Pharmaceutical composition for treating hyperuricemia
Through the treatment methods of relieving liver and clearing heat, nourishing spleen and kidneys with Chinese medicine compositions such as Bupleurum and Peony Bark, the existing drug composition has limited effect on treating hyperuricemia and damage to liver function, and has achieved effective reduction of the activity of uric acid and xanthine oxidase and ensuring the safe and toxic side effects of the liver.
Patent Information
- Application Number
- CN202510596573.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-05-09
- Publication Date
- 2025-06-27
- Estimated Expiration
- 2045-05-09
AI Technical Summary
The existing pharmaceutical compositions for treating hyperuricemia have limited therapeutic effects and cause damage to liver function, with safety and side effects.
Bupleurum and peony bark are used as the monarch medicine, combined with the pharmaceutical composition of Codonopsis pilosula, Viagra, Viagra, Lycium, Lycium and Licorice, and the treatment of relieving liver and clearing heat, nourishing the spleen and kidneys, reduce the activity of uric acid and xanthine oxidase, and treat hyperuricemia.
This pharmaceutical composition can not only effectively reduce the content of uric acid and creatinine, reduce the activity of xanthine oxidase, and accurately treat hyperuricemia, but also harmless to liver function and have no toxic side effects.
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Abstract
Description
Technical Field
[0001] The present invention belongs to the technical field of medicine, and particularly relates to a pharmaceutical composition for treating hyperuricemia. Background Art
[0002] Hyperuricemia is a metabolic disease caused by genetic inheritance or abnormal uric acid transport system, resulting in purine metabolism disorder, accumulation of uric acid in the body and obstruction of excretion. Hyperuricemia is not only the pathogenesis basis of gout, but also easily involves the kidneys and cardiovascular system, and shows a significant positive correlation with diseases such as obesity, hyperlipidemia, hypertension, diabetes, and atherosclerosis, seriously endangering human health.
[0003] Existing western medicines for reducing hyperuricemia have a fast efficacy, but at the same time bring a series of side effects. And existing pharmaceutical compositions for treating gout and / or hyperuricemia are only simple combinations of traditional Chinese medicines that are beneficial to reducing uric acid, which can only inhibit the activity of xanthine oxidase or degrade blood uric acid, with limited therapeutic effects, and the damage to liver function shows an increasing trend year by year. Therefore, it is urgent to develop a traditional Chinese medicine composition that can effectively treat hyperuricemia and is safe and non-toxic. Summary of the Invention
[0004] In view of the above technical problems, the present invention provides a pharmaceutical composition for treating hyperuricemia, which can not only effectively treat hyperuricemia, but also is safe and non-toxic to the liver.
[0005] The technical solution of the present invention is as follows:
[0006] The present invention provides a pharmaceutical composition for treating hyperuricemia, comprising the following components in parts by weight: 50 - 100 parts of Bupleuri Radix, 50 - 100 parts of Moutan Cortex, 10 - 50 parts of Codonopsis Pilosulae Radix, 10 - 50 parts of Clematidis Radix, 10 - 50 parts of Dioscoreae Hypoglaucae Rhizoma, 10 - 50 parts of Smilacis Glabrae Rhizoma, 1 - 30 parts of Lycii Fructus, and 1 - 30 parts of Glycyrrhizae Radix et Rhizoma.
[0007] As an embodiment, in the pharmaceutical composition, it comprises the following components in parts by weight: 55 - 90 parts of Bupleuri Radix, 55 - 90 parts of Moutan Cortex, 15 - 45 parts of Codonopsis Pilosulae Radix, 15 - 45 parts of Clematidis Radix, 15 - 45 parts of Dioscoreae Hypoglaucae Rhizoma, 15 - 45 parts of Smilacis Glabrae Rhizoma, 15 - 30 parts of Lycii Fructus, and 15 - 30 parts of Glycyrrhizae Radix et Rhizoma.
[0008] As an embodiment, the weight ratio of Bupleuri Radix to Moutan Cortex is 1:1 - 2:1.
