Use of a traditional Chinese medicine composition in the preparation of a medicament for treating uterine fibroids

Abstract

The present invention belongs to the field of pharmaceutical technology, and particularly relates to the application of a traditional Chinese medicine composition in the preparation of a drug for treating uterine fibroids. The raw material composition of the traditional Chinese medicine composition for this application is as follows: 1-25 parts of peach kernels, 2-40 parts of myrrh, 2-40 parts of salvia miltiorrhiza, 2-20 parts of red peony root, 2-20 parts of safflower, 2-30 parts of eupatorium japonicum, 2-20 parts of semen vaccariae, 2-30 parts of gleditsia sinensis thorns, 2-60 parts of patrinia scabiosaefolia, 2-60 parts of dandelion, 1-25 parts of toosendan fruit, 2-40 parts of angelica dahurica, 2-40 parts of pyrrosia lingua, and 1-20 parts of wolfberry fruit. This traditional Chinese medicine composition has remarkable curative effect on uterine fibroids and no toxic and side effects, providing important clinical value for making up for the shortage of varieties and poor curative effect of such traditional Chinese patent medicines in the current market.

Description

Technical Field

[0001] The present invention belongs to the technical field of medicine, and particularly relates to the application of a traditional Chinese medicine composition in the preparation of a drug for treating uterine fibroids. Background Art

[0002] Uterine fibroids are one of the most common benign tumors in the female reproductive organs and also one of the most common tumors in the human body. According to the relationship with the uterine wall, uterine fibroids can be divided into corpus myomas (about 90%) and cervical myomas (about 10%), as well as intramural myomas, subserous myomas, submucous myomas and other types. Most patients with uterine fibroids have no obvious symptoms and are only accidentally found during physical examinations. Some patients may have menstrual disorders (such as increased menstrual volume, prolonged menstrual period, etc.), abdominal masses, frequent urination, increased leucorrhea, lower abdominal distension and other symptoms. When the fibroids compress the bladder and rectum, it can cause dysuria, defecation pain and constipation.

[0003] Uterine fibroids are prone to occur in women aged 30 - 50, and are relatively rare in women under 20. Women of childbearing age are the high-incidence period of this disease, and the prevalence rate can reach about 25%. At the same time, the incidence rate of perimenopausal women cannot be ignored, accounting for about 10%. Women with polycystic ovary syndrome, those with a family history of uterine fibroids, and those who have long-term used hormonal drugs have a higher risk of getting the disease.

[0004] The etiology and pathogenesis of uterine fibroids are not yet clear, and may be related to genetic susceptibility, sex hormone levels and stem cell dysfunction disorders. The daughters of patients with uterine fibroids have an increased risk of getting the disease, and the probability of monozygotic twin women having uterine fibroids at the same time is much higher than that of dizygotic twin women. 40% - 50% of patients with uterine fibroids have chromosomal structural abnormalities, indicating that genetic factors play an important role in the occurrence of uterine fibroids. Although the role and mechanism of estrogen and progesterone in the occurrence of uterine fibroids have not been fully clarified, a large number of clinical observations and experimental results show that uterine fibroids are hormone-dependent tumors.

[0005] Due to the unclear exact etiology, modern Western medicine adopts sex hormone or surgical resection for treatment, and there is no other ideal therapy. Surgical treatment causes local damage to the whole organ of the human body, and increases the pain and economic burden of the patient. Sequelae will inevitably occur after the operation.

[0006] At present, there are very few proprietary Chinese medicines for treating uterine fibroids on the market, which cannot meet the social needs. On the other hand, the curative effects of these old varieties of drugs are still not particularly ideal, and there is a need to develop proprietary Chinese medicines with further improved curative effects. Summary of the Invention

[0007] To solve the above problems, the present invention provides an application of a traditional Chinese medicine composition in the preparation of a drug for treating uterine fibroids. This traditional Chinese medicine composition has significant efficacy for uterine fibroids and no toxic or side effects, providing important clinical value for compensating for the shortage of such traditional Chinese patent medicines and their poor efficacy in the current market.

