Application of traditional Chinese medicine composition in preparation of medicine for preventing and treating hysteromyoma

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 medicines for preventing and treating hysteromyoma. 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. The traditional Chinese medicine composition can obviously inhibit the tumor size of a rat with hysteromyoma, reduce the uterine coefficient, reduce the number and size of myoma and improve the pathological state of the uterus; moreover, the content of E2, P and ER in serum can be reduced, and the traditional Chinese medicine composition has a good effect of treating hysteromyoma.

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 uterine fibroids. Background Art

[0002] Uterine fibroids are the most common benign tumors of the female genitalia, composed of smooth muscle and connective tissue. They are common in women aged 30 to 50, and the incidence has gradually increased in recent years. Clinical manifestations include increased menstrual flow, abnormal menstruation, lower abdominal mass and increased leucorrhea, which greatly affect women's work and life. Modern medicine mainly treats this disease with drugs and surgical operations, but there are many adverse reactions and complications.

[0003] Traditional Chinese medicine believes that this disease is caused by dysfunction of internal organs, qi stagnation, blood stasis, cold stagnation, phlegm obstruction, dampness and heat, and insufficient vital energy, and belongs to the category of "stone masses". Clinical treatment of uterine fibroids is mainly based on promoting blood circulation and removing blood stasis, softening and dispersing masses. Modern research shows that traditional Chinese medicine can significantly improve symptoms, and the incidence of adverse reactions is low, which has certain advantages in treating this disease. Summary of the invention

[0004] In view of this, the present invention provides the use of a traditional Chinese medicine composition in preparing a medicine for treating and preventing uterine fibroids.

[0005] Application of a Chinese medicine composition in the preparation of a medicine for preventing and treating uterine fibroids;

[0006] 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:

[0007] 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.

[0008] 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 umbellatae, and 9.6 parts of Corydalis yanhusuo.

[0009] 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;

[0010] 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 herba, 12 parts of Sargentodoxae, 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.

[0011] In the present invention, the preparation method of the Chinese medicine composition comprises:

[0012] 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;

[0013] 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;

[0014] 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.

[0015] 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.

[0016] In the present invention, the prevention and treatment includes at least one of the following:

[0017] Reduce the uterine coefficient, reduce the number and size of fibroids, improve the pathological state of the uterus, and reduce the levels of estradiol (E2), progesterone (P) and estrogen receptor (ER) in serum.

[0018] The pathological state of the uterus includes damage to the uterus resulting in congestion, edema and / or hyperplasia.

[0019] Experiments show that the composition of the present invention can significantly reduce the uterine coefficient of rats with uterine fibroids, improve uterine color, and reduce the volume of uterine fibroids; it can significantly reduce the E2, P and ER levels in the serum of rats with uterine fibroids, indicating that the traditional Chinese medicine composition can reduce the uterine coefficient, reduce the number and size of fibroids, and improve the pathological state of the uterus (such as congestion, edema and / or hyperplasia caused by damaged uterus), and has a good therapeutic effect on uterine fibroids.

[0020] The present invention also provides a drug for preventing and treating polycystic ovary, comprising the following raw materials in parts by mass, or made from the following raw materials in parts by mass:

[0021] 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.

[0022] The raw materials are weighed according to the above proportions, conventional pharmaceutical excipients in Chinese medicine preparations are added during the preparation process, and conventional pharmaceutical methods in pharmacy are used to prepare the desired Chinese medicine preparations, including but not limited to granules, capsules, pills, tablets or suppositories.

[0023] The Chinese medicine composition of the present invention is prepared from raw materials including Gleditsia sinensis, Polygonum cuspidatum, Taraxacum officinale, Sarsaparilla dahurica, Codonopsis pilosula, Smilax china, Paeonia lactiflora, Salvia miltiorrhiza, Linderae umbellatae and Corydalis yanhusuo. The present invention has found that the Chinese medicine composition can significantly reduce the uterine coefficient, reduce the number and size of fibroids, improve the pathological state of the uterus; and can reduce the content of E2, P and ER in serum, and has a good effect in treating uterine fibroids. DETAILED DESCRIPTION

[0024] The present invention provides the use of a Chinese medicine composition in the preparation of a medicine for preventing and treating uterine fibroids. 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 replacements 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.

[0025] 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 uterine fibroids;

[0026] 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:

[0027] 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.

[0028] The application of the Chinese medicine composition provided by the present invention in preparing a medicine for preventing and treating uterine fibroids comprises:

[0029] Add 6 to 10 times the amount of 60% to 80% ethanol to Corydalis yanhusuo and Polygonum cuspidatum, reflux and extract for 1 to 3 times, each time for 0.5 to 2.5 hours, filter, combine the filtrate, and obtain the alcohol extract.

