Traditional Chinese medicine composition for treating gout as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating gout and a preparation method and application thereof. The traditional Chinese medicine composition for treating gout is prepared from the following raw materials in parts by weight: 10 to 50 parts of cudrania cochinchinensis, 10 to 50 parts of rhizoma smilacis glabrae, 10 to 50 parts of cowherb seed, 5 to 30 parts of rhizoma alismatis, 10 to 50 parts of radix achyranthis bidentatae, 10 to 100 parts of semen coicis, 10 to 50 parts of Chinese fevervine herb and root, 10 to 50 parts of radix puerariae and 10 to 50 parts of honeysuckle stem. According to the traditional Chinese medicine composition, cudrania cochinchinensis, rhizoma smilacis glabrae and cowherb seeds are taken as monarch drugs, rhizoma alismatis, radix achyranthis bidentatae, semen coicis and Chinese fevervine herbs are taken as ministerial drugs, radix puerariae and honeysuckle stems are taken as adjuvant drugs, and under the interaction of the monarch drugs, the ministerial drugs and the adjuvant drugs, the effects of easing joint movement, resisting inflammation, easing pain, promoting uric acid excretion and dissolving tophus can be achieved.

Description

Technical Field

[0001] The invention relates to a Chinese medicine composition and a preparation method and application thereof, and in particular to a Chinese medicine composition for treating gout and a preparation method and application thereof. Background Art

[0002] Gout is a disease caused by excessive uric acid levels in the blood, which leads to the deposition of uric acid crystals in the joints. The deposited crystals cause painful inflammation in and around the joints. Tophi are the characteristic clinical manifestation of gout. The incidence of gout is distributed all over the world and is affected by region, ethnicity and eating habits. In China, the prevalence of gout is about 1%-3%. With the extension of the average human life expectancy and changes in diet and lifestyle, this data has been increasing year by year.

[0003] Existing drugs for the treatment of gout mainly include two treatment methods: promoting uric acid excretion and inhibiting uric acid synthesis. Although these drugs can relieve gout symptoms to a certain extent, they also have some problems. In addition, long-term use of drugs for the treatment of gout will also cause patients to become dependent on and resistant to the drugs to varying degrees. Summary of the invention

[0004] The purpose of the present invention is to overcome the deficiencies of the above-mentioned prior art and provide a Chinese medicine composition for treating gout with significant efficacy, and a preparation method and application thereof.

[0005] To achieve the above object, the technical solution adopted by the present invention is:

[0006] In the first aspect, the present invention provides a traditional Chinese medicine composition for treating gout, comprising the following raw materials in parts by weight: 10-50 parts of Chuanpo Stone, 10-50 parts of Smilax glabra, 10-50 parts of Vaccaria segetalis, 5-30 parts of Alisma orientalis, 10-50 parts of Achyranthes bidentata, 10-100 parts of Coix seeds, 10-50 parts of Caulis Patostellariae, 10-50 parts of Puerariae root, and 10-50 parts of Honeysuckle vine.

[0007] The effects of the components in the above-mentioned Chinese medicine composition are as follows:

[0008] Chuanpo Stone: Chuanpo Stone is a plant of the genus Zhe of the Moraceae family. It contains ketones and flavonoids, among which animal experiments have shown that flavonoids have analgesic effects. Chuanpo Stone can relieve and replenish the body, and can replace the penetrating power of drugs such as pangolins, leeches, and centipedes. It has the effects of dispelling wind and dredging meridians, clearing away heat and dampness, and detoxifying and reducing swelling.

[0009] Smilax glabra: A study showed that a new polysaccharide isolated from Smilax glabra has significant immunomodulatory effects through in vitro bioactivity tests. Poria polysaccharide has significant effects in inhibiting acute and chronic inflammation, reducing TNF-α (necrotic factor produced by macrophages), IL-1β, and IL-6 levels, and inhibiting the JAK2 / STAT3 pathway.

