Application of traditional Chinese medicine composition in preparation of medicine for preventing and treating polycystic ovarian syndrome

By using traditional Chinese medicine compositions, including medicinal materials such as soapberry, kennel, and dandelion, drugs for preventing and treating polycystic ovary syndrome, the problem of narrow application scope and many adverse reactions of existing drugs is solved, and effective treatment of polycystic ovary syndrome is achieved.

CN119818623AActive Publication Date: 2025-04-15JIANGSU KANION PHARMA CO LTD
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Patent Information

Application Number
CN202510171448.8
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-02-17
Publication Date
2025-04-15
Estimated Expiration
2045-02-17

AI Technical Summary

Technical Problem

The existing drugs for treating polycystic ovary syndrome have problems such as narrow application scope and many adverse reactions, and there is no effective cure plan, so they can only undergo symptomatic treatment.

Method used

The Chinese medicine compositions, including saponin, kaleus kale, dandelion, dandelion, codonopsis, saccharomyceae, red peony, salvia, abalone, and yamsara, are prepared through specific extraction and preparation methods to prevent and treat polycystic ovary syndrome.

Benefits of technology

This traditional Chinese medicine composition can significantly inhibit the increase in ovary weight of rats with polycystic ovary syndrome and reduce the content of luteinizing hormone and testosterone in the serum, and has a good effect on the treatment of polycystic ovary syndrome.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to application of a traditional Chinese medicine composition in preparation of a medicine for preventing and treating polycystic ovarian syndrome. The traditional Chinese medicine composition comprises spina gleditsiae, polygonum cuspidatum, dandelion, sargentgloryvine stem, codonopsis pilosula, chinaroot greenbrier, radix paeoniae rubra, salvia miltiorrhiza, lindera aggregata and corydalis tuber. Experiments show that the traditional Chinese medicine composition can obviously inhibit the weight increase of the ovary of a rat with the polycystic ovarian syndrome; moreover, the content of luteinizing hormone and testosterone in serum of a rat with the polycystic ovarian syndrome can be reduced, and the traditional Chinese medicine composition has a good effect of treating the polycystic ovarian syndrome.
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Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to application of a traditional Chinese medicine composition in preparing medicines for preventing and treating polycystic ovary syndrome. Background Art

[0002] Polycystic ovary syndrome (PCOS) is a common disease caused by complex endocrine and metabolic abnormalities in women of childbearing age, characterized by chronic anovulation (ovulation dysfunction or loss) and hyperandrogenism (excessive production of male hormones in women). The main clinical manifestations are irregular menstrual cycles, infertility, hirsutism and / or acne. It is the most common female endocrine disease. The incidence rate is high during the childbearing age period, which has a serious adverse effect on female fertility.

[0003] The cause of PCOS is unknown, and there is no effective cure. Symptomatic treatment is the main treatment, and long-term health management is required. Most people believe that insulin resistance is the key link in its onset, and is related to multiple pathological links such as cell autophagy, oxidative stress, and mitochondrial dysfunction. The first-line medications for this disease, such as contraceptives and insulin sensitizers, are all off-label symptomatic treatments, and have problems such as a narrow scope of application and many adverse reactions.

[0004] In traditional Chinese medicine, PCOS falls into the categories of "late menstruation" and "infertility" according to its manifestations. Most doctors believe that its pathogenesis is based on kidney deficiency, with phlegm and blood stasis as symptoms. Treatment methods often use methods such as warming the kidney and strengthening the spleen, and resolving phlegm and removing blood stasis. Traditional Chinese medicine dialectical treatment has the advantages of overall regulation, multiple links, and multiple targets, and is expected to bring more benefits to PCOS patients. Summary of the invention

[0005] In view of this, the present invention provides the use of a Chinese medicine composition in the preparation of a drug for preventing and treating polycystic ovary syndrome

[0006] Use of the Chinese medicine composition of the present invention in preparing a medicine for preventing and treating polycystic ovary syndrome;

[0007] The Chinese medicine composition comprises the following raw materials in parts by mass, or is made from the following raw materials in parts by mass:

[0008] 8-15 parts of Gleditsia sinensis spines, 6-10 parts of Polygonum cuspidatum, 8-12 parts of Taraxacum herba, 8-12 parts of Sargentodoxae, 8-15 parts of Codonopsis pilosula, 8-15 parts of Smilax china, 6-10 parts of Paeonia lactiflora, 8-15 parts of Salvia miltiorrhiza, 6-10 parts of Linderae umbellatae, and 8-12 parts of Corydalis yanhusuo.

