Traditional Chinese medicine composition for treating gynecological diseases caused by spleen-kidney yang deficiency and damp turbid blood stasis and preparation of traditional Chinese medicine composition for treating gynecological diseases caused by spleen-kidney yang deficiency and damp turbid blood stasis

Abstract

The invention particularly relates to a traditional Chinese medicine composition for treating gynecological diseases caused by spleen-kidney yang deficiency and damp turbid blood stasis and preparation of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following raw materials: astragalus membranaceus, poria cocos, roasted rhizoma atractylodis macrocephalae, roasted semen coicis, pawpaw, cornu cervi degelatinatum, salted eucommia ulmoides, teasel root slices, radix bupleuri, pericarpium citri reticulatae, Chinese yam, cortex phellodendri, rhizoma anemarrhenae, vinegar-processed rhizoma cyperi, fructus amomi and pogostemon cablin, solves the problems of infertility and repeated planting failure caused by spleen-kidney yang deficiency and damp turbid blood stasis, has good safety and compliance, and is suitable for clinical application. And the market application prospect is good.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating gynecological diseases caused by spleen and kidney yang deficiency, dampness, turbidity and blood stasis, and a preparation method thereof. Background Art

[0002] Infertility refers to the situation where a couple has not taken any contraceptive measures during normal sexual life and has not been able to conceive for one year or more. Gynecological diseases are one of the common causes of female infertility. Depending on the cause, gynecological infertility can be divided into many types, involving various parts of the reproductive system, such as the ovaries, fallopian tubes, uterus, cervix, and endocrine system. The following will discuss in detail the infertility caused by reproductive system problems.

[0003] Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder in women of childbearing age. The disease is manifested by sparse menstruation or amenorrhea, elevated androgen levels, polycystic ovarian changes, and obesity, hirsutism, acne, insulin resistance and other symptoms. In addition, PCOS may also lead to infertility, depression, anxiety and other emotional disorders, seriously affecting the patient's physical and mental health and family harmony. At present, short-acting oral contraceptives, progesterone, glucocorticoids and other strategies are often used in clinics to regulate PCOS patients, improve patients' sugar and lipid metabolism, and correct menstrual disorders. However, oral hormone products have many adverse reactions and are prone to drug resistance. They are also rejected by young women. Therefore, new strategies are needed to treat PCOS patients. Traditional Chinese medicine believes that the cause of PCOS originates from the kidney and is inseparable from the dysfunction of the kidney-chongren-uterus axis. Kidney deficiency leads to qi and blood deficiency, and qi and blood deficiency leads to poor circulation of qi and fluid, which leads to sparse menstruation and irregular menstruation.

[0004] PCOS ovulation disorders and abnormal endocrine changes cause poor differentiation of the endometrium, affecting embryo implantation, leading to low pregnancy rates and high miscarriage rates; in addition, it also affects the normal cyclical changes of the endometrium, causing the endometrium to have varying degrees of hyperplasia and even an increased risk of developing endometrial cancer.

[0005] Repeated Implantation Failure (RIF) refers to the situation where the embryo fails to successfully implant and become pregnant after multiple embryo transfers, despite the use of assisted reproductive technology (such as in vitro fertilization-embryo transfer IVF-ET or intracytoplasmic sperm injection ICSI, etc.). Generally, repeated implantation failure is defined as the failure of successful pregnancy in three or more high-quality embryo transfers. Specifically, this failure is not limited to miscarriage after pregnancy, but refers to the inability of the embryo to successfully implant in the uterus, regardless of whether there is an embryonic heartbeat or not.

[0006] There are three methods of Western medicine to treat this type of disease, such as hormone therapy, taking drugs such as clomiphene, ovulation-inducing drugs, taking follicle-stimulating drugs, such as follicle-stimulating hormone, hCG and other drugs, and of course embryo transplantation, such as in vitro fertilization.

[0007] There is no treatment that can completely deal with the above diseases. The cost of IVF is relatively high, and the existing traditional Chinese medicine can only treat one or two of them. And the efficacy needs to be improved. Summary of the invention

[0008] The invention discloses a Chinese medicine composition specifically for treating gynecological diseases caused by spleen and kidney yang deficiency, dampness, turbidity and blood stasis, solves the problems of infertility, polycystic ovary syndrome, recurrent miscarriage, repeated implantation failure and endometriosis caused by spleen and kidney yang deficiency, dampness, turbidity and blood stasis, has good safety and compliance, and has good market application prospects.

[0009] Specifically, the technical purpose of the present invention is achieved through the following technical scheme: a traditional Chinese medicine composition for treating gynecological diseases, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 213-370 parts of astragalus, 142-247 parts of Poria, 142-247 parts of stir-fried Atractylodes, 285-494 parts of stir-fried Coix seeds, 142-247 parts of papaya, 285-494 parts of antler frost, 142-247 parts of salt Eucommia, 142-247 parts of Dipsacus asper, 142-247 parts of bupleurum, 142-247 parts of tangerine peel, 285-494 parts of yam, 42-74 parts of Phellodendron, 42-74 parts of Anemarrhena, 142-247 parts of vinegar Cyperus rotundus, 42-74 parts of Amomum, and 71-123 parts of patchouli.