[0010] Vaccaria: The alcohol extract of Vaccaria has anti-inflammatory and antioxidant activity. The results showed that after intervention with the alcohol extract of Vaccaria, the mRNA transcription and protein expression levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β) and interleukin-6 (IL-6) were significantly downregulated, indicating that Vaccaria has anti-inflammatory activity.

[0011] Alisma orientalis: Alisma orientalis ethanol extract has a significant improving effect on hyperuricemia induced by potassium oxonate in rats. Its mechanism may be to inhibit the activity of xanthine oxidase and thus reduce blood uric acid.

[0012] Millettia: The roots, stems, leaves and fruits of Millettia can be used as medicine, with anti-inflammatory, analgesic, uric acid-lowering, blood sugar-lowering, antibacterial, anti-tumor, digestive and stagnation-relieving effects. Kooa et al.'s research confirmed that Millettia can exert anti-inflammatory effects by regulating the activation of nuclear factor-κB (NF-κB). Mao Gaohui et al. found through the analysis of Millettia that its anti-inflammatory effect is related to the NF-κB pathway and the mitogen-activated protein kinase (MAPK) pathway, and has a significant inhibitory effect on the inflammatory mediators interleukin-6 (IL-6), interleukin-1β (IL-1β) and tumor necrosis factor-α (TNF-α). A few IGPS compounds can reduce the expression of inducible nitric oxide synthase (iNOS) and cyclooxygenase-2 (COX-2), and exert their effects through pathways such as NLRP3, Nrf2 / HO1, and PI3K. The research results of Hu Han et al. also showed that Parsley sphagnum extract (PSE) can reduce joint swelling, reduce the expression levels of TNF-α and IL-1β, and improve arthritis symptoms.

[0013] Pueraria root: Pueraria root has the effect of relieving muscle and fever. Other studies have found that Pueraria root polysaccharide can affect immune response by inducing the maturation of dendritic cells. Xing Zhihua et al. found that puerarin can play an anti-inflammatory role by affecting immune cells, inflammatory factors, signaling pathways, etc. At the same time, it can reduce serum uric acid levels by inhibiting (xanthin eoidase XOD) and promoting uric acid excretion, thereby achieving anti-gout effects.

[0014] The present invention uses chuanposhi, smilax glabra and wangbuliuxing as the main medicines to clear dampness and resolve turbidity, break blood stasis and dissipate stagnation; at the same time, oriental medicine, cyperus rotundus, coix seed and scutellaria baicalensis are used as the assistant medicines to strengthen heat removal, dampness removal and turbidity removal, the main medicine and the assistant medicine mutually strengthen dampness and dissipate stagnation, lead turbidity and remove blood stasis, and kudzu root and honeysuckle vine are added as adjuvants to dredge meridians and clear joints. Under the interaction of the main medicine, assistant medicine and adjuvant, the whole prescription mainly removes dampness, clears heat, removes dampness and dissipates stagnation, achieves the effect of dissolving tophi to a certain extent, and treating refractory gout.

[0015] In the Chinese medicine composition of the present invention, the amount of Smilax glabra used is lower than that of the prior art, but in combination with other specific components, due to the synergistic effect between the components, the efficacy of the Chinese medicine composition of the present invention in treating refractory gout is still very significant. In particular, the present invention also uses Millettia dungaree and Pueraria root, making the effect of treating gout more prominent.

[0016] As a preferred embodiment of the Chinese medicine composition for treating gout of the present invention, the Chinese medicine composition for treating gout comprises the following raw materials in parts by weight: 10-30 parts of Radix Chuanpodis, 10-30 parts of Rhizoma Smilacis Glabrae, 10-30 parts of Semen Vaccariae, 5-30 parts of Rhizoma Alismatis, 10-30 parts of Radix Achyranthis Bidentatae, 10-50 parts of Semen Coicis, 10-30 parts of Caulis Patriniae, 10-30 parts of Radix Puerariae, and 10-30 parts of Caulis Lonicerae. Studies have shown that under the preferred ratio, the Chinese medicine composition of the present invention has a better effect in treating gout.