[0009] The present invention also provides a method for preparing the pharmaceutical composition, which comprises the following steps: Weigh the respective parts by weight of Bupleurum chinense and Cortex Moutan, dry, pulverize and mix them to obtain material A, extract with ethanol, filter and concentrate to obtain extract A, dry and pulverize extract A to obtain an ethanol extract; Weigh the respective parts by weight of Codonopsis pilosula, Clematis chinensis, Dioscorea septemloba, Smilax glabra, Lycium barbarum and Glycyrrhiza uralensis, dry and mix them to obtain material B, extract with water, filter and concentrate to obtain extract B, dry and pulverize extract B to obtain a water extract; Mix the ethanol extract and the water extract.
[0010] As an embodiment, the weight ratio of material A to ethanol is 1:5 - 1:8.
[0011] As an embodiment, the ethanol is an ethanol aqueous solution with a volume fraction of 50% - 80%, the ethanol extraction temperature is 60 - 80°C, extract 2 - 4 times, and the extraction time for each time is 0.5 - 1 h.
[0012] As an embodiment, the temperature of the water extraction is 80 - 100°C, extract 1 - 2 times, and the extraction time for each time is 1 - 2 h.
[0013] The present invention also provides an application of the pharmaceutical composition in the preparation of a drug for preventing and / or treating hyperuricemia.
[0014] The present invention also provides a preparation for preventing and / or treating hyperuricemia, and the preparation comprises the pharmaceutical composition and pharmaceutically acceptable excipients.
[0015] As an embodiment, the pharmaceutically acceptable excipients are one or more of a disintegrant, a lubricant, a binder and a dispersant.
[0016] Compared with the prior art, the beneficial effects of the present invention:
[0017] 1. The present invention relates to a pharmaceutical composition formulated with Bupleuri Radix and Moutan Cortex as the monarch drugs, in accordance with the therapeutic principles of soothe the liver and clear heat, invigorate the spleen and replenish the kidney. Among them, saikosaponins in Bupleuri Radix exhibit antioxidant activity and hepatoprotective effects, and also have anti-inflammatory and antibacterial effects; paeonol in Moutan Cortex exerts antibacterial virulence by destroying the membrane structure and has significant inhibitory effects on Staphylococcus aureus, Escherichia coli, and Candida albicans; codonopsis polysaccharide in Codonopsis Pilosula can regulate the body's immune function, and codonopsis saponin can improve blood circulation, increase blood perfusion in the kidneys, and protect kidney cells; clematis saponin in Clematis Chinensis can inhibit the release of inflammatory mediators, increase pain threshold and play an analgesic role, and clematis polysaccharide can enhance the body's immune function and improve the body's immunity; the terpenoid components in Dioscoreae Hypoglauca Rhizoma dispel wind and relieve arthralgia, have anti-inflammatory and analgesic effects, can reduce joint inflammation and pain, and improve joint activity function; Smilax Glabra Rhizoma has a significant effect of promoting joint movement, can reduce joint inflammation and improve joint activity function. The pharmaceutical composition of the present invention embodies the synergistic effect of traditional Chinese medicine, can not only reduce the content of uric acid and creatinine, but also reduce the activity of xanthine oxidase, and has a definite effect in treating hyperuricemia.
[0018] 2. The present invention for the first time uses Bupleuri Radix and Moutan Cortex as the monarch drugs to lead the whole formula for the treatment of hyperuricemia. Long-term administration of the pharmaceutical composition of the present invention shows no obvious changes in ALT and AST in the liver function biochemical indexes. It indicates that the pharmaceutical composition of the present invention will not cause damage to liver function and is safe and non-toxic to the liver. Detailed implementation mode
[0019] The present invention provides a pharmaceutical composition for treating hyperuricemia, comprising the following components in parts by weight: 50 - 100 parts of Bupleuri Radix, 50 - 100 parts of Moutan Cortex, 10 - 50 parts of Codonopsis Pilosula, 10 - 50 parts of Clematis Chinensis, 10 - 50 parts of Dioscoreae Hypoglauca Rhizoma, 10 - 50 parts of Smilax Glabra Rhizoma, 1 - 30 parts of Lycii Fructus, and 1 - 30 parts of Glycyrrhizae Radix et Rhizoma. As an implementation mode, the components in the pharmaceutical composition are preferably as follows in parts by weight: 55 - 90 parts of Bupleuri Radix, 55 - 90 parts of Moutan Cortex, 15 - 45 parts of Codonopsis Pilosula, 15 - 45 parts of Clematis Chinensis, 15 - 45 parts of Dioscoreae Hypoglauca Rhizoma, 15 - 45 parts of Smilax Glabra Rhizoma, 15 - 30 parts of Lycii Fructus, and 15 - 30 parts of Glycyrrhizae Radix et Rhizoma.