[0010] In a preferred embodiment of the present invention, the Chinese medicine composition is made of the following raw materials in parts by weight: 285 parts of astragalus, 190 parts of Poria, 190 parts of stir-fried Atractylodes, 380 parts of stir-fried Coix seeds, 190 parts of papaya, 380 parts of antler frost, 190 parts of salt Eucommia, 190 parts of Dipsacus asper, 190 parts of bupleurum, 190 parts of tangerine peel, 380 parts of yam, 57 parts of Phellodendron, 57 parts of Anemarrhena, 190 parts of vinegar-cooked Cyperus rotundus, 57 parts of Amomum, and 95 parts of Patchouli.

[0011] In a preferred embodiment of the present invention, the Chinese medicine composition is made of the following raw materials in parts by weight: 213 parts of astragalus, 142 parts of poria, 142 parts of stir-fried atractylodes, 285 parts of stir-fried coix seeds, 142 parts of papaya, 285 parts of antler frost, 142 parts of salt eucommia, 142 parts of dipsacus, 142 parts of bupleurum, 142 parts of tangerine peel, 285 parts of yam, 42 parts of phellodendron, 42 parts of anemarrhena, 142 parts of vinegar-cooked cyperus, 42 parts of amomum, and 71 parts of patchouli.

[0012] In a preferred embodiment of the present invention, the Chinese medicine composition is made of the following raw materials in parts by weight: 370 parts of astragalus, 247 parts of poria, 247 parts of stir-fried atractylodes, 494 parts of stir-fried coix seeds, 247 parts of papaya, 494 parts of antler frost, 247 parts of salt eucommia, 247 parts of dipsacus, 247 parts of bupleurum, 247 parts of tangerine peel, 494 parts of yam, 74 parts of phellodendron, 74 parts of anemarrhena, 247 parts of vinegar-cooked cyperus, 74 parts of amomum, and 123 parts of patchouli.

[0013] By studying the dosage form of the Chinese medicine composition, it can be prepared as any oral preparation of granules, mixtures, decoctions, oral liquids, tablets, pills, capsules or pastes, and more preferably granules, i.e., Zhongyu granules.

[0014] Furthermore, the preparation method of the granules is as follows:

[0015] 1) Grind patchouli and Amomum villosum into finest powder, pass through a 120-mesh sieve, and sterilize by irradiation (8 kGy). Fine powder A is reserved for later use;

[0016] 2) Astragalus, Poria, stir-fried Atractylodes macrocephala, stir-fried Coix seeds, papaya, antler frost, salt Eucommia bark, Dipsacus asper, Bupleurum, dried orange peel, Chinese yam, Phellodendron amurense, Anemarrhena asphodeloides and vinegar fragrance are decocted three times with 8 times the amount of water, each time for 1.5 hours, the decoction is combined, filtered, and the filtrate is reserved;

[0017] 3) The filtrate of step 2) is concentrated at 70° C. to a clear paste with a relative density of 1.21-1.25, and vacuum dried to obtain a dry paste, which is crushed into fine powder B for later use;

[0018] 4) mixing the fine powder A in step 1) with maltodextrin to obtain a mixture A, and then mixing with the fine powder B in step 3) to obtain a mixture B;

[0019] 5) Add 80% ethanol to mixture B, prepare a soft material, granulate, dry, granulate, sieve, mix, and package to obtain granules.

[0020] Furthermore, the radiation sterilization dose of step 1) is 8 kGy; the vacuum drying conditions of step 3) are: 70°C, 0.08-0.1 MPa, and continuous drying for 8 hours; the weight ratio of fine powder B to mixture A in step 4) is 3:0.8-1.2, and more preferably 3:1; the step 5) is: add 80% ethanol to mixture B to make a soft material, the amount of which is 30-40% of the weight of mixture B, granulate through a 16-mesh sieve, dry at 80°C for 3 hours, sieve through a 12-mesh sieve, sieve, mix, and package to obtain the product.

[0021] Furthermore, the preparation method of the granules is as follows:

[0022] 1) Grind patchouli and Amomum villosum into finest powder, pass through a 120-mesh sieve, and sterilize by irradiation (8 kGy). Fine powder A is reserved for later use;

[0023] 2) Astragalus, Poria, stir-fried Atractylodes macrocephala, stir-fried Coix seeds, papaya, antler frost, salt Eucommia bark, Dipsacus asper, Bupleurum, dried orange peel, Chinese yam, Phellodendron amurense, Anemarrhena asphodeloides and vinegar fragrance are decocted three times with 8 times the amount of water, each time for 1.5 hours, the decoction is combined, filtered, and the filtrate is reserved;

[0024] 3) The filtrate of step 2) is concentrated at 70° C. to a clear paste with a relative density of 1.21-1.25, and then dried continuously at 70° C. and 0.08-0.1 MPa for 8 hours to obtain a dry paste, which is then crushed into fine powder B for later use;

[0025] 4) mixing the fine powder A in step 1) with maltodextrin to obtain a mixture A, and then mixing with the fine powder B in step 3) to obtain a mixture B; the weight ratio of the fine powder B to the mixture A is 3:1;

[0026] 5) Add 80% ethanol to mixture B to prepare a soft material, the amount of which is 30-40% of the weight of mixture B, granulate through a 16-mesh sieve, dry at 80° C. for 3 hours, granulate through a 12-mesh sieve, sieve, mix, and package to obtain the product.

