Traditional Chinese medicine composition for treating hyperuricemia and gout, preparation method and application

Abstract

The application discloses a traditional Chinese medicine composition for treating hyperuricemia and gout, a preparation method and application thereof, and can effectively reduce blood uric acid level, relieve gouty arthritis, and has good analgesic effect, and the curative effect is better than that of a commonly used western medicine in clinic; raw materials used are low in price, and the preparation process is simple, so that the medicine cost is greatly reduced. The traditional Chinese medicine composition for treating hyperuricemia and gout is prepared from the following raw materials in parts by weight: Huangqi 3-12 parts by weight, Huanglian 1.5-6 parts by weight, Huangbai 1.5-6 parts by weight, Zhizi 2-8 parts by weight, Chaihu 3-12 parts by weight, Lianqiao 2-8 parts by weight, and Baishao 2-8 parts by weight.

Description

Technical Field

[0001] This invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating hyperuricemia and gout, a method for preparing this traditional Chinese medicine composition for treating hyperuricemia and gout, and the application of this traditional Chinese medicine composition in the treatment of hyperuricemia and gout. Background Technology

[0002] Gout is a metabolic disease associated with purine metabolism disorder or uric acid excretion disorder. The incidence rate in China is 1.1%. Characteristic manifestations include hyperuricemia, redness, swelling, heat and pain in the joints, and deposition of urate crystals in the joints. The condition recurs frequently and may lead to tophi and deformities of the affected joints.

[0003] Hyperuricemia is a metabolic disease with a global incidence rate of 5%-25%, and an incidence rate of over 10% in China. With the improvement of living standards, the intake of high-calorie, high-fat, and high-protein foods has increased, leading to a gradual increase in the incidence of hyperuricemia, which is showing a trend towards affecting younger people. The disease is prone to recurrence and seriously endangers human health.

[0004] Uric acid is a normal metabolite in the body. Serum uric acid levels range from 149-416 μM in men and 89-357 μM in women. Clinically, the diagnostic criteria for hyperuricemia are: fasting serum uric acid levels >416.0 μM in men and >356.9 μM in women. Hyperuricemia can cause gout and kidney damage, and is a significant risk factor for diabetes, hypertension, and cardiovascular disease. When serum uric acid levels are consistently above 6.0 mg / dL, sodium urate crystals may deposit in joints and soft tissues, inducing acute arthritis and becoming a key factor in gout. Without treatment, approximately 12% of patients with hyperuricemia will develop tophi after 5 years, and the probability of developing tophi after 20 years is 55%.

[0005] Lowering blood uric acid levels and treating acute gouty arthritis are two strategies for preventing and treating gout. Lowering blood uric acid, addressing the underlying cause of gout, has become an effective treatment method. Currently, medications for lowering uric acid include: ① xanthine oxidase inhibitors such as allopurinol and febuxostat, which inhibit uric acid production; ② uricosuric agents such as probenecid and benzbromarone, which promote uric acid excretion. Commonly used medications for acute gouty arthritis include: nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine, glucocorticoids, and analgesics. The use of allopurinol and febuxostat is restricted due to the risk of kidney damage or cardiovascular death; uricosuric drugs such as benzbromarone can cause hyponatremia, hypokalemia, and hypocalcemia, and can also damage the liver and kidneys, making them unsuitable for long-term use; NSAIDs, colchicine, and glucocorticoids for acute gouty arthritis are also unsuitable for long-term use. Therefore, there is an urgent need to develop safe, effective, and long-term medications that lower uric acid and relieve gouty arthritis. Summary of the Invention

[0006] To overcome the shortcomings of the prior art, the technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for treating hyperuricemia and gout, which can effectively reduce blood uric acid levels, relieve gouty arthritis, and has a good analgesic effect. Its efficacy is better than that of commonly used Western medicines. The raw materials used are inexpensive and the preparation process is simple, which greatly reduces the cost of the medicine.

[0007] The technical solution of the present invention is: This traditional Chinese medicine composition for treating hyperuricemia and gout is made from the following raw materials in parts by weight: Scutellaria baicalensis 3-12 parts by weight, Coptis chinensis 1.5-6 parts by weight, Phellodendron chinense 1.5-6 parts by weight, Gardenia jasminoides 2-8 parts by weight, Bupleurum chinense 3-12 parts by weight, Forsythia suspensa 2-8 parts by weight, and Paeonia lactiflora 2-8 parts by weight.

[0008] The traditional Chinese medicine composition of this invention can reduce hyperuricemia and relieve gout. The raw materials used are highly safe, and long-term use will not produce adverse reactions. It effectively lowers blood uric acid levels, relieves gouty arthritis, and has a good analgesic effect, with efficacy superior to commonly used Western medicines. The traditional Chinese medicine composition of this invention is prepared into a formulation using conventional methods. The raw materials used are inexpensive, and the preparation process is simple, greatly reducing drug costs.

[0009] The invention also provides a method for preparing this traditional Chinese medicine composition for treating hyperuricemia and gout. The traditional Chinese medicine composition is formed by mixing the raw materials after pulverizing them, or by extracting the raw materials by mixing or extracting them individually, or by further refining and purifying the extract to obtain the effective fraction, or by adding pharmaceutically acceptable excipients to the extract / effective fraction to form a conventional dosage form.

