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

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating hyperuricemia and a preparation method and application thereof. The traditional Chinese medicine composition comprises the following main active ingredients in parts by mass: 15-25 parts of fried coix seeds, 15-25 parts of rhizoma smilacis glabrae, 15-25 parts of rhizoma alismatis, 5-15 parts of rhizoma atractylodis, 10-15 parts of semen plantaginis, 10-20 parts of yam rhizome, 10-20 parts of dogwood, 10-20 parts of Chinese yam, 10-20 parts of prepared rehmannia roots, 6-12 parts of prepared radix aconiti lateralis praeparata, 10-15 parts of cassia twigs and 6-12 parts of honey-fried licorice roots. The curative effect and safety evaluation research shows that the uric acid reducing effect of the traditional Chinese medicine composition after 12 weeks of treatment is equivalent to that of febuxostat, compared with febuxostat, the traditional Chinese medicine composition can remarkably reduce the occurrence rate of melt crystal pain of a patient during treatment, the liver and kidney functions of the treated patient are not obviously changed, and the safety is good. Research results show that the traditional Chinese medicine composition is remarkable in clinical curative effect and good in safety.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for treating hyperuricemia, its preparation method, and its application. Background Technology

[0002] Hyperuricemia (HUA), also known as gout, is a group of diseases caused by purine metabolism disorders. Its clinical features include hyperuricemia and recurrent attacks of acute gouty arthritis, tophi deposition, chronic tophaceous arthritis, and joint deformities. It often affects the kidneys, causing chronic interstitial nephritis and uric acid kidney stones. The disease can be divided into two main categories: primary and secondary. The etiology of primary hyperuricemia, except for a few cases caused by enzyme deficiencies, is mostly unclear. It is often accompanied by hyperlipidemia, obesity, diabetes, hypertension, arteriosclerosis, and coronary heart disease, and is considered a hereditary disease. Secondary hyperuricemia can be caused by various factors such as kidney disease, blood disorders, and medications.

[0003] Currently, medications for treating hyperuricemia include Western medicine and traditional Chinese medicine. Western medicine treatment has drawbacks such as easy relapse and large adverse reactions, which are rejected by some patients. For example, although uric acid-lowering Western medicines such as febuxostat are fast-acting, there are risks of uric acid rebound and liver and kidney damage after discontinuation of the drug. Clinical reports indicate that the incidence of elevated liver enzymes during medication is about 4.2%, and the rate of gout attacks induced by fluctuations in blood uric acid during medication is as high as 50%. Traditional Chinese medicine (TCM), based on a holistic approach and individualized diagnosis and treatment, plays a vital role in the diagnosis and treatment of hyperuricemia. It boasts advantages such as precision, individualization, and fewer adverse reactions, showing promising application prospects. However, most current TCM formulas for treating hyperuricemia do not address the root cause of the disease, resulting in incomplete treatment, symptomatic relief, and unsatisfactory efficacy. Furthermore, long-term use may lead to problems such as spleen deficiency and diarrhea. Therefore, it is necessary to develop a TCM composition that effectively treats hyperuricemia, addressing its fundamental pathogenesis, achieving stable uric acid reduction, and minimizing the occurrence of crystal-melting pain during treatment to meet clinical needs. Summary of the Invention

[0004] The first objective of this invention is to provide a traditional Chinese medicine composition for treating hyperuricemia; the second objective of this invention is to provide a method for preparing the traditional Chinese medicine composition; and the third objective of this invention is to provide the application of the traditional Chinese medicine composition.

[0005] According to a first aspect of the present invention, a traditional Chinese medicine composition for treating hyperuricemia is provided, wherein its main active ingredients, by weight, include: 15-25 parts of stir-fried coix seed, 15-25 parts of Smilax glabra, 15-25 parts of Alisma plantago-aquatica, 5-15 parts of Atractylodes lancea, 10-15 parts of Plantago asiatica, 10-20 parts of Dioscorea hypoglauca, 10-20 parts of Cornus officinalis, 10-20 parts of Dioscorea opposita, 10-20 parts of Rehmannia glutinosa (processed), 6-12 parts of processed Aconitum carmichaelii, 10-15 parts of Cinnamomum cassia, and 6-12 parts of processed Glycyrrhiza uralensis.

