CN106266002B

CN106266002B - Traditional Chinese medicine composition for treating hyperuricemia

Info

Publication number: CN106266002B
Application number: CN201510257169.XA
Authority: CN
Inventors: 李瑞明; 王根辈; 宋兆辉; 何毅; 周水平; 仝小林
Original assignee: Tasly Pharmaceutical Group Co Ltd
Current assignee: Tasly Pharmaceutical Group Co Ltd
Priority date: 2015-05-19
Filing date: 2015-05-19
Publication date: 2021-03-09
Anticipated expiration: 2035-05-19
Also published as: CN106266002A

Abstract

The invention relates to a traditional Chinese medicine composition for treating hyperuricemia, which is prepared from the following traditional Chinese medicines in parts by weight: 15-60 parts of clematis root, 10-50 parts of ash bark, 4-20 parts of rhubarb and 2-10 parts of coptis root.

Description

Traditional Chinese medicine composition for treating hyperuricemia

Technical Field

The invention relates to a traditional Chinese medicine preparation composition, in particular to a traditional Chinese medicine composition for treating hyperuricemia

Background

Hyperuricemia belongs to purine metabolic disorder diseases, the concentration of blood uric acid is increased due to increase of synthesis or reduction of excretion of uric acid in vivo, uric acid is further deposited in joints, cartilages and kidneys in a sodium salt form to cause tissue inflammatory reaction, and the clinical manifestations of acute arthritis, gout stone formation, gouty stone chronic arthritis, uric acid nephropathy, uric acid urinary calculus and the like can occur. From the point of traditional medical syndrome differentiation, the rise of blood uric acid is caused by the fact that the paste is full of the middle-jiao, the qi and blood flow is not smooth, the blood is accumulated into turbid blood, or the blood further flows into the channels and collaterals, and belongs to the category of turbid uric acid.

In recent years, the literature at home and abroad reports that hyperuricemia has correlation with incidence rates of hypertension, hyperlipidemia, coronary heart disease, cerebral apoplexy, diabetes and the like, and the prevalence rate of hyperuricemia is increased along with the improvement of living standard of people. For this reason, attention has been paid to clinical attention to treatment of hyperuricemia. At present, the hyperuricemia treatment still mainly adopts chemically synthesized medicines, such as benzbromarone (rizatriptan), probenecid, sulpirtone and the like, but the side effects of the medicines are large after long-term administration.

Modern pharmacological research shows that clematis root has the following effects

1. The effect of clematis angustifolia (namely polygonum hydropiper, clematis gossypii) on heart and blood pressure has the effects of inhibiting and exciting isolated toad heart, the drug effect of the infusion is 3-5 times greater than that of a decoction, 50 percent of the infusion (1ml/kg) can reduce the blood pressure of an anaesthetized dog and reduce the kidney volume, the drug effect of the infusion is 2 times of that of the decoction, and the blood pressure reducing effect of the infusion is similar to the inhibition on the heart.

2. Hypoglycemic effect the radix clematidis infusion has a significant glucose assimilation enhancing effect on normal rats (i.e. the urine glucose test is negative after a large amount of glucose is given to the rats), and thus may have a hypoglycemic effect.

3. The clematis angustifolia preparation with the antidiuretic effect has obvious antidiuretic effect on mice, rats and guinea pigs, the effect of an infusion agent is not obviously different from that of a decoction agent, 0.2ml of a 50% decoction agent has the antidiuretic effect equivalent to that of 0.1u of hypophysin, but the action time of the decoction agent is similar to that of the hypophysin.

4. Effect on smooth muscle the clematis angustifolia decoction has obvious excitation effect on isolated intestinal canals of mice, rats and rabbits; but has no obvious effect on the isolated uterus of the mouse.

5. The other functions are in the test tube, and the water infusion has an inhibiting effect on dermatophytes; the decoction has the effect of inhibiting staphylococcus aureus and shigella dysenteriae, the abdominal injection of the decoction can slightly improve the pain threshold of mice, and the decoction has the effect of relieving pain.

Cortex Fraxini has the following effects

1. The rat with anti-inflammatory and analgesic effects is injected with 10mg/kg of Castanea mollissima bark glycoside in abdominal cavity, and has inhibitory effects on carrageenan, dextran, 5-hydroxytryptamine and histamine arthritis, wherein the inhibitory intensity is 35, 28, 20 and 8% respectively. It has also been reported that horse chestnut bark glycoside is formaldehyde

The drug also has inhibitory effect on sexual arthritis, but is weaker than those with carrageenan, but has no obvious inhibition effect on dextran arthritis. The horse chestnut bark extract also has inhibitory effect on carrageenan arthritis at large dose. The horse chestnut bark glycoside can inhibit the formation of granuloma of rats (cotton ball method), has inhibiting effect on erythema reaction caused by guinea pig ultraviolet irradiation on the back, has more remarkable effect than horse chestnut bark glycoside, both have remarkable effect of inhibiting histamine-induced capillary permeability (caused by Bradykin, not acted), and also have weak analgesic effect (mouse hot plate method), and if the effect of morphine subcutaneous injection of 5mg/kg is taken as 100%, the oral administration of 10mg/kg of horse chestnut bark glycoside has the titer of l 4.8%.

2. The influence on urine volume and uric acid excretion is early reported that the aesculin has diuretic effect and can promote the excretion of uric acid of rabbits and patients with rheumatism. In the test of rats and rabbits, the horse chestnut bark glucoside can improve the excretion of uric acid by various administration routes. After the castanospermine is intravenously injected to rabbits, the urine volume is increased within half an hour initially, then the concentration of uric acid in blood is increased, the urine volume is gradually reduced after half an hour, and the excretion of uric acid in urine is increased continuously. The increase in urine volume is only a short term after administration (probably due to reduced tubular reabsorption), and 3-4 hours after administration, the urine volume is only 1/2 before administration. The principle of uric acid excretion enhancement, according to analysis, excites the sympathetic nervous system; furthermore, the horse chestnut bark glycoside also has direct action on the kidney, namely, the reabsorption of uric acid is inhibited. Elevated blood uric acid levels are the result of increased uric acid production in the liver. It has also been reported that the aescin has no diuretic effect on normal rats, but has a more significant diuretic effect on mice

3. Other effects the effects of castanosine on other organs are generally not significant. Has no effect on blood pressure, respiration and intestinal canal of rabbits. Has no effect on the isolated small intestine, uterus, bladder, gallbladder and isolated frog heart of guinea pig, and the in-situ uterus, blood vessel of rabbit ear and blood vessel of toad lower limb; the blood flow of the carotid artery and the femoral artery of the rabbit is not affected. Horse chestnut bark essence has mild pressure raising effect on rabbit, and can inhibit isolated toad heart and isolated rabbit intestine, slightly contract toad lower limb blood vessel, and slightly reduce excitability of isolated toad gastrocnemius muscle. The cortex Fraxini decoction also has antibacterial and chronic tracheitis treating effects. The chemical structure of horse chestnut bark glycoside is similar to that of dicoumarin, so that it has some anti-hemagglutination effect, and its 4% solution can absorb ultraviolet ray, so that it can protect skin from damage caused by sunlight irradiation.

4. The abdominal cavity injection of aesculetin suspension and aqueous solution of aesculetin with cough relieving, phlegm eliminating and asthma relieving effects has obvious cough relieving effect on mice induced cough by ammonia water spray; the aesculetin and the aesculin also have obvious phlegm eliminating effect, and experiments prove that: the aesculetin has obvious effect of relieving asthma of guinea pigs; has effects of relaxing airway smooth muscle and resisting histamine for guinea pig isolated trachea.