[0010] It also provides the use of traditional Chinese medicine compositions for treating hyperuricemia and gout in the preparation of medicaments for treating hyperuricemia and / or gout. Attached Figure Description

[0011] Figure 1 The results of pathological examination of mice in each group in Example 19 are shown in ×100. Among them, AH represents the pathological images of the normal control group, model group, prescription group 1, prescription group 2, prescription group 3, febuxostat group, benzbromarone group, and gout relief tablet group, respectively. Detailed Implementation

[0012] Pharmacological studies have shown that the traditional Chinese medicine composition of this invention can effectively reduce blood uric acid levels, relieve gouty arthritis, and has a good analgesic effect, with efficacy superior to commonly used Western medicines.

[0013] In response to the pathogenesis of gouty arthritis, this invention initially screened various drugs, such as those with heat-clearing and dampness-drying effects, such as Scutellaria baicalensis, Coptis chinensis, Phellodendron chinense, and Sophora flavescens; those with heat-clearing and detoxifying effects, such as Lonicera japonica, Forsythia suspensa, Cremastra appendiculata, and Gardenia jasminoides; those with liver-soothing and qi-regulating effects, such as Bupleurum chinense and Cyperus rotundus; those with blood-nourishing and blood-activating effects, such as Paeonia lactiflora, Angelica sinensis, Ligusticum chuanxiong, and Salvia miltiorrhiza; and those with diuretic and dampness-draining effects, such as Poria cocos, Coix lacryma-jobi, Alisma plantago-aquatica, and Artemisia capillaris.

[0014] Through screening, the specific herbal composition of this invention was finally obtained, namely, Scutellaria baicalensis, Coptis chinensis, Phellodendron chinense, stir-fried Gardenia jasminoides, Bupleurum chinense, Forsythia suspensa, and Paeonia lactiflora. Forsythia suspensa is the chief herb in this formula, clearing heat and detoxifying, eliminating carbuncles and dissipating nodules. It can enter the blood to "clear heat and transform qi," treating damp-heat that has accumulated in the blood for a long time. It can also travel through the meridians, joints, skin, muscles, and tendons, dispersing accumulated turbid toxins to relieve pain and numbness. It is most suitable for treating local redness, swelling, heat, and pain in joints, especially at night, hence it is the chief herb. Scutellaria baicalensis, Coptis chinensis, Phellodendron chinense, and Gardenia jasminoides purge the fire toxins that are congested in the triple burner, and their bitter and cold properties directly counteract excessive heat, serving as assistant herbs. Bupleurum chinense, which is bitter, pungent, and slightly cold, and Paeonia lactiflora, which is bitter, sour, and slightly cold, are added to soothe the liver, soften tendons, relieve spasms, and stop pain, assisting in the treatment of pain and limited mobility in gouty arthritis. The combination of these herbs has the functions of clearing heat, drying dampness, detoxifying, reducing swelling, and relieving pain. It is used for damp-heat and turbid toxins obstructing the joints, causing local redness, swelling, heat, and pain in the joints due to excessive heat in the triple burner. It may be accompanied by irritability, flushed face and red eyes, dry mouth and throat, excessive sweating and halitosis, and dark and scanty urine; red tongue with yellow or yellow-greasy coating, and a wiry and slippery or wiry and rapid pulse. It is also used for patients with the above symptoms during the acute phase of hyperuricemia and gouty arthritis.

[0015] The combination of Bupleurum and White Peony has the following two effects: First, both enter the Liver meridian. When used together, they nourish Liver blood, astringe Liver Yin, soothe Liver stagnation, and regulate Liver Qi, conforming to the physiological characteristic of the Liver being "Yin in substance and Yang in function." Furthermore, the Liver governs the tendons, and the knee is the junction of tendons; when tendons are supple, limbs move freely. Therefore, Bupleurum combined with White Peony can soothe the Liver, soften tendons, relieve spasms and pain, thus assisting in the treatment of pain and limited mobility in gouty arthritis. Second, most of the herbs in the formula are bitter and cold, which can hinder the rising Qi of the Lesser Yang and impede the circulation of Qi and blood. Bupleurum and White Peony, both slightly cold in nature, can both raise the Qi of the Liver and Gallbladder to regulate Qi and blood, without the risk of the dispersing herbs causing the blood to boil excessively. This combination has a counteracting effect, which is a unique feature of this invention.

[0016] This traditional Chinese medicine composition for treating hyperuricemia and gout is made from the following raw materials in parts by weight: Scutellaria baicalensis 3-12 parts by weight, Coptis chinensis 1.5-6 parts by weight, Phellodendron chinense 1.5-6 parts by weight, Gardenia jasminoides 2-8 parts by weight, Bupleurum chinense 3-12 parts by weight, Forsythia suspensa 2-8 parts by weight, and Paeonia lactiflora 2-8 parts by weight.

[0017] The traditional Chinese medicine composition of this invention can reduce hyperuricemia and relieve gout. The raw materials used are highly safe, and long-term use will not produce adverse reactions. It effectively lowers blood uric acid levels, relieves gouty arthritis, and has a good analgesic effect, with efficacy superior to commonly used Western medicines. The traditional Chinese medicine composition of this invention is prepared into a formulation using conventional methods. The raw materials used are inexpensive, and the preparation process is simple, greatly reducing drug costs.