[0020] In the present invention, there is no special limitation on the specific sources of the various traditional Chinese medicine raw materials, and commercially available products can be used.
[0021] In the present invention, the weight ratio of Bupleurum chinense DC. and Cortex Moutan is 1:1 - 2:1. As an embodiment, the weight ratio of Bupleurum chinense DC. and Cortex Moutan is 1:1 - 1.5:1. The prescription formulated according to the weight ratio described in the present invention has a good effect of reducing uric acid and xanthine oxidase. In one embodiment, the pharmaceutical composition comprises the following components in parts by weight: 90 parts of Bupleurum chinense DC., 60 parts of Cortex Moutan, 30 parts of Codonopsis pilosula (Franch.) Nannf., 30 parts of Clematis chinensis Osbeck, 30 parts of Dioscorea septemloba Thunb., 45 parts of Smilax glabra Roxb., 20 parts of Lycium barbarum L. and 20 parts of Glycyrrhiza uralensis Fisch..
[0022] The present invention also provides a preparation method of the pharmaceutical composition, comprising the following steps: weighing the Bupleurum chinense DC. and Cortex Moutan in the above-mentioned parts by weight respectively, drying, pulverizing and then mixing to obtain material A, extracting with ethanol, filtering and concentrating to obtain extract A, drying and pulverizing extract A to obtain ethanol extract; weighing the Codonopsis pilosula (Franch.) Nannf., Clematis chinensis Osbeck, Dioscorea septemloba Thunb., Smilax glabra Roxb., Lycium barbarum L. and Glycyrrhiza uralensis Fisch. in the above-mentioned parts by weight respectively, drying, cutting into sections and then mixing to obtain material B, extracting with water, filtering and concentrating to obtain extract B, drying and pulverizing extract B to obtain water extract; mixing the ethanol extract and the water extract.
[0023] In the present invention, for drying Bupleurum chinense DC. and Cortex Moutan, equipment such as an oven or a dryer can be used for drying, the drying temperature is 60°C - 80°C, and the drying time is 3 - 5 h. Pulverize the dried Bupleurum chinense DC. and Cortex Moutan, and any of a hammer mill, a ball mill or a universal pulverizer can be selected for pulverization. Pulverize through a 60 - 100 mesh sieve, and mix after sieving to obtain material A. Mix material A with an ethanol aqueous solution with a volume fraction of 50% - 80% for ethanol extraction. As an embodiment, the weight ratio of material A to ethanol is 1:5 - 1:8. In one embodiment, the weight ratio of material A to ethanol is 1:6 - 1:7. In the present invention, there is no specific limitation on the ethanol extraction method, and impregnation method, percolation method or reflux extraction method can be adopted. As an embodiment, the ethanol extraction temperature is 60 - 80°C. In one embodiment, the ethanol extraction temperature is 60 - 70°C; as an embodiment, the ethanol extraction is carried out 2 - 4 times, and the extraction time for each time is 0.5 - 1 h. In one embodiment, the ethanol extraction is carried out 2 - 3 times, and the extraction time for each time is 0.5 - 1 h. Filter after combining the extraction solutions and concentrate to obtain extract A. Dry and pulverize extract A. As an embodiment, the drying temperature is 80°C - 100°C, and the pulverization aperture is 2 - 5 mm. The drying equipment can select spray drying, vacuum drying or oven drying, and the pulverization equipment can select a hammer mill, a ball mill or a universal pulverizer.
