Application of a traditional Chinese medicine composition in preparing a medicine for treating endometriosis

Abstract

The present invention belongs to the field of medical technology, and in particular relates to an application of a Chinese medicine composition in the preparation of a drug for treating endometriosis. The raw materials of the Chinese medicine composition described in the application are: 1-25 parts of stir-fried peach kernels, 2-40 parts of stir-fried myrrh, 2-40 parts of salvia miltiorrhiza, 2-20 parts of red peony root, 2-20 parts of safflower, 2-30 parts of zedoaria, 2-20 parts of stir-fried vetchling herb, 2-30 parts of licorice root, 2-60 parts of patrinia herb, 2-60 parts of dandelion, 1-25 parts of toosendan fruit, 2-40 parts of angelica dahurica, 2-40 parts of pyrrosia, and 1-20 parts of wolfberry fruit. The Chinese medicine composition is effective in treating endometriosis, has no toxic side effects, and provides important clinical value for compensating for the lack of varieties and poor efficacy of such Chinese patent medicines currently on the market.

Description

Technical Field

[0001] The present invention belongs to the field of medical technology, and particularly relates to an application of a traditional Chinese medicine composition in preparing a medicine for treating endometriosis. Background Art

[0002] Endometriosis (EMT) refers to the growth and infiltration of endometrial tissue (glands and stroma) outside the endometrium. Recurrent bleeding can lead to the formation of nodules and masses, causing pain. While endometriosis can occur anywhere in the body, it is most often located in the pelvic organs and peritoneum, with the ovaries and uterosacral ligaments being the most common sites. The specific cause of endometriosis remains unclear, but it may be related to retrograde menstruation, genetic factors, immune factors, and inflammatory factors.

[0003] The symptoms of endometriosis are closely related to the menstrual cycle, and the main manifestations are: ⑴ Pain: 70%~80% of endometriosis patients have varying degrees of pelvic pain, including dysmenorrhea, non-menstrual abdominal pain, dyspareunia and defecation pain. Dysmenorrhea is the most typical symptom, and is often the first symptom, usually gradually worsening. ⑵ Menstrual abnormalities: 15%~30% of patients have symptoms such as increased menstrual flow, prolonged menstruation or continuous menstrual bleeding. ⑶ Infertility: The incidence of infertility in endometriosis patients is 30%~50%, and among women with infertility, approximately 20%~50% have endometriosis. ⑷ Pelvic mass: When the ovarian ectopic cyst is large, a gynecological examination may reveal a mass adhered to the uterus. In addition, if endometriosis spreads to the intestines, bladder, ureters, or even the lungs and pleura, it will also cause symptoms in the corresponding parts, such as bloody stools during menstruation, hematuria during menstruation, hydroureteral accumulation, hemoptysis during menstruation, and pneumothorax during menstruation.

[0004] Endometriosis is a chronic disease requiring long-term management. Common treatments include: medications to suppress ovarian function to prevent the growth and activity of endometrial implants; conservative surgical removal of as much endometriotic tissue as possible; a combination of the first two treatments; and total hysterectomy, which typically involves the removal of both the ovaries and fallopian tubes. Surgical treatment may lead to decreased ovarian reserve, infertility, menstrual changes, and even premature menopause, and there is a certain risk of recurrence after surgery. Medical treatments include estrogen suppression, gonadotropin-releasing hormone agonists or antagonists, androgens, and progestins, but all have side effects. For example, side effects of estrogen suppression include abdominal distension, breast tenderness, liver and kidney damage, a high recurrence rate, breakthrough bleeding, and deep vein thrombosis.

[0005] The advantage of traditional Chinese medicine is that it can avoid the pain caused by surgery and the harm of Western medicine hormones to the body. Through holistic conditioning, personalized treatment and few side effects, traditional Chinese medicine can effectively relieve symptoms, prevent recurrence, and improve the quality of life of patients, fundamentally solving the problem. Therefore, it is imperative to develop traditional Chinese medicine for the treatment of endometriosis.