[0018] Preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 4-8 parts by weight of Scutellaria baicalensis, 2-4 parts by weight of Coptis chinensis, 2-4 parts by weight of Phellodendron chinense, 3-6 parts by weight of Gardenia jasminoides, 4-8 parts by weight of Bupleurum chinense, 3-6 parts by weight of Forsythia suspensa, and 3-6 parts by weight of Paeonia lactiflora.

[0019] Preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 6 parts Scutellaria baicalensis, 3 parts Coptis chinensis, 3 parts Phellodendron chinense, 4 parts Gardenia jasminoides, 6 parts Bupleurum chinense, 4 parts Forsythia suspensa, and 4 parts Paeonia lactiflora.

[0020] Alternatively, the traditional Chinese medicine composition may be made from the following raw materials in parts by weight: 5 parts Scutellaria baicalensis, 3.5 parts Coptis chinensis, 2.5 parts Phellodendron chinense, 5.5 parts Gardenia jasminoides, 4.5 parts Bupleurum chinense, 5.5 parts Forsythia suspensa, and 3.5 parts Paeonia lactiflora.

[0021] Alternatively, use 7 parts by weight of Scutellaria baicalensis, 2.5 parts by weight of Coptis chinensis, 3.5 parts by weight of Phellodendron chinense, 3 parts by weight of Gardenia jasminoides, 7 parts by weight of Bupleurum chinense, 3 parts by weight of Forsythia suspensa, and 5 parts by weight of Paeonia lactiflora.

[0022] Preferably, the gardenia is stir-fried gardenia.

[0023] The invention also provides a method for preparing this traditional Chinese medicine composition for treating hyperuricemia and gout. The traditional Chinese medicine composition is formed by mixing the raw materials after pulverizing them, or by extracting the raw materials by mixing or extracting them individually, or by further refining and purifying the extract to obtain the effective fraction, or by adding pharmaceutically acceptable excipients to the extract / effective fraction to form a conventional dosage form.

[0024] Preferably, the extraction includes: decoction extraction, reflux extraction, maceration extraction, ultrasonic extraction, percolation extraction, and microwave extraction; the purification includes: water extraction and alcohol precipitation, alkali dissolution and acid precipitation, and various column chromatography purification methods; the conventional dosage forms include: capsules, tablets, granules, gels, sustained-release agents, oral liquids, pills, or nano-preparations; the pharmaceutically acceptable excipients include: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, and matrices; the fillers include: starch, pregelatinized starch, and emulsions. The ingredients include sugar, mannitol, chitosan, microcrystalline cellulose, and sucrose; the disintegrants include starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, croscarmellose, low-substituted hydroxypropyl cellulose, and croscarmellose sodium; the lubricant includes magnesium stearate, sodium lauryl sulfate, talc, and silica; the suspending agent includes polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, and hydroxypropyl methylcellulose; and the binder includes starch paste, polyvinylpyrrolidone, and hydroxypropyl methylcellulose.

[0025] Preferably, the extract is an aqueous extract of each active pharmaceutical ingredient, or an organic solvent extract, or a purified product obtained by further refining and purifying an aqueous extract / organic solvent extract; the organic solvent is selected from one or more of methanol, 20-95% ethanol solution, and acetone.

[0026] It also provides the use of traditional Chinese medicine compositions for treating hyperuricemia and gout in the preparation of medicaments for treating hyperuricemia and / or gout.

[0027] The embodiments of the present invention will be described in detail below.

[0028] Example 1

[0029] Formula: Scutellaria baicalensis 6g, Coptis chinensis 3g, Phellodendron chinense 3g, stir-fried Gardenia jasminoides 4g, Bupleurum chinense 6g, Forsythia suspensa 4g, Paeonia lactiflora 4g;

[0030] Take each raw material according to the proportion, crush it, and pass it through 80-mesh and 100-mesh sieves to obtain fine powder; add water at a ratio of 2:1, and make coarse pills through a pill-making machine; after polishing and drying, obtain Chinese medicine combination pills with a particle size of 4.0-4.5mm.

[0031] Example 2

[0032] Formula: Scutellaria baicalensis 5g, Coptis chinensis 3.5g, Phellodendron chinense 2.5g, stir-fried Gardenia jasminoides 5.5g, Bupleurum chinense 4.5g, Forsythia suspensa 5.5g, Paeonia lactiflora 3.5g.

[0033] Take the raw materials according to the specified proportions, crush them, and make them into capsules according to conventional pharmaceutical processes.

[0034] Example 3

[0035] Formula: Scutellaria baicalensis 7g, Coptis chinensis 2.5g, Phellodendron chinense 3.5g, stir-fried Gardenia jasminoides 3g, Bupleurum chinense 7g, Forsythia suspensa 3g, Paeonia lactiflora 5g.

[0036] Take the raw materials according to the specified proportions, pulverize them, and make them into tablets according to conventional pharmaceutical processes.

[0037] Example 4

[0038] Formula: Scutellaria baicalensis 7g, Coptis chinensis 3g, Phellodendron chinense 3g, stir-fried Gardenia jasminoides 4g, Bupleurum chinense 7g, Forsythia suspensa 4g, Paeonia lactiflora 4g.

[0039] Take the raw materials according to the proportions, crush them, and make them into powder according to conventional pharmaceutical processes.

[0040] Example 5

[0041] Formula: Scutellaria baicalensis 8g, Coptis chinensis 4g, Phellodendron chinense 4g, stir-fried Gardenia jasminoides 4g, Bupleurum chinense 8g, Forsythia suspensa 4g, Paeonia lactiflora 4g.

