Traditional Chinese medicine composition for treating hyperuricemia, active ingredient preparation method and medicine

Abstract

The invention discloses a traditional Chinese medicine composition for treating hyperuricemia, a preparation method of active ingredients and a medicine, and the traditional Chinese medicine composition is prepared from the following components in parts by mass: 5-9 parts of semen coicis, 6-10 parts of lycopodium clavatum, 3-8 parts of radix clematidis, 5-10 parts of herba siegesbeckiae and 1-4 parts of rhizoma corydalis. The active ingredients of the traditional Chinese medicine composition can be extracted by a water boiling method, and different dosage forms of medicines can be prepared on the basis of the prepared active ingredients; according to the traditional Chinese medicine composition, the lycopodium clavatum is used as the monarch, the radix clematidis, the coix seed and the herba siegesbeckiae are used as the minister, and the rhizoma corydalis is used as the assistant, so that the traditional Chinese medicine composition has the effects of dispelling turbidity and dispersing blood stasis, activating meridians to stop pain, promoting damp turbidity dispelling, dissolving stasis and reducing blood uric acid concentration.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition and a medicine, and in particular to a traditional Chinese medicine composition for treating hyperuricemia, a method for preparing an active ingredient and a medicine. Background Art

[0002] Hyperuricemia is a disease of extracellular urate supersaturation that belongs to the scope of metabolic syndrome. It is generally believed that hyperuricemia should be considered when the blood uric acid level of men and postmenopausal women is greater than 420μmol / L, and the blood uric acid level of premenopausal women is greater than 350μmol / L. The time from the increase of uric acid to the onset of symptoms of hyperuricemia can be as long as several years to decades, and asymptomatic hyperuricemia is often ignored. If hyperuricemia is not effectively controlled, it may develop into gout, followed by recurrent gouty arthritis, interstitial nephritis and tophi formation, and severe cases are accompanied by joint deformities or uric acid urinary stones; hyperuricemia synergistically with hypertension, insulin resistance, obesity, hyperlipidemia, impaired glucose tolerance and other factors will also aggravate arteriosclerosis and promote the occurrence of cardiovascular and cerebrovascular diseases. The asymptomatic period does not mean that there is no damage to human tissues and internal organs by urate deposition, but it is a critical period for the treatment of hyperuricemia.

[0003] There is no clear record of elevated blood uric acid in TCM literature, but modern TCM often classifies hyperuricemia into the categories of "arthralgia", "turbid urine", "lijie" and so on. Analyzing its etiology and pathogenesis from different perspectives, it is generally believed that the disease has the characteristics of "turbid poison", "dampness turbidity", "phlegm and stasis" and other pathological products. Hyperuricemia can be clinically divided into damp-heat accumulation type, damp-heat blood stasis type, spleen and kidney deficiency type, liver qi stagnation type and other types. For different types of symptoms, the clinical prescription has different focuses and different theories of pathogenesis, which also leads to diverse and complicated treatment plans.

[0004] There are many kinds of traditional Chinese medicine components commonly used in the treatment of hyperuricemia, such as Smilax glabra, Radix Dioscoreae, Semen Coix, Rhizoma Alismatis, Herba Plantaginis, Herba Lysimachiae, Radix Stephaniae, Rhizoma Atractylodis Macrocephalae, Radix Achyranthis Bidentatae, Cortex Phellodendri, Radix Paeoniae Rubra, Cortex Fraxini, Rhizoma Atractylodis Macrocephalae, Radix Clematis, Radix Rhei, etc. Most of these medicines are heat-clearing and dampness-removing, turbidity-removing and blood-stasis-removing medicines, and more than a dozen medicines are often needed for combined use. However, due to the complexity of the components and high cost of treatment, most patients with hyperuricemia cannot adhere to the treatment well, especially for patients with hyperuricemia in the asymptomatic period, which is often not accepted.

[0005] Therefore, the traditional Chinese medicine composition for treating hyperuricemia needs to be further optimized, the components need to be simplified while ensuring efficacy, and a traditional Chinese medicine composition with higher patient acceptance needs to be developed. Summary of the invention

[0006] The purpose of the present invention is to optimize the prescription for treating hyperuricemia, and only 5 kinds of Chinese medicine compositions are used for compatibility, which not only has a simple prescription but also has significant therapeutic effect.