[0027] Furthermore, the gynecological diseases described in the present invention are gynecological diseases caused by spleen and kidney yang deficiency, dampness, turbidity and blood stasis.

[0028] Furthermore, the gynecological diseases described in the present invention cover a variety of common female reproductive system diseases, including but not limited to infertility, polycystic ovary syndrome (PCOS), recurrent miscarriage, repeated implantation failure, and endometriosis, etc. These diseases are usually manifested in clinical practice as irregular menstruation, endocrine disorders, and chronic pelvic pain.

[0029] The prescription of the present invention is clear, does not contain the situation of 18 anti-18 fears, the mechanism in the prescription is clear, the curative effect is remarkable, and the astragalus and antler frost are the main drugs in the prescription. Astragalus has the effects of invigorating qi and strengthening the exterior, tonifying the spleen and benefiting the lungs. It can help improve the body's immunity and enhance the circulation of qi and blood, and has a good conditioning effect on qi deficiency constitution in particular. Deer antler frost has the effects of invigorating the kidney and strengthening the tendons, replenishing the essence and benefiting the marrow, and can effectively nourish the kidney essence and warm and tonify the kidney yang. The kidney is the innate foundation, and the use of deer antler frost helps to restore the fullness of kidney qi and enhance vitality. It is not dry and strong, can warm and tonify without hurting yin, and is very suitable for compatibility with astragalus, avoiding the single yang qi tonic excessive stimulation of yin fluid. It warms and nourishes the yang of the kidney and spleen, and benefits the vital energy without being too dry and harsh. Poria, stir-fried Atractylodes macrocephala, Chinese yam, and Patchouli are the assistant drugs, which strengthen the spleen and replenish qi, promote diuresis and eliminate dampness, and have a fragrant aroma to eliminate turbidity. It is assisted by dried tangerine peel, bupleurum, papaya, and Cyperus rotundus to regulate qi and dry dampness, and differentiate the turbidity of phlegm and dampness in the lipid membrane. It is assisted by Chuan Duan and Eucommia ulmoides to nourish the kidney and replenish essence, so as to help conceive the fetus. It is assisted by Amomum villosum, so that Anemarrhena asphodeloides and Phellodendron chinense can dry dampness and strengthen yin, and lead the other drugs downward to control the warm and dry nature of the other drugs, and prevent the disadvantages of damaging yin.

[0030] During the research and development of the pharmaceutical composition of the present invention, the inventor creatively discovered that if any one of the ingredients in the above-mentioned Chinese medicine composition is reduced, or some ingredients are replaced with other raw materials with similar efficacy, the overall therapeutic effect will be significantly reduced. Even if new raw material ingredients are added on this basis, although the types of ingredients are increased, the overall effect of the Chinese medicine composition is not significantly improved, but in some cases, the situation of decreased efficacy may occur. Especially in the Chinese medicine composition for kidney deficiency type menstrual disorders, the coordination between the raw material ingredients is very close, complementing each other, and the lack of any one ingredient may affect the efficacy. The results of the pharmacological experiment further confirmed that the pharmaceutical composition of the present invention is an indivisible whole, and all ingredients are indispensable.

[0031] Compared with the prior art, the present invention has the following advantages:

[0032] (1) The Chinese medicine composition of the present invention has all the main, secondary, auxiliary and guiding drugs, and all the drugs work together. The prescription not only replenishes qi and blood and kidney yang, but also avoids the disadvantages of excessive dryness and excessive heat damaging yin through the configuration of leading and harmonizing drugs such as Amomum villosum, Anemarrhena asphodeloides and Phellodendron chinense. It can regulate and improve ovarian function, promote ovulation, promote conception, etc.; the drugs are mutually restrained and complementary in medicinal properties, and are safe for use and suitable for a wide range of people.

[0033] (2) The preparation method of the granules of the Chinese medicine composition provided by the present invention is convenient for clinical use. The preparation method of the Chinese medicine composition of the present invention is simple and has broad market application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 After treatment, the thickness of the endometrium in the test group was significantly higher than that in the control group, and there was a significant statistical difference (p<0.05). This indicates that Chinese medicine treatment may have a positive effect on the growth or recovery of the endometrium, which in turn illustrates that the therapeutic effect of the test composition of the present invention is significant.

[0035] Figure 2 : It shows the comparison result of the average ovulation number of female mice in the relevant examples. Compared with the comparative examples 1-5, there is a significant difference in Example 1 (P<0.05).

