A pharmaceutical composition for treating hyperuricemia

Abstract

The present invention relates to the field of medical technology, and specifically to a kind of pharmaceutical composition for treating hyperuricemia.Pharmaceutical composition of the present invention includes the component of following parts by weight: 50-100 parts of bupleurum, 50-100 parts of moutan bark, 10-50 parts of codonopsis pilosula, 10-50 parts of clematis root, 10-50 parts of radix polygoni multiflori, 10-50 parts of rhizoma smilacis, 1-30 parts of fructus wolfberries and 1-30 parts of licorice.Pharmaceutical composition of the present invention embodies the synergistic effect of traditional Chinese medicine, can not only reduce the content of uric acid, creatinine, can also reduce the activity of xanthine oxidase, with the effect of definite treatment hyperuricemia.Long-term taking pharmaceutical composition of the present invention, ALT and AST in liver function biochemical indexes do not have obvious change, show that pharmaceutical composition of the present invention does not cause damage to liver function, to liver safety without toxic side effect.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to a pharmaceutical composition for treating hyperuricemia. Background Technology

[0002] Hyperuricemia is a metabolic disease caused by purine metabolism disorders resulting from genetic factors or abnormalities in the uric acid transport system, leading to the accumulation of uric acid in the body and impaired excretion. Hyperuricemia not only forms the basis for gout but also easily affects the kidneys and cardiovascular system. It is significantly positively correlated with obesity, hyperlipidemia, hypertension, diabetes, and atherosclerosis, seriously endangering human health.

[0003] Existing Western medicines for lowering high uric acid are fast-acting, but they also bring a series of side effects. Current drug compositions for treating gout and / or hyperuricemia are simply combinations of traditional Chinese medicines that help lower uric acid; they can only inhibit xanthine oxidase activity or degrade blood uric acid, resulting in limited therapeutic effects, and the risk of liver damage is increasing year by year. Therefore, it is urgent to develop a traditional Chinese medicine composition that can effectively treat hyperuricemia while being safe and free of toxic side effects. Summary of the Invention

[0004] To address the aforementioned technical problems, the present invention provides a pharmaceutical composition for treating hyperuricemia, which not only effectively treats hyperuricemia but is also safe and free of toxic side effects on the liver.

[0005] The technical solution of the present invention is as follows:

[0006] This invention provides a pharmaceutical composition for treating hyperuricemia, comprising the following components in parts by weight: Bupleurum chinense 50-100 parts, Paeonia suffruticosa 50-100 parts, Codonopsis pilosula 10-50 parts, Clematis chinensis 10-50 parts, Dioscorea hypoglauca 10-50 parts, Smilax glabra 10-50 parts, Lycium barbarum 1-30 parts, and Glycyrrhiza uralensis 1-30 parts.

[0007] In one embodiment, the pharmaceutical composition comprises the following components in parts by weight: Bupleurum chinense 55-90 parts, Paeonia suffruticosa 55-90 parts, Codonopsis pilosula 15-45 parts, Clematis chinensis 15-45 parts, Dioscorea hypoglauca 15-45 parts, Smilax glabra 15-45 parts, Lycium barbarum 15-30 parts, and Glycyrrhiza uralensis 15-30 parts.

[0008] In one embodiment, the weight ratio of Bupleurum chinense and Paeonia suffruticosa is 1:1 to 2:1.

[0009] The present invention also provides a method for preparing the pharmaceutical composition, comprising the following steps: weighing the parts by weight of Bupleurum chinense and Paeonia suffruticosa, drying and pulverizing them, and mixing them to obtain material A; extracting with ethanol, filtering and concentrating to obtain extract A; drying and pulverizing extract A to obtain an alcohol extract; weighing the parts by weight of Codonopsis pilosula, Clematis chinensis, Dioscorea hypoglauca, Smilax glabra, Lycium barbarum and Glycyrrhiza uralensis, drying them, and mixing them to obtain material B; extracting with water, filtering and concentrating to obtain extract B; drying and pulverizing extract B to obtain an aqueous extract; and mixing the alcohol extract and the aqueous extract.

[0010] In one embodiment, the weight ratio of material A to ethanol is 1:5 to 1:8.

[0011] In one embodiment, the ethanol is an aqueous solution with a volume fraction of 50%-80%, the ethanol extraction temperature is 60-80℃, the extraction is performed 2-4 times, and the extraction time for each extraction is 0.5-1h.