[0007] The technical solution adopted by the present invention provides a traditional Chinese medicine composition for treating hyperuricemia. The key point is that, calculated by weight, the traditional Chinese medicine composition is composed of 5-9 parts of coix seed, 6-10 parts of lycopodiella ciliata, 3-8 parts of clematis root, 5-10 parts of siegetable herb, and 1-4 parts of corydalis yanhusuo.

[0008] Calculated by weight, the above-mentioned traditional Chinese medicine composition consists of 5 parts of coix seeds, 10 parts of lycopodiella ciliata, 3 parts of clematis root, 10 parts of siegetable herb and 1 part of yanhusuo.

[0009] Calculated by weight, the above-mentioned traditional Chinese medicine composition consists of 9 parts of coix seeds, 6 parts of lycopodiella ciliata, 8 parts of clematis root, 5 parts of siegetable herb and 4 parts of corydalis yanhusuo.

[0010] Calculated by weight, the above-mentioned traditional Chinese medicine composition consists of 7 parts of coix seeds, 8 parts of lycopodiella ciliata, 5 parts of clematis root, 7 parts of siegetable herb and 3 parts of yanhusuo.

[0011] The key to the preparation method of the active ingredient of the above-mentioned traditional Chinese medicine composition is that the above-mentioned preparation method adopts a water decoction method.

[0012] Furthermore, the water decoction method is as follows: add 8 to 10 times the mass of the above-mentioned medicinal composition in water, soak for 0.2h to 1h, decoct 1 to 3 times, each time for 1h to 2.5h, filter the decoction, and concentrate it into a thick paste; dry the thick paste to obtain a dry paste, crush it, and sieve it to obtain a dry powder.

[0013] Furthermore, the relative density of the thick paste is 1.15-1.30; the drying is reduced pressure drying at a temperature of 60°C-80°C.

[0014] A drug for treating hyperuricemia, the key point being that the drug contains the active ingredient described in claim 5.

[0015] Furthermore, the dosage form of the above-mentioned medicine is an oral preparation or an injection.

[0016] Specifically, the above-mentioned oral preparations are tablets, granules, capsules, oral liquids, pills, suspensions, powders, and syrups.

[0017] In order to achieve the purpose of the present invention, the Chinese medicine composition is made into various pharmaceutical dosage forms. In theory, the Chinese medicine composition of the present invention can be made into any dosage form according to the general preparation method. According to its applicable objects and indications, it is preferably a decoction, tablet, granule, capsule, oral liquid, pill, suspension, syrup. In order to make the above dosage forms possible, pharmaceutically acceptable excipients such as fillers, disintegrants, lubricants, suspending agents, adhesives, sweeteners, flavoring agents, preservatives, bases, etc. need to be added when preparing these dosage forms. Fillers include starch, pregelatinized starch, lactose, mannitol, chitosan, microcrystalline cellulose, sucrose, etc.; disintegrants include starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, cross-linked polyvinyl pyrrolidone, low-substituted hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, etc.; lubricants include magnesium stearate, sodium lauryl sulfate, talc, silicon dioxide, etc.; suspending agents include polyvinyl pyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, etc.; binders include starch slurry, polyvinyl pyrrolidone, hydroxypropyl methylcellulose, etc.; sweeteners include sodium saccharin, aspartame, sucrose, sodium cyclamate, glycyrrhetinic acid, etc.; flavoring agents include sweeteners and various flavors; preservatives include parabens, benzoic acid, sodium benzoate, sorbic acid and its salts, benzalkonium bromide, chloroethidine acetate, eucalyptus oil, etc.; matrices include PEG6000, PEG4000, insect wax, etc.