[0024] In the present invention, Codonopsis pilosula, Clematis chinensis, Dioscorea septemloba, Smilax glabra, Lycium barbarum and Glycyrrhiza uralensis are dried using equipment such as an oven or a dryer. The drying temperature is 60°C - 80°C, and the drying time is 3 - 5 h. The dried Codonopsis pilosula, Clematis chinensis, Dioscorea septemloba, Smilax glabra, Lycium barbarum and Glycyrrhiza uralensis are cut into sections or pulverized. The length of the cut sections is 2 - 5 cm. For pulverization, a hammer mill, a ball mill or a universal pulverizer can be selected, and the pulverized product is sieved through a 40 - 60 mesh sieve to obtain Material B. Material B is mixed with water for water extraction. As one embodiment, the weight ratio of Material B to water is 1:8 - 1:10. In one embodiment, the weight ratio of Material B to water is 1:9 - 1:10. In the present invention, there is no specific limitation on the water extraction method, and decoction or maceration can be used. As one embodiment, the water extraction temperature is 80 - 100°C. As one embodiment, the water extraction is carried out 1 - 2 times, and the extraction time for each time is 1 - 2 h. After combining the extraction solutions, they are filtered and concentrated to obtain Extract B. Extract B is dried and pulverized. As one embodiment, the drying temperature is 80°C - 100°C, and the pulverization aperture is 2 - 5 mm. The drying equipment can be spray drying, vacuum drying or oven drying, and the pulverization equipment can be a hammer mill, a ball mill or a universal pulverizer. The prescription prepared by the preparation method of the present invention has a good effect of reducing uric acid and xanthine oxidase.
[0025] The present invention also provides an application of the above - mentioned pharmaceutical composition in the preparation of a drug for preventing and / or treating hyperuricemia. The pharmaceutical composition of the present invention can not only reduce the contents of uric acid and creatinine, but also reduce the activity of xanthine oxidase, and has a definite effect on treating hyperuricemia.
[0026] The present invention also provides a preparation for preventing and / or treating hyperuricemia, which includes the above - mentioned pharmaceutical composition and pharmaceutically acceptable excipients. As one embodiment, the pharmaceutically acceptable excipients are one or more of disintegrants, lubricants, binders and dispersants.
[0027] To make the purpose, technical solution and advantages of the present invention clearer, the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the protection scope of the present invention.
[0028] For the materials, reagents, etc. used in the following embodiments, unless otherwise specified, the reagents, consumables, etc. involved in the present invention can be obtained from commercial channels. If the specific use conditions are not indicated, they are usually carried out under conventional conditions or according to the conditions recommended by the company.
[0029] Example 1
[0030] 90 parts of Bupleurum chinense, 60 parts of Cortex Moutan, 30 parts of Codonopsis pilosula, 30 parts of Clematis chinensis, 30 parts of Dioscorea septemloba, 45 parts of Smilax glabra, 20 parts of Lycium barbarum, and 20 parts of Glycyrrhiza uralensis.
[0031] Preparation method: Weigh the Bupleurum chinense, Cortex Moutan, Codonopsis pilosula, Clematis chinensis, Dioscorea septemloba, Smilax glabra, Lycium barbarum, and Glycyrrhiza uralensis of the above-mentioned weight parts respectively, and place them in an oven at 70 °C for drying for 5 h.
[0032] Crush the dried Bupleurum chinense and Cortex Moutan through a 60-mesh sieve respectively, and mix them to obtain material A. Mix material A with 60% ethanol aqueous solution at a weight ratio of 1:6, reflux and extract at 60 °C. After extracting for 0.5 h, obtain the extract. Repeat the ethanol extraction 3 times, combine the 3 extracts, filter, and concentrate to obtain extract A. Dry extract A in an oven at 80 °C, and then put it into a ball mill for crushing until the crushing particle size passes through a 3-mm aperture to obtain the alcohol extract.
[0033] Cut the dried Codonopsis pilosula, Clematis chinensis, Dioscorea septemloba, Smilax glabra, Lycium barbarum, and Glycyrrhiza uralensis into sections with a length of 3 cm, and mix them to obtain material B. Mix material B with water at a weight ratio of 1:10, and perform water decoction. After decocting for 1.5 h, obtain the decoction. Repeat the water decoction 2 times, combine the 2 decoctions, filter, and concentrate to obtain extract B. Dry extract B in an oven at 80 °C, and then put it into a ball mill for crushing until the crushing particle size passes through a 3-mm aperture to obtain the water extract.
[0034] Mix the alcohol extract and the water extract to obtain the pharmaceutical composition.