[0006] Qianliexin Capsule is an existing drug used to treat chronic prostatitis and prostatic hyperplasia symptoms caused by blood stasis and damp-heat. It is composed of fried peach kernel, fried myrrh, salvia miltiorrhiza, red peony root, safflower, zedoaria, fried fenugreek, soapberry thorn, patrinia herb, dandelion, toosendan fruit, angelica dahurica, pyrifera, and wolfberry. There are no reports of its use in the treatment of endometriosis. Summary of the Invention

[0007] In order 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 endometriosis. The traditional Chinese medicine composition has significant efficacy in treating endometriosis and has no toxic side effects. It provides important clinical value to make up for the small number of traditional Chinese medicines for this treatment and their poor efficacy on the market, and also expands the new use of the traditional Chinese medicine formula used in Qianliexin Capsules.

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

[0009] A use of a traditional Chinese medicine composition in preparing a medicament for treating endometriosis, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0010] 1-25 parts of stir-fried peach kernels, 2-40 parts of stir-fried myrrh, 2-40 parts of salvia miltiorrhiza, 2-20 parts of red peony root, 2-20 parts of safflower, 2-30 parts of zedoaria, 2-20 parts of stir-fried vaccaria, 2-30 parts of gleditsia thorns, 2-60 parts of patrinia herba, 2-60 parts of dandelion, 1-25 parts of toosendan fruit, 2-40 parts of angelica dahurica, 2-40 parts of pyrrosia, and 1-20 parts of wolfberry fruit.

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

[0012] Take the above-mentioned parts by weight of stir-fried myrrh, honey locust thorns, 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 evenly, and finally process it into an oral preparation to obtain.

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

[0014] Furthermore, the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0015] 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 gleditsia spinosae, 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, 15 parts of wolfberry fruits.

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

[0017] The Chinese medicine composition of the present invention comprises stir-fried peach kernel, stir-fried myrrh, salvia miltiorrhiza, red peony root, safflower, honeysuckle, herbaceous zedoaria, and stir-fried vaccaria segetalis as monarch drugs, which together exert the effects of promoting blood circulation, removing blood stasis, reducing swelling and relieving pain; supplemented by dandelion, herbaceous patrinia, and pyrrosia as ministerial drugs, which focus on clearing dampness and heat; supplemented by wolfberry fruit to tonify the kidney and replenish essence; and angelica dahurica and toosendan fruit to regulate qi and unblock menstruation, guiding the other drugs to the affected area, which serve as guiding drugs. The Chinese medicine composition is fully compatible and has the effects of promoting blood circulation, removing blood stasis, detoxifying and reducing swelling, regulating qi and relieving pain, and tonifying the kidney and replenishing essence, and is significantly effective for treating female endometriosis. As a drug currently only used to improve the symptoms of chronic prostatitis and benign prostatic hyperplasia, the application of the present invention has important clinical significance for expanding the new uses of the drug formula. DETAILED DESCRIPTION

[0018] To clearly illustrate the technical features of this solution, the present invention is described in detail below through specific embodiments. The scope of the present invention is not limited to the following embodiments. Those skilled in the art will appreciate that various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention. Example 1

[0019] This embodiment is a hard capsule preparation of the Chinese medicine composition of the present invention.

[0020] The prescription is: fried myrrh 500g, soapberry thorn 500g, angelica powder 500g, fried peach kernel 500g, salvia miltiorrhiza 500g, red peony root 500g, safflower 500g, zedoary root 500g, fried fenugreek 500g, 1666g of patina herb, 1666g of dandelion, toosendan fruit 500g, pyrrosia 833g, and wolfberry 500g.