[0042] Take each raw material according to the proportion, decoct in water to extract, and then use the decoction to make an oral liquid according to conventional preparation process.

[0043] Example 6

[0044] Formula: Scutellaria baicalensis 3.5g, Coptis chinensis 5.5g, Phellodendron chinense 1.5g, stir-fried Gardenia jasminoides 7.5g, Bupleurum chinense 3.5g, Forsythia suspensa 7.5g, Paeonia lactiflora 2g.

[0045] Take each raw material according to the proportion, decoct in water to extract, and then process the decoction into granules according to conventional pharmaceutical processes.

[0046] Example 7

[0047] Formula: Scutellaria baicalensis 10g, Coptis chinensis 1.5g, Phellodendron chinense 5g, stir-fried Gardenia jasminoides 2g, Bupleurum chinense 10g, Forsythia suspensa 2g, Paeonia lactiflora 7g.

[0048] Take each raw material according to the proportion, add 75% ethanol and reflux to extract, and make capsules from the extract according to conventional pharmaceutical processes.

[0049] Example 8

[0050] Formula: Scutellaria baicalensis 4g, Coptis chinensis 4.5g, Phellodendron chinense 2g, stir-fried Gardenia jasminoides 6.5g, Bupleurum chinense 4g, Forsythia suspensa 6.5g, Paeonia lactiflora 2.5g.

[0051] Take each raw material according to the proportion, add 75% ethanol for reflux extraction, and make tablets from the extract according to conventional pharmaceutical processes.

[0052] Example 9

[0053] Formula: Scutellaria baicalensis 9g, Coptis chinensis 2g, Phellodendron chinense 4.5g, stir-fried Gardenia jasminoides 2.5g, Bupleurum chinense 9g, Forsythia suspensa 2.5g, Paeonia lactiflora 6.5g.

[0054] Take each raw material according to the proportion, add 75% ethanol and reflux to extract, and make the extract into pills according to conventional preparation process.

[0055] Example 10

[0056] Formula: Scutellaria baicalensis extract 6g, Coptis chinensis extract 3g, Phellodendron chinense extract 3g, Gardenia jasminoides extract 4g, Bupleurum chinense extract 6g, Forsythia suspensa extract 4g, Paeonia lactiflora extract 4g.

[0057] Example 11

[0058] Formula: Scutellaria baicalensis extract 5g, Coptis chinensis extract 3.5g, Phellodendron chinense extract 2.5g, Gardenia jasminoides extract 5.5g, Bupleurum chinense extract 4.5g, Forsythia suspensa extract 5.5g, Paeonia lactiflora extract 3.5g.

[0059] Example 12

[0060] Formula: Scutellaria baicalensis extract 7g, Coptis chinensis extract 2.5g, Phellodendron chinense extract 3.5g, Gardenia jasminoides extract 3g, Bupleurum chinense extract 7g, Forsythia suspensa extract 3g, Paeonia lactiflora extract 5g.

[0061] Example 13

[0062] Formula: Scutellaria baicalensis extract 7g, Coptis chinensis extract 3g, Phellodendron chinense extract 3g, Gardenia jasminoides extract 4g, Bupleurum chinense extract 7g, Forsythia suspensa extract 4g, Paeonia lactiflora extract 4g.

[0063] Example 14

[0064] Formula: Scutellaria baicalensis extract 8g, Coptis chinensis extract 4g, Phellodendron chinense extract 4g, Gardenia jasminoides extract 4g, Bupleurum chinense extract 8g, Forsythia suspensa extract 4g, Paeonia lactiflora extract 4g.

[0065] Example 15

[0066] Formula: Scutellaria baicalensis extract 3.5g, Coptis chinensis extract 5.5g, Phellodendron chinense extract 1.5g, Gardenia jasminoides extract 7.5g, Bupleurum chinense extract 3.5g, Forsythia suspensa extract 7.5g, Paeonia lactiflora extract 2g.

[0067] Example 16

[0068] Formula: Scutellaria baicalensis extract 10g, Coptis chinensis extract 1.5g, Phellodendron chinense extract 5g, Gardenia jasminoides extract 2g, Bupleurum chinense extract 10g, Forsythia suspensa extract 2g, Paeonia lactiflora extract 7g.

[0069] Example 17

[0070] Formulation: 4 g of Scutellaria baicalensis extract, 4.5 g of Coptis chinensis extract, 2 g of Phellodendron amurense extract, 6.5 g of stir-fried Gardenia jasminoides Ellis extract, 4 g of Bupleurum chinense extract, 6.5 g of Forsythia suspensa extract, 2.5 g of Paeonia lactiflora Pall extract.

[0071] Example 18

[0072] Formulation: 9 g of Scutellaria baicalensis extract, 2 g of Coptis chinensis extract, 4.5 g of Phellodendron amurense extract, 2.5 g of stir-fried Gardenia jasminoides Ellis extract, 9 g of Bupleurum chinense extract, 2.5 g of Forsythia suspensa extract, 6.5 g of Paeonia lactiflora Pall extract.

[0073] The extracts described in Examples 10 - 18 above are respectively water extracts of each raw material medicine. After the extracts are combined according to the formula amount, they are prepared into conventional oral dosage forms such as tablets, capsules, or granules according to the conventional preparation process.