[0006] This invention is based on the principle that hyperuricemia is fundamentally due to deficiency of both the spleen and kidneys, and superficially due to internal retention of dampness and turbidity. The treatment method is to tonify the spleen and kidneys and clear away dampness and turbidity.

[0007] This invention uses stir-fried coix seed and alisma as the principal herbs to invigorate the spleen, eliminate dampness, promote urination, and excrete uric acid. The secondary herbs are cornus officinalis and prepared rehmannia root to tonify the kidneys and replenish essence, and yam, smilax glabra, and atractylodes lancea to invigorate the spleen and eliminate dampness. The combination of these two herbs strengthens the body and prevents recurrence. The adjuvant herbs are plantain seed and dioscorea hypoglauca to clear turbidity and resolve dampness, and prepared aconite root and cinnamon twig to warm the yang and promote qi circulation. The guiding herb is prepared licorice root to harmonize the medicinal properties. The entire formula is meticulously formulated, simultaneously clearing dampness and turbidity while tonifying the spleen and kidneys, addressing both deficiency and excess, and treating both the root cause and symptoms. It not only improves patients' uric acid levels but also restores normal metabolism by regulating spleen and kidney function, reducing gout attacks. The treatment is effective and safe.

[0008] The raw materials for this formula come from the following sources: Fried Job's tears: A processed product made from Job's tears, a traditional Chinese medicine, through frying. Job's tears are the dried, mature seeds of the Job's tears plant (Coix lacryma-jobi). They are sweet and bland in taste, cool in nature, and enter the spleen, stomach, and lung meridians. Frying makes Job's tears milder, enhances its spleen-strengthening and diarrhea-relieving effects, and reduces the stomach-damaging effects of raw Job's tears.

[0009] Smilax glabra Roxb., a plant in the Liliaceae family, is a dried rhizome. It has a sweet and bland taste, is neutral in nature, and enters the liver and stomach meridians.

[0010] Alisma: The dried tuber of Alisma orientale (Sam.) Juzep. or Alisma plantago-aquatica Linn., belonging to the Alismataceae family. It has a sweet and bland taste, and is cold in nature; it enters the kidney and bladder meridians.

[0011] Atractylodes lancea (Thunb.) DC. or Atractylodes chinensis (DC.) Koidz., both belonging to the genus Atractylodes in the family Asteraceae, is a dried rhizome. It has a pungent and bitter taste, and is warm in nature; it enters the spleen, stomach, and liver meridians.

[0012] Plantain seed: The dried, mature seeds of Plantago asiatica L. or Plantago depressa Willd., plants of the Plantaginaceae family. It has a sweet taste and cold nature, and enters the liver, kidney, lung, and small intestine meridians.

[0013] Dioscorea hypoglauca: The dried rhizome of Dioscorea hypoglauca, Dioscorea fruticosa, or Dioscorea glutinosa, all belonging to the genus Dioscorea in the family Dioscoreaceae. It has a bitter taste, is neutral in nature, and enters the kidney and stomach meridians.

[0014] Cornus officinalis: The dried, ripe pulp of Cornus officinalis Sieb. et Zucc., a plant belonging to the genus Cornus in the family Cornaceae. It has a sour and astringent taste, and is slightly warm in nature; it enters the liver and kidney meridians.

[0015] Yam: The rhizome of Dioscorea opposita Thunb., a plant belonging to the genus Dioscorea in the family Dioscoreaceae. It has a sweet taste and neutral properties; it enters the spleen, lung, and kidney meridians.