[0017] As a more preferred embodiment of the Chinese medicine composition for treating gout of the present invention, the ratio of the sum of the weight of the radix smilax, smilax and vaccaria to the sum of the weight of the rhizoma alisma, achyranthes, coix seed and scutellariae rubra and the sum of the weight of the radix puerariae and honeysuckle is (radix smilax + rhizoma smilax + vaccariae): (rhizoma alisma + achyranthes + coix seed + scutellariae rubra): (radix puerariae + honeysuckle) = 60:65:30. As the best embodiment of the Chinese medicine composition for treating gout of the present invention, the Chinese medicine composition for treating gout comprises the following raw materials in parts by weight: 20 parts of radix smilax, 20 parts of rhizoma smilax, 20 parts of vaccariae, 15 parts of rhizoma alisma, 15 parts of achyranthes, 20 parts of coix seed, 15 parts of scutellariae rubra, 15 parts of scutellariae rubra, and 15 parts of honeysuckle. In the Chinese medicine composition of the present invention, the main drug, the auxiliary drug and the adjuvant drug cooperate with each other and work together. When the weight ratio is 60:65:30, the efficacy of the Chinese medicine composition can be better exerted, and the therapeutic effect of treating gout is significantly enhanced. Especially under the ratio of the best embodiment, the Chinese medicine composition of the present invention has the best therapeutic effect on gout.

[0018] As a preferred embodiment of the Chinese medicine composition for treating gout of the present invention, the Chinese medicine composition for treating gout also includes the following raw materials in parts by weight: 10-30 parts of mistletoe, 10-30 parts of chicken's gizzard lining, 10-30 parts of astragalus, 10-30 parts of atractylodes macrocephala, and 5-10 parts of licorice. Among them, mistletoe has the effects of nourishing the liver and kidney, promoting blood circulation and activating collaterals, chicken's gizzard lining has the effects of digesting food, eliminating accumulation, strengthening the spleen and removing dampness, astragalus nourishes the kidney and replenishes qi, atractylodes macrocephala can strengthen the spleen and remove dampness, and licorice can reconcile various medicines. Mulberry and astragalus strengthen the kidney and enhance renal function, which is beneficial to uric acid excretion; atractylodes macrocephala and chicken's gizzard lining nourish the spleen and digest food. They jointly assist the above-mentioned 9 kinds of Chinese medicines, one excretion and one supplement (excretion of uric acid, nourishing the kidney and strengthening the spleen), repair and enhance spleen and kidney function, promote uric acid excretion without hurting the spleen and kidney.

[0019] In a second aspect, the present invention provides a method for preparing the above-mentioned Chinese medicine composition for treating gout, which comprises the following steps:

[0020] The components in the raw materials are weighed according to the ratio, and soaked in water; then, the components are decocted and concentrated in sequence to obtain the traditional Chinese medicine composition for treating gout.

[0021] As a preferred embodiment of the preparation method of the traditional Chinese medicine composition for treating gout according to the present invention, the preparation method is: weigh each component in the preparation raw material according to the ratio, soak in water for 15 minutes; then fry over high heat for 15 minutes, then fry over medium heat for 30 minutes, and finally concentrate over low heat to obtain the traditional Chinese medicine composition for treating gout.

[0022] In a third aspect, the present invention provides a medicine for treating gout, which comprises the above-mentioned traditional Chinese medicine composition and excipients, and the medicine for treating gout uses the traditional Chinese medicine composition as an active ingredient.

[0023] As a preferred embodiment of the drug for treating gout of the present invention, the dosage form of the drug is decoction, granules, powder, paste, injection, tablet or capsule.

[0024] As a preferred embodiment of the drug for treating gout of the present invention, the dosage form of the drug is granules, and the auxiliary materials include sucrose and dextrin.