[0036] Figure 3 : It shows the comparison of the average number of cystic dilated follicles in the relevant examples. The model group has significant differences compared with each group (P<0.01), and the number of cystic dilated follicles in Example 1 is significantly lower than that in Comparative Examples 1-5.

[0037] Figure 4 : It shows the comparison results of serum hormone level testosterone (T) in the related examples. Example 1 has significant difference compared with Comparative Examples 1-5 (P<0.01).

[0038] Figure 5 : Shows the comparison results of serum hormone level luteinizing hormone (LH) in the related examples.

[0039] Example 1 has significant difference compared with Comparative Examples 1-5 (P<0.01).

[0040] Figure 6 : It shows the comparison results of fasting blood glucose (FPG) of the related examples. There is no significant difference between the comparative example 2-3 groups and the example 1 group (P>0.05); there is no significant difference between the comparative example 1 and 5 groups and the example 1 group.

[0041] Figure 7 : represents the comparison results of fasting insulin (FINS) of the related examples. Example 1 has significant difference compared with Comparative Examples 1-5 (P<0.01). DETAILED DESCRIPTION

[0042] In order to make the purpose and technical solution of the present invention clearer, the present invention is further described below in conjunction with embodiments, but the protection scope of the present invention is not limited to these embodiments, and the embodiments are only used to explain the present invention. It should be understood by those skilled in the art that any changes or equivalent substitutions that do not deviate from the concept of the present invention are included in the protection scope of the present invention.

[0043] Example 1: A Chinese medicine composition for treating gynecological diseases, the Chinese medicine composition is made of the following raw materials in parts by weight:

[0044] 285g of Astragalus, 190g of Poria, 190g of stir-fried Atractylodes, 380g of stir-fried Coix seeds, 190g of papaya, 380g of antler powder, 190g of salt Eucommia, 190g of Dipsacus asper, 190g of Bupleurum, 190g of dried tangerine peel, 380g of yam, 57g of Phellodendron, 57g of Anemarrhena, 190g of vinegar-cooked Cyperus rotundus, 57g of Amomum, and 95g of Patchouli.

[0045] The preparation process is as follows:

[0046] 1) Grind patchouli and Amomum villosum into finest powder, pass through a 120-mesh sieve, and sterilize by irradiation (8 kGy) to obtain fine powder A for later use;

[0047] 2) Astragalus, Poria, stir-fried Atractylodes macrocephala, stir-fried Coix seeds, papaya, antler frost, salt Eucommia bark, Dipsacus asper, Bupleurum, dried orange peel, Chinese yam, Phellodendron amurense, Anemarrhena asphodeloides and vinegar fragrance are decocted three times with 8 times the amount of water, each time for 15 hours, the decoction is combined, filtered, and the filtrate is reserved;

[0048] 3) The filtrate of step 2) is concentrated at 70°C to a clear paste with a relative density of 123, and then dried continuously at 70°C, 0.08-0.1 MPa for 8 hours to obtain a dry paste, which is then crushed into fine powder B for later use;

[0049] 4) mixing the fine powder A in step 1) with maltodextrin to obtain a mixture A, and then mixing with the fine powder B in step 3) to obtain a mixture B; the weight ratio of the fine powder B to the mixture A is 3:1;

[0050] 5) Add 80% ethanol to mixture B to prepare a soft material, the amount of which is 35% of the weight of mixture B, granulate through a 16-mesh sieve, dry at 80° C. for 3 hours, granulate through a 12-mesh sieve, sieve, mix, and package to obtain the product.

[0051] Example 2: A Chinese medicine composition for treating gynecological diseases, the Chinese medicine composition is made of the following raw materials in parts by weight:

[0052] Astragalus 213g, Poria 142g, stir-fried Atractylodes 142g, stir-fried Coix seeds 285g, Papaya 142g, Deer Horn Powder 285g, Salt Eucommia 142g, Dipsacus asper 142g, Bupleurum 142g, Tangerine peel 142g, Dioscorea batatas 285g, Phellodendron chinense 42g, Anemarrhena asphodeloides 42g, Vinegar-cooked Cyperus rotundus 142g, Amomum villosum 42g, and Patchouli 71g.

[0053] The preparation process is as follows:

[0054] 1) Grind patchouli and Amomum villosum into finest powder, pass through a 120-mesh sieve, and sterilize by irradiation (8 kGy) to obtain fine powder A for later use;

[0055] 2) Astragalus, Poria, stir-fried Atractylodes macrocephala, stir-fried Coix seeds, papaya, antler frost, salt Eucommia bark, Dipsacus asper, Bupleurum, dried orange peel, Chinese yam, Phellodendron amurense, Anemarrhena asphodeloides and vinegar fragrance are decocted three times with 8 times the amount of water, each time for 15 hours, the decoction is combined, filtered, and the filtrate is reserved;

[0056] 3) The filtrate of step 2) is concentrated at 70°C to a clear paste with a relative density of 121, and then dried continuously at 70°C, 0.08-0.1 MPa for 8 hours to obtain a dry paste, which is then crushed into fine powder B for later use;

[0057] 4) mixing the fine powder A in step 1) with maltodextrin to obtain a mixture A, and then mixing it with the fine powder B in step 3) to obtain a mixture B; the weight ratio of the fine powder B to the mixture A is 3:1;

[0058] 5) Add 80% ethanol to mixture B to prepare a soft material, the amount of which is 30% of the weight of mixture B, granulate through a 16-mesh sieve, dry at 80° C. for 3 hours, granulate through a 12-mesh sieve, sieve, mix, and package to obtain the product.