[0030] Add 10-15 times the amount of water to Gleditsia sinensis thorns, dandelion, Sargentophyllum, Codonopsis pilosula, Smilax china, Paeonia lactiflora, Salvia miltiorrhiza, and Linderae scutellariae, and boil for 1-4 times, each time for 1-3 hours, filter, combine the filtrate, concentrate under reduced pressure, add ethanol to the alcohol content of 60%, let stand for 24-36 hours, and collect the supernatant of the alcohol precipitation.

[0031] 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.

[0032] In some specific embodiments, the preparation method of the Chinese medicine composition comprises:

[0033] 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;

[0034] 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), added with 1 times of the weight of the extract, 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.

[0035] 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.

[0036] 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.

[0037] The present invention will be further described below in conjunction with embodiments:

[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℃-70℃), 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 clear liquid 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), water of 1 times the weight of the extract is added and mixed, and the mixture is allowed to stand for 24 to 36 hours. The supernatant is taken and concentrated under reduced pressure to an extract with a relative density of 1.12-1.18 (60°C-70°C), spray-dried, and pulverized to obtain a dry paste powder, and appropriate amounts of dextrin and stevioside are added, and dry granulation is performed to prepare 1000g granules.

[0041] Experimental Example 2 The Chinese medicine composition has an improving effect on the uterine physiological state of the rat uterine fibroid model induced by estrogen loading method

[0042] 1. Experimental Materials

[0043] 1.1 Animals

[0044] 48 SPF-grade 8-week-old female SD rats, weighing (200-220) g, were purchased from Nanjing Qinglongshan Animal Farm (production), production license number: SCXK (Zhejiang) 2019-0002.

[0045] 1.2 Drugs

[0046] The Chinese medicine composition prepared in Example 1 was produced by Jiangsu Kangyuan Pharmaceutical Co., Ltd. Guizhi Fuling Capsule was produced by Jiangsu Kangyuan Pharmaceutical Co., Ltd.

[0047] 1.3 Instruments

[0048] Refrigerator (Haier Company, model: BCD-51OWDEM); electronic balance (Mettler Toledo, model: ME55 / 02); purified water instrument (Millipore, Germany, model: Milli-QPlus); animal weight scale (Shanghai Xiangchuan Electronic Scale Co., Ltd., model: ACX-SC-DA); vernier caliper (Deli).

[0049] 2. Dosage design

[0050] The unit prescription amount of the Chinese medicine composition is 2051g of crude drug, and the excipients are added to obtain 1000g of the finished product. Six bags are taken per day (three times a day, two 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 for 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] 48 SD rats were adaptively fed for 7 days and had free access to feed and water. They were randomly divided into 6 groups, 8 in each group, and the uterine fibroid model was established by estrogen loading method. Except for the blank group, rats in each group were injected with estradiol benzoate (0.5 mg / kg) into the medial thigh muscle every day, and progesterone (1 mg / kg) was injected into the medial thigh of the other side every day. At the same time, the blank group was injected with an equal dose of normal saline. After 5 weeks of modeling, the uterine pathology of the rats showed glandular hyperplasia and obvious hyperplasia of muscle fibers, indicating that the modeling was successful. After the modeling was successful, the Guizhi Fuling Capsule group was gavaged with 0.5 g / kg daily, and the Chinese medicine composition group was gavaged with high, medium and low doses of 41.66 g / kg, 20.83 g / kg and 10.42 g / kg respectively. The blank and model groups were gavaged with an equal amount of normal saline every day.

[0053] Detection indicators:

[0054] Pathological examination of rat uterus, observation of behavioral status of rats in each group during modeling, opening of rat abdominal cavity 4 weeks after administration, observation of uterine and fibroid morphology, cutting of uterus along the junction of uterus and bladder, removal of fat, photographing, wet weight weighing using electronic balance, and calculation of uterine coefficient (uterine weight / rat body weight, mg / g). Under normal circumstances, the ratio of rat uterine mass to body mass, i.e., uterine coefficient, is constant; when the uterus is damaged and congestion, edema, or hyperplasia occurs, the uterine coefficient increases, and the larger the value, the more severe the damage.

[0055] 4. Statistical methods

[0056] The results were statistically analyzed using t-test.

[0057] 5. Experimental Results

[0058] The results showed that after 5 weeks of estrogen loading method to establish uterine fibroid model, there was no significant change in the blank group, and the rats after modeling had rough hair and were irritable. The uterus of the blank group rats was observed by naked eye to be "Y" shaped, with uniform color and thickness. The uterus of the model group rats was significantly larger than that of the blank group, dark red, thickened, and some rats were accompanied by uterine fibroid hyperplasia, indicating the success of modeling. After 4 weeks of administration, the uterine coefficient of rats in the medium and high dose groups of the Chinese medicine composition was significantly reduced compared with the model group (***P<0.001, **P<0.01). The uterine volume of rats in each drug-treated group was slightly larger than that of the blank group, the color was slightly improved, and the volume and number of uterine fibroids were reduced. The results are shown in Table 1.

[0059] Table 1 Effect of Chinese medicine composition on the experimental results of uterine coefficient of rats in each group after modeling ( n=8)

[0060]

[0061]

[0062] Note: Compared with the blank group, ## P<0.01; compared with the model group, *P<0.05, **P<0.01, ***P<0.001.