[0025] The preparation method of the above-mentioned medicine for treating gout comprises the following steps:

[0026] Weigh each component of the raw material according to the ratio, soak it in water, and then boil and concentrate it in sequence to obtain a clear paste;

[0027] The obtained clear paste is mixed with sucrose and dextrin, and a binder is added to form a soft material, and then the soft material is formed into wet granules;

[0028] The obtained wet granules are dried to obtain the medicament for treating gout.

[0029] In a fourth aspect, the present invention provides the use of the above-mentioned Chinese medicine composition or the drug for treating gout in the preparation of a pharmaceutical product for treatment of gout by combined use with a western medicine, wherein the western medicine is at least one of febuxostat and etoricoxib. Preferably, the western medicine is febuxostat and etoricoxib.

[0030] The Chinese medicine composition or the medicine for treating gout of the present invention can be combined with western medicine to prepare medicine boxes and other products. By combined administration, the effect of western medicine in treating gout can be enhanced, and the uric acid level can be significantly reduced; and the liver function and kidney function are less affected after combined use.

[0031] Compared with the prior art, the present invention has the following beneficial effects:

[0032] The traditional Chinese medicine composition of the present invention comprises radix schizonepetae, rhizoma smilax and rhizoma pulex as main medicines, rhizoma alismatis, rhizoma achyranthis Bidentatae, rhizoma coicis and rhizoma scutellariae as assistant medicines, and root of kudzu and vine of honeysuckle as adjuvant medicines. Under the interaction of the main medicine, assistant medicine and adjuvant medicines, the whole medicine can achieve the effects of dredging joints, resisting inflammation and relieving pain, promoting uric acid excretion and dissolving tophi.

[0033] The Chinese medicine composition of the present invention can not only greatly reduce the frequency of acute attacks of refractory gout and accelerate the dissolution of tophi, but also has low cost, definite efficacy, and small side effects, and is accepted by more patients, thus having positive economic and social benefits. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 These are photographs of the hand conditions of a gout patient before and after treatment in Effective Example 1 of the present invention. DETAILED DESCRIPTION

[0035] In order to better illustrate the purpose, technical solutions and effects of the present invention, the present invention will be further described below in conjunction with specific embodiments.

[0036] Examples 1-8 and Comparative Examples 1-3

[0037] The raw materials for preparing the Chinese medicine composition for treating gout in Examples 1-8 of the present invention are shown in Table 1-1 below, and the raw materials for preparing the Chinese medicine composition in Comparative Examples 1-3 are shown in Table 1-2 below.

[0038] Table 1-1

[0039]

[0040] Table 1-2

[0041] Comparative Example 1 / part by weight Comparative Example 2 / parts by weight Comparative Example 3 / part by weight Piercing Stone 7 10 20 Smilax glabra 50 60 20 Vaccaria 53 40 20 Alisma orientalis 40 30 15 Achyranthes bidentata 50 60 15 Job's tears 30 20 20 Cistanche 40 50 0 Pueraria root 30 30 15 Honeysuckle 50 50 15 Atractylodes macrocephala 0 0 15

[0042] The preparation method of the Chinese medicine composition of Examples 1-8 and Comparative Examples 1-3 is as follows: weigh each component in the preparation raw materials according to the ratio, soak in water for 15 minutes; then fry over high heat for 15 minutes, then fry over medium heat for 30 minutes, and finally concentrate over low heat to obtain the Chinese medicine composition for treating gout.