[0012] In one embodiment, the water extraction temperature is 80-100℃, the extraction is performed 1-2 times, and the extraction time is 1-2 hours each time.

[0013] The present invention also provides the use of the pharmaceutical composition in the preparation of a medicament for the prevention and / or treatment of hyperuricemia.

[0014] The present invention also provides an formulation for the prevention and / or treatment of hyperuricemia, the formulation comprising the pharmaceutical composition and pharmaceutically acceptable excipients.

[0015] As one implementation, the pharmaceutically acceptable excipient is one or more of a disintegrant, lubricant, binder, and dispersant.

[0016] The advantages of this invention compared to existing technologies are as follows:

[0017] 1. This invention is a pharmaceutical composition formulated with Bupleurum chinense and Paeonia suffruticosa as principal herbs, based on the principles of soothing the liver and clearing heat, tonifying the spleen and benefiting the kidneys. Specifically, Bupleurum chinense contains saikosaponins, which exhibit antioxidant activity and hepatoprotective effects, as well as anti-inflammatory and antibacterial properties; Paeonol in Paeonia suffruticosa exerts antibacterial activity by disrupting membrane structures, showing significant inhibitory effects against Staphylococcus aureus, Escherichia coli, and Candida albicans; Codonopsis pilosula contains polysaccharides that regulate the body's immune function, and Codonopsis pilosula saponins that improve blood circulation, increase renal blood perfusion, and protect renal cells; Clematis chinensis contains clematis saponins that inhibit the release of inflammatory mediators, raise the pain threshold, and exert an analgesic effect, while Clematis chinensis polysaccharides enhance the body's immune function and improve immunity; Dioscorea hypoglauca contains terpenoids that dispel wind and dampness, and have anti-inflammatory and analgesic effects, reducing joint inflammation and pain, and improving joint function; Smilax glabra has significant joint-clearing effects, reducing joint inflammation and improving joint mobility. The pharmaceutical composition described in this invention embodies the synergistic effect of traditional Chinese medicine, which can not only reduce the content of uric acid and creatinine, but also reduce the activity of xanthine oxidase, thus having a definite therapeutic effect on hyperuricemia.

[0018] 2. This invention is the first to use Bupleurum chinense and Paeonia suffruticosa as the principal herbs, leading the entire formula for the treatment of hyperuricemia. Long-term use of the drug composition of this invention did not result in significant changes in ALT and AST levels in liver function biochemical indicators. This indicates that the drug composition of this invention does not damage liver function and is safe and has no toxic side effects on the liver. Detailed Implementation

[0019] This invention provides a pharmaceutical composition for treating hyperuricemia, comprising the following components in parts by weight: Bupleurum chinense 50-100 parts, Paeonia suffruticosa 50-100 parts, Codonopsis pilosula 10-50 parts, Clematis chinensis 10-50 parts, Dioscorea hypoglauca 10-50 parts, Smilax glabra 10-50 parts, Lycium barbarum 1-30 parts, and Glycyrrhiza uralensis 1-30 parts. As one embodiment, the preferred components in the pharmaceutical composition are: Bupleurum chinense 55-90 parts, Paeonia suffruticosa 55-90 parts, Codonopsis pilosula 15-45 parts, Clematis chinensis 15-45 parts, Dioscorea hypoglauca 15-45 parts, Smilax glabra 15-45 parts, Lycium barbarum 15-30 parts, and Glycyrrhiza uralensis 15-30 parts.

[0020] In this invention, there are no special restrictions on the specific sources of each Chinese herbal raw material; commercially available products can be used.

[0021] In this invention, the weight ratio of Bupleurum chinense and Paeonia suffruticosa is 1:1-2:1. As one embodiment, the weight ratio of Bupleurum chinense and Paeonia suffruticosa is 1:1-1.5:1. The formula prepared according to the weight ratio described in this invention has good effects in lowering uric acid and xanthine oxidase. In one embodiment, the pharmaceutical composition comprises the following components in parts by weight: 90 parts Bupleurum chinense, 60 parts Paeonia suffruticosa, 30 parts Codonopsis pilosula, 30 parts Clematis chinensis, 30 parts Dioscorea hypoglauca, 45 parts Smilax glabra, 20 parts Lycium barbarum, and 20 parts Glycyrrhiza uralensis.