[0059] Example 3: A Chinese medicine composition for treating gynecological diseases, wherein the Chinese medicine composition is made of the following raw materials in parts by weight:

[0060] 370g of Astragalus, 247g of Poria, 247g of stir-fried Atractylodes, 494g of stir-fried Coix seeds, 247g of papaya, 494g of antler powder, 247g of salt Eucommia, 247g of Dipsacus asper, 247g of Bupleurum, 247g of dried tangerine peel, 494g of Dioscorea batatas, 74g of Phellodendron, 74g of Anemarrhena, 247g of vinegar-cooked Cyperus rotundus, 74g of Amomum villosum, and 123g of Patchouli.

[0061] The preparation process is as follows:

[0062] 1) Grind patchouli and Amomum villosum into finest powder, pass through a 120-mesh sieve, and sterilize by irradiation (8 kGy) to obtain fine powder A for later use;

[0063] 2) Astragalus, Poria, stir-fried Atractylodes macrocephala, stir-fried Coix seeds, papaya, antler frost, salt Eucommia bark, Dipsacus asper, Bupleurum, dried orange peel, Chinese yam, Phellodendron amurense, Anemarrhena asphodeloides and vinegar fragrance are decocted three times with 8 times the amount of water, each time for 15 hours, the decoction is combined, filtered, and the filtrate is reserved;

[0064] 3) The filtrate of step 2) is concentrated at 70°C to a clear paste with a relative density of 125, and then dried continuously at 70°C, 0.08-0.1 MPa for 8 hours to obtain a dry paste, which is then crushed into fine powder B for later use;

[0065] 4) mixing the fine powder A in step 1) with maltodextrin to obtain a mixture A, and then mixing it with the fine powder B in step 3) to obtain a mixture B; the weight ratio of the fine powder B to the mixture A is 3:1;

[0066] 5) Add 80% ethanol to mixture B to prepare a soft material in an amount of 40% by weight of mixture B, granulate through a 16-mesh sieve, dry at 80° C. for 3 hours, granulate through a 12-mesh sieve, sieve, mix, and package to obtain the product.

[0067] Example 4: A Chinese medicine composition for treating gynecological diseases, the Chinese medicine composition is made of the following raw materials in parts by weight:

[0068] Astragalus 28.5g, Poria 19g, stir-fried Atractylodes 19g, stir-fried Coix seeds 38g, papaya 19g, antler frost 38g, salt Eucommia 19g, Dipsacus asper 19g, Bupleurum 19g, dried tangerine peel 19g, yam 38g, Phellodendron chinense 5.7g, Anemarrhena asphodeloides 5.7g, vinegar-cooked Cyperus rotundus 19g, Amomum villosum 5.7g, and Patchouli 9.5g.

[0069] The decoction is prepared by conventional process.

[0070] Comparative Example 1: A Chinese medicine composition for treating gynecological diseases, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0071] 285g of Astragalus, 190g of Poria, 190g of Pseudostellaria, 380g of stir-fried Coix seeds, 190g of papaya, 380g of antler powder, 190g of salt Eucommia, 190g of Dipsacus asper, 190g of malt, 190g of stir-fried Shenqu, 380g of hawthorn, 57g of Citrus aurantium, 57g of licorice, 190g of vinegar-soaked Cyperus rotundus, 57g of mint, and 95g of patchouli.

[0072] The preparation process is the same as that of Example 1.

[0073] Comparative Example 2: A Chinese medicine composition for treating gynecological diseases, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0074] 285g of Astragalus, 190g of Poria, 190g of stir-fried Atractylodes, 380g of stir-fried Coix seeds, 190g of papaya, 190g of salted Eucommia, 190g of Dipsacus asper, 190g of Bupleurum, 190g of dried tangerine peel, 380g of Chinese yam, 57g of Phellodendron, 57g of Anemarrhena, 190g of vinegar-cooked Cyperus rotundus, 57g of Amomum, and 95g of Patchouli.

[0075] The preparation process is the same as that of Example 1.

[0076] Comparative Example 3: A Chinese medicine composition for treating gynecological diseases, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0077] 190g Poria cocos, 190g stir-fried Atractylodes macrocephala, 380g stir-fried Coix seeds, 190g papaya, 190g salt Eucommia ulmoides, 190g Dipsacus asper, 190g Bupleurum chinense, 190g dried orange peel, 380g Chinese yam, 57g Phellodendron chinense, 57g Anemarrhena asphodeloides, 190g vinegar-cooked Cyperus rotundus, 57g Amomum villosum, and 95g Patchouli.