[0074] Example 19 Influence of the traditional Chinese medicine composition of the present invention on the acute gouty arthritis model

[0075] 1 Experimental purpose: An acute gouty arthritis mouse model was established by the method of "injecting sodium urate into the left ankle joint" (Experimental study on Danxi gout formula for acute gouty arthritis in mice [J]. Acta Chinese Medicine and Pharmacology, 2015, 43(01): 59 - 62), and the influence of each prescription on acute gouty arthritis in mice was observed.

[0076] 2 Experimental materials

[0077] 2.1 Experimental animals

[0078] 160 healthy KM mice, male, 18 - 20 g, SPF grade, purchased from Spf(Beijing) Biotechnology Co., Ltd., license number: scxk(Beijing) 2019 - 0010.

[0079] 2.2 Test drugs

[0080] Prescription 1: 6 g of Scutellaria baicalensis, 3 g of Coptis chinensis, 3 g of Phellodendron amurense, 4 g of stir-fried Gardenia jasminoides Ellis, mixed in proportion, pulverized, and passed through an 80-mesh sieve.

[0081] Prescription 2: 6 g of Bupleurum chinense, 4 g of Forsythia suspensa, 4 g of Paeonia lactiflora Pall, mixed in proportion, pulverized, and passed through an 80-mesh sieve.

[0082] Prescription 3: 6 g of Scutellaria baicalensis, 3 g of Coptis chinensis, 3 g of Phellodendron amurense, 4 g of stir-fried Gardenia jasminoides Ellis, 6 g of Bupleurum chinense, 4 g of Forsythia suspensa, 4 g of Paeonia lactiflora Pall, mixed in proportion, pulverized, and passed through an 80-mesh sieve.

[0083] Preparation method:

[0084] Weigh 16.25 mg of the medicinal powder respectively, add purified water to 50 ml, mix well, and use it as the solutions of Prescription 1, Prescription 2, and Prescription 3.

[0085] Administer via gavage at a dose of 20 ml / kg body weight. The dosage for prescription groups 1, 2, and 3 is 6.5 mg crude drug / kg.

[0086] Positive drug:

[0087] Benzbromarone tablets: Hermann Pharmaceuticals, Germany; Batch number: 2112357; Specification: 50mg;

[0088] Febuxostat tablets: Jiangsu Wanbang Biochemical Pharmaceutical Group Co., Ltd., batch number: 623117051, specification: 40mg;

[0089] Gout Relief Tablets: Guizhou Kehui Pharmaceutical Co., Ltd., Batch No.: 230802, Specification: 0.35g per tablet;

[0090] Preparation method:

[0091] ① Dissolve one benzbromarone tablet in water to obtain a 0.5 mg / ml solution. The administration volume is 20 ml / kg body weight. The dosage for mice is 10 mg / kg.

[0092] ② Dissolve one febuxostat tablet in water to obtain a 0.52 mg / ml solution. The administration volume is 20 ml / kg body weight. The dose for mice is 10.4 mg / kg.

[0093] ③ Dissolve one Gout Relief Tablet in water to obtain a 27.3 mg / ml solution. The administration volume is 20 ml / kg body weight. The dose for mice is 546 mg / kg.

[0094] 2.3 Reagents

[0095] Sodium urate: Sigma, Product No.: U2875-100G

[0096] 3 Experimental Methods

[0097] 3.1 Grouping, Modeling, and Drug Administration

[0098] Eighty male KM mice, weighing 18-20g, were acclimatized for three days and randomly divided into four groups (n=10 per group): a normal control group, a model group, prescription group 1, prescription group 2, prescription group 3, febuxostat group, benzbromarone tablet group, and gout relief tablet group. Each group received pre-treatment for 7 days. One hour after the last administration, 30 μl of sodium urate suspension was injected intra-articularly into the left ankle joint of each mouse. The control group received physiological saline. Eighteen hours after model establishment, blood was collected from the eyeballs, and the ankle joints of the mice were harvested for pathological examination and ELISA detection of IL-6.

[0099] Eighty male KM mice, weighing 18-20g, were acclimatized for three days and randomly divided into four groups (n=10 per group): a normal control group, a model group, prescription group 1, prescription group 2, prescription group 3, febuxostat group, benzbromarone tablet group, and gout relief tablet group. Each group received pre-treatment for 7 days. One hour after the last administration, 30 μl of sodium urate suspension was injected intra-articularly into the left ankle joint cavity of each mouse. The control group received physiological saline. The diameter of the left ankle joint was measured before modeling and at 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours after modeling. Swelling was calculated.

[0100] 3.2 Statistical Analysis Methods

[0101] The data table is expressed as mean ± standard deviation. The data were tested using SPSS 21.0 software, and the independent samples Mann-Whitney U test was used for statistical processing in nonparametric statistics. P < 0.05 was considered statistically significant.

[0102] 4 Experimental Results

[0103] 4.1 Pathological examination results of mouse ankle joints

[0104] 4.1.1 Evaluation Criteria

[0105] Table 1 Evaluation Criteria

[0106]

[0107] Note: The evaluation criteria are based on the International Standard for Terminology and Diagnostic Criteria of Pathological Changes in Rats and Mice (INHAND) [M], translated by Yang Lifeng, Zhou Xiangmei, and Zhao Deming. Beijing: China Agriculture Press, 2019.