[0022] The present invention also provides a method for preparing the pharmaceutical composition, comprising the following steps: weighing the Bupleurum chinense and Paeonia suffruticosa in the specified weight parts, drying and pulverizing them, and mixing them to obtain material A; extracting with ethanol, filtering and concentrating to obtain extract A; drying and pulverizing extract A to obtain an alcohol extract; weighing the Codonopsis pilosula, Clematis chinensis, Dioscorea hypoglauca, Smilax glabra, Lycium barbarum and Glycyrrhiza uralensis in the specified weight parts, drying and cutting them into sections, and mixing them to obtain material B; extracting with water, filtering and concentrating to obtain extract B; drying and pulverizing extract B to obtain an aqueous extract; and mixing the alcohol extract and the aqueous extract.

[0023] In this invention, Bupleurum chinense and Paeonia suffruticosa are dried using equipment such as an oven or dryer at a temperature of 60℃-80℃ for 3-5 hours. The dried Bupleurum chinense and Paeonia suffruticosa are then pulverized using a hammer mill, ball mill, or universal pulverizer, passing through a 60-100 mesh sieve. The pulverized materials are then mixed to obtain material A. Material A is then mixed with a 50%-80% (v / v) ethanol aqueous solution for ethanol extraction. In one embodiment, the weight ratio of material A to ethanol is 1:5-1:8; in another embodiment, the weight ratio is 1:6-1:7. This invention does not specifically limit the ethanol extraction method; maceration, percolation, or reflux extraction can be used. In one embodiment, the ethanol extraction temperature is 60-80℃; in another embodiment, the ethanol extraction temperature is 60-70℃. In one embodiment, the ethanol is extracted 2-4 times, with each extraction lasting 0.5-1 hour; in another embodiment, the ethanol is extracted 2-3 times, with each extraction lasting 0.5-1 hour. The combined extracts are filtered and concentrated to obtain extract A. Extract A is then dried and pulverized. In one embodiment, the drying temperature is 80℃-100℃, and the pulverization aperture is 2-5 mm. The drying equipment can be spray drying, vacuum drying, or oven drying; the pulverization equipment can be a hammer mill, ball mill, or universal pulverizer.

[0024] In this invention, Codonopsis pilosula, Clematis chinensis, Dioscorea hypoglauca, Smilax glabra, Lycium barbarum, and Glycyrrhiza uralensis are dried using equipment such as an oven or dryer at a temperature of 60℃-80℃ for 3-5 hours. The dried Codonopsis pilosula, Clematis chinensis, Dioscorea hypoglauca, Smilax glabra, Lycium barbarum, and Glycyrrhiza uralensis are then cut into segments or pulverized. The segments are 2-5 cm in length. A hammer mill, ball mill, or universal pulverizer can be used for pulverization, passing the pulverized material through a 40-60 mesh sieve. The resulting mixture yields material B. Material B is then mixed with water for water extraction. In one embodiment, the weight ratio of material B to water is 1:8-1:10; in another embodiment, the weight ratio is 1:9-1:10. This invention does not specifically limit the water extraction method; decoction or soaking methods can be used. In one embodiment, the water extraction temperature is 80-100℃, and the water extraction is performed 1-2 times, with each extraction lasting 1-2 hours. The extracts are combined, filtered, and concentrated to obtain extract B. Extract B is then dried and pulverized. In one embodiment, the drying temperature is 80℃-100℃, and the pulverization pore size is 2-5mm. The drying equipment can be spray drying, vacuum drying, or oven drying, and the pulverization equipment can be a hammer mill, ball mill, or universal pulverizer. The formula prepared by the method of this invention has good effects in lowering uric acid and xanthine oxidase.

[0025] This invention also provides an application of the aforementioned pharmaceutical composition in the preparation of a medicament for the prevention and / or treatment of hyperuricemia. The pharmaceutical composition of this invention not only reduces the levels of uric acid and creatinine, but also reduces the activity of xanthine oxidase, thus exhibiting a definite therapeutic effect on hyperuricemia.

[0026] The present invention also provides an formulation for the prevention and / or treatment of hyperuricemia, the formulation comprising the pharmaceutical composition and a pharmaceutically acceptable excipient. As one embodiment, the pharmaceutically acceptable excipient is one or more selected from disintegrants, lubricants, binders, and dispersants.

[0027] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be described in detail below with reference to the embodiments, but these should not be construed as limiting the scope of protection of this invention.