5. The aesculetin and the aesculetin are injected into anaesthetized cat and rabbit vein to raise blood pressure slightly and has no obvious effect on respiration during raising blood pressure.

6. The pathogenic microorganism resistant effect experiment shows that: cortex Fraxini decoction has inhibitory effect on Staphylococcus aureus, Escherichia coli, Shigella flexneri and Shigella sonnei, cortex Picrasmae has strongest inhibitory effect, and has similar inhibitory effect to Coptidis rhizoma.

The cortex Fraxini also has certain inhibitory effect on virus, such as anti-influenza virus, herpes virus, etc.

7. The aesculin has diuretic effect on influence of urine volume and uric acid excretion, and can promote excretion of uric acid of rabbit and rheumatism patients. Both the aesculin and aesculin have the effect of promoting uric acid excretion, which may be the excitation of sympathetic nervous system and direct action on kidney, i.e. inhibition of renal tubule reabsorption of uric acid.

8. Aesculetin (1:2500) has inhibitory effect on isolated enteron muscle of rabbit and isolated uterus of rat, and is manifested by reduced contraction amplitude, prolonged relaxation period and reduced frequency, while esculin has no obvious effect on smooth muscle.

Radix et rhizoma Rhei has the following effects

Influence on digestive system

(1) Purgative effect:

the action performance is as follows: the excrement is generally excreted 6 to 10 hours after the medicine is taken.

Effective components for purgation: it is thought to be primarily sennosides.

The purgative mechanism of action: the sennosides are decomposed under the action of intestinal bacterial enzymes to generate rhein anthrone, which can stimulate large intestine mucosa to increase intestinal motility and purge. In addition, the composition can inhibit Na +, K + -ATP enzyme on intestinal cell membrane, inhibit Na + transport, increase intestinal osmotic pressure, retain large amount of water, and promote intestinal motility and purgation.

(2) Benefiting gallbladder and protecting liver

(3) Promoting pancreatic secretion, and inhibiting pancreatic enzyme activity

(4) Anti-gastric and duodenal ulcer

Influence on the blood System

(1) Hemostasis effect:

the method is characterized in that: has definite action and quick response.

The effective hemostatic ingredients: alpha-catechin and gallic acid.

The mechanism of hemostasis action: promoting the adhesion and aggregation function of platelets; increasing platelet count and fibrinogen content; reducing antithrombin III activity; causing vasoconstriction of the injured part

(2) And (3) reducing blood fat:

reducing total cholesterol, triglyceride, low density lipoprotein, very low density lipoprotein and lipid peroxide.

Anti-infection effect

(1) The function of resisting pathogenic microorganisms:

and (3) antibacterial spectrum:

the sensitive bacteria include Staphylococcus, hemolytic streptococcus, gonococcus, diphtheria bacillus, typhoid bacillus, dysentery bacillus, etc.

The sensitive viruses include influenza virus, orphan virus, hepatitis B virus, poliovirus and the like.

Other sensitive microorganisms include amebiasis, trichomonas vaginalis, schistosoma japonicum, leptospira, and the like.

The antibacterial active ingredients are as follows: rhein, emodin, and aloe-emodin.

The antibacterial action mechanism is as follows: an enzyme system that affects folate; inhibiting bacterial nucleic acid and protein synthesis; inhibiting bacterial biooxidase systems; inducing interferon.

(2) Antiinflammatory and antipyretic effects

(3) And (3) immune regulation: anthraquinone derivatives can inhibit nonspecific immune function.

(4) Has the functions of anti-aging and anti-oxidation, and more scholars at home and abroad prove that the tannin contained in the rhubarb has good anti-oxidation effect!

The Chinese goldthread has the following functions

Pathogenic microorganism resisting method

Antibacterial effect is caused by Staphylococcus aureus, hemolytic streptococcus, pneumococcus, meningococcus, Shigella dysenteriae, Bacillus anthracis, etc.

The antiviral effect can inhibit influenza virus and hepatitis B virus.

Antiprotozoal effects inhibit amebiasis, trichomonas vaginalis, trypanosomes in vitro.

Effects on the cardiovascular System

One, influence

1. Anti-arrhythmic

Berberine is effective component.

Action mechanism of coptis chinensis-Chinese medicinal herb decoction pieces

Firstly, the action potential time course and the effective refractory period are prolonged.

② sodium channel is inhibited, conduction is slowed down, and reentry is eliminated.

Thirdly, the internal flow of calcium ions is inhibited.

Fourthly, the medicine can resist the damage of free radicals and protect cell membranes.

2. Blood pressure lowering effect

Berberine is effective component.

Characteristics of action

The diastolic pressure is obviously reduced, and the pulse pressure difference is increased.

② no quick tolerance phenomenon.

And limb and internal organ volume increase during hypertension.

The mechanism of action competitively blocks alpha-receptors, reduces peripheral resistance and slows down heart rate.

3. Positive inotropic effect

The effective components are as follows: berberine is prepared from berberine.

The action performance is as follows: the heart is excited, the myocardial contractility is enhanced, and the cardiotonic effect is not influenced by reserpine, propranolol, phentolamine and vagus nerve cutting.

Secondly, the action mechanism is as follows:

1. preventing the outflow of K +.

2. Increasing intracellular Ca2+ concentration.

3. Inhibit the generation of free radicals, and reduce the damage of lipid peroxide to myocardial cells.

4. Reducing oxygen consumption of myocardium.

Detoxification action

Resisting bacterial toxin, reducing titer of coagulase and hemolysin of Staphylococcus aureus, and reducing toxicity of Escherichia coli.

Anti-inflammatory and antipyretic

1. Inhibit various experimental inflammations, the effective component is berberine, and the anti-inflammatory mechanism is related to the stimulation of corticotropin release.

2. Antipyretic effects are associated with inhibition of neuronal cAMP production in the central PO/AH region.

Inhibiting platelet aggregation

Firstly, the effective components: berberine is prepared from berberine.

Second, mechanism of action

1. Inhibiting the production of TXA2 in platelets.

2. Inhibit the release of arachidonic acid from platelet membranes and affect their metabolism.

3. Inhibit the external calcium inflow.

The disclosures of the above-mentioned drugs do not include an anti-uric acid effect. Therefore, the invention researches the uric acid resisting effect of the medicine and obtains unexpected technical effects.

Some traditional Chinese medicine preparations for treating hyperuricemia appear in the market at present, but some of the existing medicines belong to temporary solution and permanent solution, some of the existing medicines use expensive components, and some of the existing medicines are interrupted in use due to inaccurate curative effect in the application process. The present inventors have studied to overcome the above-mentioned drawbacks.

Disclosure of Invention

In order to solve the existing problems, the invention aims to provide a traditional Chinese medicine composition for treating hyperuricemia.

The invention also aims to provide a preparation method of the traditional Chinese medicine composition.

The invention also aims to provide the application of the traditional Chinese medicine composition in preparing the medicine for treating hyperuricemia.

The invention also aims to provide application of the traditional Chinese medicine composition in preparing a medicine for improving or treating renal water metabolism disorder.

The traditional Chinese medicine composition is prepared by taking the following traditional Chinese medicines in parts by weight as raw materials:

15-60 parts of clematis root, 10-50 parts of ash bark, 4-20 parts of rhubarb and 2-10 parts of coptis root.