[0008] The present invention provides the following technical solutions:

[0009] An application of a traditional Chinese medicine composition in the preparation of a drug for treating uterine fibroids, wherein the traditional Chinese medicine composition is made from the following raw materials in parts by weight:

[0010] Peach kernels (fried) 1 - 25 parts, myrrh (fried) 2 - 40 parts, salvia miltiorrhiza 2 - 40 parts, red peony root 2 - 20 parts, safflower 2 - 20 parts, eupatorium japonicum 2 - 30 parts, semen vaccariae (fried) 2 - 20 parts, gleditsia spine 2 - 30 parts, patrinia scabiosaefolia 2 - 60 parts, dandelion 2 - 60 parts, toosendan fruit 1 - 25 parts, angelica dahurica 2 - 40 parts, pyrrosia lingua 2 - 40 parts, wolfberry fruit 1 - 20 parts.

[0011] Further, the preparation method of the traditional Chinese medicine composition is as follows:

[0012] Take the above-mentioned parts by weight of myrrh (fried), gleditsia spine, and angelica dahurica, and pulverize them into fine powder; add water to decoct the remaining 11 raw materials 2 - 4 times, each time for 0.5 - 2 hours, combine the extraction liquids, filter, concentrate the filtrate into a thick paste, add the above-mentioned fine powder, dry, continue to pulverize into fine powder, mix evenly, and finally process it into an oral preparation to obtain the product.

[0013] Further, the oral preparation is powder, capsule, tablet, granule or pill.

[0014] Further, the traditional Chinese medicine composition is made from the following raw materials in parts by weight:

[0015] Peach kernels (fried) 15 parts, myrrh (fried) 15 parts, salvia miltiorrhiza 15 parts, red peony root 15 parts, safflower 15 parts, eupatorium japonicum 15 parts, semen vaccariae (fried) 15 parts, gleditsia spine 15 parts, patrinia scabiosaefolia 50 parts, dandelion 50 parts, toosendan fruit 15 parts, angelica dahurica 15 parts, pyrrosia lingua 25 parts, wolfberry fruit 15 parts.

[0016] The beneficial effects of the present invention include but are not limited to:

[0017] In the traditional Chinese medicine composition of the present invention, peach kernels, myrrh, salvia miltiorrhiza, red peony root, safflower, gleditsia spine, eupatorium japonicum, and semen vaccariae together serve as the monarch drugs, jointly exerting the effects of promoting blood circulation to remove blood stasis and dissipating swelling and relieving pain; supplemented by dandelion, patrinia scabiosaefolia, and pyrrosia lingua as the minister drugs, mainly clearing damp - heat; assisted by wolfberry fruit for tonifying the kidney and replenishing essence; angelica dahurica and toosendan fruit regulate qi and dredge the meridians, guiding all the drugs to reach the affected area, serving as the envoy drugs. The whole formula of this traditional Chinese medicine composition is compatibly formulated, having the effects of promoting blood circulation to remove stasis, detoxifying and dissipating swelling, regulating qi and relieving pain, and tonifying the kidney and replenishing essence, and is used for diseases such as uterine fibroids in women caused by qi stagnation and blood stasis, and stasis - heat internal accumulation.

[0018] Animal experiment results show that the traditional Chinese medicine composition of the present invention has equivalent efficacy to the existing therapeutic drug mifepristone; after administration, the uterine coefficients and estradiol and progesterone levels of the modeled animals are significantly reduced; and the content of Bax in uterine fibroids cells is significantly reduced and the expression of Bax is increased, which is beneficial to promoting the apoptosis of uterine fibroids cells, thereby treating uterine fibroids. Detailed implementation manners

[0019] To clearly illustrate the technical characteristics of this solution, the present invention will be elaborated in detail below through specific implementation manners. The scope of the present invention is not limited to the following embodiments. Professionals in the field can understand that various changes and modifications can be made to the present invention without departing from the spirit and scope of the present invention.