[0028] Unless otherwise specified, the materials, reagents, etc. used in the following examples are commercially available. Unless otherwise specified, they are generally used under conventional conditions or under conditions recommended by the company.

[0029] Example 1

[0030] Bupleurum chinense 90 parts, Paeonia suffruticosa 60 parts, Codonopsis pilosula 30 parts, Clematis chinensis 30 parts, Dioscorea hypoglauca 30 parts, Smilax glabra 45 parts, Lycium barbarum 20 parts, and Glycyrrhiza uralensis 20 parts.

[0031] Preparation method: Weigh out the following ingredients by weight: Bupleurum chinense, Paeonia suffruticosa, Codonopsis pilosula, Clematis chinensis, Dioscorea hypoglauca, Smilax glabra, Lycium barbarum and Glycyrrhiza uralensis, and dry them in an oven at 70°C for 5 hours.

[0032] Dried Bupleurum chinense and Paeonia suffruticosa root bark were separately pulverized and passed through a 60-mesh sieve, then mixed to obtain material A. Material A was mixed with a 60% ethanol aqueous solution at a weight ratio of 1:6, and extracted by reflux at 60℃ for 0.5 hours to obtain the extract. The ethanol extraction was repeated three times, and the three extracts were combined, filtered, and concentrated to obtain extract A. Extract A was dried in an oven at 80℃, and then pulverized in a ball mill to a particle size of 3 mm to obtain the ethanol extract.

[0033] The dried Codonopsis pilosula, Clematis chinensis, Dioscorea hypoglauca, Smilax glabra, Lycium barbarum, and Glycyrrhiza uralensis were cut into 3cm segments and mixed to obtain material B. Material B was mixed with water at a weight ratio of 1:10 and decocted for 1.5 hours to obtain the decoction. The decoction was repeated twice, and the two decoctions were combined, filtered, and concentrated to obtain extract B. Extract B was dried in an oven at 80℃ and then pulverized in a ball mill to a particle size of 3mm to obtain the water extract.

[0034] The pharmaceutical composition is obtained by mixing the alcohol extract and the water extract.

[0035] Example 2

[0036] Bupleurum 100 parts, Moutan bark 50 parts, Codonopsis pilosula 25 parts, Clematis chinensis 30 parts, Dioscorea hypoglauca 30 parts, Smilax glabra 40 parts, Lycium barbarum 20 parts, and Glycyrrhiza uralensis 20 parts.

[0037] The preparation method is the same as in Example 1, except that material A is mixed with 60% ethanol aqueous solution at a weight ratio of 1:7, and extracted by reflux at 65°C. After extraction for 1 hour, the extract is obtained, and the ethanol extraction is repeated twice.

[0038] Example 3

[0039] Bupleurum chinense 60 parts, Paeonia suffruticosa 60 parts, Codonopsis pilosula 20 parts, Clematis chinensis 20 parts, Dioscorea hypoglauca 20 parts, Smilax glabra 20 parts, Lycium barbarum 15 parts, and Glycyrrhiza uralensis 15 parts.

[0040] The preparation method is the same as in Example 1, except that material B is mixed with water at a weight ratio of 1:9 and decocted for 2 hours to obtain the decoction. The decoction is decocted once.

[0041] Comparative Example 1

[0042] Same as Example 1, except that the ingredients are Bupleurum chinense 30 parts, Paeonia suffruticosa 30 parts, Codonopsis pilosula 30 parts, Clematis chinensis 30 parts, Dioscorea hypoglauca 30 parts, Smilax glabra 45 parts, Lycium barbarum 20 parts and Glycyrrhiza uralensis 20 parts.

[0043] Comparative Example 2

[0044] Same as Example 1, except that the ingredients are Bupleurum chinense 200 parts, Paeonia suffruticosa 200 parts, Codonopsis pilosula 30 parts, Clematis chinensis 30 parts, Dioscorea hypoglauca 30 parts, Smilax glabra 45 parts, Lycium barbarum 20 parts and Glycyrrhiza uralensis 20 parts.

[0045] Comparative Example 3

[0046] Same as Example 1, except that the ingredients are Bupleurum chinense 60 parts, Paeonia suffruticosa 180 parts, Codonopsis pilosula 30 parts, Clematis chinensis 30 parts, Dioscorea hypoglauca 30 parts, Smilax glabra 45 parts, Lycium barbarum 20 parts and Glycyrrhiza uralensis 20 parts.