[0078] Comparative Example 4: A Chinese medicine composition for treating gynecological diseases, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0079] 285g of Cistanche deserticola, 190g of Poria cocos, 190g of stir-fried Atractylodes macrocephala, 380g of stir-fried Coix seeds, 190g of papaya, 380g of Cuscuta australis, 190g of salt Eucommia ulmoides, 190g of Dipsacus asper, 190g of Bupleurum chinense, 190g of dried tangerine peel, 380g of Dioscorea batatas, 57g of Phellodendron amurense, 57g of Anemarrhena asphodeloides, 190g of vinegar-cooked Cyperus rotundus, 57g of Amomum villosum, and 95g of Patchouli.

[0080] The preparation process is the same as that of Example 1.

[0081] Comparative Example 5: A Chinese medicine composition for treating gynecological diseases, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0082] 285g of Astragalus, 190g of Poria, 190g of stir-fried Atractylodes, 380g of stir-fried Coix seeds, 190g of papaya, 380g of antler powder, 190g of salt Eucommia, 190g of Dipsacus asper, 190g of Bupleurum, 190g of dried tangerine peel, 380g of yam, 57g of Phellodendron, 57g of Anemarrhena, 190g of vinegar-cooked Cyperus rotundus, 57g of Amomum, and 95g of Patchouli.

[0083] The preparation process is the same as that of Example 1.

[0084] 1. Clinical Trials

[0085] 1 Research subjects

[0086] All cases were from patients admitted to the Department of Reproductive Medicine, South Campus, First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from February 2024 to October 2024. Baseline comparison, statistical processing, the two groups were balanced in age, infertility course, infertility factors, infertility type, number of transplants, FET preparation scheme, basal endometrial thickness, basal hormone levels, and there was no significant difference between the two groups, which was comparable (P>0.05).

[0087] 2 Case selection

[0088] 2.1 Diagnostic criteria

[0089] 2.1.1 Western medicine diagnostic criteria: In line with IVF-ET / ICSI indications:

[0090] 1) Tubal infertility; 2) Endometriosis; 3) Male factor infertility; 4) Abnormal ovulation; 5) Unexplained infertility; 6) Cervical factors, etc.

[0091] 2.2.2 TCM syndrome differentiation criteria for kidney (yang) deficiency and blood stasis:

[0092] 1) Main symptoms: long-term infertility, late or infrequent menstruation, scanty menstruation or even amenorrhea, light color, or clots;

[0093] 2) Secondary symptoms: dizziness, tinnitus, soreness in waist and knees, cold lower abdomen, frequent urination at night, heavy and watery vaginal discharge, dark eye sockets, dark spots on the face, lack of sexual desire, and mental fatigue;

[0094] 3) Tongue and pulse: pale tongue, white fur, deep and thin or slow pulse;

[0095] If the main symptoms are 2 and the secondary symptoms are 1-2, the diagnosis can be made by referring to the tongue and pulse.

[0096] 2.3 Inclusion criteria

[0097] 1) Meet the indications for entering the IVF-ET cycle and meet the TCM syndrome differentiation criteria for kidney deficiency and blood stasis;

[0098] 2) Aged 25-45 years old;

[0099] 3) Those who have failed to achieve pregnancy after three or more embryo transfers;

[0100] 4) Those without uterine cavity lesions or who have been cured by hysteroscopy or other surgeries;

[0101] 5) Those without hydrosalpinx or who have undergone surgical ligation;

[0102] 6) Sign the informed consent form.

[0103] 2.4 Exclusion criteria

[0104] 1) Uterine and uterine cavity lesions that have not been treated or cured by hysteroscopy, such as uterine malformation, uterine fibroids, endometrial polyps, endometritis, uterine cavity adhesions, uterine cavity fibrosis, adenomyosis, etc.;

[0105] 2) Patients with hydrosalpinx who have not undergone surgery;

[0106] 3) Those who are unable to cooperate, such as those with neurological or mental illness;

[0107] 4) Those with incomplete information;

[0108] 5) Those who are allergic to the drugs used;

[0109] 6) Currently participating in other clinical research.

[0110] Those who meet any of the above conditions will be excluded.

[0111] 2.5 Rejection and shedding criteria

[0112] 1) Those who are unable to continue treatment due to various reasons; 2) Those who have adverse drug reactions; 3) Those who have concurrent diseases; 4) Those who voluntarily withdraw from the trial.

[0113] 3 Treatment options

[0114] 3.1 Randomization

[0115] 109 RIF patients were screened for endometrial preparation, and SPSS210 statistical software was used to generate random numbers according to the number of cases. They were divided into an experimental group and a control group according to the order of admission, with 55 cases in the experimental group and 54 cases in the control group.