[0020] Example 1

[0021] This example is a hard capsule preparation of the traditional Chinese medicine composition of the present invention.

[0022] The prescription is as follows: Myrrh (fried) 500 g, Gleditsia spine 500 g, Angelica dahurica powder 500 g, Peach kernel (fried) 500 g, Salvia miltiorrhiza 500 g, Red peony root 500 g, Safflower 500 g, Lycopus lucidus 500 g, Vaccaria segetalis (fried) 500 g, Patrinia scabiosaefolia 1666 g, Taraxacum mongolicum 1666 g, Toosendan fruit 500 g, Pyrrosia lingua 833 g, Chinese wolfberry 500 g.

[0023] The preparation method is as follows: Take Myrrh (fried) 500 g, Gleditsia spine 500 g, and Angelica dahurica powder 500 g, and crush them into fine powder for standby; take another 500 g of Peach kernel (fried), 500 g of Salvia miltiorrhiza, 500 g of Red peony root, 500 g of Safflower, 500 g of Lycopus lucidus, 500 g of Vaccaria segetalis (fried), 1666 g of Patrinia scabiosaefolia, 1666 g of Taraxacum mongolicum, 500 g of Toosendan fruit, 833 g of Pyrrosia lingua, and 500 g of Chinese wolfberry, mix them, add 65 L of water and decoct for 2 times, each time for 1 hour. Combine the extraction solutions, filter, concentrate the filtrate into a thick paste, add the above-mentioned standby fine powder, dry, crush into fine powder, sieve, make into fine powder, mix evenly, and fill into gelatin capsules to make hard capsules.

[0024] Dosage and administration: Oral administration. 4 - 6 capsules each time, 3 times a day; or as prescribed by the doctor.

[0025] Example 2

[0026] This example is a water pill preparation of the traditional Chinese medicine composition of the present invention.

[0027] Prescription: Myrrh (fried) 400g, Gleditsia spine 400g, Angelica dahurica powder 400g, Peach kernel (fried) 500g, Salvia miltiorrhiza 500g, Red peony root 500g, Safflower 500g, Eupatorium japonicum 500g, Semen vaccariae (fried) 500g, Patrinia scabiosaefolia 1666g, Taraxacum mongolicum 1666g, Szechwan Chinaberry fruit 500g, Pyrrosia lingua 833g, Chinese wolfberry 500g.

[0028] Preparation method: Take Myrrh (fried) 400g, Gleditsia spine 400g, Angelica dahurica powder 400g, and crush them into fine powder for standby; take another Peach kernel (fried) 500g, Salvia miltiorrhiza 500g, Red peony root 500g, Safflower 500g, Eupatorium japonicum 500g, Semen vaccariae (fried) 500g, Patrinia scabiosaefolia 1666g, Taraxacum mongolicum 1666g, Szechwan Chinaberry fruit 500g, Pyrrosia lingua 833g, Chinese wolfberry 500g, mix them, add 65L of water and decoct for 2 times, each time for 1 hour. Combine the extraction liquids, filter, concentrate the filtrate into a thick paste, add the above-mentioned standby fine powder, dry, crush into fine powder, sieve, make it into fine powder, mix well, and make water pills with water.

[0029] Dosage and administration: Oral administration. 20 - 30 pills each time, 3 times a day; or as directed by a doctor.

[0030] Example 3

[0031] This example is the tablet of the traditional Chinese medicine composition of the present invention.

[0032] Prescription: Myrrh (fried) 500g, Gleditsia spine 500g, Angelica dahurica powder 500g, Peach kernel (fried) 400g, Salvia miltiorrhiza 400g, Red peony root 400g, Safflower 400g, Eupatorium japonicum 400g, Semen vaccariae (fried) 400g, Patrinia scabiosaefolia 1500g, Taraxacum mongolicum 1500g, Szechwan Chinaberry fruit 400g, Pyrrosia lingua 800g, Chinese wolfberry 400g.