[0018] Compared with the prior art, the present invention has the following beneficial effects:

[0019] Hyperuricemia has no obvious clinical symptoms before gout attacks, and belongs to the category of "pre-disease" or "hidden evil" in traditional Chinese medicine. When complicated with arthritis or kidney damage, joint swelling and pain, deformation, urinary tract stones or renal insufficiency, it can be classified into the categories of "arthralgia", "rheumatism", "stranguria" and "edema". According to the patient characteristics of "favorable to people with plump body and like to eat fat and sweet food" and the clinical characteristics of "pain is worse at midnight, and there are stones, or ulcers and fat fluid", Professor Zhu Liangchun, a master of traditional Chinese medicine, believes that this disease is different from the broad arthralgia in traditional Chinese medicine literature, and first proposed the name of "turbid stasis arthralgia". From the perspective of the location of the disease in the spleen and kidney, the present invention belongs to the syndrome of mixed deficiency and excess, with dampness, turbidity, phlegm, stasis and heat as the main pathogenesis. Improper diet and excessive work and rest are its inducements. Therefore, the treatment of the present invention is mainly based on the methods of strengthening the spleen and eliminating dampness, purging turbidity and removing blood stasis, and relaxing muscles and unblocking collaterals.

[0020] In this prescription, the herb is slightly bitter, pungent, and warm, and has the effects of dispelling wind and dampness, relaxing muscles and activating collaterals. It is used for joint pain and poor flexion and extension. It is the main drug in the prescription, which has the functions of relaxing muscles and activating blood circulation, dispelling wind and cold, and removing dampness and detoxification. Clematis is pungent, warm, and salty, and it belongs to the bladder meridian. It can dispel rheumatism, dredge meridians and relieve pain. It is used for rheumatic arthralgia, numbness of limbs, muscle spasm, and poor flexion and extension. Coix seed is sweet, light, and cool. It belongs to the spleen, stomach, and lung meridians. It has the effects of promoting water and dampness, strengthening the spleen and removing arthralgia, and detoxifying and dispersing knots; it can be used for spleen deficiency and dampness stagnation, damp arthralgia and spasm. Siegesbeckia is pungent, bitter, and cold. It belongs to the liver and kidney meridians. It can dispel rheumatism between muscles and bones, dredge meridians, and benefit joints; the three drugs are combined as ministers. With the help of Corydalis yanhusuo, which can promote blood circulation and qi, dissipate blood stasis and relieve pain, the whole formula can work together to dispel wind and remove numbness, strengthen the spleen and dissipate dampness, dissipate turbidity and dissipate blood stasis, and relieve pain, promoting the dissipation of dampness and turbidity, and dissolving blood stasis, thereby achieving the effect of reducing blood uric acid concentration and reducing gout attacks. Modern pharmacological studies have shown that striata herba, clematis radix, and siegesbeckia sibiricum have clear pharmacological effects such as analgesia, anti-inflammatory, and lowering uric acid.

[0021] The invention mainly treats the hyperuricemia by invigorating the spleen and removing dampness, removing turbidity and removing blood stasis, and relaxing muscles and tendons. The disclosed Chinese medicine composition for treating hyperuricemia has a simple formula, only 5 Chinese medicine raw materials, and significant efficacy. The active ingredients can be extracted to further prepare drugs in various dosage forms, which are convenient for patients to take. DETAILED DESCRIPTION

[0022] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0023] Embodiment 1 to Embodiment 4

[0024] A Chinese medicine composition for treating hyperuricemia, comprising the following Chinese medicines: coix seed, smilax china, clematis root, siegetable herb, and yanhusuo. Specific dosages are shown in Table 1.

[0025] The Chinese medicine composition of Example 1 or Example 4 was soaked in cold water for 30 minutes, and decocted over low heat from the time the pot boiled, i.e., the first decoction was 30 minutes; the second decoction was 10 minutes, and a total of about 300 mL of juice was obtained.

[0026] The Chinese medicine composition of Example 2 was soaked in cold water for 35 minutes, and decocted over low heat from the time the pot boiled, i.e., the first decoction was 25 minutes; the second decoction was 15 minutes, and a total of about 300 mL of juice was obtained.

[0027] The Chinese medicine composition of Example 3 was soaked in cold water for 25 minutes, and decocted over low heat from the time the pot boiled, i.e., the first decoction was 35 minutes; the second decoction was 10 minutes, and a total of about 300 mL of juice was obtained.