[0108] 4.1.2 Pathological examination results

[0109] The results are shown in Table 2. Figure 1 Seven days after modeling, HE staining was performed on the ankle joints of mice. In the control group, the cartilage surface was smooth and flat, the chondrocytes were evenly distributed and neatly arranged, the layers were clear, the synovial structure was normal, and no hyperplasia or inflammatory cell infiltration was observed. No secretions were observed in the joint cavity. In the model group, the joint surface structure was intact, the cartilage surface was smooth and flat, the chondrocytes were evenly distributed and neatly arranged, synovial hyperplasia and synovial vascularization were accompanied by inflammatory cell infiltration, and a large amount of fibrous inflammatory exudate was visible in the joint cavity. Compared with the model group, the joint pathological damage of mice in prescription 1, prescription 2, prescription 3, febuxostat group and gout relief tablet group was reduced to varying degrees, and the pathological scores of prescription 3 and gout relief tablet group were significantly reduced (P<0.05).

[0110] Table 2. Pathological scoring of ankle joints in mice of each group.

[0111]

[0112]

[0113] *Compared with the model group, P<0.05; △ Compared with the control group, P<0.05.

[0114] 4.2 IL-6 test results

[0115] The results are shown in Table 3. Compared with the control group, the serum IL-6 level in the model group mice was significantly increased (P<0.05); compared with the model group, the serum IL-6 level in the prescription group 3, febuxostat tablet group, benzbromarone tablet group, and gout relief tablet group mice was significantly decreased (P<0.05).

[0116] Table 3. Serum IL-6 levels in mice of each group ( n=10)

[0117]

[0118] *Compared with the model group, P<0.05; △ Compared with the control group, P<0.05.

[0119] 4.3 Results of swelling of the left ankle joint in mice

[0120] The results are shown in Tables 4-1 and 4-2. In the model group, the swelling of the left ankle joint was significantly increased compared to the control group after injection of sodium urate, with significant differences at 6h, 12h, 24h, 48h, 72h, 96h, and 120h after administration (P<0.05). Compared to the model group, prescription one significantly reduced swelling at 48h, 72h, 96h, and 120h after administration (P<0.05); prescription two significantly reduced swelling at 12h, 48h, 72h, 96h, and 120h after administration (P<0.05); prescription three significantly reduced swelling at 6h, 1... Swelling was significantly reduced at 2h, 24h, 48h, 72h, 96h, and 120h (P<0.05); swelling was significantly reduced at 6h, 12h, 24h, 48h, 72h, 96h, and 120h after administration in the febuxostat group (P<0.05); swelling was significantly reduced at 12h, 48h, 72h, 96h, and 120h after administration in the benzbromarone group (P<0.05); and swelling was significantly reduced at 12h, 72h, 96h, and 120h after administration in the gout relief tablet group (P<0.05).

[0121] Table 4-1 Results of swelling of the left ankle joint of mice at different time points ( n=10)

[0122]

[0123] Table 4-2 Results of swelling degree of left ankle joint of mice at different time points( n = 10)

[0124]

[0125] The above experimental results show that the traditional Chinese medicine composition of the present invention can reduce the joint pathological damage of gouty arthritis mice and relieve joint swelling.

[0126] Example 20 Effect of the traditional Chinese medicine composition of the present invention on hyperuricemic animal models

[0127] 1 Experimental purpose

[0128] The method of "intraperitoneal injection of potassium oxonate" (Research on the intervention effect of Phyllanthus emblica freeze-dried powder on hyperuricemia and gout animal models [D]. Dali University, 2024) was used to establish a hyperuricemic mouse model, and the effect of the drug on the hyperuricemic mouse model was observed to determine its effect of reducing uric acid.

[0129] 2 Experimental materials

[0130] 2.1 Experimental animals

[0131] 80 healthy KM mice, male, 18 - 20 g, SPF grade, purchased from Beijing Spepharm Biotechnology Co., Ltd., license number: scxk(Beijing)2019 - 0010.

[0132] 2.2 Test drugs

[0133] Prescription 1: Scutellaria baicalensis 6 g, Coptis chinensis 3 g, Phellodendron amurense 3 g, stir-fried Gardenia jasminoides 4 g were mixed in proportion, pulverized, and passed through an 80-mesh sieve.

[0134] Prescription 2: Bupleurum chinense 6 g, Forsythia suspensa 4 g, Paeonia lactiflora 4 g were mixed in proportion, pulverized, and passed through an 80-mesh sieve.

[0135] Prescription 3: Scutellaria baicalensis 6 g, Coptis chinensis 3 g, Phellodendron amurense 3 g, stir-fried Gardenia jasminoides 4 g, Bupleurum chinense 6 g, Forsythia suspensa 4 g, Paeonia lactiflora 4 g were mixed in proportion, pulverized, and passed through an 80-mesh sieve.

[0136] Preparation method:

[0137] Weigh 16.25 mg of the powder respectively, add purified water to 50 ml, and mix well to obtain the solutions of Prescription 1, Prescription 2, and Prescription 3.