[0016] Prepared Rehmannia Root: The dried tuberous root of Rehmannia glutinosa Libosch., a plant in the Scrophulariaceae family. It is slightly warm in nature, sweet in taste, and enters the liver and kidney meridians.

[0017] Prepared aconite root: A traditional Chinese medicine product made by processing aconite root. It is warm in nature, pungent in taste, and enters the heart, kidney, and spleen meridians.

[0018] Cinnamon twig: The tender branch of Cinnamomum cassia Presl, a plant belonging to the genus Cinnamomum in the family Lauraceae.

[0019] Prepared licorice root: A processed form of licorice root in traditional Chinese medicine, it is the dried root and rhizome of *Glycyrrhiza uralensis* Fisch., *Glycyrrhiza inflata* Bat., or *Glycyrrhiza glabra* L., all belonging to the legume family. It is prepared through cleaning, cutting, and honey-processing. It has a sweet taste, is neutral to slightly warm in nature, and enters the heart, lung, spleen, and stomach meridians. Honey-processing enhances its spleen-tonifying and stomach-strengthening effects and can alleviate the toxicity of aconite.

[0020] In some embodiments, the main active ingredients, by weight, include: 20 parts of stir-fried coix seed, 20 parts of Smilax glabra, 20 parts of Alisma plantago-aquatica, 10 parts of Atractylodes lancea, 12 parts of Plantago asiatica, 15 parts of Dioscorea hypoglauca, 15 parts of Cornus officinalis, 15 parts of Dioscorea opposita, 15 parts of Rehmannia glutinosa, 9 parts of Aconitum carmichaelii, 12 parts of Cinnamomum cassia, and 9 parts of Glycyrrhiza uralensis.

[0021] In some embodiments, at least one of the following raw materials in parts by weight may also be added: Clematis chinensis 10-15 parts, Spatholobus suberectus 10-15 parts, stir-fried Atractylodes macrocephala 10-20 parts, Euryale ferox 10-20 parts, Artemisia capillaris 5-15 parts, Polygonum cuspidatum 5-15 parts.

[0022] Generally, if it is accompanied by joint swelling and pain, Clematis chinensis and Spatholobus suberectus can be added; if it is accompanied by spleen deficiency and loose stools, stir-fried Atractylodes macrocephala and Euryale ferox can be added; if it is accompanied by damp-heat accumulation, Artemisia capillaris and Polygonum cuspidatum can be added.

[0023] In some embodiments, pharmaceutically acceptable excipients may also be added. Specifically, the excipients used are carriers or excipients commonly used in the art, including but not limited to magnesium stearate, maltodextrin, starch, lactose, glucose, sodium carboxymethyl cellulose, ethyl cellulose, methyl cellulose, malt, gelatin, polyols (such as propylene glycol, glycerol, mannitol), tablets, etc., to help improve the stability or activity of the drug, or to produce an acceptable taste or odor when taken orally.

[0024] In some embodiments, the dosage form of the traditional Chinese medicine composition is capsules, granules, tablets, decoctions, oral liquids, or pills. This facilitates clinical administration.

[0025] According to a second aspect of the present invention, a method for preparing the above-mentioned traditional Chinese medicine composition for treating hyperuricemia is provided, wherein when the dosage form of the traditional Chinese medicine composition is a capsule, the preparation method includes the following steps: (1) Boil the raw materials twice with water. For the first decoction, add 8-10 times the amount of water equivalent to the total mass of the raw materials, heat to boiling, and keep simmering for 1-2 hours. After separation, obtain the first decoction and the dregs. For the second decoction, take the dregs obtained after the first decoction, add 8-10 times the amount of water equivalent to the total mass of the raw materials, heat to boiling, and keep simmering for 1-2 hours. After separation, obtain the second decoction and the dregs. Combine the first and second decoctions to obtain the combined decoction. (2) The combined decoction obtained in step (1) is concentrated under reduced pressure at 60°C to a clear extract with a relative density of 1.25; (3) The ointment obtained in step (2) is spray-dried to obtain dry ointment powder, wherein the spray drying process parameters are: air inlet temperature 170℃, air outlet temperature 85℃; (4) Add excipients to the dry powder obtained in step (3), and mix with a mixer for 30 minutes to make it evenly mixed, to obtain a mixed powder; (5) Fill the mixed powder obtained in step (4) into a hollow hard capsule or seal it in an elastic soft capsule to obtain the product.