[0047] Comparative Example 4

[0048] Same as Example 1, except that the ingredients are: 90 parts of peony bark, 30 parts of codonopsis, 30 parts of clematis root, 30 parts of dioscorea hypoglauca, 45 parts of smilax glabra, 20 parts of wolfberry fruit, and 20 parts of licorice root.

[0049] Comparative Example 5

[0050] Same as Example 1, except that the ingredients are Bupleurum chinense 90 parts, Codonopsis pilosula 30 parts, Clematis chinensis 30 parts, Dioscorea hypoglauca 30 parts, Smilax glabra 45 parts, Lycium barbarum 20 parts and Glycyrrhiza uralensis 20 parts.

[0051] Comparative Example 6

[0052] Same as Example 1, except that Codonopsis pilosula 30 parts, Clematis chinensis 30 parts, Dioscorea hypoglauca 30 parts, Smilax glabra 45 parts, Lycium barbarum 20 parts and Glycyrrhiza uralensis 20 parts.

[0053] Comparative Example 7

[0054] Similar to Example 1, except that the dried Bupleurum, Moutan Bark, Codonopsis, Clematis, Dioscorea, Smilax, Lycium, and Licorice were all extracted with ethanol.

[0055] Comparative Example 8

[0056] Similar to Example 1, except that the dried Bupleurum, Moutan Bark, Codonopsis, Clematis, Dioscorea, Smilax, Lycium, and Licorice were all extracted by decoction with water.

[0057] Animal modeling and grouping

[0058] One hundred and forty adult mice were randomly divided into 14 groups of 10 mice each: a model group, a control group, a positive control group, and an experimental group (groups 1-3 in Examples and groups 1-8 in Comparative Examples). Mice in all groups had free access to food and water. The model group, positive control group, and experimental group received intraperitoneal injections of potassium oxonate (300 mg / kg) daily to induce hyperuricemia. The control group received the same intraperitoneal injection of sterile saline.

[0059] After inducing hyperuricemia in mice, the blank group and the model group were administered the same dose of sterile saline by gavage, the positive group was administered 5 mg / kg of allopurinol by gavage, and the groups in Examples 1-3 and Comparative Examples 1-8 were administered 500 mg / kg by gavage, and the treatment was repeated for 3 months.

[0060] Test Example 1

[0061] After one month of continuous drug administration, blood was collected from the eyeballs of mice in each group. The serum was collected by centrifugation at 3000 r / min for 15 min. The levels of uric acid and xanthine oxidase in the serum were measured according to the uric acid assay kit, creatinine assay kit, and xanthine oxidase assay kit (purchased from Nanjing Jiancheng). The results are shown in Table 1.

[0062] Table 1. Detection results of serum markers in each group of mice.

[0063]

[0064]

[0065] Note: *P<0.05 indicates a significant difference compared to the model group; **P<0.01 indicates a highly significant difference compared to the model group; ##P<0.01 indicates a highly significant difference compared to the blank group.

[0066] As shown in Table 1 above, compared with the blank group, the serum uric acid, creatinine and xanthine oxidase in the model group mice showed extremely significant differences (P<0.01), indicating that the model group was successfully modeled.

[0067] The serum uric acid, creatinine, and xanthine oxidase levels in mice in Examples 1-3 were significantly different from those in the model group (P<0.01), indicating that the pharmaceutical composition of the present invention can significantly reduce serum uric acid and xanthine oxidase levels, thereby improving or treating hyperuricemia. Compared to the model group, Comparative Examples 1-8 also improved serum uric acid and xanthine oxidase levels in mice, but the improvement was less pronounced than in the positive group. Based on the experimental results of Examples 1-3, the weight ratio of Bupleurum chinense and Paeonia suffruticosa in the pharmaceutical composition of the present invention of 1:1-2:1 has a better technical effect in lowering uric acid and xanthine oxidase.

[0068] Experimental Example 2

[0069] Blood was collected from the tail veins of mice in the blank group, model group, positive group, and Examples 1-3 groups after continuous administration for 1 month and 3 months. The plasma was collected by centrifugation at 3000 r / min for 15 min. The levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in the plasma were detected using a kit (purchased from Nanjing Jiancheng). The results are shown in Table 2.

[0070] Table 2. Detection results of plasma parameters in mice of each group

[0071]

[0072]

[0073] Note: *P<0.05 indicates a significant difference compared to the positive group; *P<0.01 indicates a highly significant difference compared to the positive group; #P<0.05 indicates a significant difference compared to the blank group; ##P<0.01 indicates a highly significant difference compared to the blank group.