Preferably, the traditional Chinese medicine composition is prepared by taking the following traditional Chinese medicines in parts by weight as raw materials:

30-50 parts of clematis root, 20-40 parts of ash bark, 5-10 parts of rhubarb and 3-5 parts of coptis root.

Most preferably, the traditional Chinese medicine composition is prepared by taking the following traditional Chinese medicines in parts by weight as raw materials:

45 parts of clematis root, 30 parts of ash bark, 6 parts of rhubarb and 3 parts of coptis root.

In the above composition, the weight of each medicine is calculated by crude drug, and the dosage of the medicinal preparation which can be prepared by taking gram as unit is 1-3 times.

The components are proportioned according to weight, and can be increased or reduced according to corresponding proportion during production, for example, the mass production can be in kg or t (ton); small-scale formulations may also be in units of g. The weight can be increased or decreased, but the weight proportion of the crude drugs among the components is not changed.

The proportion of the weight proportion is obtained by scientific screening, and for special patients, such as severe or mild patients, obese patients or lean patients, the proportion of the components can be correspondingly adjusted, the increase or decrease is not more than 10 percent, and the drug effect is basically unchanged.

The traditional Chinese medicine composition is prepared by extracting or processing traditional Chinese medicine raw materials consisting of the formula in other modes to prepare a pharmaceutically active substance, and then taking the substance as a raw material, adding a pharmaceutically acceptable carrier if necessary and preparing the composition according to the conventional technology of pharmaceutics. The active substance can be obtained by respectively crushing or extracting traditional Chinese medicine raw materials, or by jointly crushing or extracting traditional Chinese medicine raw materials, or by other methods, such as: the active substances are obtained by crushing, squeezing, grinding, sieving, percolating, extracting, water extracting, alcohol extracting, ester extracting, chromatography and the like, can be in a powder form or an extract form, can be dry extract or fluid extract, and are prepared into different concentrations according to different requirements of preparations.

The traditional Chinese medicine composition of the invention, preferably in the form of unit dose pharmaceutical preparation, can be prepared into any pharmaceutically acceptable dosage forms when being prepared into the pharmaceutical preparation, and the dosage forms are selected from: tablets, sugar-coated tablets, film-coated tablets, enteric-coated tablets, capsules, hard capsules, soft capsules, oral liquids, buccal agents, granules, pills, powders, ointments, pellets, suspensions, solutions, injections, suppositories, ointments, plasters, creams, sprays, patches. The oral preparation form is preferred, and the tablet, capsule and granule are most preferred.

The traditional Chinese medicine composition can be added with some pharmaceutically acceptable carriers according to needs, and the pharmaceutical preparation can be prepared by adopting the conventional technology of pharmaceutical preparation, such as mixing the pharmaceutically active substance with the pharmaceutically acceptable carriers. The pharmaceutically acceptable carrier is selected from the group consisting of: mannitol, sorbitol, sorbic acid or potassium salt, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, thioglycolic acid, methionine, vitamin A, vitamin C, vitamin E, vitamin D, azone, disodium EDTA, calcium sodium EDTA, carbonates of monovalent alkali metals, acetates, phosphates or aqueous solutions thereof, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acids, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivatives, cellulose and derivatives thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, propylene glycol, ethanol, Tween 60-80, span-80, beeswax, lanolin, liquid paraffin, cetyl alcohol, gallic acid esters, agar, triethanolamine, basic amino acids, Urea, allantoin, calcium carbonate, calcium bicarbonate, surfactant, polyethylene glycol, cyclodextrin, beta-cyclodextrin, phospholipid material, kaolin, talcum powder, calcium stearate, magnesium stearate and the like.

When the traditional Chinese medicine composition is prepared into a medicament, the medicament with unit dose can contain 0.1-1000mg of the medicinal active substance, and the balance is a pharmaceutically acceptable carrier. The pharmaceutically acceptable carrier may be 0.1-99.9% by weight of the total weight of the formulation.

The usage amount of the traditional Chinese medicine composition is determined according to the condition of a patient when the traditional Chinese medicine composition is used.

The traditional Chinese medicine composition can be prepared by the following method:

the whole formula water extraction method comprises the following steps: adding water in an amount which is 5-15 times the weight of the Chinese medicinal materials including clematis root, ash bark, rhubarb and coptis chinensis, and performing reflux extraction for 1-3 times, wherein each time is 0.5-2 hours; mixing extractive solutions, standing, filtering, reducing pressure, and drying to obtain pharmaceutically active substance;

or

Water extraction and alcohol precipitation: adding water in an amount which is 5-15 times the weight of the Chinese medicinal materials including clematis root, ash bark, rhubarb and coptis chinensis, and performing reflux extraction for 1-3 times, wherein each time is 0.5-2 hours; mixing the extracting solutions, adding 70-95% ethanol, precipitating to 50-70%, standing for 8-24 hours, concentrating the supernatant into a thick extract, and drying to obtain a pharmaceutically active substance;

or

The whole formula alcohol extraction method comprises the following steps: adding 6-10 times of 70-95% ethanol into the clematis root, the ash bark, the wine-treated rhubarb and the coptis root, heating, refluxing and extracting for 1-3 times, each time for 1-3 hours, combining the extracting solutions, concentrating under reduced pressure to obtain a thick extract, and drying to obtain the medicinal active substance.

Preferably comprising the steps of:

the whole formula water extraction method comprises the following steps: adding 8 times of water into the medicinal materials of clematis root, ash bark, rhubarb and coptis root, and carrying out reflux extraction for 2 hours each time; mixing extractive solutions, standing, filtering, vacuum concentrating, and drying to obtain pharmaceutically active substance;

or water extraction and alcohol precipitation: adding 8 times of water into the medicinal materials of clematis root, ash bark, rhubarb and coptis root, performing reflux extraction for 2 times, wherein each time lasts for 1 hour, combining the extracting solutions, concentrating the extracting solution to 1.15-1.20, adding 95% ethanol, precipitating to 60%, standing for 12 hours, sucking supernatant, concentrating the supernatant into thick extract, and drying to obtain a medicinal active substance;

or the whole formula alcohol extraction method: adding 8 times of 70% ethanol into radix Clematidis, cortex Fraxini, radix et rhizoma Rhei, and Coptidis rhizoma, heating and reflux-extracting for 3 times, each for 1 hr, mixing extractive solutions, vacuum concentrating under reduced pressure below 70 deg.C to obtain soft extract, and drying to obtain pharmaceutically active substance.

In order to have better drug effect, the preparation method of the medicinal active substance is preferably a complete formula water extraction method or a water extraction and alcohol precipitation method.

The following experimental data illustrate the beneficial effects of the present invention:

action of hyperuricemia model rat fed with high-purine feed

1. Materials and instruments

1.1 animals: 80 SD rats, male, with weight of 180-: SCXK (zhe) 20080033.

1.2 medicine and preparation

1.2.1 hyperuricemia formula and medicine

(1) Hyperuricemia formula: 45kg of clematis root, 30kg of ash bark, 6kg of wine-processed rhubarb and 3kg of coptis root for later use.