[0028] Take the medicine juice orally twice a day, morning and evening. The course of treatment is 2 to 4 weeks depending on the patient's actual situation.

[0029] Table 1: Dosage table of Chinese medicine composition

[0030]

[0031]

[0032] Comparative Example 1

[0033] The Chinese medicine composition of this comparative example is composed of the following Chinese medicines: 8g of coix seed, 8g of lycopodiella ciliata, 5g of clematis root, 8g of siegetable oil herb, and 3g of chuanxiong.

[0034] The Chinese medicine composition of this comparative example was soaked in cold water for 30 minutes, and decocted over low heat from the time the pot boiled, i.e., the first decocting was 30 minutes; the second decocting was 10 minutes, and a total of about 300 mL of juice was obtained.

[0035] Comparative Example 2

[0036] The Chinese medicine composition of this comparative example is composed of the following Chinese medicines: 9g of Smilax glabra, 6g of Herba Lycopodii, 5g of Radix Clematis, 8g of Herba Siegesbeckiae, and 3g of Rhizoma Corydalis.

[0037] The Chinese medicine composition of this comparative example was soaked in cold water for 30 minutes, and decocted over low heat from the time the pot boiled, i.e., the first decocting was 30 minutes; the second decocting was 10 minutes, and a total of about 300 mL of juice was obtained.

[0038] Comparative Example 3

[0039] The Chinese medicine composition of this comparative example is composed of the following Chinese medicines: 10g of coix seed, 8g of clematis root, 10g of siegetable herb, and 2g of yanhusuo.

[0040] The Chinese medicine composition of this comparative example was soaked in cold water for 30 minutes, and decocted over low heat from the time the pot boiled, i.e., the first decocting was 30 minutes; the second decocting was 10 minutes, and a total of about 300 mL of juice was obtained.

[0041] Comparative Example 4

[0042] Tongfengshu Capsules; Dosage and Administration: Oral, 2 to 4 capsules at a time, 3 times a day, after meals.

[0043] Embodiment 5 to Embodiment 10

[0044] A method for preparing an active ingredient of a traditional Chinese medicine composition for treating hyperuricemia, comprising the following specific steps:

[0045] Add 8 to 10 times the mass of the Chinese medicine composition (by mass fraction) of water, soak for 0.2h to 1h, decoct 1 to 3 times, each time for 1h to 2.5h, filter the decoction, and concentrate to a thick paste; dry the thick paste under reduced pressure to obtain a dry paste, crush it, and sieve it to obtain a dry powder. See Table 2 for specific process parameters.

[0046] Table 2: Preparation process parameters of active ingredients of traditional Chinese medicine composition

[0047]

[0048] Embodiment 11

[0049] A drug for treating hyperuricemia, comprising the active ingredients of the Chinese medicine composition prepared in Example 5, in the form of tablets, and the specific preparation process is as follows:

[0050] The prepared dry powder was added with 1% magnesium stearate and pressed into 760 tablets.

[0051] Embodiment 12

[0052] A drug for treating hyperuricemia, comprising the active ingredients of the Chinese medicine composition prepared in Example 5, in the form of granules, and the specific preparation process is as follows:

[0053] The prepared dry powder is added with sucrose and dextrin in an amount of 5 times the mass of the dry powder, and a small amount of ethanol is added to make a soft material; granulated through a 14-mesh sieve, dried, sieved again to form whole particles, and fine powder is removed; volatile oil and ethanol are mixed, mixed evenly, sealed, and packaged to obtain granules.

[0054] Embodiment 13

[0055] A drug for treating hyperuricemia, comprising the active ingredients of the Chinese medicine composition prepared in Example 6, in the form of a capsule, and the specific preparation process is as follows:

[0056] Add 2 times the weight of starch to the prepared dry powder, mix evenly, add an appropriate amount of ethanol to make a suitable soft material; pass through a 14-mesh sieve and granulate, dry at 70°C, sieve the whole granules again, add 0.8% magnesium stearate, mix evenly; put into 1000 capsules to prepare capsules.