[0009] In some specific embodiments, the raw materials in the Chinese medicine composition include: 12 parts of Gleditsia sinensis thorn, 8 parts of Polygonum cuspidatum, 9.6 parts of Taraxacum mongolicum, 9.6 parts of Sargentodoxa chinensis, 12 parts of Codonopsis pilosula, 12 parts of Smilax china, 8 parts of Paeonia lactiflora, 12 parts of Salvia miltiorrhiza, 8 parts of Linderae scutellariae, and 9.6 parts of Corydalis yanhusuo.

[0010] In some specific embodiments, the raw materials in the Chinese medicine composition include: 8 parts of Gleditsia sinensis, 6 parts of Polygonum cuspidatum, 8 parts of Taraxacum officinale, 8 parts of Sargentodoxae, 8 parts of Codonopsis pilosula, 8 parts of Smilax china, 6 parts of Paeonia lactiflora, 8 parts of Salvia miltiorrhiza, 6 parts of Linderae umbellatae, and 8 parts of Corydalis yanhusuo;

[0011] In some specific embodiments, the raw materials in the Chinese medicine composition include: 15 parts of Gleditsia sinensis thorns, 10 parts of Polygonum cuspidatum, 12 parts of Taraxacum herb, 12 parts of Sargentodoxa chinensis, 15 parts of Codonopsis pilosula, 15 parts of Smilax china, 10 parts of Paeonia lactiflora, 15 parts of Salvia miltiorrhiza, 10 parts of Linderae umbellatae, and 12 parts of Corydalis yanhusuo.

[0012] In the present invention, the preparation method of the Chinese medicine composition comprises:

[0013] Add 60% to 80% ethanol to Corydalis yanhusuo and Polygonum cuspidatum in 6-10 times amount, reflux extract 1-3 times, each time for 0.5 to 2.5 hours, filter, combine the filtrate, and obtain the alcohol extract;

[0014] Add 10-15 times the amount of water to Gleditsia sinensis, dandelion, Sarsaparilla dahurica, Codonopsis pilosula, Smilax china, Paeonia lactiflora, Salvia miltiorrhiza, and Linderae striata, and boil for 1-4 times, each time for 1-3 hours, filter, combine the filtrate, concentrate under reduced pressure, let stand for 24-36 hours, and collect the alcohol precipitation supernatant;

[0015] The alcohol precipitation supernatant and the alcohol extract are combined, concentrated under reduced pressure to obtain an extract, 1-3 times the weight of water of the extract is added to mix well, ethanol is added until the alcohol content reaches 60%, and the mixture is allowed to stand for 24-36 hours; the supernatant is taken, dried, and crushed.

[0016] In the present invention, the effective dosage of the traditional Chinese medicine composition is 201.6 g to 403.2 g of crude drug per day.

[0017] In the present invention, the control includes at least one of the following 1) to 2):

[0018] 1) Decreased luteinizing hormone and / or testosterone levels;

[0019] 2) Inhibit the increase of body weight and / or inhibit the increase of ovarian weight.

[0020] In some embodiments, the luteinizing hormone and testosterone are luteinizing hormone and testosterone in serum.

[0021] The present invention also provides a drug for preventing and treating polycystic ovary, characterized in that it comprises the following raw materials in parts by mass, or is made from the following raw materials in parts by mass:

[0022] 8-15 parts of Gleditsia sinensis spines, 6-10 parts of Polygonum cuspidatum, 8-12 parts of Taraxacum herba, 8-12 parts of Sargentodoxae, 8-15 parts of Codonopsis pilosula, 8-15 parts of Smilax china, 6-10 parts of Paeonia lactiflora, 8-15 parts of Salvia miltiorrhiza, 6-10 parts of Linderae umbellatae, and 8-12 parts of Corydalis yanhusuo.

[0023] After weighing the raw materials according to the above proportions, conventional pharmaceutical excipients in traditional Chinese medicine preparations are added, and conventional pharmaceutical methods in pharmacy are used to prepare the desired traditional Chinese medicine preparations, including but not limited to granules, capsules, pills, tablets and suppositories.