[0138] Administer the drugs by gavage at a dose of 按照20ml / kg体重灌胃给药. The administration doses of Prescription 1, Prescription 2, and Prescription 3 groups are 6.5 mg crude drug / kg. 0]

[0139] Positive drug: 4]

[0140] Benzbromarone tablets: Hermann Pharmaceuticals, Germany; Batch number: 2112357; Specification: 50mg;

[0141] Febuxostat tablets: Jiangsu Wanbang Biochemical Pharmaceutical Group Co., Ltd., batch number: 623117051, specification: 40mg;

[0142] Gout Relief Tablets: Guizhou Kehui Pharmaceutical Co., Ltd., Batch No.: 230802, Specification: 0.35g per tablet.

[0143] Preparation method:

[0144] ① Dissolve one benzbromarone tablet in water to obtain a 0.5 mg / ml solution. The administration volume is 20 ml / kg body weight. The dosage for mice is 10 mg / kg.

[0145] ② Dissolve one febuxostat tablet in water to obtain a 0.52 mg / ml solution. The administration volume is 20 ml / kg body weight. The dose for mice is 10.4 mg / kg.

[0146] ③ Dissolve one Gout Relief Tablet in water to obtain a 27.3 mg / ml solution. The administration volume is 20 ml / kg body weight. The dose for mice is 546 mg / kg.

[0147] 2.3 Reagents

[0148] Potassium oxazine: Shanghai Maclean Biochemical Technology Co., Ltd., batch number: C14819603.

[0149] 3 Experimental Methods

[0150] 3.1 Grouping, Modeling, and Drug Administration

[0151] Eighty male KM mice were acclimatized for 3 days and randomly divided into four groups (n=10 per group): a normal control group, a model group, prescription group 1, prescription group 2, prescription group 3, febuxostat group, benzbromarone group, and gout relief group. Each group received the corresponding drug via gavage daily, while the normal and model groups received an equal volume of purified water via gavage for 7 consecutive days. Except for the normal group, all other animals underwent intraperitoneal injection of potassium oxonate at 300 mg / kg 1 hour after drug administration to induce the model. One hour after the last model initiation, blood was collected, and the supernatant was obtained by centrifugation. Serum uric acid (UA) and creatinine (Cr) levels were measured.

[0152] 3.2 Statistical Analysis Methods

[0153] The data table is expressed as mean ± standard deviation. The data were tested using SPSS 21.0 software, and the independent samples Mann-Whitney U test was used for statistical processing in nonparametric statistics. P < 0.05 was considered statistically significant.

[0154] 4 Experimental Results

[0155] The results are shown in Table 5. Compared with the control group, the levels of UA and Cr in the serum of mice in the model group were significantly increased (P<0.05), indicating the successful establishment of the model. Compared with the model group, the levels of UA and Cr in the serum of mice in Prescription Group 3, Febuxostat Tablets Group, Benzbromarone Tablets Group, and Tongfengshu Tablets Group were significantly decreased (P<0.05).

[0156] Table 5 Results of UA and Cr Levels in the Serum of Mice in Each Group( n = 10)

[0157]

[0158]

[0159] *Compared with the model group, P<0.05; △ Compared with the control group, P<0.05.

[0160] The above experimental results indicate that the traditional Chinese medicine composition of the present invention has a certain effect of reducing uric acid.

[0161] Example 21 Antipyretic and Analgesic Experiment of the Traditional Chinese Medicine Composition of the Present Invention

[0162] (1) Influence on the analgesic effect of acetic acid-induced writhing animal model

[0163] 1 Experimental purpose: To establish a pain model in mice by intraperitoneal injection of 0.6% glacial acetic acid, and to observe the effect of the drug on the pain model in mice to determine its analgesic effect.

[0164] 2 Experimental materials

[0165] ​​​​​​​​​​​​​​​​​​​

[0172] Take 20 ml of the medium-dose solution and add purified water to make 40 ml. Mix well to obtain the low-dose solution.

[0173] The drug was administered via gavage at a dose of 20 ml / kg body weight. The dosages for the high, medium, and low dose groups were 13 mg crude drug / kg, 6.5 mg crude drug / kg, and 3.25 mg crude drug / kg, respectively.

[0174] Positive drug:

[0175] Ibuprofen sustained-release capsules: Jilin Lisheng Pharmaceutical Co., Ltd., specification: 0.3g, batch number: 20200913. The clinical daily dosage is 0.6g.

[0176] Preparation method:

[0177] Dissolve one capsule in water to obtain a 0.05 mg / ml solution. The administration volume is 0.2 ml / 10 g body weight. The dose for mice is 1 mg / kg.

[0178] 2.3 Reagents

[0179] Glacial acetic acid: analytical grade, Beijing Chemical Plant, batch number: 190507.

[0180] 3 Experimental Methods

[0181] 3.1 Grouping, Modeling, and Drug Administration

[0182] Sixty-six KM mice were randomly divided into six groups: a normal control group, a model group, high-, medium-, and low-dose experimental drug groups, and a positive control group, with 11 mice in each group. Animals in each drug-treated group were administered the corresponding drug via gavage, while the control group was administered an equal volume of purified water via gavage. The drugs were administered once daily for seven consecutive days. One hour after the last administration, all animals in each group were intraperitoneally injected with 0.6% glacial acetic acid. The number of writhing responses (defined as trunk and hind limb extension) and latency were recorded within 15 minutes of injection.

[0183] Analgesia rate = (Number of writhing responses in the control group - Number of writhing responses in the treatment group) / Number of writhing responses in the control group × 100%.