[0021] The preparation method is as follows: take 500g of fried myrrh, 500g of soapberry thorn, and 500g of angelica powder, crush them into fine powder and set aside; take another 500g of fried peach kernel, 500g of salvia miltiorrhiza, 500g of red peony root, 500g of safflower, 500g of zedoaria, 500g of fried fenugreek, 1666g of patrinia herb, 1666g of dandelion, 500g of toosendan fruit, 833g of pyrrosia, and 500g of wolfberry, mix them, add 65L of water and boil them, boil them twice, each time for 1 hour, combine the extracts, filter, and concentrate the filtrate into a thick paste, add the above-mentioned fine powder, dry, grind into fine powder, sieve to make fine powder, mix well, and put into capsules to make hard capsules.

[0022] Dosage and Administration: Oral. 4-6 capsules at a time, 3 times a day; or as directed by a physician. Example 2

[0023] This embodiment is a water pill of the Chinese medicine composition of the present invention.

[0024] Prescription: fried myrrh 400g, soapberry thorn 400g, angelica powder 400g, fried peach kernel 500g, salvia miltiorrhiza 500g, red peony root 500g, safflower 500g, zedoaria 500g, fried fenugreek 500g, patula 1666g, dandelion 1666g, toosendan fruit 500g, pyrrosia 833g, wolfberry 500g.

[0025] The preparation method is as follows: take 400g of fried myrrh, 400g of soapberry thorn, and 400g of angelica powder, crush them into fine powder and set aside; take another 500g of fried peach kernel, 500g of salvia miltiorrhiza, 500g of red peony root, 500g of safflower, 500g of zedoaria, 500g of fried fenugreek, 1666g of patrinia herb, 1666g of dandelion, 500g of toosendan fruit, 833g of pyrrosia, and 500g of wolfberry, mix them, add 65L of water and boil them, boil them twice, each time for 1 hour, combine the extracts, filter, and concentrate the filtrate into a thick paste, add the above-mentioned fine powder, dry it, grind it into fine powder, sieve it to make fine powder, mix it evenly, and make water pills with water.

[0026] Dosage and Administration: Oral. Take 20-30 capsules at a time, 3 times a day; or as directed by a physician. Example 3

[0027] This embodiment is a tablet of the Chinese medicine composition of the present invention.

[0028] Prescription: 500g of fried myrrh, 500g of soapberry thorn, 500g of angelica powder, 400g of fried peach kernel, 400g of salvia miltiorrhiza, 400g of red peony root, 400g of safflower, 400g of zedoaria, 400g of fried fenugreek, 1500g of patina, 1500g of dandelion, 400g of toosendan fruit, 800g of pyrrosia, and 400g of wolfberry.

[0029] The preparation method is as follows: take 500g of fried myrrh, 500g of soapberry thorn, and 500g of angelica powder, crush them into fine powder and set aside; take another 400g of fried peach kernel, 400g of salvia miltiorrhiza, 400g of red peony root, 400g of safflower, 400g of zedoaria, 400g of fried fenugreek, 1500g of patrinia herb, 1500g of dandelion, 400g of toosendan fruit, 800g of pyrrosia, and 400g of wolfberry, mix them, add 65L of water and boil them twice, boiling them for 1 hour each time, combine the extracts, filter, and concentrate the filtrate into a thick paste, add the above-mentioned fine powder and soluble starch to make tablets.

[0030] Dosage and Administration: Oral. 4-6 tablets at a time, 3 times a day; or as directed by a physician.

[0031] The fine powders of the pharmaceutical preparations prepared in Examples 1-3 above were respectively used for animal experiments.

[0032] The following endometriosis model animal experiment was conducted to experimentally study and verify the effect of the drug prepared by the present invention on treating endometriosis.

[0033] 1. Test Drugs

[0034] 1.1 Chinese medicine composition examples 1, 2 and 3 correspond to the pharmaceutical prescriptions and preparation methods of the aforementioned examples 1, 2 and 3, respectively. The fine powders sieved from examples 1 and 2 and the fine drug powder before tableting from example 3 were taken.

[0035] 1.2 Control drug: Guizhi Fuling Capsule.

[0036] 2. Experimental study on endometriosis in rats

[0037] 2.1 Experimental animals

[0038] Sixty healthy female SD rats weighing 250±20 g were used.