[0057] Embodiment 14

[0058] A drug for treating hyperuricemia, comprising the active ingredients of the Chinese medicine composition prepared in Example 7, in the form of an oral solution, and the specific preparation process is as follows:

[0059] The impurities in the dry powder are removed by a water extraction and alcohol precipitation purification method, 2% of a flavoring agent and 0.5% of a preservative are added, and the mixture is packaged into oral ampoules after fine filtration. The flavoring agents in this embodiment are honey and stevioside, and the preservative is potassium sorbate.

[0060] Embodiment 15

[0061] A drug for treating hyperuricemia, comprising the active ingredients of the Chinese medicine composition prepared in Example 8, in the form of a pill, and the specific preparation process is as follows:

[0062] Add honey 1.5 times the mass of the dry powder and an appropriate amount of water as a binder to the prepared dry powder, and mix the powder, make it into strips, and form it into pills, and then package it to obtain pills.

[0063] Embodiment 16

[0064] A drug for treating hyperuricemia, comprising the active ingredients of the Chinese medicine composition prepared in Example 9, the dosage form of which is a suspension, and the specific preparation process is as follows:

[0065] Add 20% of the dry powder mass of filler, 1% of flavoring agent, and 12% of suspending agent to the prepared dry powder, mix well, add an appropriate amount of wetting agent to make a soft material, pass through a 30-mesh sieve, and sieve the whole grain after drying. The filler in this embodiment is starch and mannitol, the flavoring agent is a sweetener, the suspending agent is microcrystalline cellulose, and the wetting agent is polysorbate.

[0066] Embodiment 17

[0067] A drug for treating hyperuricemia, comprising the active ingredients of the Chinese medicine composition prepared in Example 10, in the form of a syrup, and the specific preparation process is as follows:

[0068] Add water twice the mass of the dry powder, 30% sucrose and 0.2% preservative to the prepared dry powder, filter and stir evenly, and package to obtain a syrup.

[0069] Embodiment 18

[0070] In this example, a mouse hyperuricemia model was constructed to investigate the effect of the Chinese medicine composition of the present invention on hyperuricemia. The hyperuricemia model was induced by potassium oxonate combined with hypoxanthine to observe the effect of the test drug on the serum uric acid level of mice. The specific investigation steps are as follows:

[0071] 1 Test materials

[0072] 1.1 Experimental animals

[0073] KM mice SPF grade, male, 80, 4-5 weeks old, weighing 18-20g. Newly received animals were quarantined for 5 days, during which time the animals' drinking water, food intake and health conditions were normal, and no signs of disease or death were found. Animals were marked with a laboratory animal marker pen.

[0074] 1.2 Positive drugs, tool drugs and main reagents

[0075] Positive drugs: Allopurinol tablets were used as the Western medicine control drug; Tongfengshu capsules were used as the Chinese medicine control drug.

[0076] Tool drugs: potassium oxonate, hypoxanthine.

[0077] Main reagents: normal saline, uric acid detection kit (uricase-anti-VC method).

[0078] 2 Test methods

[0079] 2.1 Test system selection instructions

[0080] The uricase inhibitor oxonoic acid potassium salt is a chemical inducer that can inhibit the decomposition of uric acid in mice. Hypoxanthine can produce uric acid under the action of xanthine oxidase. The combination of the two is often used to evaluate the efficacy of drugs for hyperuricemia.

[0081] 2.2 Trial Grouping

[0082] 80 KM mice were randomly divided into 8 groups according to their body weight: a blank group, a model group, a western medicine control (allopurinol, the dosage for mice was 10 mg / kg), Example (the decoction prepared in Example 1), Comparative Example 1 (the decoction prepared in Comparative Example 1), Comparative Example 2 (the decoction prepared in Comparative Example 2), Comparative Example 3 (the decoction prepared in Comparative Example 3), and Comparative Example 4 (commercially available Chinese medicine Tongfengshu capsules, the dosage for mice was 0.4 g / kg).

[0083] 2.3 Administration

[0084] The mice were intragastrically administered at a volume of 10 mL / kg. The blank and model groups were given corresponding volumes of pure water for 7 consecutive days.