[0043] The raw materials prepared in Examples 1-8 (as described in Table 1-1) can be further prepared into a drug for treating gout, for example, a Chinese medicine granule. The Chinese medicine granule comprises the above-mentioned Chinese medicine composition, sucrose and dextrin, and the preparation method thereof is as follows:

[0044] (1) Preparation of medicinal materials: weigh each medicinal material in the preparation raw materials according to Table 1-1 above and chop it;

[0045] (2) Decoction: Put the chopped medicinal materials in step (1) into a multifunctional extraction tank (steam pressure of 0.2MPa), wash with water, soak for one hour, open the steam valve for decoction, add water and decoct three times. The first time, the amount of water added is slightly enough to cover the medicinal materials, and decoction is for 1.5 hours. The second and third times, the amount of water added is gradually reduced, and decoction is for 1 hour. After filtering with a 60-mesh screen, input it into a designated storage tank, and record the amount of medicinal liquid added by the storage tank liquid level meter. Combine the three decoctions, let it stand for more than 12 hours, and the supernatant should be clarified for use;

[0046] (3) Concentration: Close the vent valve, open the vacuum valve and condensate valve, and suck the supernatant in the liquid storage tank into the vacuum decompression concentration tank (temperature 70-85°C, steam pressure 0.15MPa, vacuum degree -0.06-0.08MPa), open the steam valve on the heater, and stop concentrating when the liquid is concentrated to a relative density of 1.35-1.38 (50-60°C), and the clear paste is obtained;

[0047] (4) Granulation: Add twice the amount of sucrose powder and twice the amount of dextrin into a trough mixer and mix. After mixing, slowly add the clear paste prepared in step (3) and spray 75% ethanol as a binder while adding the clear paste to prepare a suitable soft material. According to the requirement that the soft material "can be held into a ball and falls apart when touched", the soft material is put into a swing granulator with a No. 1 sieve to prepare wet granules.

[0048] (5) Drying: The wet granules to be dried prepared in step (4) are evenly spread on a baking tray with a thickness of less than 2 cm, and the baking tray is placed on a drying cart and sent into a GMP-1 hot air circulation oven (purchased from Changzhou Jie Chuang Drying Equipment Co., Ltd.) for drying, with the tray turned over every hour;

[0049] (6) Granulation: The dried qualified granules (moisture content meets the requirements of the pharmacopoeia and is less than 3%) are granulated through the No. 1 sieve of the swing granulator, and then the granules are sieved through the No. 5 sieve to remove fine powder, and the material balance is calculated;

[0050] (7) Packaging: Prepare the packaging materials and use the DXDK80C-H granule packaging machine (purchased from Beijing Dasong Bochuan Packaging Machinery Co., Ltd.) to pack the prepared granules according to the specified specifications. Outer packaging: Transfer the packed granules to the outer packaging room through the transfer window for outer packaging (large label, small label, instruction manual, outer box).

[0051] Effect Example 1

[0052] This effect example studies the physical condition of gout patients before and after taking the Chinese medicine composition for the treatment of gout in Example 1. Specifically as follows: The patient is a 47-year-old male with repeated systemic multi-joint swelling and pain and tophi for more than 6 years, which has increased for half a year. In the past six months, repeated joint swelling and pain have occurred, and the continuous use of anti-inflammatory, analgesic and uric acid-lowering drugs has poor results. In March 2023, he was treated in the hospital, and the uric acid was 647umol / L, creatinine 112mmol / L, ESR: 78mm / H CRP: 49mg / L, blood lipids: triglycerides: 3.2mg / L, and liver function and blood routine were normal. The treatment plan is as follows: give etoricoxib 60mg, once a day, 1 tablet each time (2 months); Febuxostat 40mg once a day, 1 tablet each time (long-term); and Example 1 Chinese medicine composition for the treatment of gout 1 dose per day, hospital decoction, take 200ml / time per day, twice a day. In the second month follow-up, the joint swelling and pain were significantly relieved compared with before, so etoricoxib was discontinued, and febuxostat and the Chinese medicine composition for treating gout in Example 1 were continued. The tophi in the whole body gradually shrank and softened. Around 19 months, the tophi in the joints between the fingers of both hands were completely dissolved. The patient continued to come for follow-up every month, and there was no swelling and pain in the joints, and no anti-tophis. The condition of the patient's hands before and after treatment is as follows Figure 1 As shown. It can be seen that the Chinese medicine composition for treating gout of the present invention can be used in combination with western medicine for treating gout to enhance the effect of western medicine for treating gout.