The total formula of the water extract (2.2 g/kg): adding 8 times of water into the four medicinal materials of clematis root, ash bark, wine-treated rhubarb and coptis root, heating and refluxing for 1 hour, filtering an extracting solution for later use, adding 8 times of water into dregs, heating and refluxing for 1 hour, filtering the extracting solutions, combining the three extracting solutions, concentrating the extracting solutions under vacuum and reduced pressure below 70 ℃ into a thick extract, and drying the thick extract under reduced pressure to obtain the extract. Aqueous ethanol precipitate (1.1 g/kg): adding 8 times of water into the four medicinal materials of clematis root, ash bark, rhubarb and coptis root, heating, refluxing and extracting for 1 hour, filtering an extracting solution for later use, adding 8 times of water into dregs, heating, refluxing and extracting for 1 hour, filtering the extracting solution, combining the extracting solutions for three times, concentrating the extracting solution at the temperature of below 70 ℃ under vacuum and reduced pressure until the specific gravity of the extracting solution is 1.20, adding 95% ethanol, precipitating the extracting solution to 60 percent, standing the extracting solution for 12 hours, absorbing and taking supernatant, concentrating the supernatant at the temperature of below 70 ℃ under vacuum.

The total formula ethanol extract (1.5 g/kg): adding 8 times of 70% ethanol into the four medicinal materials of clematis root, ash bark, wine-treated rhubarb and coptis root, heating and refluxing for 1 hour, filtering the extracting solution for later use, adding 8 times of 70% ethanol into the dregs of a decoction, heating and refluxing for 1 hour, filtering the extracting solution, combining the three extracting solutions, concentrating the three extracting solutions under vacuum and reduced pressure below 70 ℃ into thick extract, and drying the extract under vacuum and reduced pressure to obtain the extract.

Squares test (1.3 g/kg): adding 8 times of water into radix Clematidis, heating and reflux-extracting for 1 hr, filtering the extractive solution, adding 8 times of water into the residue, heating and reflux-extracting for 1 hr, filtering the extractive solution, mixing the three extractive solutions, vacuum concentrating at 70 deg.C below to obtain soft extract, and vacuum drying under reduced pressure to obtain the extract.

(2) Medicine

Yeast cream: lot 120628, Shanghai-sourced Biotech, Inc.

Adenine: lot 12063, Shanghai-sourced Biotech, Inc.

Allopurinol tablets: batch number 20120907, Jiangsu Party enforces the pharmaceutical factory, Limited liability company.

Benzbromarone tablets: batch No. 1108867, Herman Dairy, Germany.

Sodium carboxymethylcellulose: batch No. 20090222, Dougulong chemical plant.

Sodium chloride: batch number 081001, shanghai test tetrahherv dimension chemical ltd.

1.2.2 preparation of test drugs

Taking the water extract, the water extract and the alcohol precipitate of the whole formula, the alcohol extract of the whole formula and the stock solution of the prescription test substance, and adding water to prepare liquid medicines with the concentrations of 0.224g/ml, 0.112g/ml, 0.154g/ml and 0.134g/ml respectively.

1.2.3 preparation of Molding Compound

Uniformly mixing the yeast extract and the adenine with the content of 10 percent and 0.1 percent respectively into the crushed rat granulated feed, and pelleting again to obtain the high-purine feed.

1.2.4 preparation of Positive drug

Accurately weighing sodium carboxymethylcellulose (CMC-Na) powder, and preparing into 8g/L suspension with physiological saline. Taking benzbromarone tablets, accurately weighing the benzbromarone tablets, finely grinding the benzbromarone tablets by a mortar, and preparing a suspension with the concentration of 0.5mg/ml by using 8g/L CMC-Na for later use. Taking allopurinol tablets, accurately weighing the allopurinol tablets, finely grinding the allopurinol tablets by a mortar, and preparing a suspension with the concentration of 1.0mg/ml by using 8g/L CMC-Na for later use.

1.3 reagents and instruments

1.3.1 reagents

Uric Acid (UA) kit, lot numbers 20120912, 20121026; urea Nitrogen (BUN) kit, lot numbers 20120829, 20121024; creatinine (Cr) kit, lot No. 20121022; the kit is provided by Ningbo Meikang Biotechnology Ltd.

Creatinine (Cr) kit, lot No. D1101063; total Protein (TP) kit, lot No. L1105013; albumin (ALB) kit, lot No. L1107023; xanthine Oxidase (XOD) kit, lot numbers 20120922, 20121019, 20121123; adenosine Deaminase (ADA) kits, lots 20120828, 20121105, 20121112, 20121123, which were provided by Nanjing institute of bioengineering.

1.3.2 instruments

JY10001 type electronic balance, Shanghai Minqiao precision instruments, Inc.; TBA-40 FR full-automatic biochemical analyzer; powerwave340 microplate reader, Bio-TEK, USA; microc117 centrifuge: thermo; h-11041170 electric heating constant temperature water bath, Shanghai sperm macroexperimental facilities, Inc.; WH-861 Mixer, Taicang scientific and educational facilities; KQ-500 DE model digital control ultrasonic cleaner, Kunshan ultrasonic instruments Inc.;

CM-230 pure water System, Jieda purification technologies, Inc., Hangzhou.

2. Test method

2.1 animals and groups

SD rat, weight 180-220 g. After 7 days of adaptive feeding, blood is taken from the orbit, supernatant fluid is taken by centrifugation, UA in serum is measured and is divided into 8 groups according to UA: a normal control group, a model control group, a positive control group (benzbromarone tablets and allopurinol tablets), a complete formula water extraction group (2.2g/kg), a water extraction and alcohol precipitation group (1.1g/kg), a complete formula alcohol extraction group (1.5g/kg) and a formula removal test group (1.3 g/kg).

2.2 Molding

The other groups were fed with yeast extract and adenine-containing feed every day for 11 weeks, except the normal group. 2.3 administration of drugs

The hyperuricemia formula samples are both administered by intragastric administration according to 1ml/100g, the normal control group and the model control group are both administered with water with corresponding volume by intragastric administration, and the positive control drug is administered by intragastric administration according to 6 times of the specified dose of a human body once a day for 11 weeks.

2.4 statistical treatment

Measure data results to

As indicated, the difference between groups was t-test.

3. Index (I)

3.1 behavioral indicators

Rats were observed daily for general signs (gross, mental status), weighed every 3 days, and recorded for weight changes.

3.2 Biochemical index

Taking blood from orbit, separating serum, centrifuging at 3500 rpm for 10min after administration for 3, 6, 9, and 11 weeks; the full-automatic biochemical analyzer is used for measuring serum UA, Cr, TP, ALB and BUN. The kit is used for measuring serum XOD and ADA; at 3 and 11 weeks of administration, all animals were placed in metabolism cages, 24h urine was collected, urine volume and UA content were measured, and 24h total uric acid excretion and uric acid clearance were calculated.

4. Results

4.1 Effect of hyperuricemic Agents on the serum UA levels in hyperuricemic rats

Compared with a normal control group, the model group rats start to remarkably increase the serum UA at the 6 th week of model building (p <0.01), and continuously remarkably increase the serum UA at the 9 th and 11 th weeks (p < 0.01); compared with a model control group, the serum UA of rats in the whole formula water extraction group (2.2g/kg), rats in the water extraction and alcohol precipitation group (1.1g/kg) and rats in the whole formula alcohol extraction group (1.5g/kg) is remarkably reduced (p is less than 0.01) at the 9 th week of administration, and the serum UA of rats in the whole formula water extraction group (2.2g/kg), rats in the water extraction and alcohol precipitation group (1.1g/kg), rats in the whole formula alcohol extraction group (1.5g/kg) and rats in the prescription removal test group (1.3g/kg) is remarkably reduced (p is less than 0.05) at the 11 th week of administration. The results are shown in Table 1.