[0026] In some implementations, the excipient is magnesium stearate.

[0027] According to a third aspect of the present invention, the use of the above-described traditional Chinese medicine composition for treating hyperuricemia in the preparation of a medicament for treating hyperuricemia is provided.

[0028] According to a fourth aspect of the present invention, the above-described traditional Chinese medicine composition for treating hyperuricemia is provided for use in the preparation of a medicine for treating hyperuricemia with spleen and kidney deficiency and internal dampness.

[0029] The beneficial effects of this invention include: Efficacy and safety evaluation studies have shown that the traditional Chinese medicine composition of this invention has a uric acid-lowering effect comparable to febuxostat after 12 weeks of treatment. Compared with febuxostat, it significantly reduces the incidence of crystalloid dissolution pain during treatment, and there are no significant changes in liver and kidney function after treatment, indicating good safety. These results demonstrate that the traditional Chinese medicine composition of this invention has significant clinical efficacy and good safety. Detailed Implementation

[0030] The present invention will be further described in detail below with reference to specific embodiments. Unless otherwise specified, all raw materials and reagents used in the present invention are commercially available. Experimental methods not specifically described are conventional methods known in the art.

[0031] Example 1 The traditional Chinese medicine capsule for treating hyperuricemia in this embodiment is made from the following raw materials: 20g of stir-fried coix seed, 20g of Smilax glabra, 20g of Alisma plantago-aquatica, 10g of Atractylodes lancea, 12g of Plantago asiatica, 15g of Dioscorea hypoglauca, 15g of Cornus officinalis, 15g of Dioscorea opposita, 15g of Rehmannia glutinosa, 9g of Aconitum carmichaelii, 12g of Cinnamomum cassia, and 9g of Glycyrrhiza uralensis.

[0032] Its preparation method includes the following steps: (1) The raw materials are decocted twice with water. For the first decoction, add water equivalent to 10 times the total mass of the raw materials, heat to boiling, and keep simmering for 1.5 hours. After separation, the first decoction and the dregs are obtained. For the second decoction, take the dregs obtained after the first decoction, add water equivalent to 8 times the total mass of the raw materials, heat to boiling, and keep simmering for 1 hour. After separation, the second decoction and the dregs are obtained. Combine the first decoction and the second decoction to obtain the combined decoction. (2) The combined decoction obtained in step (1) is concentrated under reduced pressure at 60°C to a clear extract with a relative density of 1.25; (3) The ointment obtained in step (2) is spray-dried to obtain dry ointment powder, wherein the spray drying process parameters are: air inlet temperature 170℃, air outlet temperature 85℃; (4) Add 0.5% by weight of magnesium stearate to the dry powder obtained in step (3), and mix it with a mixer for 30 minutes to make it uniform, so as to obtain a mixed powder; (5) Fill the mixed powder obtained in step (4) into No. 0 capsules (each capsule is equivalent to 0.33g of raw medicinal material). Dosage: 4 capsules 3 times a day, taken with warm water after meals.

[0033] Example 2 The traditional Chinese medicine capsule for treating hyperuricemia in this embodiment is made from the following raw materials: 25g of stir-fried coix seed, 25g of Smilax glabra, 25g of Alisma plantago-aquatica, 15g of Atractylodes lancea, 15g of Plantago asiatica, 20g of Dioscorea hypoglauca, 20g of Cornus officinalis, 20g of Dioscorea opposita, 20g of Rehmannia glutinosa, 12g of Aconitum carmichaelii, 15g of Cinnamomum cassia, and 12g of Glycyrrhiza uralensis.