[0039] 2.2 Experimental Grouping

[0040] After the experimental animals were adaptively raised for 3 days, 10 were randomly selected as the blank control group; the remaining 50 were used for modeling, and after successful modeling, the animals were divided into the model group, the Chinese medicine composition example 1 group, the Chinese medicine composition example 2 group, the Chinese medicine composition example 3 group and the Guizhi Fuling capsule control group.

[0041] 2.3 Modeling

[0042] The day before modeling, each rat received a subcutaneous injection of 0.1 mg / kg·day of estradiol benzoate. Rats were anesthetized with an intraperitoneal injection of 20% urethane (4 ml / kg). The lower abdomen was shaved and disinfected with 75% alcohol. A 2 cm longitudinal incision was made midline to expose the uterus. The right ovarian end was ligated, and the uterine segment, approximately 1.5 cm distal to the right uterine horn, was ligated and removed. The uterine tissue (including the myometrium) was then placed in a Petri dish filled with sterile saline. The uterine tissue (including the myometrium) was cut into two 5 mm × 5 mm pieces, with the serosa facing the peritoneum and the mucosal surface facing the abdominal cavity. The four corners were secured to the abdominal wall muscles on both sides of the incision with 6-0 non-absorbable sutures. The abdominal incision was sutured layer by layer, and the abdomen was closed as usual. The rat's breathing and heartbeat were monitored, and the rat was allowed to awaken naturally. Penicillin was administered intramuscularly for 3 days postoperatively to prevent infection. On the second day after surgery, 0.1 mg / kg·day of estradiol benzoate was administered every three days for a total of five injections.

[0043] 2.4 Administration

[0044] On the 15th day after surgery, the animals with successful modeling were randomly divided into 5 groups, namely, the model group, the Chinese medicine composition example 1 group (1.6 g / kg; equivalent to 5.215 g / kg of crude drugs), the Chinese medicine composition example 2 group (1.6 g / kg; equivalent to 5.215 g / kg of crude drugs), the Chinese medicine composition example 3 group (1.6 g / kg; equivalent to 5.215 g / kg of crude drugs) and the Guizhi Fuling capsule control group (0.25 g / kg). The corresponding concentrations of drugs were prepared and administered by gavage at 1.0 ml / 100 g. The blank control group was gavaged with distilled water 1.0 ml / 100 g. The drugs were administered continuously for 30 days.

[0045] After administration, all rats were anesthetized with ether, and the abdominal cavity was opened to observe the growth of ectopic endometrial lesions. The length, width, and thickness of the ectopic endometrium were measured and recorded, and the ectopic volume was calculated. The capillaries and adhesions of the ectopic tissue were recorded. The ectopic tissue together with the adherent adjacent tissues were excised and fixed in 10% formaldehyde for pathological examination and immunohistochemical detection of CD34 expression. The ovaries were dissected and weighed, and the organ coefficient (ovary weight / rat body weight × 100%) was calculated.

[0046] Immunohistochemical staining steps: paraffin sections were routinely dewaxed and hydrated, 4% hydrogen peroxide was added, and the sections were left for 20 minutes. The antigens were heated for 30 minutes and then rinsed with PBS phosphate buffer for 3 minutes × 3 times. The primary antibody (1:50) was added and the sections were incubated at 4°C overnight. The sections were rinsed with PBS for 3 minutes × 3 times. The sections were incubated with secondary antibodies for 20 minutes and then rinsed with PBS for 3 minutes × 3 times. The sections were developed with DBA, counterstained with hematoxylin, and then mounted with neutral gum for observation under a microscope. After staining, a representative 400x magnification visual field was randomly selected from each experimental animal slice for observation and counting. The slices were read according to the Formwitz scoring method, with the cells in the middle of the slice as the base number 100%. The slices were divided into four grades according to the percentage of receptor-positive cells and the depth of staining: - grade (negative): positive cells <25% (1 point) or no staining (1 point); + grade (weakly positive): positive cells 25% to 50% (2 points), positive staining was yellow and clear (2 points); ++ grade (positive): positive cells 51% to 75% (3 points), positive staining was brown and clear (3 points); +++ grade (strongly positive): positive cells >75% (4 points), and the cytoplasm was brown (4 points). The product of the two scores was used as the final score.