[0053] Effect Example 2

[0054] In order to study the therapeutic effect of the Chinese medicine composition for treating gout of the present invention on gout, the applicant selected 480 patients with refractory gout of damp-heat type and compared their physical conditions after taking the Chinese medicine composition of Examples 1-6 of the present invention and Comparative Examples 1-3 and / or Western medicine for the treatment of gout.

[0055] Among them, the selection criteria for 480 patients with damp-heat type refractory gout were: average age of 45.54±10.72 years, good treatment compliance. Exclusion criteria: severe liver and kidney dysfunction; severe cardiovascular and lung diseases; pregnancy and mental illness; combined with other blood system diseases; recent use of drugs that affect uric acid metabolism or excretion; need to continue taking aspirin and azathioprine.

[0056] 480 patients with refractory gout of damp-heat type were divided into 12 groups on average, 40 people in each group, 38 males and 2 females in each group, and the general data of each group were basically the same (P>0.05). Groups 1-6 took 1 dose of the Chinese medicine composition for treating gout of Examples 1-6 of the present invention every day, twice a day, 200 mL each time. Groups 7-9 took 1 dose of the Chinese medicine composition of Comparative Examples 1-3 every day, twice a day, 200 mL each time. Group 10 took 1 tablet of etoricoxib (60 mg) and 1 tablet of febuxostat (40 mg) every day, both etoricoxib and febuxostat once a day; and took 1 dose of the Chinese medicine composition for treating gout of Example 1 every day, twice a day, 200 mL each time. The only difference between Group 11 and Group 10 is that the Chinese medicine composition taken by Group 11 is the Chinese medicine composition of Example 5, not the Chinese medicine composition of Example 1. Group 12 took 1 tablet of etoricoxib (60 mg) and 1 tablet of febuxostat (40 mg) every day, both etoricoxib and febuxostat once a day. Groups 1-12 took the medicine for 2 months, and the changes in blood uric acid levels of patients in each group before and after treatment were compared. The test results are shown in Table 2 below. Among them, blood uric acid was detected by uricase test method.

[0057] Table 2

[0058]

[0059]

[0060] Percentage reduction of serum uric acid = (serum uric acid before treatment - serum uric acid after treatment) / serum uric acid before treatment × 100%

[0061] As can be seen from the test results of the 1st to 8th groups in Table 2, the Chinese medicine composition of the present invention can treat gout, and if the raw material ratio is not within the scope of the present invention, the curative effect of the Chinese medicine composition for treating gout will be greatly reduced. The effect of the Chinese medicine composition for treating gout in the third and fourth groups is compared with the Chinese medicine composition in the fifth and sixth groups. It can be seen that under the following preferred ratio (the third and fourth groups) - 10-30 parts of Radix Chuanposhi, 10-30 parts of Rhizoma Smilacis Glabrae, 10-30 parts of Semen Vaccariae, 5-30 parts of Rhizoma Alismatis, 10-30 parts of Radix Achyranthis Bidentatae, 10-50 parts of Semen Coicis, 10-30 parts of Caulis Patriniae, 10-30 parts of Radix Puerariae, 10-30 parts of Caulis Lonicerae, the effect of the Chinese medicine composition of the present invention for treating gout is better. In addition, in Group 1 and Group 2, the weight ratio of the main drug, the auxiliary drug and the adjuvant drug is 60:65:30, and the effect of the Chinese medicine composition in treating gout is further improved, especially when the raw materials for its preparation are in the specific ratio in Example 1, the effect of the Chinese medicine composition in treating gout is optimal.

[0062] Further comparison of the results of Group 9 revealed that the raw materials in the Chinese medicine composition of the present invention cannot be replaced, otherwise the efficacy of treating gout will be greatly reduced.