[0035] Example 2
[0036] 100 parts of Bupleurum chinense, 50 parts of Cortex Moutan, 25 parts of Codonopsis pilosula, 30 parts of Clematis chinensis, 30 parts of Dioscorea septemloba, 40 parts of Smilax glabra, 20 parts of Lycium barbarum, and 20 parts of Glycyrrhiza uralensis.
[0037] The preparation method is the same as that of Example 1, except that material A is mixed with 60% ethanol aqueous solution at a weight ratio of 1:7, reflux and extract at 65 °C. After extracting for 1 h, obtain the extract. Repeat the ethanol extraction 2 times.
[0038] Example 3
[0039] 60 parts of Bupleurum chinense, 60 parts of Cortex Moutan, 20 parts of Codonopsis pilosula, 20 parts of Clematis chinensis, 20 parts of Dioscorea septemloba, 20 parts of Smilax glabra, 15 parts of Lycium barbarum, and 15 parts of Glycyrrhiza uralensis.
[0040] The preparation method is the same as that of Example 1, except that material B is mixed with water at a weight ratio of 1:9, and water decoction is performed. After decocting for 2 h, obtain the decoction, and perform water decoction 1 time.
[0041] Comparative Example 1
[0042] Same as Example 1, except that it contains 30 parts of Bupleuri Radix, 30 parts of Moutan Cortex, 30 parts of Codonopsis Pilosula, 30 parts of Clematidis Radix, 30 parts of Dioscoreae Hypoglaucae Rhizoma, 45 parts of Smilacis Glabrae Rhizoma, 20 parts of Lycii Fructus, and 20 parts of Glycyrrhizae Radix et Rhizoma.
[0043] Comparative Example 2
[0044] Same as Example 1, except that it contains 200 parts of Bupleuri Radix, 200 parts of Moutan Cortex, 30 parts of Codonopsis Pilosula, 30 parts of Clematidis Radix, 30 parts of Dioscoreae Hypoglaucae Rhizoma, 45 parts of Smilacis Glabrae Rhizoma, 20 parts of Lycii Fructus, and 20 parts of Glycyrrhizae Radix et Rhizoma.
[0045] Comparative Example 3
[0046] Same as Example 1, except that it contains 60 parts of Bupleuri Radix, 180 parts of Moutan Cortex, 30 parts of Codonopsis Pilosula, 30 parts of Clematidis Radix, 30 parts of Dioscoreae Hypoglaucae Rhizoma, 45 parts of Smilacis Glabrae Rhizoma, 20 parts of Lycii Fructus, and 20 parts of Glycyrrhizae Radix et Rhizoma.
[0047] Comparative Example 4
[0048] Same as Example 1, except that it contains 90 parts of Moutan Cortex, 30 parts of Codonopsis Pilosula, 30 parts of Clematidis Radix, 30 parts of Dioscoreae Hypoglaucae Rhizoma, 45 parts of Smilacis Glabrae Rhizoma, 20 parts of Lycii Fructus, and 20 parts of Glycyrrhizae Radix et Rhizoma.
[0049] Comparative Example 5
[0050] Same as Example 1, except that it contains 90 parts of Bupleuri Radix, 30 parts of Codonopsis Pilosula, 30 parts of Clematidis Radix, 30 parts of Dioscoreae Hypoglaucae Rhizoma, 45 parts of Smilacis Glabrae Rhizoma, 20 parts of Lycii Fructus, and 20 parts of Glycyrrhizae Radix et Rhizoma.
[0051] Comparative Example 6
[0052] Same as Example 1, except that it contains 30 parts of Codonopsis Pilosula, 30 parts of Clematidis Radix, 30 parts of Dioscoreae Hypoglaucae Rhizoma, 45 parts of Smilacis Glabrae Rhizoma, 20 parts of Lycii Fructus, and 20 parts of Glycyrrhizae Radix et Rhizoma.
[0053] Comparative Example 7
[0054] Same as Example 1, except that the dried Bupleuri Radix, Moutan Cortex, Codonopsis Pilosula, Clematidis Radix, Dioscoreae Hypoglaucae Rhizoma, Smilacis Glabrae Rhizoma, Lycii Fructus, and Glycyrrhizae Radix et Rhizoma are all extracted with ethanol.