[0047] 2.5 Data Statistical Methods

[0048] The statistical analysis of the data was performed using SPSS 17.0 statistical software, and the results were expressed as mean ± standard deviation ( ) and used t test.

[0049] 2.6 Results of the Experimental Study on the Effect of the Chinese Medicine Composition of the Present Invention on Endometriosis in Rats

[0050] 2.6.1 Effects on rat body weight and ovarian coefficient. Results are shown in Table 1.

[0051]

[0052] 2.6.2 Comparison of endometriotic lesion growth. Results are shown in Table 2.

[0053] After the animals were sacrificed, laparotomy was performed to observe their appearance, and the height of the cystic fluid in each group of ectopic foci was measured with a caliper. The growth of the ectopic foci on both sides was divided into 4 levels: (1) atrophy or no growth (-): the ectopic foci were reduced or accompanied by yellowing, or only the ectopic foci were seen but no fluid accumulation; (2) low growth (+): there was a small amount of fluid in the ectopic foci; (3) moderate growth (++): there was cystic fluid in the ectopic foci, but the height of the fluid accumulation was <2 mm; (4) good growth (+++): the height of the cystic fluid in the ectopic foci was ≥2 mm.

[0054]

[0055] 2.6.3 Observation of vascular richness in endometriotic foci. The results are shown in Table 3.

[0056] Grading criteria: (1) The ectopic lesion has rich blood vessels (+++); (2) The ectopic lesion has few blood vessels (++); (3) The ectopic lesion has almost no blood vessels (+); (4) No blood vessels are found in the ectopic tissue (-).

[0057]

[0058] 2.6.4 Observation of adhesions of endometriotic foci. The results are shown in Table 4.

[0059] Grading criteria: (1) The ectopic tissue is highly adhered to the intestinal mucosa or other tissues (+++) and covered with adipose tissue; (2) The ectopic tissue is slightly adhered to other tissues and covered with a small amount of adipose tissue (++); (3) The ectopic tissue has almost no adhesion or can be peeled off easily (+); (4) The ectopic tissue has no adhesion at all (-).

[0060]

[0061] 2.6.5 Observation and comparison of endometriosis lesion area and volume. The results are shown in Table 5.

[0062]

[0063] 2.6.6 Changes in CD34 expression in endometriotic lesions. Results are shown in Table 6.

[0064]

[0065] 2.6.7 Comparison of the degree of endometrial lesions. See Table 7 for the results.

[0066]

[0067] 3. Experimental Study on Endometriosis in Mice

[0068] 3.1 Experimental animals: 80 female Kunming mice, weighing 25±2 g.

[0069] 3.2 Experimental Grouping

[0070] Twelve animals were randomly selected as the blank control group; the remaining 68 animals were used for modeling, and after successful modeling, the animals were divided into the model group, the Chinese medicine composition example 1 group, the Chinese medicine composition example 2 group, the Chinese medicine composition example 3 group and the Guizhi Fuling capsule group.

[0071] 3.3 Modeling

[0072] Two days before modeling, estradiol benzoate (0.05 mL / animal / day) was injected intramuscularly. On the third day, all 68 animals, except for 12 in the normal control group, underwent modeling. They were anesthetized with an intraperitoneal injection of 10% urethane (25 mL / kg), secured to the operating table, and their abdomens disinfected. The abdominal cavity was opened, and the left uterus, ovarian end, and vaginal end of the mice were bilaterally ligated. The uterus was then cut and longitudinally cut into two pieces (5 mm × 5 mm) and sutured to the bilateral abdominal walls. For three days postoperatively, penicillin (1.7 million U / kg) was injected intraperitoneally daily. Estradiol benzoate (0.05 mL / animal / time) was administered intramuscularly twice weekly to promote the growth of ectopic endometrium.