[0085] 2.4 Experimental steps and observation indicators

[0086] After the experimental animals were grouped, oral administration began, and the administration was continued for 7 days. About 1 hour after the last administration (fasting for at least 15 hours before the last administration), potassium oxonate was injected subcutaneously in the neck and hypoxanthine was injected intraperitoneally to establish the model. The dose of potassium oxonate was 300 mg / kg (10 mL / kg), and the dose of hypoxanthine was 100 mg / kg (10 mL / kg), both of which were prepared with normal saline. About 1 hour after modeling, blood was collected from the animal's orbit, centrifuged at 3000 rpm for 10 minutes, and serum was separated. The uric acid level was detected by uricase-anti-VC method.

[0087] 3 Results (see Table 3 for details)

[0088] Compared with the blank group, the serum uric acid level of mice in the model group was significantly increased (P<0.01).

[0089] Compared with the model group: the serum uric acid level of mice in the allopurinol group, Example 1 group, and Comparative Examples 1, 2, and 4 groups was significantly reduced (P<0.05 or P<0.01). Although the uric acid level in Comparative Example 3 group was reduced, no significant difference was observed (P>0.05).

[0090] Compared with the example group: the uric acid levels in the comparative example 1, 2, and 3 groups were significantly higher than those in the example group (P<0.05).

[0091] Table 3: Serum uric acid levels in mouse hyperuricemia model

[0092] Group N Uric acid (μmol / L) Blank group 10 101.30±17.82 Model Group 10 300.40±60.57## Western medicine control (allopurinol) 10 38.60±10.41** Example 10 184.20±51.77** Comparative Example 1 10 241.40±45.42*△ Comparative Example 2 10 238.70±55.15*△ Comparative Example 3 10 253.00±58.44△ Comparative Example 4 (commercially available Chinese medicine) 10 225.50±39.42**

[0093] Note: Comparison between model group and normal group: ##P<0.01; Comparison between drug administration group and model group: *P<0.05, **P<0.01; Comparison between comparative example and embodiment: △P<0.05.

[0094] 4 Conclusion

[0095] This experiment used a hyperuricemia model induced by potassium oxonate combined with hypoxanthine to observe the effects of each test drug on the serum uric acid level of mice. The test results showed that each test drug could reduce the serum uric acid level to a certain extent, and the uric acid reduction degree was ranked from high to low: Western medicine control (allopurinol) > Example > Comparative Example 4 (commercially available Chinese medicine Tongfengshu capsules) > Comparative Example 2 > Comparative Example 1 > Comparative Example 4. Except for the Western medicine control drug, the effect of the Example group was the most significant.

[0096] Embodiment 19

[0097] In this example, an acute gouty arthritis model of rats was constructed to investigate the effect of the Chinese medicine composition of the present invention on the treatment of acute gout. Sodium urate was injected into the ankle joints of rats to observe the effects of each test drug on acute gouty arthritis of rats. The specific investigation steps are as follows:

[0098] 1 Test materials

[0099] 1.1 Experimental animals

[0100] 80 male SPF SD rats, 5-6 weeks old, weighing 180-200g. Newly received animals were quarantined for 5 days, during which time there were no abnormalities in the animals' drinking water, food intake, and health status, and no signs of disease or death were found. Animal identification was marked with a laboratory animal marker pen.

[0101] 1.2 Positive drugs and tool drugs

[0102] Positive drugs: The Western medicine control drug is diclofenac sodium tablets; the Chinese medicine control drug is Tongfengshu capsules.

[0103] Tool drugs: sodium urate, Tween-80, isoflurane, normal saline, chloral hydrate.

[0104] 2 Test methods

[0105] 2.1 Test system selection instructions

[0106] During an acute gouty arthritis attack, deposited urate crystals can induce a large number of inflammatory cells (such as neutrophils and monocytes) to infiltrate the synovial membrane of the joints, accompanied by severe redness, swelling, heat, pain, and increased vascular permeability. Animal model studies have shown that injection of urate crystals into the ankle joint of rats can induce an acute gouty arthritis attack, and the clinical manifestations and inflammatory cell infiltration are consistent with those of acute attacks in patients with gout.