[0024] The present invention provides an application of a Chinese medicine composition in the preparation of a drug for preventing and treating polycystic ovary. The Chinese medicine composition comprises Gleditsia sinensis, Polygonum cuspidatum, Taraxacum officinale, Sargentodoxae, Codonopsis pilosula, Smilax china, Paeonia lactiflora, Salvia miltiorrhiza, Linderae umbellatae and Corydalis yanhusuo. Experiments show that the Chinese medicine composition can significantly inhibit the increase of ovarian weight in rats with polycystic ovary syndrome; and can reduce the content of luteinizing hormone and testosterone in the serum of rats with polycystic ovary syndrome, and has a good effect in treating polycystic ovary syndrome. DETAILED DESCRIPTION

[0025] The present invention provides the use of a Chinese medicine composition in the preparation of a medicine for preventing and treating polycystic ovary syndrome. Those skilled in the art can refer to the content of this article and appropriately improve the process parameters to achieve it. It is particularly important to point out that all similar substitutions and modifications are obvious to those skilled in the art, and they are all considered to be included in the present invention. The method and application of the present invention have been described through preferred embodiments, and relevant personnel can obviously modify or appropriately change and combine the method and application of this article without departing from the content, spirit and scope of the present invention to realize and apply the technology of the present invention.

[0026] As mentioned above, the present invention aims to provide a use of a Chinese medicine composition in the preparation of a drug for preventing and treating polycystic ovary;

[0027] The Chinese medicine composition comprises the following raw materials in parts by mass, or is made from the following raw materials in parts by mass:

[0028] 8-15 parts of Gleditsia sinensis thorns, 6-10 parts of Polygonum cuspidatum, 8-12 parts of Taraxacum herba, 8-12 parts of Sargentodoxae, 8-15 parts of Codonopsis pilosula, 8-15 parts of Smilax china, 6-10 parts of Paeonia lactiflora, 8-15 parts of Salvia miltiorrhiza, 6-10 parts of Linderae umbellatae and 8-12 parts of Corydalis yanhusuo.

[0029] In the present invention, the preparation method of the Chinese medicine composition comprises

[0030] Add 60% to 80% ethanol to Corydalis yanhusuo and Polygonum cuspidatum in 6-10 times amount, reflux extract 1-3 times, each time for 0.5 to 2.5 hours, filter, combine the filtrate, and obtain the alcohol extract;

[0031] Add 10-15 times the amount of water to Gleditsia sinensis, dandelion, Sarsaparilla dahurica, Codonopsis pilosula, Smilax china, Paeonia lactiflora, Salvia miltiorrhiza, and Linderae striata, and boil for 1-4 times, each time for 1-3 hours, filter, combine the filtrate, concentrate under reduced pressure, add ethanol until the alcohol content reaches 60%, let stand for 24-36 hours, and collect the alcohol precipitation supernatant;

[0032] The alcohol precipitation supernatant and the alcohol extract are combined, concentrated under reduced pressure to obtain an extract, 1-3 times the weight of water of the extract is added to mix well, and allowed to stand for 24-36 hours; the supernatant is dried and crushed, conventional pharmaceutical excipients are added, and the desired Chinese medicine dosage form is prepared by conventional methods in pharmacy.

[0033] In some specific embodiments, the preparation method of the Chinese medicine composition specifically includes:

[0034] Add 10 times the amount of 60% ethanol to Corydalis yanhusuo and Polygonum cuspidatum, reflux and extract for 3 times, each time for 1.5 hours, filter, combine the filtrate, and obtain the alcohol extract;

[0035] Gleditsia sinensis, dandelion, Sargentodoxae, Codonopsis pilosula, Smilax china, Paeonia lactiflora, Salvia miltiorrhiza, and Linderae umbellatae are added with 10 times of water, boiled for 3 times, each time for 1.5 hours, filtered, combined with the filtrate, concentrated under reduced pressure to an extract with a relative density of 1.08-1.12 (60°C-70°C), added with ethanol to make the alcohol content of the medicinal solution reach 60%, and allowed to stand for 24 to 36 hours. The alcohol precipitation supernatant is taken, combined with the alcohol extract, concentrated under reduced pressure to an extract with a relative density of 1.04-1.06 (60°C-70°C), water of 1 times the weight of the extract is added and mixed, allowed to stand for 24 to 36 hours, the supernatant is taken, concentrated under reduced pressure to an extract with a relative density of 1.12-1.18 (60°C-70°C), spray dried, crushed to obtain a dry paste powder, added with appropriate amounts of dextrin and stevioside, dry granulated, and made into 1000g granules.

[0036] The following experiments, if no specific conditions are specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The APIs or excipients, reagents or instruments used, if the manufacturer is not specified, are all conventional products that can be purchased commercially. Unless otherwise specified, all percentages, ratios, proportions or parts are by weight.