TABLE 1 Effect of hyperuricemic Agents on the level of UA (. mu. mol/l) in the serum of hyperuricemic rats (. mu.mol/l) (-

n＝10)

Comparison with normal control group:^△P<0.05，^△△P<0.01; comparison with model control group: p<0.05，**P<0.01

4.2 Effect of hyperuricemia recipe on Cr in hyperuricemia rats

Statistically, there were no significant differences between groups. The results are shown in Table 2.

TABLE 2 Effect of hyperuricemic Agents on serum Cr (μmol/l) in hyperuricemic rat: (

n＝10)

4.3 Effect of hyperuricemia recipe on the BUN of hyperuricemia rats

Compared with a normal control group, the serum BUN of the model group rats is remarkably increased at the 6 th week of model building (p < 0.05); compared with a model control group, the serum BUN of rats in the whole ethanol extraction group (1.5g/kg) and the rats in the prescription-dismantling test group (1.3g/kg) is remarkably reduced at weeks 3 and 9 after administration (p is less than 0.05). The results are shown in Table 3.

TABLE 3 Effect of hyperuricemic Agents on the BUN (mmol/L) in the serum of hyperuricemic rat: (

n＝10)

4.4 Effect of hyperuricemia formula on hyperuricemia rat ALB

Compared with the normal control group, the serum ALB of the model group rats is remarkably reduced at the 6 th week of model building (p < 0.05); compared with a model control group, the serum ALB of rats in a complete formula water extraction group (2.2g/kg), rats in a water extraction and alcohol precipitation group (1.1g/kg), rats in a complete formula alcohol extraction group (1.5g/kg) and rats in a prescription removal test group (1.3g/kg) is remarkably increased (p is less than 0.05) at the 3 rd week of administration; rats in a water extraction and alcohol precipitation group (1.1g/kg), rats in a complete formula alcohol extraction group (1.5g/kg) and rats in a prescription removal test group (1.3g/kg) have a significant increase in serum ALB (p <0.05) at the 6 th week of administration. The results are shown in Table 4.

TABLE 4 hyperuricemia vs. altitudeEffect of uricemia rat serum ALB (g/l) ((

n＝10)

4.5 Effect of hyperuricemia recipe on hyperuricemia rat TP

Compared with the normal control group, the model group rats have significantly reduced serum TP (p <0.05) at the 6 th and 11 th weeks of the model building; compared with the model control group, rats in the water extraction and alcohol precipitation group (1.1g/kg) have a significant increase in serum TP (p <0.05) at weeks 6 and 11 after administration. The results are shown in Table 5.

TABLE 5 Effect of hyperuricemic Agents on the serum TP (g/l) of hyperuricemic rat: (

n＝10)

4.6 Effect of hyperuricemia recipe on hyperuricemia rat XOD

Compared with a normal control group, the serum XOD of the model group rats starts to be obviously increased at the modeling weeks 3, 6, 9 and 11 (p < 0.01); compared with a model control group, the serum XOD of rats in the whole formula alcohol extraction group (1.5g/kg) and the rats in the prescription removal test group (1.3g/kg) is obviously reduced (p is less than 0.05) at the 6 th week of administration; the serum XOD of rats in a complete formula water extraction group (2.2g/kg), a water extraction and alcohol precipitation group (1.1g/kg) and a prescription removal test group (1.3g/kg) is remarkably reduced (p is less than 0.05) at 9 weeks of administration; rats in a complete formula water extraction group (2.2g/kg), rats in a water extraction and alcohol precipitation group (1.1g/kg), rats in a complete formula alcohol extraction group (1.5g/kg) and rats in a formula removal test group (1.3g/kg) have a significant reduction in serum XOD (p <0.01) at the 11 th week of administration. The results are shown in Table 6.

TABLE 6 Effect of hyperuricemic Agents on XOD (U/L) in hyperuricemic rat serum: (

n＝10)

4.7 Effect of hyperuricemia formula on hyperuricemia rat ADA

Compared with the normal control group, the model group rats have the significant increase of serum ADA (p <0.01) at the 3 rd, 6 th, 9 th and 11 th weeks of modeling; compared with a model control group, the serum ADA of rats in a complete formula water extraction group (2.2g/kg), rats in a water extraction and alcohol precipitation group (1.1g/kg), rats in a complete formula alcohol extraction group (1.5g/kg) and rats in a prescription removal test group (1.3g/kg) is remarkably reduced (p is less than 0.05) at 9 and 11 weeks after administration. The results are shown in Table 7.

TABLE 7 Effect of hyperuricemic Agents on the serum ADA (U/ml) of hyperuricemic rat ((U/ml))

n＝10)

4.8 Effect of hyperuricemia formula on uric acid clearance rate of hyperuricemia rats

Compared with a model control group, the uric acid clearance of rats in a complete formula water extraction group (2.2g/kg) and rats in a water extraction and alcohol precipitation group (1.1g/kg) is remarkably increased (p is less than 0.05) at 11 weeks of administration. The results are shown in Table 8.

TABLE 8 Effect of hyperuricemia formula on uric acid clearance (ml/min) in hyperuricemia rats (II)

n＝10)

5. Analysis and discussion

5.1 serum UA

Uric acid, as the end product of purine metabolism, is a major indicator of hyperuricemia. The experimental research result shows that the whole formula water extraction group (2.2g/kg), the water extraction and alcohol precipitation group (1.1g/kg), the whole formula alcohol extraction group (1.5g/kg) and the prescription removal test group (1.3g/kg) all have certain functions of reducing the content of uric acid in hyperuricemia model rats fed by high-purine feed, and the indications are that the whole formula water extract (2.2g/kg), the water extraction and alcohol precipitation (1.1g/kg), the whole formula alcohol extract (1.5g/kg) and the prescription removal test extract (1.3g/kg) all have the effect of reducing uric acid, and the whole formula water extract has quick effect and the effect of reducing uric acid is better than other effects.

5.2 serum Cr, BUN

Hyperuricemia marks a metabolic disorder of the renal fluid. The experimental research result shows that although blood creatinine has no obvious difference in statistics, the numerical values show that the whole formula water extraction group (2.2g/kg) and the water extraction and alcohol precipitation group (1.1g/kg) have certain effects of increasing the serum creatinine content, the whole formula alcohol extraction group (1.5g/kg) and the prescription removal test group (1.3g/kg) have certain effects of reducing the serum creatinine content, and the slight increase of the blood creatinine can be related to the whole formula water extraction and alcohol precipitation to promote creatine to slowly form creatinine through irreversible non-enzymatic dehydration reaction and then release the creatinine to blood, and part of the creatinine is finally discharged out of the body along with urine; the whole formula alcohol extraction group (2.2g/kg) and the prescription splitting test group (1.3g/kg) have serum BUN content reduction with different degrees, although the whole formula water extraction group (2.2g/kg) and the water extraction and alcohol precipitation group (1.1g/kg) have no statistically obvious difference, the results show that the whole formula water extraction group (2.2g/kg) and the water extraction and alcohol precipitation group (1.1g/kg) have certain serum BUN content reduction effects, and the results show that the whole formula water extraction extract (2.2g/kg), the water extraction and alcohol precipitation extract (1.1g/kg), the whole formula alcohol extraction extract (1.5g/kg) and the prescription splitting test extract (1.3g/kg) can improve kidney water metabolism disorder to a certain extent when the serum UA level of a model rat is reduced, and have a certain renal function protection effect.