[0107] 2.2 Trial Grouping

[0108] 80 SD rats were randomly divided into 8 groups according to their body weight: blank group, model group, western medicine control (diclofenac sodium, rat dosage of 10 mg / kg), Example (decoction prepared in Example 1), Comparative Example 1 (decoction prepared in Comparative Example 1), Comparative Example 2 (decoction prepared in Comparative Example 2), Comparative Example 3 (decoction prepared in Comparative Example 3), Comparative Example 4 (commercially available Chinese medicine Tongfengshu capsules, rat dosage of 0.6 g / kg).

[0109] 2.3 Administration

[0110] The mice were intragastrically administered at a volume of 10 mL / kg. The blank and model groups were given corresponding volumes of pure water for 9 consecutive days.

[0111] 2.4 Animal models

[0112] After the experimental animals were grouped, oral administration began. On the 7th day after administration, the animals were anesthetized with isoflurane and disinfected locally with alcohol. Then, except for the blank group, the rats underwent right posterior ankle joint injection surgery, and 0.1 ml of 50 mg / ml sodium urate suspension was injected into the ankle joint cavity of the rats. The blank group rats were injected with an equal amount of solvent.

[0113] 2.5 Observation indicators

[0114] (1) Determination of joint swelling: Before modeling and about 24 h and 48 h after modeling, the ankle diameter of rats was measured with a vernier caliper to observe changes in joint swelling and calculate the 48 h swelling inhibition rate.

[0115] Swelling degree = diameter after modeling - diameter before modeling

[0116] Swelling inhibition rate % = (joint swelling degree of drug administration group - joint swelling degree of model group) / joint swelling degree of model group × 100

[0117] (2) Pain test: On the day after modeling, the plantar pain threshold of rats was measured and the pain inhibition rate was calculated.

[0118] Pain inhibition rate % = (pain threshold of drug administration group - pain threshold of model group) / pain threshold of model group × 100

[0119] 3 Results

[0120] (1) Joint swelling (see Table 4 for details)

[0121] Compared with the blank group, the swelling of the ankle joints of rats in the model group increased significantly 24h and 48h after injection of sodium urate (P<0.01).

[0122] Compared with the model group: the swelling of the positive drug diclofenac sodium group and the example group was significantly reduced at 24h and 48h after modeling (P<0.05 or P<0.01); the swelling of the comparative example 2 and comparative example 4 groups was significantly reduced only after 24h (P<0.05); although the swelling of the comparative example 1 and comparative example 3 groups was reduced, there was no statistical difference (P>0.05).

[0123] Compared with the example groups: only the swelling degree of comparative example 3 at 48h increased significantly (P<0.05).

[0124] Arranged from high to low by joint swelling inhibition rate: Western medicine control diclofenac sodium > Example > Comparative Example 4 Tongfengshu Capsules > Comparative Example 1 > Comparative Example 2 > Comparative Example 3.

[0125] Table 4: Joint swelling in rat gouty arthritis model

[0126] Group N 24h swelling Swelling after 48 hours 48h swelling inhibition rate Blank group 10 0.013±0.007 0.010±0.012 —— Model Group 10 0.263±0.046## 0.132±0.044## —— Western medicine control (diclofenac sodium) 10 0.157±0.069** 0.085±0.051* 35.6％ Example 10 0.185±0.072** 0.092±0.039* 30.3％ Comparative Example 1 10 0.219±0.065 0.107±0.073 18.9％ Comparative Example 2 10 0.211±0.062* 0.119±0.042 9.8％ Comparative Example 3 10 0.222±0.060 0.127±0.032△ 3.8％ Comparative Example 4 (commercially available Chinese medicine) 10 0.199±0.065* 0.101±0.027 23.5％

[0127] Note: Comparison between model group and normal group: ##P<0.01; Comparison between drug administration group and model group: *P<0.05, **P<0.01; Comparison between comparative example and embodiment: △P<0.05.

[0128] (2) Pain threshold (see Table 5 for details)

[0129] Compared with the blank group, the plantar pain threshold of rats in the model group was significantly reduced (P<0.01).