[0055] Comparative Example 8
[0056] Same as Example 1, except that the dried Bupleuri Radix, Moutan Cortex, Codonopsis Pilosula, Clematidis Radix, Dioscoreae Hypoglaucae Rhizoma, Smilacis Glabrae Rhizoma, Lycii Fructus, and Glycyrrhizae Radix et Rhizoma are all extracted by decoction with water.
[0057] Animal Modeling and Grouping
[0058] 140 adult mice were randomly divided into 14 groups, with 10 mice in each group, and were respectively divided into a model group, a blank group, a positive group and experimental groups (Example 1 - 3 groups and Comparative Example 1 - 8 groups). During feeding, the mice in each group had free access to food and water. The mice in the model group, positive group and experimental groups were intraperitoneally injected with potassium oxonate (the dosing dose was 300 mg / kg) every day according to the body weight of the mice to induce hyperuricemia in the mice. The blank group was intraperitoneally injected with the same dose of sterilized normal saline.
[0059] After inducing hyperuricemia in the mice, the blank group and the model group were intragastrically administered the same dose of sterilized normal saline, the positive group was intragastrically administered 5 mg / kg of allopurinol, and the Example 1 - 3 groups and Comparative Example 1 - 8 groups were intragastrically administered at 500 mg / kg respectively, and this was repeated for 3 months.
[0060] Test Example 1
[0061] After continuous administration for 1 month, the eyeballs of the mice in each group were removed to collect blood, centrifuged at 3000 r / min for 15 min, and the serum was collected. The levels of uric acid and xanthine oxidase in the serum were detected according to the uric acid detection kit, creatinine kit and xanthine oxidase detection kit (purchased from Nanjing Jiancheng), and the results are shown in Table 1.
[0062] Table 1 Detection results of serum indexes of mice in each group
[0063]
[0064]
[0065] Note: *P < 0.05 indicates a significant difference compared with the model group, **P < 0.01 indicates a highly significant difference compared with the model group; ##P < 0.01 indicates a highly significant difference compared with the blank group.
[0066] As can be seen from Table 1 above, compared with the blank group, there were highly significant differences in uric acid, creatinine and xanthine oxidase in the serum of the mice in the model group (P < 0.01), indicating that the model was successfully established.
[0067] The levels of uric acid, creatinine and xanthine oxidase in the serum of the mice in the Example 1 - 3 groups were all significantly different from those in the model group (P < 0.01), indicating that the pharmaceutical composition of the present invention can significantly reduce the levels of uric acid and xanthine oxidase in the serum, thereby improving or treating hyperuricemia. Compared with the model group, the Comparative Example 1 - 8 groups could also improve the levels of uric acid and xanthine oxidase in the serum of the mice, but the improvement effect was worse than that of the positive group. According to the experimental results of Example 1 - 3, it shows that the weight ratio of bupleurum and moutan bark in the pharmaceutical composition of the present invention being 1:1 - 2:1 has better technical effects of reducing uric acid and reducing xanthine oxidase.
[0068] Experimental Example 2
[0069] Take the tail vein blood of the blank group, model group, positive group and the groups of Examples 1 - 3 of mice after continuous administration for 1 month and 3 months, centrifuge at 3000 r / min for 15 min, collect the plasma, and use alanine aminotransferase detection kit (ALT) and aspartate aminotransferase detection kit (AST) (purchased from Nanjing Jiancheng) to detect the levels of alanine aminotransferase and aspartate aminotransferase in the plasma. The results are shown in Table 2.
[0070] Table 2 Detection results of plasma indexes of mice in each group
[0071]
[0072]
[0073] Note: *P < 0.05 indicates significant difference compared with the positive group, and *P < 0.01 indicates extremely significant difference compared with the positive group; #P < 0.05 indicates significant difference compared with the blank group, and ##P < 0.01 indicates extremely significant difference compared with the blank group.