[0037] Unless otherwise defined, all professional and scientific terms used herein have the same meanings as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to those described herein can be applied to the present invention.

[0038] Example 1 Preparation of Chinese medicine composition

[0039] The Chinese medicine composition granules are prepared from the following raw materials in parts by weight: 15 parts of Gleditsia sinensis thorns, 10 parts of Polygonum cuspidatum, 12 parts of Taraxacum herba, 12 parts of Sargentodoxae cyrtonema, 15 parts of Codonopsis pilosula, 15 parts of Smilax china, 10 parts of Paeonia lactiflora, 15 parts of Salvia miltiorrhiza, 10 parts of Linderae umbellatae and 12 parts of Corydalis yanhusuo.

[0040] For the above ten herbs, Polygonum cuspidatum and Corydalis yanhusuo were refluxed and extracted three times with 10 times the amount of 60% ethanol, each time for 1.5 hours, filtered, and the filtrates were combined to obtain an alcohol extract for later use; the remaining eight herbs were decocted three times with 10 times the amount of water, each time for 1.5 hours, filtered, and the filtrates were combined, and concentrated under reduced pressure to an extract with a relative density of 1.08-1.12 (60°C-70°C), and ethanol was added to make the alcohol content of the liquid reach 60%, and it was allowed to stand for 24 to 36 hours, and the alcohol precipitate was taken. The supernatant is combined with the alcohol extract, concentrated under reduced pressure to an extract with a relative density of 1.04-1.06 (60°C-70°C), and water of 1 times the weight of the extract is added and mixed. The mixture is allowed to stand for 24 to 36 hours, and the supernatant is taken out and concentrated under reduced pressure to an extract with a relative density of 1.12-1.18 (60°C-70°C). The mixture is spray-dried and pulverized to obtain a dry paste powder. An appropriate amount of dextrin and stevioside are added, and dry granulation is performed to prepare 1000 g of granules.

[0041] Experimental Example 2 Effect of Chinese herbal composition on improving body weight and ovarian weight in rats with polycystic ovary syndrome

[0042] 1. Experimental Materials

[0043] 1.1 Animals

[0044] Forty SPF 8-week-old female SD rats, weighing (180-200) g, were purchased from Hangzhou Medical College (production), production license number: SCXK (Zhejiang) 2019-0002.

[0045] 1.2 Drugs

[0046] The Chinese medicine composition prepared in Example 1, Jiangsu Kangyuan Pharmaceutical Co., Ltd.

[0047] 1.3 Instruments

[0048] Refrigerator (Haier Company, model: BCD-216SZ); electronic balance (Sartorius Scientific Instrument Company, model: BSA224S-CW); purified water instrument (Millipore Company, Germany, model: Milli-QPlus); animal weight scale (Shanghai Xiangchuan Electronic Scale Co., Ltd., model: ACX-SC-DA).

[0049] 2. Dosage design

[0050] The unit prescription amount of the Chinese medicine composition is 5599g of crude drug, and the excipients are added to obtain 1000g of the finished product. Six bags are taken per day (twice a day, 3 bags each time), which is equivalent to 201.6g of crude drug per person per day. According to the body surface area conversion method, the equivalent dose of rats is 201.6g / 60kg*6.2=20.83g / kg, and this dose is used as the medium dose. According to the 0.5:1:2 dosing method, the low dose is 10.42g / kg and the high dose is 41.66g / kg.

[0051] 3. Experimental Methods

[0052] Rats were fed adaptively for 3 days and were free to eat feed and water. They were randomly divided into a blank control group and a modeling group. The modeling group rats were given 1 mg / kg letrozole by gavage every day, and the blank control group was injected with an equal dose of pure water. The modeling period was 21 days. On the 21st day, the rats with successful modeling were divided into 4 groups, 8 rats in each of the model control group and the low, medium and high dose (10.42 g / kg, 20.83 g / kg, 41.66 g / kg) groups of the Chinese medicine composition. The blank and model groups were given an equal amount of pure water, and the remaining groups were gavaged with the corresponding drug solution for 7 consecutive days, and the rats were killed and blood and ovaries were taken.

[0053] Detection indicators: The ovarian mass was weighed 35 days after modeling to evaluate the polycystic ovary syndrome modeling.

[0054] 4. Statistical methods

[0055] The results were statistically analyzed using t-test.