[0116] 3.2 Treatment methods

[0117] (1) Endometrial preparation: Subjects entered the week on the 2nd to 3rd day after the menstrual cycle or drug withdrawal bleeding. After the first B-ultrasound ruled out ovarian cysts, they were given Yiweixian (each tablet contains: estradiol valerate 2 mg, norethindrone 0.7 mg, Zhejiang Xianju Pharmaceutical Co., Ltd., batch number: National Medicine Standard H20020299, taken according to the instructions, and a second B-ultrasound was performed to monitor the endometrial thickness after 12 consecutive days of oral administration. If the endometrial thickness was ≥8 mm and the serum E2 value was >200 pg / ml on the same day, compound estradiol tablets (each tablet contains: estradiol 1 mg, norethindrone acetate 0.5 mg) were used instead. , Kunming Sino Pharmaceutical Co., Ltd., according to the instructions, 4 mg, twice a day, for 3 consecutive days of oral administration for endometrial transformation, the day is defined as the endometrial transformation day), cleavage stage embryos can be transplanted 3 days after transformation or blastocysts can be transplanted 5 days after transformation; if the subject's second B-ultrasound monitoring of the endometrial thickness <8mm, then add estradiol valerate tablets (estradiol valerate 1mg, Zhejiang Xianju Pharmaceutical Co., Ltd., approval number National Medicine Standard H20244319) 1mg, once a day, vaginal medication. Estrogen can be taken for up to 3 weeks. If the endometrium is still <8cm, cancel the cycle.

[0118] (2) Luteal support: After frozen embryo transfer, Yiweixian (each tablet contains: estradiol valerate 2 mg, norethindrone 0.7 mg, Zhejiang Xianjun Pharmaceutical Co., Ltd., batch number: National Medicine Standard H20020299), twice a day; Laiting (progesterone soft capsule 0.1 g, Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory, National Medicine Standard H20040982), twice a day.

[0119] (3) Experimental group: In addition to routine endometrial preparation and corpus luteum preparation, the subjects began to orally take the granules of Example 1 of the present invention on the 2nd to 3rd day of the menstrual cycle or after drug withdrawal bleeding. The drug composition was as follows: 285 g of Astragalus, 190 g of Poria, 190 g of stir-fried Atractylodes macrocephala, 380 g of stir-fried Coix seeds, 190 g of papaya, 380 g of antler frost, 190 g of salt Eucommia, 190 g of Dipsacus asper, 190 g of Bupleurum, 190 g of dried orange peel, 380 g of Chinese yam, 57 g of Phellodendron, 57 g of Rhizoma Anemarrhenae, 190 g of vinegar-soaked Cyperus, 57 g of Amomum, and 95 g of Patchouli (Preparation of granules: Patchouli and Amomum were crushed into the finest powder, and then the mixture was washed with water and the mixture was stirred for 2 hours.) 120 mesh sieve, irradiation sterilization (8kGy), standby; the remaining 14 herbs such as Astragalus are decocted three times with 8 times the amount of water, each time for 1.5 hours, the decoction is combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.21-1.25 (70°C), vacuum dried (70°C, 0.08-0.1MPa, 8 hours), the dry paste is crushed into fine powder, the above-mentioned patchouli, the finest powder of Amomum villosum and maltodextrin are added to a total of 1 / 3 times the amount of dry paste powder, 80% ethanol is added, and soft material is made, the amount is 35% of the powder plus auxiliary materials, 16 mesh sieve granulation, 80°C drying for 3 hours, 12 mesh sieve granules, sieve, mix, package, and obtain. Make granules). Take the granules twice a day, 15g each time, and take it continuously until 14 days after embryo transplantation.

[0120] (4) Control group: Frozen embryo transfer was performed using only conventional endometrial preparation + luteal support regimen.

[0121] 3.3 Observation indicators and methods

[0122] General information: patient age, years of infertility, type of infertility, infertility factors, number of previous transplants, basal hormone levels, and basal endometrial status.

[0123] 3.3.1 Clinical pregnancy rate

[0124] Clinical pregnancy rate = (number of clinical pregnancy cycles / total number of transplantation cycles) × 100%

[0125] 3.3.2 Endometrial vaginal ultrasound indicators:

[0126] Endometrial thickness on the day of endometrial transformation: ask the subject to lie on her back on the examination bed in the lithotomy position, cover the surface of the vaginal probe with a disposable condom and slowly insert it into the subject's vagina, rotate the vaginal probe until the sagittal plane of the uterus is clearly displayed, and the standard for measuring endometrial thickness is the distance between the interface between the anterior and posterior myometrium and the endometrium about 2 cm below the fundus of the uterus.

[0127] 4 Results

[0128] 4.1 Comparison of clinical pregnancy rate and abortion rate

[0129]

[0130] There was no significant difference in clinical pregnancy rate between the two groups of patients (p<0.05). After treatment with the pharmaceutical composition of the present invention, the pregnancy rate was significantly improved.

[0131] 4.2 Comparison of endometrial thickness (mm)

[0132] Figure 1 After treatment, the thickness of the endometrium in the test group was significantly higher than that in the control group, and there was a significant statistical difference (p<0.05). This indicates that Chinese medicine treatment may have a positive effect on the growth or recovery of the endometrium, which in turn illustrates that the therapeutic effect of the test composition of the present invention is significant.