5.3 serum XOD, ADA: XOD (xanthine oxidase) is an enzyme which has low specificity, can catalyze hypoxanthine to produce xanthine and further produce uric acid, and can directly catalyze xanthine to produce uric acid. ADA (adenosine deaminase) is an important enzyme in purine nucleotide metabolism, belongs to sulfhydrylase, can catalyze adenosine to be converted into inosine, generates inosine through the action of nucleoside phosphorylase, and the final product of metabolic relaxation is uric acid. The experimental research result shows that the whole formula water extraction group (2.2g/kg), the whole formula alcohol extraction and alcohol precipitation group (1.1g/kg), the whole formula alcohol extraction group (1.5g/kg) and the prescription removal test group (1.3g/kg) can reduce the serum XOD and ADA levels to a certain degree, and the uric acid reduction mechanism of the whole formula water extract (8.4g/kg), the whole formula alcohol extraction and alcohol precipitation (1.1g/kg), the whole formula alcohol extract (1.5g/kg) and the prescription removal test extract (1.3g/kg) can be related to the inhibition of serum XOD and ADA activities.

5.4 uric acid clearance rate

The experimental result shows that the complete formula water extraction group (2.2g/kg) and the water extraction and alcohol precipitation group (1.1g/kg) can obviously increase the uric acid clearance rate, and the mechanism of reducing uric acid of the complete formula water extract (2.2g/kg) and the water extraction and alcohol precipitation (1.1g/kg) is probably related to promoting uric acid excretion.

6. Small knot

The experimental result shows that the whole formula water extract (2.2g/kg), the water and alcohol extract (1.1g/kg), the whole formula alcohol extract (1.5g/kg) and the prescription breaking test substance (1.3g/kg) have a certain effect of reducing uric acid on hyperuricemia model rats fed by the high purine feed, and the whole formula water extract and water and alcohol extraction group has quick effect, and the effect of reducing uric acid is better than other effects. Can reduce the serum UA level of a model rat, improve the metabolic disturbance of kidney water and protect the kidney function to a certain extent. The mechanism of reducing uric acid is probably related to inhibiting the activity of XOD and ADA in serum and promoting the excretion of uric acid.

Second, the effect of the drug on hyperuricemia model rats caused by intragastric administration of the fat emulsion after drinking

1. Materials and instruments

1.1 animals

100 SD rats, male, weight 180-: SCXK (zhe) 20080033.

1.2 medicine and preparation

1.2.1 preparation of Molding Compound

The (red star Erguotou, Beijing Erguotou) white spirit is prepared into the white spirit with the alcohol concentration of 5%, 10%, 12%, 14%, 16%, 18%, 19%, 20%, 21% and 22%.

Preparing the fat emulsion: placing 250g of lard in a 1L beaker, heating and melting the lard on an electric furnace, adding 40g of cholesterol to melt the lard, adding 100g of cholesterol and 10g of propylthiouracil tablets, fully stirring the mixture, and then adding 250mL of tween-80 to prepare an oil phase; adding 300mL of distilled water and 200mL of propylene glycol into another beaker, heating the beaker on an electric furnace to 60 ℃, adding 20g of sodium deoxycholate, fully stirring until the sodium deoxycholate is completely dissolved into a water phase, adding the water phase into an oil phase, fully mixing uniformly, and diluting the mixture to 2L with distilled water.

1.2.2 recipe for hyperuricemia

The medicament is prepared from 2.2g/kg of water extract of the whole formula, 1.1g/kg of water extract and alcohol precipitate of the whole formula, 1.5g/kg of alcohol extract of the whole formula and 1.3g/kg of prescription breaking test extract, and the medicaments are provided by Tianjin Tianshili pharmaceutical corporation. Taking the water extract, the water extract and the alcohol precipitate of the whole formula, the alcohol extract of the whole formula and the stock solution of the prescription test substance, and adding water to prepare liquid medicines with the concentrations of 0.224g/ml, 0.112g/ml, 0.154g/ml and 0.134g/ml respectively.

1.2.3 preparation of Positive drug

Allopurinol tablets: batch number 20120907, Jiangsu Party enforces the pharmaceutical factory, Limited liability company. Benzbromarone tablets: batch No. 1202498, Herman Dairy, Germany. Sodium carboxymethylcellulose: batch No. 20090222, Dougulong chemical plant. Accurately weighing sodium carboxymethylcellulose (CMC-Na) powder, and preparing into 3g/L suspension with distilled water. Taking benzbromarone tablets, accurately weighing the benzbromarone tablets, finely grinding the benzbromarone tablets by a mortar, and preparing a suspension with the concentration of 0.5mg/ml by using 3g/L CMC-Na for later use. Taking allopurinol tablets, accurately weighing the allopurinol tablets, finely grinding the allopurinol tablets by a mortar, and preparing a suspension with the concentration of 1.0mg/ml by using 3g/L CMC-Na for later use.

1.3 reagents and instruments

1.3.1 reagents

Uric Acid (UA) kit, lot numbers 20121126, 20130222, 20130415, 20130423, 20130424, 20130510, 20130608; urea Nitrogen (BUN) kit, lot numbers 20121212, 20130122, 20130321, 20130508, 20130613, 20130712, 20130805; creatinine (Cr) kit, lot numbers 20121022, 20130402, 20130418; alanine Aminotransferase (ALT) kit, lot numbers 20121101, 20130423, 20130517, 20130710, 20130712; aspartate Aminotransferase (AST) kits, lot numbers 20121120, 20121212, 20130412, 20130514, 20130608, 20130710 are available from ningbo meikang biotech gmbh.

Xanthine Oxidase (XOD) kit, lot numbers 20121123, 20130304, 20130401, 20130607, 20130810; adenosine Deaminase (ADA) kit, lots 20121112, 20121123, 20130305, 20130401, 20130614, which was provided by Nanjing institute of bioengineering.

1.3.2 instruments

JY10001 type electronic balance, Shanghai Minqiao precision instruments, Inc.; TBA-40 FR full-automatic biochemical analyzer; powerwave340 microplate reader, Bio-TEK, USA; microc117 centrifuge: thermo; h-11041170 electric heating constant temperature water bath, Shanghai sperm macroexperimental facilities, Inc.; WH-861 Mixer, Taicang scientific and educational facilities; KQ-500 DE model digital control ultrasonic cleaner, Kunshan ultrasonic instruments Inc.; CM-230 pure water System, Jieda purification technologies, Inc., Hangzhou.

2. Test method

2.1 animals and groups

SD rat, weight 180-220 g. After 7 days of adaptive feeding, blood is taken from the orbit, supernatant fluid is taken by centrifugation, UA in serum is measured and is divided into 8 groups according to UA: normal control group, model building group (7 groups); blood is collected from the orbit at the 27 th week, supernatant is obtained by centrifugation, UA in serum is determined, and the blood is divided into 8 groups according to UA: a normal control group, a model control group, a positive control group (benzbromarone tablets and allopurinol tablets), a complete formula water extraction group (2.2g/kg), a water extraction and alcohol precipitation group (1.1g/kg), a complete formula alcohol extraction group (1.5g/kg) and a formula removal test group (1.3 g/kg).