[0056] 5. Experimental Results

[0057] The results showed that there was no significant change in the blank control group. The body weight and left and right ovary weights of the model group rats were significantly increased compared with the blank control group after oral administration of 1 mg / kg letrozole for 21 days (P<0.0001), indicating that the model was successfully established. After 7 days of administration, the body weight and left and right ovary weights of the rats in the low, medium and high dose groups of the Chinese medicine composition were significantly reduced compared with the model group (***P<0.001, **P<0.01, *P<0.05). The results are shown in Table 1.

[0058] Table 1 Effect of Chinese medicine composition on body weight and ovary weight of rats in each group after modeling ( n=8)

[0059]

[0060] Note: Compared with the blank control group, #### P<0.0001; compared with the model group, *P<0.05, **P<0.01, ****P<0.0001.

[0061] 6. Experimental conclusion

[0062] The body weight and ovary weight of rats can be used to evaluate the modeling of polycystic ovary syndrome. After administration of low, medium and high doses of the Chinese medicine composition, the body weight and left and right ovary weights of rats were significantly reduced compared with the model group. Experimental Example 3 Effect of the Chinese medicine composition on serum hormone levels in rats with polycystic ovary syndrome

[0063] 1. Experimental Materials

[0064] 1.1 Animals

[0065] Forty SPF-grade 8-week-old female SD rats, weighing (180-200) g, were purchased from Hangzhou Medical College (production), production license number: SCXK (Zhejiang) 2019-0002.

[0066] 1.2 Drugs

[0067] The Chinese medicine composition was prepared according to the method of Example 1 and provided by Jiangsu Kangyuan Pharmaceutical Co., Ltd.

[0068] 1.3 Instruments

[0069] Refrigerator (Haier Company, model: BCD-216SZ); electronic balance (Sartorius Scientific Instruments Company, model: BSA224S-CW); multifunctional microplate reader (MD Company, USA, model: Flexstation 3); animal weighing scale (Shanghai Xiangchuan Electronic Scale Co., Ltd., model: ACX-SC-DA); luteinizing hormone and testosterone ELISA kits (elabscience Company, USA).

[0070] 2. Dosage design

[0071] The daily dosage of the Chinese medicine composition is 5599g of crude drug, and the excipients are added to obtain 1000g of the finished product. Six bags are taken every day (twice a day, 3 bags each time), which is equivalent to 201.6g of crude drug per person per day. According to the body surface area conversion method, the equivalent dose of rats is 201.6g / 60kg*6.2=20.83g / kg, and this dose is used as the medium dose. According to the 0.5:1:2 dosing method, the low dose is 10.42g / kg and the high dose is 41.66g / kg.

[0072] 3. Experimental Methods

[0073] After the ovary weight was weighed in Example 1, the rat blood was centrifuged at 12000 r / min for 5 min, the supernatant was stored in a -80°C refrigerator, and the ELISA detection kits for luteinizing hormone and testosterone were used to detect the hormone levels in the serum. The operation was carried out strictly in accordance with the instructions of the kits.

[0074] Detection indicators: Determination of hormone levels in serum.

[0075] 4. Statistical methods

[0076] The results were statistically analyzed using t-test.

[0077] 5. Experimental Results

[0078] Results showed that compared with the blank control group, the levels of luteinizing hormone and testosterone in the serum of rats in the model group increased significantly (P<0.0001), indicating that the model was successfully established. Compared with the model group, the levels of luteinizing hormone and testosterone decreased significantly after low, medium and high doses of the Chinese medicine composition (*P<0.05, **P<0.01, ***P<0.001, ****P<0.0001), among which the high dose group of the Chinese medicine composition had the greatest difference from the model group and the most significant improvement effect. The above results show that the Chinese medicine composition has a good therapeutic effect on the hormone levels of rats with polycystic ovary syndrome. The results are shown in Table 2.

[0079] Table 2 Comparison of luteinizing hormone and testosterone levels in rat serum ( n=8)

[0080]

[0081] Note: Compared with the blank control group, #### P<0.0001; compared with the model group, *P<0.05, **P<0.01, ***P<0.001, ****P<0.0001.

[0082] 6. Experimental conclusion

[0083] After administration of low, medium and high doses of the Chinese medicine composition, the levels of luteinizing hormone and testosterone in the serum of rats with polycystic ovary syndrome were reduced, indicating that the Chinese medicine composition has a good therapeutic effect on rats with polycystic ovary syndrome.