[0184] 3.2 Statistical Analysis Methods

[0185] The data table is expressed as mean ± standard deviation. The data were tested using SPSS 21.0 software, and the independent samples Mann-Whitney U test was used for statistical processing in nonparametric statistics. P < 0.05 was considered statistically significant.

[0186] 4 Experimental Results

[0187] The results are shown in Table 6. Compared with the model group, the writhing latency of mice in the medium-dose, low-dose groups of the experimental drug and the positive drug group was significantly increased (P<0.05); the number of writhing of mice in the high-dose, medium-dose, low-dose groups of the experimental drug and the positive drug group was significantly decreased (P<0.05).

[0188] Table 6 Effects of acetic acid on the number of writhing in mice( n = 11)

[0189]

[0190]

[0191] *Compared with the model group, P<0.05.

[0192] (2) Hot plate pain threshold experiment

[0193] 1 Experimental materials

[0194] 1.1 Experimental animals

[0195] 80 healthy KM mice, weighing 18 - 20 g, SPF grade, purchased from Spf (Beijing) Biotechnology Co., Ltd., license number: scxk (Beijing) 2019 - 0010.

[0196] 1.2 Test drugs

[0197] Experimental drug: Scutellaria baicalensis 6 g, Coptis chinensis 3 g, Phellodendron amurense 3 g, stir-fried Gardenia jasminoides 4 g, Bupleurum chinense 6 g, Forsythia suspensa 4 g, Paeonia lactiflora 4 g, mixed in proportion, pulverized, and passed through an 80-mesh sieve.

[0198] Preparation method: \

[0199] Weigh 55.25 mg of the powder, add purified water to 85 ml, and mix well to obtain the high-dose solution; \

[0200] Take 35 ml of the high-dose solution, add purified water to 70 ml, and mix well to obtain the medium-dose solution;

[0201] Take 20 ml of the medium-dose solution, add purified water to 40 ml, and mix well to obtain the low-dose solution.

[0202] Administer the drug by gavage at a dose of 20 ml / kg body weight. The administration doses of the high-dose, medium-dose, and low-dose groups are 13 mg crude drug / kg, 6.5 mg crude drug / kg, and 3.25 mg crude drug / kg, respectively.

[0203] Positive drug: Ibuprofen Sustained Release Capsules, Jilin Lisheng Pharmaceutical Co., Ltd., specification: 0.3 g, batch number: 20200913, clinical daily dosage: 0.6 g.

[0204] 2 Experimental methods

[0205] 2.1 Grouping, Modeling, and Drug Administration

[0206] Sixty KM mice were randomly divided into six groups: a normal control group, a model group, high-, medium-, and low-dose experimental drug groups, and a positive control group, with ten mice in each group. Animals in each drug-treated group were administered the corresponding drug via gavage, while the control group was administered an equal volume of purified water via gavage. The drugs were administered once daily for seven consecutive days. One hour after the last administration, the pain threshold time for each group was measured.

[0207] 2.2 Statistical Analysis Methods

[0208] The data table is expressed as mean ± standard deviation. The data were tested using SPSS 21.0 software, and the independent samples Mann-Whitney U test was used for statistical processing in nonparametric statistics. P < 0.05 was considered statistically significant.

[0209] 3 Experimental Results

[0210] The results are shown in Table 7. Compared with the model group, the pain threshold of mice in the high- and medium-dose experimental drug groups and the positive drug group was significantly increased (P<0.05).

[0211] Table 7. Effects on hot plate pain threshold in mice ( n=10)

[0212] Grouping Pain threshold (S) Model group 7.99±1.43 High-dose group 13.77±3.24* medium dose group 11.34±3.36* low-dose group 8.29±1.69 Positive drug group 11.06±2.33*

[0213] *Compared with the model group, P<0.05.

[0214] The above experimental results show that the traditional Chinese medicine composition of the present invention has a significant analgesic effect.

[0215] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Any simple modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of the present invention shall still fall within the protection scope of the present invention.

Claims

1. The application of a traditional Chinese medicine composition in the preparation of a drug for treating hyperuricemia and / or gout, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Scutellaria baicalensis 3-12 parts by weight, Coptis chinensis 1.5-3 parts by weight, Phellodendron chinense 1.5-6 parts by weight, Gardenia jasminoides 2-8 parts by weight, Bupleurum chinense 3-12 parts by weight, Forsythia suspensa 4-8 parts by weight, and Paeonia lactiflora 2-8 parts by weight. The traditional Chinese medicine composition is made by mixing the raw materials after pulverizing them.

2. The application according to claim 1, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Scutellaria baicalensis 4-8 parts by weight, Coptis chinensis 2-3 parts by weight, Phellodendron chinense 2-4 parts by weight, Gardenia jasminoides 3-6 parts by weight, Bupleurum chinense 4-8 parts by weight, Forsythia suspensa 4-6 parts by weight, and Paeonia lactiflora 3-6 parts by weight.

3. The application according to claim 2, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 6 parts of Scutellaria baicalensis, 3 parts of Coptis chinensis, 3 parts of Phellodendron chinense, 4 parts of Gardenia jasminoides, 6 parts of Bupleurum chinense, 4 parts of Forsythia suspensa, and 4 parts of Paeonia lactiflora.

4. The application according to any one of claims 1-3, characterized in that: The gardenia mentioned is stir-fried gardenia.

5. The application according to claim 1, characterized in that: The medications used to treat hyperuricemia and / or gout are in the form of pills, capsules, tablets, or powders.

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