2.2 Molding

Except the normal group, the other groups were drunk randomly 3 days with 5% alcohol volume concentration every day, the 4 th day was changed to 10%, and the alcohol volume was increased by 2% every 1 week until 18%; then increase 1% weekly until 22% alcohol; drinking the wine continuously from drinking 22% alcohol; the mold was made for 23 weeks. Starting at 24 weeks, feeding with normal feed, and freely drinking water; each of the other groups except the normal group was perfused with a fat emulsion (1mL/100 g).

2.3 statistical treatment

Measure data results to

As indicated, the difference between groups was t-test.

3. Index (I)

3.1 behavioral indicators

The rats were observed daily for general signs (gross, mental), weighed every 7 days during molding, and every 3 days during dosing, and the weight changes were recorded.

3.2 Biochemical index

After 0, 9, 11, 14, 16, 18, 20, 23, 27, 31 and 33 weeks of modeling, blood is taken from the orbit, serum is separated, and the orbit is centrifuged for 10min at 3500 rpm; the full-automatic biochemical analyzer is used for measuring serum UA, Cr, BUN, AST and ALT. The kit is used for measuring serum XOD and ADA.

4. Results

4.1 Effect of hyperuricemic Agents on the serum UA levels in hyperuricemic rats

The first 27 weeks, the model group serum UA values were not significantly different compared to the normal group. At week 27, the UA values in the serum of the model group were significantly increased compared to the normal group (P < 0.01). At week 31, model group serum UA values were significantly elevated compared to normal group (P < 0.01); compared with the model group, the serum UA value of the whole formula water extraction group is obviously reduced (P < 0.05). At week 33, model group serum UA values were significantly elevated compared to normal group (P < 0.01); compared with the model group, the serum UA values of the whole formula water extraction group and the water extraction and alcohol precipitation group are obviously reduced (P is less than 0.01). The results are shown in Table 9.

TABLE 12 Effect of hyperuricemic Agents on the XOD serum in hyperuricemic rat: (

n＝10)

4.5 Effect of hyperuricemia formula on hyperuricemia rat ADA

The serum ADA values of the model groups were not significantly different from those of the normal group for the first 27 weeks. At the 27 th week, the ADA value of the serum of the model group is obviously increased compared with that of the normal group (P < 0.05-0.01). At week 33, the serum ADA values were significantly elevated in the model group compared to the normal group (P < 0.01); compared with a model group, the ADA value of the serum of the whole formula in a water extraction group and a water extraction and alcohol precipitation group is obviously reduced (P is less than 0.05-0.01). The results are shown in Table 13.

TABLE 13 Effect of hyperuricemic Agents on serum ADA in hyperuricemic rats ((

n＝10)

4.6 Effect of the hyperuricemia formula on the hyperuricemia rat ALT

Compared with a normal group, the serum ALT of the model group is obviously increased (P is less than 0.05-0.01) at the 16 th week; at week 27, serum ALT was significantly elevated in the whole water-extracted group (P < 0.05). Others did not differ significantly. The results are shown in Table 14.

TABLE 14 Effect of the hyperuricemic Agents on serum ALT in hyperuricemic rat: (

n＝10)

4.7 Effect of hyperuricemia recipe on hyperuricemia rat AST

The modeling group was not significantly different from the normal group. The results are shown in Table 15.

TABLE 15 Effect of hyperuricemic Agents on serum AST in hyperuricemic rats: (

n＝10)

5. Discussion and analysis

In the first 23 weeks, the wine is drunk for molding, the blood uric acid of the molding group is unstable in change, and the molding is unsuccessful. The elevation of Cr, BUN and ALT is obvious, which indicates that the function of liver and kidney begins to be damaged.

Starting the fat emulsion intragastric modeling at the 24 th week (except for the normal group), and finding that the serum UA, CR and BUN of rats in the model group can be obviously increased by adding the fat emulsion at the 27 th week, and the hyperuricemia model modeling is successful; the administration is started at week 27, and after 4 weeks of administration, the whole formula water extract can obviously reduce the serum UA level, and has no obvious difference on CR and BUN. After being administrated for 6 weeks, the water extract of the whole formula can obviously reduce the UA and CR levels of serum and the activity of XOD and ADA, and has the tendency of reducing BUN; the water extract and alcohol precipitate can obviously reduce the UA, CR and BUN levels of serum and the XOD and ADA activities; the alcohol extract of the whole formula can obviously reduce the XOD activity of the serum; the prescription trial was able to significantly reduce serum BUN levels and XOD activity.

6. Small knot

The experimental result shows that the water extract (2.2g/kg) and the water-alcohol precipitate (1.1g/kg) of the whole formula have certain uric acid reducing effect on hyperuricemia model rats caused by drinking wine, adding a fat emulsion and performing gastric administration, and the uric acid reducing mechanism of the uric acid reducing effect is probably related to the inhibition of the activity of serum XOD and ADA.

The test examples are merely illustrative of the pharmacodynamic action of the composition of the present invention and are not intended to be limiting. The Chinese medicinal composition in the scope of the claims of the invention has the same medicinal effect result as the Chinese medicinal composition in the test example.

Detailed Description

Example 1 preparation of granules according to the invention

Clematis root 45 parts by weight of ash bark 30 parts by weight of wine rhubarb 6 parts by weight of coptis root 3 parts by weight

Adding 8 times of water, extracting under reflux for 2 times, each for 1 hr; mixing extractive solutions, standing, filtering, vacuum concentrating, drying, pulverizing dry extract, and sieving with 80 mesh sieve to obtain extract.

Mixing the above dry powder, adding dextrin and correctant, and making into granule.

EXAMPLE 2 preparation of tablets of the invention

Adding 10 times of water, extracting under reflux for 0.5 hr for 2 times; mixing extractive solutions, standing, filtering, vacuum concentrating, drying, pulverizing dry extract, and sieving with 80 mesh sieve to obtain extract.

Mixing the above dry powder, adding starch and sodium carboxymethyl starch or other disintegrating agents, and making into tablet.

EXAMPLE 3 preparation of concentrated pellets of the present invention

Adding 8 times of water, extracting under reflux for 2 times, each for 2 hr; mixing extractive solutions, standing, filtering, vacuum concentrating, drying, pulverizing dry extract, and sieving with 80 mesh sieve to obtain extract.

Mixing the above dry powder, adding microcrystalline cellulose, and making into concentrated pill.

EXAMPLE 4 preparation of capsules of the invention

Adding 8 times of water, extracting under reflux for 3 times, each for 1 hr; mixing extractive solutions, standing, filtering, vacuum concentrating, drying, pulverizing dry extract, and sieving with 80 mesh sieve to obtain extract.

Mixing the above dry powder, adding microcrystalline cellulose and disintegrating agent, granulating, and making into capsule.

EXAMPLE 5 preparation of capsules of the invention

Radix clematidis 15 parts by weight of cortex fraxini 10 parts by weight/wine rhubarb 4 parts by weight of coptis root 2 parts by weight

Adding 12 times of water, extracting under reflux for 2 times, each for 1 hr; mixing extractive solutions, standing, filtering, vacuum concentrating under reduced pressure, concentrating the above extract to obtain extract, adding microcrystalline cellulose as base material and concentrated extract as slurry, granulating with fluidized bed, grading, and making into capsule.