[0084] The above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the embodiments here. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. Use of a Chinese medicine composition in the preparation of a drug for preventing and treating polycystic ovary syndrome; The Chinese medicine composition comprises the following raw materials in parts by mass, or is made from the following raw materials in parts by mass: 8-15 parts of Gleditsia sinensis spines, 6-10 parts of Polygonum cuspidatum, 8-12 parts of Taraxacum herba, 8-12 parts of Sargentodoxae, 8-15 parts of Codonopsis pilosula, 8-15 parts of Smilax china, 6-10 parts of Paeonia lactiflora, 8-15 parts of Salvia miltiorrhiza, 6-10 parts of Linderae umbellatae, and 8-12 parts of Corydalis yanhusuo.

2. The use according to claim 1, characterized in that: The raw materials in the Chinese medicine composition include: 12 parts of Gleditsia sinensis thorns, 8 parts of Polygonum cuspidatum, 9.6 parts of Taraxacum mongolicum, 9.6 parts of Sargentodoxae, 12 parts of Codonopsis pilosula, 12 parts of Smilax china, 8 parts of Paeonia lactiflora, 12 parts of Salvia miltiorrhiza, 8 parts of Linderae umbellatae, and 9.6 parts of Corydalis yanhusuo.

3. The use according to claim 1, characterized in that: The raw materials in the Chinese medicine composition include: 8 parts of Gleditsia sinensis, 6 parts of Polygonum cuspidatum, 8 parts of Taraxacum herba, 8 parts of Sargentodoxae, 8 parts of Codonopsis pilosula, 8 parts of Smilax china, 6 parts of Paeonia lactiflora, 8 parts of Salvia miltiorrhiza, 6 parts of Linderae umbellatae, and 8 parts of Corydalis yanhusuo.

4. The use according to claim 1, characterized in that: The raw materials in the Chinese medicine composition include: 15 parts of Gleditsia sinensis thorns, 10 parts of Polygonum cuspidatum, 12 parts of Taraxacum herba, 12 parts of Sargentodoxae cyrtonema, 15 parts of Codonopsis pilosula, 15 parts of Smilax china, 10 parts of Paeonia lactiflora, 15 parts of Salvia miltiorrhiza, 10 parts of Linderae umbellatae, and 12 parts of Corydalis yanhusuo.

5. The use according to any one of claims 1 to 4, characterized in that: The preparation method of the Chinese medicine composition comprises: Add 6 to 10 times the amount of 60% to 80% ethanol to Corydalis yanhusuo and Polygonum cuspidatum, reflux and extract 1 to 3 times, each time for 0.5 to 2.5 hours, filter, combine the filtrate, and obtain the alcohol extract; Add 10-15 times the amount of water to Gleditsia sinensis, dandelion, Sarsaparilla dahurica, Codonopsis pilosula, Smilax china, Paeonia lactiflora, Salvia miltiorrhiza, and Linderae striata, and decoct for 1-4 times, each time for 1-3 hours, filter, combine the filtrate, concentrate under reduced pressure, add ethanol until the alcohol content reaches 60%, let stand for 24-36 hours, and collect the alcohol precipitation supernatant; The alcohol precipitation supernatant and the alcohol extract are combined, concentrated under reduced pressure to obtain an extract, 1-3 times the weight of water of the extract is added to mix well, and allowed to stand for 24-36 hours; the supernatant is taken, dried, and crushed.

6. The use according to any one of claims 1 to 5, characterized in that: The effective dosage of the traditional Chinese medicine composition is 201.6 g to 403.2 g of crude drug per day.

7. The use according to any one of claims 1 to 6, characterized in that: The control comprises at least one of the following 1) to 2): 1) Reduced luteinizing hormone and / or testosterone levels; 2) Inhibit the increase of body weight and / or inhibit the increase of ovarian weight.

8. The use according to claim 7, characterized in that: The luteinizing hormone and testosterone are luteinizing hormone and testosterone in serum.

9. A drug for preventing and treating polycystic ovary syndrome, characterized in that: The invention comprises the following raw materials in parts by weight, or is made from the following raw materials in parts by weight: 8-15 parts of Gleditsia sinensis spines, 6-10 parts of Polygonum cuspidatum, 8-12 parts of Taraxacum herba, 8-12 parts of Sargentodoxae, 8-15 parts of Codonopsis pilosula, 8-15 parts of Smilax china, 6-10 parts of Paeonia lactiflora, 8-15 parts of Salvia miltiorrhiza, 6-10 parts of Linderae umbellatae, and 8-12 parts of Corydalis yanhusuo.

10. The drug according to 9, characterized in that The dosage form of the drug includes granules, capsules, pills, tablets or suppositories.

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