[0033] Preparation method: Take Myrrh (fried) 500g, Gleditsia spine 500g, Angelica dahurica powder 500g, and crush them into fine powder for standby; take another Peach kernel (fried) 400g, Salvia miltiorrhiza 400g, Red peony root 400g, Safflower 400g, Eupatorium japonicum 400g, Semen vaccariae (fried) 400g, Patrinia scabiosaefolia 1500g, Taraxacum mongolicum 1500g, Szechwan Chinaberry fruit 400g, Pyrrosia lingua 800g, Chinese wolfberry 400g, mix them, add 65L of water and decoct for 2 times, each time for 1 hour. Combine the extraction liquids, filter, concentrate the filtrate into a thick paste, add the above-mentioned standby fine powder and soluble starch, and make tablets.

[0034] Dosage and administration: Oral administration. 4 - 6 tablets each time, 3 times a day; or as directed by a doctor.

[0035] Respectively take the fine powders of the medicaments in Examples 1 - 3 above, make them into suspension, and conduct animal experiment research.

[0036] The following is an experimental study and verification of the effects of the traditional Chinese medicine composition of the present invention and the samples prepared in the comparative examples on treating uterine fibroids through animal experiments on uterine fibroid models.

[0037] I. Experimental animals

[0038] SD rats, female, weighing 180 - 220 g, from Liaoning Changsheng Biotechnology Co., Ltd. (Animal Qualification Certificate No. SCXK(Liao)2015 - 0001). They were randomly divided into 8 groups with 10 rats in each group; namely, blank control group, model control group, positive control group, and test drug groups (5 groups).

[0039] II. Test drugs

[0040] 2.1 Traditional Chinese medicine composition Example 1:

[0041] Corresponding to the pharmaceutical prescription and preparation of Example 1, take 500 g of myrrh (fried), 500 g of saponins, and 500 g of angelica dahurica powder, crush them into fine powder and set aside; then take 500 g of peach kernel (fried), 500 g of salvia miltiorrhiza, 500 g of red peony root, 500 g of safflower, 500 g of eupatorium japonicum, 500 g of semen vaccaria (fried), 1666 g of patrinia scabiosaefolia, 1666 g of dandelion, 500 g of toosendan fruit, 833 g of pyrrosia lingua, and 500 g of wolfberry fruit, mix them, add 65 L of water and decoct for 2 times, each time for 1 hour. Combine the extraction liquids, filter, concentrate the filtrate into a thick paste, add the above - set - aside fine powder, dry, pulverize into fine powder, and mix evenly. Take an appropriate amount of the fine powder and add it to distilled water to prepare a suspension with a concentration of 1.0 g of crude drug / mL.

[0042] 2.2 Traditional Chinese medicine composition Example 2:

[0043] Corresponding to the pharmaceutical prescription and preparation of Example 2, take 400 g of myrrh (fried), 400 g of saponins, and 400 g of angelica dahurica powder, crush them into fine powder and set aside; then take 500 g of peach kernel (fried), 500 g of salvia miltiorrhiza, 500 g of red peony root, 500 g of safflower, 500 g of eupatorium japonicum, 500 g of semen vaccaria (fried), 1666 g of patrinia scabiosaefolia, 1666 g of dandelion, 500 g of toosendan fruit, 833 g of pyrrosia lingua, and 500 g of wolfberry fruit, mix them, add 60 L of water and decoct for 2 times, each time for 1 hour. Combine the extraction liquids, filter, concentrate the filtrate into a thick paste, add the above - set - aside fine powder, dry, pulverize into fine powder, and mix evenly. Take an appropriate amount of the fine powder and add it to distilled water to prepare a suspension with a concentration of 1.0 g of crude drug / mL.