EXAMPLE 6 preparation of pharmaceutical tablets of the invention

22.5 parts of clematis root, 15 parts of ash bark, 10 parts of wine rhubarb and 5 parts of coptis root

Adding 10 times of water, extracting under reflux for 2 times, each for 2 hr; mixing extractive solutions, standing, filtering, vacuum concentrating under reduced pressure, collecting the above extract, concentrating to obtain extract, adding compressible starch as base material, and concentrating to obtain slurry, granulating with fluidized bed, grading, adding disintegrating agent and flavoring agent, mixing, and making into tablet.

EXAMPLE 7 preparation of concentrated pellets of the present invention

Adding 15 times of water, extracting under reflux for 2 times, each for 1 hr; mixing extractive solutions, standing, filtering, vacuum concentrating, drying, pulverizing dry extract, and sieving with 80 mesh sieve to obtain extract.

Mixing the dry extract powder, adding microcrystalline cellulose, and making into concentrated pill.

EXAMPLE 8 preparation of granules of the invention

Clematis root 60 parts by weight, ash bark 50 parts by weight, wine rhubarb 20 parts by weight, coptis root 10 parts by weight

Adding 5 times of water, extracting under reflux for 3 times, each for 1 hr; mixing extractive solutions, standing, filtering, vacuum concentrating, drying, pulverizing dry extract, and sieving with 80 mesh sieve to obtain extract.

Taking the extract dry powder, adding an appropriate amount of dextrin, mixing uniformly, and making into granules.

Example 9 preparation of granules according to the invention

28 parts of clematis root, 14 parts of ash bark, 18 parts of wine-treated rhubarb and 8 parts of coptis root

Adding 8 times of water, extracting under reflux for 3 times, each for 1 hr; mixing the extracting solutions, standing, filtering, concentrating under reduced pressure in vacuum until the relative density is 1.15-1.20, adding 95% ethanol, precipitating with ethanol to 50%, standing for more than 12 hours, sucking supernatant, concentrating under reduced pressure, drying, pulverizing dry extract, and sieving with a 80-mesh sieve to obtain the extract.

EXAMPLE 10 preparation of granules of the invention

Clematis root 30 parts by weight, ash bark 40 parts by weight, wine rhubarb 5 parts by weight and coptis root 6 parts by weight

Adding 5 times of water, extracting under reflux for 3 times, each for 0.5 hr; mixing the extracting solutions, standing, filtering, concentrating under reduced pressure in vacuum until the relative density is 1.15-1.20, adding 95% ethanol, precipitating with ethanol to 60%, standing for more than 12 hours, sucking supernatant, concentrating under reduced pressure, drying, pulverizing dry extract, and sieving with a 80-mesh sieve to obtain the extract.

EXAMPLE 11 preparation of capsules of the invention

20 parts of clematis root, 20 parts of ash bark, 10 parts of wine rhubarb and 2 parts of coptis root

Adding 12 times of water, extracting under reflux for 2 times, each for 2 hr; mixing the extractive solutions, filtering, vacuum concentrating to relative density of 1.15-1.20, adding 95% ethanol, precipitating with ethanol to 60%, standing for more than 12 hr, collecting supernatant, vacuum concentrating to obtain extract, adding appropriate amount of microcrystalline, fluidized bed granulating, grading, and making into capsule.

EXAMPLE 12 preparation of granules according to the invention

45 parts of clematis root, 10 parts of ash bark, 14 parts of wine rhubarb and 10 parts of coptis root

Example 13 preparation of granules according to the invention

Example 14 preparation of granules according to the invention

50 parts of clematis root, 40 parts of ash bark, 10 parts of wine rhubarb and 5 parts of coptis root

Adding 8 times of water, extracting under reflux for 3 times, each for 1 hr; mixing extractive solutions, standing, filtering, vacuum concentrating to relative density of 1.15-1.20, adding 95% ethanol, precipitating with ethanol to 50%, standing for more than 12 hr, collecting supernatant, vacuum concentrating, drying, pulverizing dry extract, and sieving with 80 mesh sieve to obtain extract.

EXAMPLE 15 preparation of granules of the invention

30 parts of clematis root, 20 parts of ash bark, 5 parts of rhubarb and 3 parts of coptis root.

Claims

1. A traditional Chinese medicine composition for treating hyperuricemia is prepared from the following traditional Chinese medicines in parts by weight: 30-50 parts of clematis root, 20-40 parts of ash bark, 5-10 parts of wine-treated rhubarb and 3-5 parts of coptis root.

2. The traditional Chinese medicine composition of claim 1, which is prepared from the following traditional Chinese medicines in parts by weight: 45 parts of clematis root, 30 parts of ash bark, 6 parts of wine rhubarb and 3 parts of coptis root.

3. The Chinese medicinal composition of any one of claims 1 or 2, which can be prepared into any one of pharmaceutically acceptable dosage forms.

4. The traditional Chinese medicine composition of claim 3, wherein the dosage form is selected from the group consisting of: granule, concentrated pill, capsule, and tablet.

5. The method for preparing any one of the Chinese medicinal compositions of claim 1 or 2, which comprises the following steps:

adding water in an amount which is 5-15 times the weight of the Chinese medicinal materials including clematis root, ash bark, wine-treated rhubarb and coptis root into the Chinese medicinal materials, and performing reflux extraction for 1-3 times, wherein each time is 0.5-2 hours; mixing extractive solutions, standing, filtering, reducing pressure, and drying to obtain Chinese medicinal composition;

or

Adding water in an amount which is 5-15 times the weight of the Chinese medicinal materials including clematis root, ash bark, wine-treated rhubarb and coptis root into the Chinese medicinal materials, and performing reflux extraction for 1-3 times, wherein each time is 0.5-2 hours; mixing the extracting solutions, adding 70-95% ethanol, precipitating to 50-70%, standing for 8-24 hours, concentrating the supernatant into a thick extract, and drying to obtain a traditional Chinese medicine composition;

or

Adding 6-10 times of 70-95% ethanol into the clematis root, the ash bark, the wine-treated rhubarb and the coptis root, heating, refluxing and extracting for 1-3 times, each time for 1-3 hours, combining the extracting solutions, concentrating under reduced pressure to obtain a thick extract, and drying to obtain the traditional Chinese medicine composition.

6. The method of claim 5, comprising the steps of:

adding 8 times of water into the medicinal materials of clematis root, ash bark, wine-processed rhubarb and coptis root, and carrying out reflux extraction for 2 times, wherein each time lasts for 1 hour; mixing the extractive solutions, standing, filtering, vacuum concentrating, and drying to obtain the Chinese medicinal composition;

or adding 8 times of water into the medicinal materials of the clematis root, the ash bark, the wine-treated rhubarb and the coptis root, performing reflux extraction for 2 times, wherein each time lasts for 1 hour, combining the extracting solutions, concentrating the extracting solution to 1.15-1.20, adding 95% ethanol, precipitating to 60%, standing for 12 hours, sucking supernatant, concentrating the supernatant into thick extract, and drying to obtain the traditional Chinese medicine composition; or adding 8 times of 70% ethanol into radix Clematidis, cortex Fraxini, radix et rhizoma Rhei preparata, and Coptidis rhizoma, reflux-extracting for 3 times each for 1 hr, mixing extractive solutions, vacuum concentrating under reduced pressure below 70 deg.C to obtain soft extract, and drying to obtain Chinese medicinal composition.

7. Use of any one of the Chinese medicinal compositions of claim 1 or 2 for the preparation of a medicament for the treatment of hyperuricemia.