[0074] Compared with the blank group, the levels of ALT and AST in the plasma of the model group mice at 1 month and 3 months both showed significant differences (P < 0.05). The levels of ALT and AST in the plasma of the positive group mice at 1 month showed significant differences (P < 0.05), and the levels of ALT and AST in the plasma of the positive group mice at 3 months showed extremely significant differences (P < 0.01). Compared with the positive group, after 1 month of administration to the groups of Examples 1 - 3, the levels of ALT and AST in the plasma of mice showed significant differences (P < 0.05). Moreover, after 3 months of administration to the groups of Examples 1 - 3, the levels of ALT and AST in the plasma of mice showed extremely significant differences (P < 0.01). According to the experimental results of continuous administration for 1 month and 3 months in Examples 1 - 3, it shows that the pharmaceutical composition of the present invention can improve or treat hyperuricemia without causing adverse effects on the liver function of mice due to long - term administration, and is safe and non - toxic to the liver.
[0075] In summary, it can be seen that the pharmaceutical composition of the present invention embodies the synergistic effect of traditional Chinese medicine. It can not only reduce the contents of uric acid and creatinine, but also reduce the activity of xanthine oxidase, and has a definite effect in treating hyperuricemia. After long - term administration of the pharmaceutical composition of the present invention, there are no obvious changes in ALT and AST in the liver function biochemical indexes, indicating that the pharmaceutical composition of the present invention will not cause damage to the liver function and is safe and non - toxic to the liver.
[0076] The above are only embodiments of the present invention, and do not thus limit the patent scope of the present invention. Any equivalent structure or equivalent process transformation made by using the content of the specification of the present invention, or directly or indirectly applied in other related technical fields, shall similarly be included within the patent protection scope of the present invention.
Claims
1. A pharmaceutical composition for treating hyperuricemia, characterized in that: The invention comprises the following components in parts by weight: 50-100 parts of bupleurum, 50-100 parts of peony bark, 10-50 parts of codonopsis pilosula, 10-50 parts of clematis, 10-50 parts of radix polygoni multiflori, 10-50 parts of rhizoma smilax, 10-50 parts of wolfberry and 1-30 parts of liquorice.
2. The pharmaceutical composition according to claim 1, characterized in that The invention comprises the following components in parts by weight: 55-90 parts of bupleurum, 55-90 parts of peony bark, 15-45 parts of codonopsis pilosula, 15-45 parts of clematis, 15-45 parts of radix polygoni multiflori, 15-45 parts of rhizoma smilax, 15-30 parts of wolfberry and 15-30 parts of liquorice.
3. The pharmaceutical composition according to claim 1, characterized in that The weight ratio of the radix bupleuri to the cortex moutan is 1:1-2:
1.
4. A method for preparing the pharmaceutical composition according to any one of claims 1 to 3, characterized in that: The following steps are involved: Weigh the weight portions of Bupleurum and Paeonia suffruticosa respectively, dry and crush them, mix them to obtain material A, extract them with ethanol, filter and concentrate them to obtain extract A, and dry and crush the extract A to obtain an alcohol extract; Weigh the weight portions of Codonopsis pilosula, Clematis chinensis, Radix Dioscoreae, Rhizoma Smilacis Glabrae, Fructus Lycii and Radix Glycyrrhizae respectively, dry and mix them to obtain material B, extract with water, filter and concentrate to obtain extract B, and dry and crush the extract B to obtain a 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 the material A to ethanol is 1:5-1:
8.
6. The preparation method according to claim 4, characterized in that: The ethanol is an ethanol aqueous solution with a volume fraction of 50-80%, the ethanol extraction temperature is 60-80° C., the extraction is performed 2-4 times, and the extraction time for each time is 0.5-1 hour.
7. The preparation method according to claim 4, characterized in that: The water extraction temperature is 80-100° C., the extraction is performed 1-2 times, and the extraction time each time is 1-2 hours.
8. Use of the pharmaceutical composition according to any one of claims 1 to 4 in the preparation of a medicament for preventing and / or treating hyperuricemia.
9. A preparation for preventing and / or treating hyperuricemia, characterized in that: The preparation comprises the pharmaceutical composition according to any one of claims 1 to 3 and pharmaceutically acceptable excipients.
10. The preparation for preventing and / or treating hyperuricemia according to claim 9, characterized in that: The pharmaceutically acceptable excipient is one or more of a disintegrant, a lubricant, a binder and a dispersant.
Citation Information
Patent Citations
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