[0063] As can be seen from the above, the Chinese medicine composition of the present invention has a synergistic effect through the combination of specific raw materials in a specific ratio.

[0064] Comparing the results of groups 10-12, it can be further found that the Chinese medicine composition of the present invention can be used in combination with western medicine to significantly enhance the effect of western medicine in treating gout.

[0065] Effect Example 3

[0066] This effect example studies the effect of the Chinese medicine composition for treating gout of the present invention on the treatment of gout with Western medicine. The applicant divided 80 patients with refractory gout into a control group and a treatment group, with 40 patients in each group. All enrolled patients were aged 15-70 years old; treatment compliance was good. Exclusion criteria: severe liver and kidney dysfunction; severe cardiovascular disease and lung disease; pregnant and mentally ill patients; combined with other blood system diseases; recent use of drugs that affect uric acid metabolism or excretion; need to continue taking aspirin and azathioprine. There were 38 males and 2 females in both the control group and the treatment group; aged 15-70 years, with an average of (45.54±10.72) years; course of disease 3-14 years, with an average of (7.86±2.92) years. The general data of the two groups were basically consistent (P>0.05).

[0067] The control group was given Febuxostat [specification 40 mg*16 tablets, national medicine standard J20180084, Wanbang Pharmaceutical (China) Co., Ltd.] orally, 40 mg each time, once a day.

[0068] Treatment group medication: on the basis of the treatment of the control group, the Chinese medicine composition for treating gout of the present invention is added, and the Chinese medicine composition is made of the following raw materials: 20g of Radix Chuanpo, 20g of Vaccariae Semen, 20g of Smilax Leucorrhizae, 20g of Coix Seed, 15g of Achyranthes Bidentatae, 15g of Rhizoma Alismatis, 15g of Radix Puerariae, 15g of Caulis Patriniae, and 15g of Caulis Lonicerae. The preparation method of the Chinese medicine composition is: weigh each component in the raw materials according to weight, soak in water for 15 minutes; then fry with high heat for 15 minutes, fry with medium heat for 30 minutes, and finally concentrate with low heat to obtain the Chinese medicine composition for treating gout. One month is one course of treatment, and the medication time for each course of treatment is not less than 15 days, and at least 6 courses of treatment are taken.

[0069] Observation indicators:

[0070] (1) TCM syndrome score: Refer to the Guidelines for Clinical Research of New Chinese Medicines (Trial) [7], and score the severity of the symptoms of refractory gout caused by damp-heat accumulation syndrome, including joint swelling and pain that refuses to be pressed, local burning sensation, relief from cold, fever, thirst, and yellow and red urine, with a total score of 0-15 points. The lower the score, the milder the symptoms. The TCM syndrome scores were compared before treatment and 3 months after treatment.

[0071] (2) Inflammatory factors: 3 ml of venous blood was collected from the patients before and 3 months after treatment, and the levels of interleukin-1, C-reactive protein, and tumor necrosis factor-ɑ were detected by enzyme-linked immunosorbent assay. Joint fluid was collected and the nucleotide-binding oligomerization domain-like receptor protein 3 (NLRP3) was detected using the real-time fluorescence quantitative polymerase chain reaction kit of TopBio.

[0072] (3) Adverse reactions: The skin rash, liver and kidney damage, and gastrointestinal reactions of the two groups of patients were recorded.

[0073] The TCM syndrome scores of the control group and the treatment group before and after treatment are shown in Table 3, the levels of inflammatory factors are shown in Table 4, and the incidence of adverse reactions is shown in Table 5.

[0074] Table 3 Comparison of TCM syndrome scores between the two groups before and after treatment [(x±s), points]

[0075]

[0076] As shown in Table 3, after treatment, the TCM syndrome score in the treatment group was lower than that in the control group (P<0.05).

[0077] Table 4 Comparison of inflammatory factor levels between the two groups before and after treatment

[0078]

[0079] As shown in Table 4, after treatment, the serum interleukin-1, C-reactive protein, tumor necrosis factor-ɑ levels and NLRP3 levels in the treatment group were lower than those in the reference group (P<0.05).