[0034] Its preparation method is the same as that of Example 1.

[0035] Example 3 The traditional Chinese medicine capsule for treating hyperuricemia in this embodiment is made from the following raw materials: 15g of stir-fried coix seed, 15g of Smilax glabra, 15g of Alisma plantago-aquatica, 5g of Atractylodes lancea, 10g of Plantago asiatica, 10g of Dioscorea hypoglauca, 10g of Cornus officinalis, 10g of Dioscorea opposita, 10g of Rehmannia glutinosa, 6g of Aconitum carmichaelii, 10g of Cinnamomum cassia, and 6g of Glycyrrhiza uralensis.

[0036] Its preparation method is the same as that of Example 1.

[0037] To verify the therapeutic effect of the traditional Chinese medicine composition of the present invention on hyperuricemia, an efficacy and safety evaluation study was conducted on the traditional Chinese medicine composition of the present invention. The study process and results are as follows: I. Inclusion Criteria (1) Meets the Western medical diagnostic criteria for hyperuricemia (HUA) and the TCM syndrome differentiation of spleen and kidney deficiency with internal dampness and turbidity (loose stools, fatigue; swollen tongue with teeth marks, pale tongue, white coating; soft right Guan pulse and deep Chi pulse).

[0038] (2) The patient's age is between 30 and 65 years old.

[0039] (3) Two weeks before inclusion in the observation, health education was conducted to inform patients to eat a reasonable diet and maintain regular daily routines. Two weeks later, serum uric acid (SUA) was measured. Patients without complications with SUA ≥ 540 μmol / L and patients with a history of gout attacks and other metabolic diseases with SUA ≥ 480 μmol / L were included in this study.

[0040] (4) Have not taken uric acid-lowering drugs for at least 4 weeks.

[0041] (5) Inform the patient of matters related to this study, agree to participate and sign the informed consent form.

[0042] II. Exclusion Criteria (1) Individuals allergic to the drugs used in this study.

[0043] (2) Women who are trying to conceive or who are pregnant or breastfeeding.

[0044] (3) Clearly identify secondary uric acid elevation caused by kidney disease, lead poisoning, or tumor requiring radiotherapy or chemotherapy.

[0045] (4) If there are serious primary diseases such as heart, liver, and kidney, the medications taken may affect uric acid excretion or promote uric acid reabsorption.

[0046] III. Research Methods and Content 1. Case grouping Using a randomized controlled blind selection method, and referring to the above criteria, 104 qualified subjects were selected and divided into a traditional Chinese medicine group (n=52) and a febuxostat group (n=52).

[0047] 2. Treatment methods (1) Basic treatment and requirements All patients included in the study received health education on the lifestyle and diet of hyperuricemia (HUA) before being grouped. Patients were advised to eat a reasonable diet, which should be low in purines, protein, and sugar, with plenty of fresh vegetables, and drink more than 2000 mL of water per day to promote urination and help excrete uric acid. They were also advised to engage in half an hour of physical exercise every day to lose weight. Patients with hypertension, cardiovascular and cerebrovascular diseases or other chronic diseases were given appropriate antihypertensive and circulation-improving treatments. Thiazide diuretics, vitamin B12 and other drugs that affect uric acid levels were strictly prohibited.

[0048] (2) Group treatment Febuxostat group: Febuxostat 40 mg once daily, orally after breakfast.

[0049] Traditional Chinese Medicine Group: The traditional Chinese medicine capsules of Example 1 are taken 3 times a day, 4 capsules each time, with warm water after meals.

[0050] The treatment period for both the febuxostat group and the traditional Chinese medicine group was 12 weeks.

[0051] IV. Observation Indicators 1. Main therapeutic indicators Observe the changes in serum uric acid (SUA) before and after treatment.