[0063] 6. Experimental conclusion

[0064] The estrogen loading method was used to establish a uterine fibroid model to evaluate the efficacy of drugs in treating uterine fibroids. The uterine coefficients of rats in the medium and high dose groups of the Chinese medicine composition were significantly reduced compared with those in the model group, with the high dose group having the best effect. The uterine volume of rats in each drug-treated group was slightly larger than that in the blank group, the color was slightly improved, and the volume and number of uterine fibroids were reduced.

[0065] Experimental Example 3 Effect of Chinese herbal medicine composition on serum E2, P and ER levels in rat uterine fibroid model induced by estrogen loading method

[0066] 1. Experimental Materials

[0067] 1.1 Animals

[0068] 48 SPF-grade 8-week-old female SD rats, weighing (200-220) g, were purchased from Nanjing Qinglongshan Animal Farm (production), production license number: SCXK (Zhejiang) 2019-0002.

[0069] 1.2 Drugs

[0070] The Chinese medicine composition was prepared according to the method of Example 1 and provided by Jiangsu Kangyuan Pharmaceutical Co., Ltd. Estradiol (E2) ELISA detection kit (ELISA, ml002871), estradiol receptor (ER) ELISA detection kit (ELISA, ml002869), progesterone / progesterone (P) ELISA detection kit (ELISA, ml002894).

[0071] 1.3 Instruments

[0072] Refrigerator (Haier Company, model: BCD-51OWDEM); electronic balance (Mettler Toledo, model: ME55 / 02); purified water instrument (Millipore, Germany, model: Milli-QPlus); animal weight scale (Shanghai Xiangchuan Electronic Scale Co., Ltd., model: ACX-SC-DA); multifunctional enzyme plate reader (Perkin Elmer, model: Inspire).

[0073] 2. Dosage design

[0074] The daily dosage of the Chinese medicine composition is 2051g 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 123g 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.

[0075] 3. Experimental Methods

[0076] The mice were randomly divided into 6 groups, 8 in each group, and the uterine fibroid model was established by estrogen loading method, and the construction method was the same as that in Example 2. After the model was successfully established, the Guizhi Fuling capsule group was intragastrically administered with 0.5 g / kg daily, and the Chinese medicine composition group was intragastrically administered with high, medium and low doses of 41.66 g / kg, 20.83 g / kg and 10.42 g / kg respectively. The blank and model groups were intragastrically administered with an equal amount of normal saline every day.

[0077] After intraperitoneal anesthesia, blood was collected from the abdominal aorta of rats and centrifuged at 12000r / min for 5min to separate serum. The levels of E2, P, and ER were detected by enzyme-linked immunosorbent assay (ELISA) using a kit. The operation was carried out strictly in accordance with the instructions of the ELISA kit.

[0078] Detection indicators:

[0079] Serum estradiol (E2), progesterone (P) and estrogen receptor (ER) levels were measured.

[0080] 4. Statistical methods

[0081] The results were statistically analyzed using t-test.

[0082] 5. Experimental Results

[0083] Results showed that compared with the blank group, the E2, P and ER contents in the serum of the model group rats were significantly increased (P<0.01), indicating that the model was successfully established. Compared with the model group, the E2, P and ER contents in the lung serum of the positive drug group and the low, medium and high dose groups of the Chinese medicine composition were significantly reduced, among which the difference between the medium and high dose groups of the Chinese medicine composition and the model group was statistically significant (*P<0.05, ****P<0.0001), and the difference between the high dose group and the model group was the largest, and the improvement effect was the most significant. The results are shown in Table 2.

[0084] Table 2 Comparison of E2, P, and ER levels in rat serum ( n=8)

[0085]

[0086]

[0087] Note: Compared with the blank group, # P<0.05, ## P<0.01, ### P < 0.001, #### P<0.0001; compared with the model group, *P<0.05, **P<0.01, ***P<0.001, ****P<0.0001.

[0088] 6. Experimental conclusion

[0089] After administration of low, medium and high doses of the Chinese medicine composition, the E2, P and ER levels in the serum of rats with uterine fibroids were significantly decreased, among which the high dose group of the Chinese medicine composition had the best effect, indicating that the Chinese medicine composition has a good regulatory effect on rats with uterine fibroids model.

[0090] 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. Application of a Chinese medicine composition in the preparation of a drug for preventing and treating uterine fibroids; 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 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; 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: Reduce the uterine coefficient, reduce the number and size of fibroids, improve the pathological state of the uterus, and reduce the levels of estradiol, progesterone and estrogen receptors in serum.

8. The use according to claim 7, characterized in that: The pathological state of the uterus includes uterine damage resulting in congestion, edema and / or hyperplasia.

9. A drug for preventing and treating polycystic ovary, 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 claim 9, characterized in that The dosage form of the drug includes granules, capsules, pills, tablets or suppositories.

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