[0044] 2.3 Traditional Chinese medicine composition Example 3:

[0045] For the pharmaceutical prescription and preparation of Example 3, take 500 g of myrrh (fried), 500 g of saponins, and 500 g of angelica dahurica powder, crush them into fine powder, and set aside; separately take 400 g of peach kernel (fried), 400 g of salvia miltiorrhiza, 400 g of red peony root, 400 g of safflower, 400 g of lycopus lucidus, 400 g of semen vaccariae (fried), 1500 g of patrinia scabiosaefolia, 1500 g of dandelion, 400 g of toosendan fruit, 800 g of pyrrosia lingua, and 400 g of wolfberry fruit, mix them, add 55 L of water and decoct for 2 times, the first time for 1 hour and the second time for 0.5 hour, combine the extraction solutions, filter, concentrate the filtrate into a thick paste, add the above-mentioned reserved fine powder, dry, crush into fine powder, and mix evenly. Take an appropriate amount of the fine powder and add it to distilled water to make a suspension with a concentration of 1.0 g of crude drug / mL.

[0046] 2.4 Comparative Example A

[0047] Take 400 g of saponins and 300 g of angelica dahurica powder, crush them into fine powder, and set aside; separately take 400 g of peach kernel (fried), 200 g of salvia miltiorrhiza, 400 g of red peony root, 200 g of safflower, 200 g of patrinia scabiosaefolia, 300 g of dandelion, 400 g of toosendan fruit, 200 g of pyrrosia lingua, and 500 g of wolfberry fruit, mix them, add 25 L of water and decoct for 2 times, each time for 1 hour, combine the extraction solutions, filter, concentrate the filtrate into a thick paste, add the above-mentioned reserved fine powder, dry, crush into fine powder, and mix evenly. Take an appropriate amount of the fine powder and add it to distilled water to make a suspension with a concentration of 1.0 g of crude drug / mL.

[0048] 2.5 Comparative Example B

[0049] Take 200 g of myrrh (fried) and 200 g of saponins, crush them into fine powder, and set aside; separately take 400 g of red peony root, 400 g of lycopus lucidus, 300 g of semen vaccariae (fried), 300 g of patrinia scabiosaefolia, 300 g of dandelion, 300 g of toosendan fruit, 100 g of pyrrosia lingua, and 400 g of wolfberry fruit, mix them, add 20 L of water and decoct for 2 times, the first time for 1 hour and the second time for 0.5 hour, combine the extraction solutions, filter, concentrate the filtrate into a thick paste, add the above-mentioned reserved fine powder, dry, crush into fine powder, and mix evenly. Take an appropriate amount of the fine powder and add it to distilled water to make a suspension with a concentration of 1.0 g of crude drug / mL.

[0050] 2.6 Positive control drug

[0051] Mifepristone (produced by Wuhan Jiulong Renfu Pharmaceutical Co., Ltd., production batch number: 05210301, specification: 25 mg / tablet).

[0052] III. Model establishment

[0053] The blank group was intramuscularly injected with 1 mL / 100 g of normal saline once a day for 6 consecutive weeks.

[0054] The remaining groups were intramuscularly injected with estradiol benzoate (0.5 mg / kg) once a day. At the same time, progesterone (4 mg / kg) was injected once a week for 5 consecutive weeks. In the 6th week, the two hormones were injected simultaneously with the same dose once a day. After the model establishment, 1 rat was randomly selected from each group to detect the contents of estradiol (E2) and progesterone (P), and the uterine coefficient was measured at the same time to determine whether the model was successful.

[0055] IV. Experimental process

[0056] The blank group and the model control group were intragastrically administered the same volume of normal saline every day; the positive control group was intraperitoneally injected with mifepristone 1.25 mg / kg (Maclin Co., Ltd.) once a day; the suspension of the aforementioned traditional Chinese medicine compositions Example 1, 2, 3 and Comparative Examples A and B of the present invention was intragastrically administered at 1 mL / 100 g each time, twice a day in the morning and evening, and each group was continuously administered for 4 weeks.

[0057] V. Index observation

[0058] 5.1 Contents of estradiol (E2) and progesterone (P)

[0059] After 4 weeks, the rats were anesthetized intraperitoneally with sodium pentobarbital at 40 mg / kg, blood was taken from the aorta, serum was centrifuged, and the contents of estradiol (E2) and progesterone (P) were measured according to the kit method.