[0073] 3.4 Administration

[0074] The animals were randomly divided into five groups after successful modeling in the second week of the experiment: the model group, the Chinese medicine composition example 1 group (1.6 g / kg; equivalent to 5.215 g / kg of crude drugs), the Chinese medicine composition example 2 group (1.6 g / kg; equivalent to 5.215 g / kg of crude drugs), the Chinese medicine composition example 3 group (1.6 g / kg; equivalent to 5.215 g / kg of crude drugs), and the Guizhi Fuling capsule group (1.6 g / kg). The test samples in each group were prepared to the corresponding drug concentration and administered orally at 0.2 mL / 10 g. The blank control group and the model group were given equal amounts of distilled water, respectively, for 5 consecutive weeks.

[0075] Thirty minutes after the last administration, the animals were sacrificed by cervical dislocation, fixed on the operating table, shaved, and the abdomen disinfected. The abdominal cavity was opened to observe the growth of ectopic endometrial lesions, and the length, width, and thickness of the ectopic endometrium were measured and recorded. The uterus and ectopic tissue together with the adherent adjacent tissues were excised and fixed in 10% formaldehyde for pathological examination. The expression of CD34 and VEGF was detected by immunohistochemistry. The ovaries were weighed, and the organ coefficient (ovary weight / mouse body weight × 100%) was calculated.

[0076] Immunohistochemical staining steps: paraffin sections were routinely dewaxed and hydrated, 4% hydrogen peroxide was added, and the sections were left for 20 minutes. The antigens were heated for 30 minutes and then rinsed with PBS phosphate buffer for 3 minutes × 3 times. The primary antibody (VEGF 1:50, CD34 1:50) was added and the sections were incubated at 4°C overnight. The sections were rinsed with PBS for 3 minutes × 3 times. The sections were incubated with secondary antibodies for 20 minutes and rinsed with PBS for 3 minutes × 3 times. The sections were developed with DBA, counterstained with hematoxylin, and then mounted with neutral gum for observation under a microscope. After staining, a representative 400x magnification visual field was randomly selected from each experimental animal slice for observation and counting. The slices were read according to the Formwitz scoring method, with the cells in the middle of the slice as the base number 100%. The slices were divided into four grades according to the percentage of receptor-positive cells and the depth of staining: - grade (negative): positive cells <25% (1 point) or no staining (1 point); + grade (weakly positive): positive cells 25% to 50% (2 points), positive staining was yellow and clear (2 points); ++ grade (positive): positive cells 51% to 75% (3 points), positive staining was brown and clear (3 points); +++ grade (strongly positive): positive cells >75% (4 points), and the cytoplasm was brown (4 points). The product of the two scores was used as the final score.

[0077] 3.5 Data Statistical Methods

[0078] The statistical analysis of the data was performed using SPSS 17.0 statistical software, and the results were expressed as mean ± standard deviation ( ) and used t test.

[0079] 3.6 Study results on the effect of the composition of the present invention on endometriosis in mice

[0080] 3.6.1 Effects on mouse body weight. Results are shown in Table 8.

[0081]

[0082] 3.6.2 Effects on ectopic endometrial lesions in mice. Results are shown in Table 9.

[0083]

[0084] 3.6.3 Effect on the heterozygous ovary coefficient of mice with endometriosis. The results are shown in Table 10.

[0085]

[0086] 3.6.4 Expression of CD34 and VEGF in mouse endometriotic lesions. The results are shown in Table 11.

[0087]

[0088] 3.6.5 Pathological observation of the effect of the composition of the present invention on the ectopic endometrium of mice. The results are shown in Table 12.