[0130] Compared with the model group: the pain thresholds of the positive drug diclofenac sodium group, the example group, the ratio group 1, and the comparative example group 4 were significantly increased (P<0.05 or P<0.01); although the pain threshold of the comparative example group 2 was increased, there was no statistical difference (P>0.05).

[0131] Compared with the example group: the pain threshold of comparative example 3 was significantly reduced (P<0.05).

[0132] Arranged from high to low by pain suppression rate: Western medicine control diclofenac sodium > Example > Comparative Example 4 Tongfengshu Capsules > Comparative Example 1 > Comparative Example 2 > Comparative Example 3.

[0133] Table 5: Changes in pain threshold in rat gouty arthritis model

[0134] Group N Pain threshold(s) Pain suppression rate Blank group 10 26.67±7.66 —— Model Group 10 8.88±2.13## —— Western medicine control (diclofenac sodium) 10 13.60±3.16** 53.2％ Example 10 12.01±2.01** 35.2％ Comparative Example 1 10 11.37±2.82* 28.0％ Comparative Example 2 10 11.09±2.73 24.9％ Comparative Example 3 10 9.92±2.27△ 11.7％ Comparative Example 4 (commercially available Chinese medicine) 10 11.46±3.03* 29.1％

[0135] Note: Comparison between model group and normal group: ##P<0.01; Comparison between drug administration group and model group: *P<0.05, **P<0.01; Comparison between comparative example and embodiment: △P<0.05.

[0136] 4 Conclusion

[0137] This experiment uses sodium urate injection into the ankle joint of rats to observe the effects of each test drug on acute gouty arthritis in rats. The test results show that each test drug can reduce ankle swelling to a certain extent and increase the pain threshold of the sole of the foot. Except for the Western medicine control drug diclofenac sodium, the effect of the example group is the most significant.

Claims

1. A Chinese medicine composition for treating hyperuricemia, characterized in that: Calculated by weight, the traditional Chinese medicine composition consists of 5-9 parts of coix seeds, 6-10 parts of lycopodiella ciliata, 3-8 parts of clematis root, 5-10 parts of siegetable herb and 1-4 parts of corydalis yanhusuo.

2. The Chinese medicine composition according to claim 1, characterized in that: Calculated by weight, the traditional Chinese medicine composition consists of 5 parts of coix seeds, 10 parts of lycopodiella ciliata, 3 parts of clematis root, 10 parts of siegetable herb and 1 part of yanhusuo.

3. The Chinese medicine composition according to claim 1, characterized in that Calculated by weight, the traditional Chinese medicine composition consists of 9 parts of coix seeds, 6 parts of lycopodiella ciliata, 8 parts of clematis root, 5 parts of siegetable herb and 4 parts of yanhusuo.

4. The Chinese medicine composition according to claim 1, characterized in that: Calculated by weight, the traditional Chinese medicine composition consists of 7 parts of coix seeds, 8 parts of lycopodiella ciliata, 5 parts of clematis root, 7 parts of siegetable herb and 3 parts of yanhusuo.

5. The method for preparing the active ingredient of the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The preparation method adopts a water decoction method.

6. The method for preparing the active ingredient according to claim 5, characterized in that: The water decoction method is as follows: adding water of 8 to 10 times the mass of the traditional Chinese medicine composition, soaking for 0.2 to 1 hour, decocting 1 to 3 times, each time for 1 to 2.5 hours, filtering the decoction, and concentrating it into a thick paste; drying the thick paste to obtain a dry paste, crushing it, and sieving it to obtain a dry powder.

7. The method for preparing the active ingredient according to claim 6, characterized in that: The relative density of the thick paste is 1.15-1.30; the drying is reduced pressure drying at a temperature of 60°C-80°C.

8. A drug for treating hyperuricemia, characterized in that: The medicine comprises the active ingredient according to claim 5.

9. The drug according to claim 8, characterized in that The dosage form of the medicine is oral preparation or injection.

10. The drug according to claim 9, characterized in that The oral preparations are tablets, granules, capsules, oral liquids, pills, suspensions, and syrups.

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