[0060] 5.2 Uterine coefficient

[0061] The uterus of the rats was separated, and the morphology and color of the uterus of each group of rats were observed macroscopically, weighed, and the uterine coefficient was calculated. Uterine coefficient (%) = (m 子宫 / m 体重 ) × 100%; among them, the estradiol detection kit and the progesterone detection kit were purchased from Shanghai Enzyme-linked Biotechnology Co., Ltd.

[0062] 5.3 Immunohistological observation

[0063] The expressions of Bcl-2 and Bax in uterine fibroids were detected by immunohistochemistry in uterine fibroids cells. Bcl-2 is a proto-oncogene that can prevent apoptosis and prolong cell life, and the Bax gene can antagonize the activity of Bcl-2 and has the function of directly promoting apoptosis.

[0064] Grading standard: Semi-quantitative determination was performed by combining the proportion of positive cells and staining intensity.

[0065] The staining intensity was evaluated according to the following standards:

[0066] Negative was 0 point; although the staining was weak but significantly stronger than the negative control was 1 point; the staining intensity was medium was 2 points; the staining was strong was 3 points.

[0067] The evaluation criterion for the proportion of stained positive cells is as follows:

[0068] When the number of positive cells < 5%, it is negative: 0 points; when it is 6% - 15%, it is weakly positive: 1 point; when it is 16% - 30%, it is positive: 2 points; when it > 31%, it is strongly positive: 3 points.

[0069] Composite score: The two scores are added together, and the results are divided into 4 grades:

[0070] 0 - 1 point is (-);

[0071] 2 points is (+); 3 - 4 points is (++); 5 - 6 points is (+++).

[0072] The change situation of the section index is evaluated according to the grade of the composite score.

[0073] VI. Statistical methods

[0074] The statistical analysis of the data was performed using SPSS 13.0 statistical software. The measurement data was expressed as ±s and the t-test was used; the rank sum test was used for the count data, and P < 0.05 was considered statistically significant.

[0075] VII. Experimental results

[0076] 7.1 Effects of the test samples on the uterine coefficient and hormone levels of rats

[0077] It can be seen from the data in Table 1 below that the uterine coefficient, estradiol, and progesterone levels in the serum of the rats in the model group were significantly higher than those in the blank control group (P < 0.01), indicating that the modeling was successful.

[0078] After administration according to the aforementioned "IV", the uterine coefficient, estradiol, and progesterone levels in the positive control group and groups 1 - 3 of the traditional Chinese medicine composition were significantly decreased, indicating that both mifepristone and the composition of the present invention can reduce the uterine coefficient of rats and the estrogen and progesterone levels in the serum, that is, the therapeutic effects of groups 1 - 3 of the traditional Chinese medicine composition of the present invention on uterine fibroids in rats are equivalent to those of mifepristone. In Comparative Examples A and B, there were no significant differences in the uterine coefficient of rats and the estrogen and progesterone levels in the serum compared with the model group, indicating that their therapeutic effects were significantly worse than those of groups 1 - 3 of the traditional Chinese medicine composition of the present invention.

[0079]

[0080] 7.2 Effects of the test samples on the contents of Bcl-2 and Bax in uterine myocytes

[0081] As can be seen from the data in Table 2, the Bcl-2 protein-positive cells in the cytoplasm of uterine smooth muscle cells of rats in the blank control group were mostly weakly positive and scattered; the number of Bcl-2 protein-positive cells in the cytoplasm of uterine smooth muscle cells of rats in the model group increased significantly. Compared with the blank control group, there was a significant difference in the positive expression of Bcl-2 between the two groups (P<0.05). Compared with the model group, the number of Bcl-2 protein-positive cells in the cytoplasm of uterine smooth muscle cells of rats in the positive control group and Groups 1, 2, and 3 of the traditional Chinese medicine composition of the present invention decreased significantly, and the intensity weakened significantly, showing a significant difference compared with the model group (P<0.05). The results showed that the traditional Chinese medicine composition of the present invention could significantly reduce the content of Bcl-2 protein in muscle cells of rats with uterine fibroids, and the effect was equivalent to that of the control drug mifepristone; there was no obvious difference in Groups A and B of the comparative example compared with the model group.