[0052] 2. Secondary therapeutic indicators The difference in the frequency of crystalloid pain attacks between the two groups of patients was observed during the treatment period.

[0053] 3. Safety observation indicators Safety indicators: Liver function indicators: alanine aminotransferase (ALT), aspartate aminotransferase (AST); kidney function indicators: creatinine (Cr). Patients underwent examinations before and after treatment, and the results were recorded. Adverse reactions occurring during the study were recorded and managed promptly.

[0054] V. Statistical Analysis This study used SPSS 26 for statistical analysis of the data. For normally distributed measurement data, independent samples t-tests were used for between-group comparisons, and paired samples t-tests were used for within-group comparisons, expressed as mean ± standard deviation. For non-normally distributed measurement data, independent samples rank-sum tests were used for between-group comparisons, and paired samples rank-sum tests were used for within-group comparisons, expressed as quartile M(Q25, Q75). Count data were analyzed using chi-square tests. P A value <0.05 indicates a statistically significant difference.

[0055] VI. Research Results 1. Comparison of uric acid levels before and after treatment The Z-scores for each group were calculated using the independent samples Z-test. P The values ​​of uric acid before and after treatment were compared between groups. The results showed that: at week 4 of treatment, the uric acid reduction in the traditional Chinese medicine group was significantly lower than that in the febuxostat group (P=0.01); at week 8 of treatment, the uric acid reduction in the traditional Chinese medicine group was still significantly lower than that in the febuxostat group (P=0.014); at week 12 of treatment, there was no statistically significant difference in the uric acid reduction between the traditional Chinese medicine group and the febuxostat group (P = 0.560), and the uric acid reduction values ​​in the two groups were very similar (see Table 1). Therefore, within 8 weeks of treatment, the febuxostat group had a better uric acid-lowering effect than the traditional Chinese medicine group, which was statistically significant. P <0.05; After 12 weeks of treatment, the effects of the traditional Chinese medicine group and the febuxostat group on improving patients' serum uric acid levels were comparable, and the difference was not statistically significant. P >0.05). This indicates that the uric acid-lowering effect of the traditional Chinese medicine composition of the present invention is comparable to that of febuxostat after 12 weeks of treatment.

[0056] Table 1. Intergroup comparison of uric acid differences before and after treatment (μmol / L)

[0057] 2. Comparison of the incidence of crystalloid melting pain During treatment, the incidence of crystalloid dysplasia in the traditional Chinese medicine group was 0.79 times / person, while the incidence in the febuxostat group was 1.19 times / person. The incidence of crystalloid dysplasia in the traditional Chinese medicine group was lower than that in the febuxostat group. Based on the Poisson's ratio test, the difference in the incidence of crystalloid dysplasia between the two groups was statistically significant (P=0.0387), as shown in Table 2. This indicates that the traditional Chinese medicine composition of the present invention can significantly reduce the incidence of crystalloid dysplasia in patients during treatment compared with febuxostat.

[0058] Table 2. Incidence of crystalloid pain during treatment in both groups of patients.

[0059] 3. Comparison of safety indicators In the febuxostat group, aspartate aminotransferase (AST) levels significantly increased after treatment compared to before treatment (P < 0.05), indicating that febuxostat has some adverse effects on liver function. In contrast, in the traditional Chinese medicine group, there were no significant changes in AST, alanine aminotransferase (ALT), and serum creatinine (Cr) levels before and after treatment (P > 0.05), indicating that there were no significant changes in liver and kidney function after treatment in the traditional Chinese medicine group, demonstrating the good safety of the traditional Chinese medicine composition of this invention. See Table 3.

[0060] Table 3 Comparison of safety indicators between the two groups of patients

[0061] 4. Summary The traditional Chinese medicine composition of this invention showed comparable uric acid-lowering effects to febuxostat after 12 weeks of treatment. Compared to febuxostat, it significantly reduced the incidence of crystalloid reflux pain during treatment, and there were no significant changes in liver and kidney function after treatment, indicating good safety. These results demonstrate that the traditional Chinese medicine composition of this invention has significant clinical efficacy and good safety.

