: Comparing to Blank control group, each group is p > 0.05; Comparing to Model control group, each group is p > 0.05.

(81) As it can be seen from Table 2, each group of rats had essentially similar body weights prior to modeling (prior to administration), because grouping is randomly assigned with respect to body weights. After continuous feeding for 10 days (10 d), 20 days (20 d) and 30 days (30 d), each group of rats gained weight. Upon 10 d feeding, comparing with Blank control group, the other groups of rats grew faster but had no statistical difference (p>0.05); upon 20 d feeding, comparing with Blank control group, the other groups of rats grew faster but still had no statistical difference (p>0.05); upon 30 d feeding, comparing with Blank control group, the body weights of each other group of rats had no statistically difference either (p>0.05).

(82) TABLE-US-00002 TABLE 2 Effects on body weights of each group of rats (X S) Weight prior to administration Grouping n (g) 10 d weight (g) 20 d weight (g) 30 d weight (g) Blank control 10 145.4 15.3 173.2 20.0 204.5 18.7 241.9 17.2 group Sample 10 145.7 23.8 185.4 25.3 210.8 32.0 238.0 36.4 control group Model control 10 144.6 15.7 191.2 18.0 215.5 19.4 244.6 22.8 group Test sample 8-10 145.9 12.0 190.1 15.7 222.0 26.4 236.25 32.9 prevention group Positive 10 143.5 11.4 185.7 15.9 224.2 21.8 254.4 23.1 control group Notes: Comparing to Blank control group, each group is p > 0.05; Comparing to Model control group, each group is p > 0.05.

(83) TABLE-US-00003 TABLE 3 UA, BUN, CR levels in the sera of rats upon 30 d administration (X S) UA BUN CR UA Reduction Grouping n (mol/L) (mmol/L) (mol/L) (%) Blank control group 10 5.97 1.06 36.30 6.03 73.10 21.86 / Sample control 10 .sup.5.06 0.57.sup.# .sup.42.40 3.77.sup.# 67.70 25.67 7.4 group Model control 10 5.34 0.64 38.20 7.53 .sup.135.50 19.57.sup.## / group Test sample 8 5.24 0.96 40.25 7.69 106.63 24.4* 21.3 prevention group Positive control 10 5.53 0.79 40.40 7.32 63.20 17.19** 53.4 group Notes: Comparing to Blank control group, # p < 0.05, ## p < 0.01; Comparing to Model control group, *indicates p < 0.05, **indicates p < 0.01; the reduction of Sample control group is calculated in comparison with Blank control group, the reduction of other groups are calculated in comparison with Model control group.

(84) It is seen from Table 3 that, upon 30 d Administration (30 d modeling), in comparison with

(85) Blank control group, Sample control group: UA level showed some reduction (7.4%) but without a statistic significance, BUN showed an increase(p<0.01), and CR level showed no significant change (p>0.05); Model control group: UA showed an significantly increase (p<0.01) (as the UA level of Blank control group was 73.1021.86 mol/L while UA level of Model control group was 135.5019.57 mol/L), changes in BUN and CR levels in sera were not significant (p>0.05). In comparison with Model control group, Test group showed a significant reduction in blood UA level (p<0.05), with a changing rate of 21.3%; Positive control group (with allopurinol) also showed a significant reduction in blood UA level significantly (p<0.01) with a changing rate of 53.4%.

(86) While there have been described and pointed out fundamental novel features of the invention as applied to a preferred embodiment thereof, it will be understood that various omissions and substitutions and changes, in the form and details of the embodiments illustrated, may be made by those skilled in the art without departing from the spirit of the invention. The invention is not limited by the embodiments described above which are presented as examples only but can be modified in various ways within the scope of protection defined by the appended patent claims.

CONCLUSION

(87) Upon 30 d oral administration of the test sample, in comparison with Model control group, the uric acid value of serum was significantly reduced, having a statistical significance (p<0.05), which indicates that said test sample has an effect of reducing uric acid.