[0082]

[0083] As can be seen from the data in Table 3, the expression level of Bax in rats in the model group was lower than that in the blank control group, and the difference was statistically significant (P<0.05). The expression levels of Bax in rats in the positive control group and Groups 1, 2, and 3 of the traditional Chinese medicine composition of the present invention were all higher than those in the model group, and the differences were statistically significant (P<0.05), indicating that the traditional Chinese medicine composition of the present invention could increase the expression of Bax in the rat model of uterine fibroids. There was no obvious difference in Groups A and B of the comparative example compared with the model group.

[0084]

[0085] VIII. Preliminary Toxicity Study

[0086] The acute toxicity test showed that when the sample of Example 1 was administered to mice at a dose of 13 g / kg / time, which was more than 100 times the daily dose of an adult (70 kg) per day, and administered by gavage 3 times within 24 hours and observed for one week, no abnormalities were found and no animal deaths occurred. According to the requirements of the tolerance test, when mice can tolerate 60-100 times the adult dose, it can be considered that the tolerance test is qualified. The dosage of the sample of Example 1 far exceeded the above requirements, so it can be considered that the traditional Chinese medicine composition is relatively safe.

[0087] The long-term toxicity test showed that the samples of Example 1 were administered to three groups of mice A, B, and C at 0.65 g / 100 g, 0.39 g / 100 g, and 0.13 g / 100 g respectively, which were equivalent to 50 times, 30 times, and 10 times the human dosage. During the 180 days of continuous administration, no abnormalities were found in the appearance and activities of the animals. The body weights of the animals in each group continued to increase. At the end of the experiment, the body weights of the large (Group A), medium (Group B), small (Group C) dose groups and the control group increased by 249.5 g, 240.0 g, 232.0 g, and 226.5 g respectively compared with before administration. The difference was extremely significant (P < 0.001) when compared before and after administration, but there was no difference between groups (P > 0.05), indicating that the test sample did not affect the food intake and body weight gain of the animals under the experimental conditions. At the end of the experiment, no abnormalities were found during macroscopic observation during dissection, and no pathological changes related to the test sample were found in the pathological microscopy of important organs (heart, liver, lungs, kidneys, testes, ovaries, etc.), indicating that the traditional Chinese medicine composition was relatively safe.

[0088] As described above, these are only the embodiments of the present application. The protection scope of the present application is not limited by these specific embodiments, but is determined by the claims of the present application. For those skilled in the art, various changes and modifications can be made to the present application. Any modifications, equivalent replacements, improvements, etc. made within the technical idea and principle of the present application shall be included within the protection scope of the present application.

Claims

1. Use of a Chinese medicine composition in preparing a drug for treating uterine fibroids, characterized in that: The Chinese medicine composition is made from the following raw materials in parts by weight: 15 parts of stir-fried peach kernel, 15 parts of stir-fried myrrh, 15 parts of salvia miltiorrhiza, 15 parts of red peony root, 15 parts of safflower, 15 parts of herba zedoariae, 15 parts of stir-fried vaccariae, 15 parts of gleditsiae spinulosae, 50 parts of herba patriniae, 50 parts of herba dandelions, 15 parts of toosendan fruits, 15 parts of the root of angelica dahurica, 25 parts of pyrrosiae, and 15 parts of wolfberry fruits.

2. The use according to claim 1, characterized in that The preparation method of the Chinese medicine composition is as follows: Take the above-mentioned parts by weight of stir-fried myrrh, honey locust thorn, and angelica dahurica, and grind them into fine powder; add water to the remaining 11 raw materials and boil them for 2 to 4 times, each time for 0.5 to 2 hours, combine the extracts, filter, and concentrate the filtrate into a thick paste, add the above-mentioned fine powder, dry, continue to grind into fine powder, mix well, and finally process it into an oral preparation.

3. The use according to claim 2, characterized in that The oral preparation is powder, capsule, tablet, granule or pill.

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