[0074] Compared to the control group, the plasma ALT and AST levels in the model group mice showed significant differences at 1 and 3 months (P<0.05), and the plasma ALT and AST levels in the positive control group mice showed significant differences at 1 month (P<0.05), and highly significant differences at 3 months (P<0.01). Compared to the positive control group, the plasma ALT and AST levels in the groups of Examples 1-3 showed significant differences at 1 month (P<0.05), and highly significant differences at 3 months (P<0.01). Based on the experimental results of continuous administration for 1 and 3 months in Examples 1-3, the pharmaceutical composition of the present invention improves or treats hyperuricemia without adversely affecting liver function in mice with long-term use, and is safe and has no toxic side effects on the liver.

[0075] In summary, the pharmaceutical composition of this invention demonstrates the synergistic effect of traditional Chinese medicine, not only reducing uric acid and creatinine levels but also decreasing xanthine oxidase activity, thus exhibiting a definite therapeutic effect on hyperuricemia. Long-term use of the pharmaceutical composition of this invention did not result in significant changes in liver function biochemical indicators ALT and AST, indicating that the pharmaceutical composition of this invention does not damage liver function and is safe and free of toxic side effects on the liver.

[0076] The above description is merely an embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structural or procedural transformations made based on the content of the present invention specification, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of the present invention.

Claims

1. A pharmaceutical composition for treating hyperuricemia, characterized in that, It consists of the following components in parts by weight: Bupleurum chinense 50-100 parts, Paeonia suffruticosa 50-100 parts, Codonopsis pilosula 10-50 parts, Clematis chinensis 10-50 parts, Dioscorea hypoglauca 10-50 parts, Smilax glabra 10-50 parts, Lycium barbarum 1-30 parts, and Glycyrrhiza uralensis 1-30 parts.

2. The pharmaceutical composition according to claim 1, characterized in that, It consists of the following components in parts by weight: Bupleurum chinense 55-90 parts, Paeonia suffruticosa 55-90 parts, Codonopsis pilosula 15-45 parts, Clematis chinensis 15-45 parts, Dioscorea hypoglauca 15-45 parts, Smilax glabra 15-45 parts, Lycium barbarum 15-30 parts, and Glycyrrhiza uralensis 15-30 parts.

3. The pharmaceutical composition according to claim 1, characterized in that, The weight ratio of Bupleurum chinense and Paeonia suffruticosa is 1:1 to 2:

1.

4. A method for preparing the pharmaceutical composition according to any one of claims 1-3, characterized in that, Includes the following steps: Weigh out the specified weight parts of Bupleurum chinense and Paeonia suffruticosa, dry and pulverize them, then mix them to obtain material A. Extract with ethanol, filter and concentrate to obtain extract A. Dry and pulverize extract A to obtain alcohol extract. Weigh out the specified weight parts of Codonopsis pilosula, Clematis chinensis, Dioscorea hypoglauca, Smilax glabra, Lycium barbarum and Glycyrrhiza uralensis, dry them and mix them to obtain material B. Extract B is obtained by water extraction, filtration and concentration. Extract B is then dried and pulverized to obtain water extract. The alcohol extract and the water extract are mixed.

5. The preparation method according to claim 4, characterized in that, The weight ratio of material A to ethanol is 1:5 to 1:

8.

6. The preparation method according to claim 4, characterized in that, The ethanol is an aqueous solution with a volume fraction of 50-80%, and the ethanol extraction temperature is 60-80℃, with 2-4 extractions and an extraction time of 0.5-1h for each extraction.

7. The preparation method according to claim 4, characterized in that, The water extraction temperature is 80-100℃, and the extraction is performed 1-2 times, with each extraction lasting 1-2 hours.

8. Use of the pharmaceutical composition according to any one of claims 1-4 in the preparation of a medicament for the prevention and / or treatment of hyperuricemia.

9. A preparation for the prevention and / or treatment of hyperuricemia, characterized in that, The formulation comprises the pharmaceutical composition of any one of claims 1-3 and pharmaceutically acceptable excipients.

10. The preparation for the prevention and / or treatment of hyperuricemia according to claim 9, characterized in that, The pharmaceutically acceptable excipients are one or more of the following: disintegrants, lubricants, binders, and dispersants.

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