[0089]

[0090] The experimental results showed that Chinese herbal composition examples 1, 2, and 3 could inhibit the growth of endometriotic tissue in rats, and reduced the degree and range of endometrial pseudoglandular and inflammatory cell infiltration in rats compared with the model group; the immunohistochemistry results, analyzed by the scoring method, showed that the positive expression in the rat endometriosis model group was significantly higher than that in the blank control group, and the difference was statistically significant (P < 0.05); compared with the model group, the expression of CD34 in Chinese herbal composition examples 1, 2, and 3 showed a downward trend, but there was no significant difference, and there was no significant difference in the cinnamon twig and fuling group compared with the model group (P>0.05).

[0091] The positive expression of the mouse endometriosis model group was significantly higher than that of the blank control group (P < 0.05); compared with the model group, there was no significant difference in the positive expression of the Guizhi Fuling group compared with the model group. The CD34 of the Chinese medicine composition examples 1, 2, and 3 treatment groups was significantly lower than that of the model group (P < 0.05), indicating that the Chinese medicine composition examples 1, 2, and 3 can reduce the expression of CD34 in the endometrial transplantation tissue of experimental animals; the VEGF expression of the Chinese medicine composition examples 1, 2, and 3 groups was significantly decreased (P < 0.05), indicating that the Chinese medicine composition examples 1, 2, and 3 groups can reduce the expression level of VEGF in the endometriosis tissue of mice.

[0092] The experiment found that the ovarian coefficient of the rat endometriosis model group was significantly higher than that of the normal control group (P<0.01). After the action of the drug, the ovarian coefficient of the experimental animals in each group decreased. The ovarian coefficient of the experimental animals in groups 1, 2, and 3 of the Chinese medicine combination was significantly lower than that of the model group (P<0.01), and there was no significant difference compared with the blank control group (P>0.05).

[0093] The experiment found that the ovarian coefficient of the mouse endometriosis model group was lower than that of the normal control group, while that of the Chinese medicine composition groups 1, 2, 3 and the positive control group all increased to varying degrees.

[0094] In summary, the Chinese medicine compositions Examples 1, 2, and 3 have certain therapeutic effects on endometriosis in experimental rats and mice.

[0095] IV. Preliminary Toxicity Studies

[0096] Acute toxicity testing showed that mice administered the sample from Example 1 at a dose of 13g / kg / dose—over 100 times the daily dose for a 70kg human—did not experience any abnormalities or animal mortality. According to tolerance testing requirements, mice are considered to have passed the tolerance test when they can tolerate 60-100 times the adult dose. The dosage of the powder in Example 1 far exceeds this requirement, so the Chinese medicine composition is considered relatively safe.

[0097] Long-term toxicity studies showed that the sample from Example 1 was administered to mice in groups A, B, and C at doses of 0.65g / 100g, 0.39g / 100g, and 0.13g / 100g, respectively, equivalent to 50, 30, and 10 times the human dose. During the 180 days of continuous administration, no abnormalities were observed in the animals' appearance or activity. The weight of the animals in each group continued to increase. At the end of the experiment, the weight of the high-dose (Group A), medium-dose (Group B), low-dose (Group C), and control group increased by 249.5g, 240.0g, 232.0g, and 226.5g, respectively, compared to pre-dose weight gain. The pre- and post-dose weight gain differences were highly significant (P<0.001), but no differences were observed between groups (P>0.05). This indicates that the sample did not affect the animals' food intake or weight gain under the experimental conditions. At the end of the experiment, no abnormalities were found during the macroscopic examination of the dissection. Pathological microscopic examination of important organs (heart, liver, lungs, kidneys, testicles, ovaries, etc.) also revealed no pathological changes related to the test samples, indicating that the Chinese medicine composition is relatively safe.

[0098] The foregoing is merely an embodiment of the present application, and the scope of protection 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, the present application may have various modifications and variations. Any modifications, equivalent substitutions, improvements, etc. made within the technical ideas and principles of the present application should be included in the scope of protection of the present application.

Claims

1. Use of a traditional Chinese medicine composition in the preparation of a medicament for treating endometriosis, wherein the traditional Chinese medicine composition is prepared 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 gleditsia spinosae, 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, 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 thorns, 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 evenly, and finally process it into an oral preparation to obtain.

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

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