[0080] Table 5 Comparison of the incidence of adverse reactions between the two groups [cases (%)]

[0081]

[0082] As shown in Table 5, the incidence of adverse reactions in the two groups was basically the same (P>0.05).

[0083] In summary, the combined use of the Chinese medicine composition of the present invention and Western medicine enhances the effect of Western medicine in treating gout.

[0084] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present invention can be modified or replaced by equivalents without departing from the essence and scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for treating gout, characterized in that: The preparation comprises the following raw materials in parts by weight: 10-50 parts of radix smilax, 10-50 parts of rhizoma smilax, 10-50 parts of fenugreek, 5-30 parts of rhizoma alismatis, 10-50 parts of achyranthes bidentata, 10-100 parts of coix seeds, 10-50 parts of scutellaria baicalensis, 10-50 parts of kudzu root and 10-50 parts of honeysuckle vine.

2. The Chinese medicine composition for treating gout according to claim 1, characterized in that: The preparation method comprises the following raw materials in parts by weight: 10-30 parts of radix smilax, 10-30 parts of rhizoma smilax, 10-30 parts of fenugreek, 5-30 parts of rhizoma alismatis, 10-30 parts of achyranthes bidentata, 10-50 parts of coix seeds, 10-30 parts of scutellaria baicalensis, 10-30 parts of kudzu root and 10-30 parts of honeysuckle vine.

3. The Chinese medicine composition for treating gout according to claim 2, characterized in that: The ratio of the sum of the weights of the radix smilax, smilax glabra and vaccaria to the sum of the weights of the rhizoma alismatis, achyranthes bidentata, coix seed and scutellaria baicalensis and the sum of the weights of the radix puerariae and honeysuckle is (radix puerariae + radix smilax + vaccariae): (rhizoma alismatis + achyranthes bidentata + coix seed + scutellaria baicalensis): (radix puerariae + honeysuckle) = 60:65:

30.

4. The Chinese medicine composition for treating gout according to claim 3, characterized in that: The preparation method comprises the following raw materials in parts by weight: 20 parts of radix smilax, 20 parts of rhizoma smilax, 20 parts of fenugreek, 15 parts of oriental water plantain, 15 parts of achyranthes bidentata, 20 parts of coix seeds, 15 parts of scutellaria baicalensis, 15 parts of kudzu root, and 15 parts of honeysuckle vine.

5. The Chinese medicine composition for treating gout according to any one of claims 1 to 4, characterized in that: The preparation method also includes the following raw materials in parts by weight: 10-30 parts of mistletoe, 10-30 parts of chicken's gizzard lining, 10-30 parts of astragalus, 10-30 parts of atractylodes, and 5-10 parts of liquorice.

6. A method for preparing a Chinese medicine composition for treating gout as claimed in any one of claims 1 to 5, characterized in that: The following steps are involved: The components in the preparation raw materials are weighed according to the ratio, and soaked in water; then, the components are decocted and concentrated in sequence to obtain the traditional Chinese medicine composition for treating gout.

7. A drug for treating gout, characterized in that: The invention comprises the Chinese medicine composition according to any one of claims 1 to 5 and excipients, wherein the medicine for treating gout uses the Chinese medicine composition as an active ingredient.

8. The drug for treating gout according to claim 7, characterized in that: The dosage form of the medicine is decoction, granules, powder, paste, injection, tablet or capsule.

9. The drug for treating gout according to claim 8, characterized in that: The dosage form of the medicine is granules, and the auxiliary materials include sucrose and dextrin.

10. Use of the Chinese medicine composition according to any one of claims 1 to 5 or the drug for treating gout according to any one of claims 7 to 8 in the preparation of a pharmaceutical product for use in combination with a western medicine for treating gout, wherein the western medicine is at least one of febuxostat and etoricoxib.

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