[0062] The above descriptions are merely some embodiments of the present invention. Those skilled in the art can make various modifications and improvements without departing from the inventive concept of the present invention, and these all fall within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating hyperuricemia, characterized in that, Its main active ingredients, by weight, include: 15-25 parts of stir-fried coix seed, 15-25 parts of Smilax glabra, 15-25 parts of Alisma plantago-aquatica, 5-15 parts of Atractylodes lancea, 10-15 parts of Plantago asiatica, 10-20 parts of Dioscorea hypoglauca, 10-20 parts of Cornus officinalis, 10-20 parts of Dioscorea opposita, 10-20 parts of Rehmannia glutinosa (processed), 6-12 parts of Aconitum carmichaelii (processed), 10-15 parts of Cinnamomum cassia, and 6-12 parts of Glycyrrhiza uralensis (processed).

2. The traditional Chinese medicine composition according to claim 1, characterized in that, Its main active ingredients, by weight, include: 20 parts of stir-fried coix seed, 20 parts of Smilax glabra, 20 parts of Alisma plantago-aquatica, 10 parts of Atractylodes lancea, 12 parts of Plantago asiatica, 15 parts of Dioscorea hypoglauca, 15 parts of Cornus officinalis, 15 parts of Dioscorea opposita, 15 parts of Rehmannia glutinosa, 9 parts of Aconitum carmichaelii, 12 parts of Cinnamomum cassia, and 9 parts of Glycyrrhiza uralensis.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, At least one of the following raw materials by weight may also be added: Clematis chinensis 10-15 parts, Spatholobus suberectus 10-15 parts, stir-fried Atractylodes macrocephala 10-20 parts, Euryale ferox 10-20 parts, Artemisia capillaris 5-15 parts, Polygonum cuspidatum 5-15 parts.

4. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Pharmaceutically acceptable excipients can also be added.

5. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The dosage form of the traditional Chinese medicine composition is capsule, granule, tablet, decoction, oral liquid or drop pill.

6. A method for preparing the traditional Chinese medicine composition for treating hyperuricemia according to any one of claims 1-5, characterized in that, When the dosage form of the traditional Chinese medicine composition is a capsule, its preparation method includes the following steps: (1) Boil the raw materials twice with water. For the first decoction, add 8-10 times the amount of water equivalent to the total mass of the raw materials, heat to boiling, and keep simmering for 1-2 hours. After separation, obtain the first decoction and the dregs. For the second decoction, take the dregs obtained after the first decoction, add 8-10 times the amount of water equivalent to the total mass of the raw materials, heat to boiling, and keep simmering for 1-2 hours. After separation, obtain the second decoction and the dregs. Combine the first and second decoctions to obtain the combined decoction. (2) The combined decoction obtained in step (1) is concentrated under reduced pressure at 60°C to a clear extract with a relative density of 1.25; (3) The ointment obtained in step (2) is spray-dried to obtain dry ointment powder, wherein the spray drying process parameters are: air inlet temperature 170℃, air outlet temperature 85℃; (4) Add excipients to the dry powder obtained in step (3), and mix with a mixer for 30 minutes to make it evenly mixed, to obtain a mixed powder; (5) Fill the mixed powder obtained in step (4) into a hollow hard capsule or seal it in an elastic soft capsule to obtain the product.

7. The preparation method according to claim 6, characterized in that, The excipient is magnesium stearate.

8. The use of the traditional Chinese medicine composition for treating hyperuricemia according to any one of claims 1-5 in the preparation of a medicament for treating hyperuricemia.

9. The use of the traditional Chinese medicine composition for treating hyperuricemia according to any one of claims 1-5 in the preparation of a medicine for treating hyperuricemia with spleen and kidney deficiency and internal dampness.

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