[0133] 2. Observation on the clinical efficacy of infertility

[0134] 1) Gao##: Married for 1 year, regular sex life, no contraception, no pregnancy. Regular menstruation, 5-6 / 28-30 days, LMP: December 20, 2023, medium volume, red color, blood clots (-), dysmenorrhea (-). Transparent stringy leucorrhea can be seen between two menstrual periods. Now I want to complete the examination and consult about pregnancy preparation. The details are as follows:

[0135] Auxiliary examination: Three thyroid function tests (pregnancy) South Hospital (February 15, 2024, Reproductive): TSH: 0.7043uIU / mL, FT4: 1.07ng / dL, TPO-Ab: 0.68IU / mL.

[0136] Initial diagnosis: primary infertility

[0137] TCM disease name: infertility

[0138] TCM Syndrome Type: Spleen and Kidney Yang Deficiency Syndrome

[0139] The granules prepared in Example 1 were taken with boiled water in the morning and evening, twice a day, for 1 week.

[0140] The second visit on January 20, 2024 and the third visit on February 15, 2024 showed that the patient was pregnant, and Chinese medicine was continued to be used to preserve the pregnancy.

[0141] Follow-up: Follow-up at 20 weeks of pregnancy was normal.

[0142] There were 13 patients with similar conditions to Gao## who were diagnosed with primary infertility, 9 of whom successfully gave birth to babies and 3 are already pregnant.

[0143] 2) Wang #: Married for 7 years, used contraceptive tools for 1 year, gave birth to a baby boy by cesarean section in a central hospital in 2018, did not use contraception and did not get pregnant for 3 years, and had a regular sex life. In November 2022, the patient underwent a short plan due to unexplained infertility and underwent IVF in a central hospital. 16 eggs were retrieved, 4 embryos were formed, and 1 was transplanted, but no pregnancy. One embryo was transplanted in January 2023, and the fetus stopped growing. The existing frozen embryos are to be transplanted after conditioning. Current symptoms: good appetite and sleep, sticky stools, and normal urination. Usually mild temperament, light diet without partiality, fear of cold limbs, cold hands and feet, fatigue, less breath and lazy to speak, no panic, chest tightness, not easy to get angry, moderate leucorrhea, transparent drawing during ovulation, no odor

[0144] Auxiliary examination: Sex hormone test reported normal, salpingography (2021.10.22, Tianjin First Central Hospital): bilateral fallopian tubes are patency. Hysteroscopy (2021.11, Tianjin First Central Hospital): self-reported chronic endometritis, chromosome test reported normal without single.

[0145] Preliminary diagnosis: secondary infertility

[0146] TCM disease name: infertility

[0147] TCM Syndrome Type: Spleen and Kidney Yang Deficiency Syndrome

[0148] The decoction prepared in Example 4 was for a total of 7 doses, 1 dose per day, decocted in 200 ml of water, taken morning and evening (warm), after two visits (14 pairs), three visits (14 pairs), four visits (10 pairs), five visits (10 pairs), six visits (10 pairs), seven visits (10 pairs), eight visits (10 pairs), nine visits (10 pairs), ten visits (10 pairs), eleven visits (10 pairs) and twelve visits (7 pairs, the patient had amenorrhea for more than 40 days, and HCG was positive in an external hospital. Occasionally there was backache, pale red tongue, thin white fur, and slippery pulse, and 7 pairs of Chinese medicine were given for conditioning).

[0149] Follow-up status: The patient is now 26 weeks pregnant and is normal.

[0150] There were 8 cases of secondary infertility similar to Wang#, with 4-8 consultations. Wang# was the patient with the most consultations, 12 times. Currently, 5 of the 8 cases successfully gave birth to babies, including 2 natural births. The other 3 cases dropped out, all due to their old age (over 43 years old) and giving up treatment.

[0151] 3. Observation on the clinical efficacy of recurrent spontaneous abortion

[0152] 1) Sun## complained: No pregnancy for 5 months without contraception, 3 spontaneous abortions after IVF-ET, 1 failed IVF-ET, current medical history: married for 5 years, no pregnancy for 5 months without contraception, regular sexual life. In 2019, IVF was performed, 13 eggs were retrieved, 7 embryos were formed, 1 fresh embryo was transferred, and the fetus stopped growing. In June 2020, 1 FET was performed, which did not implant. In September, 2 FETs were performed, and 1 biochemical pregnancy occurred. There were no frozen embryos at that time. In November 2020, IVF was performed, 13 eggs were retrieved, 9 embryos were formed, 2 fresh embryos were transferred, and 1 mid-term induced labor was performed. There are currently 6 frozen embryos and 1 blastocyst. In 2017, laparoscopic cystectomy was performed at Zhong Obstetrics and Gynecology. The menstruation was regular, accompanied by general fatigue during menstruation. Transparent stringy leucorrhea was seen during two menstruations, which was not seen after the fetal growth stopped growing in 2020. There was occasional slight itching in the vulva.

[0153] Current symptoms: Appetite is good, difficulty falling asleep, frequent dreams, regular urination, slightly loose stools, one bowel movement per day, usually irritable and easily angered, occasional tingling pain 3 fingers below the navel.

[0154] Past medical history: laparoscopic cystectomy at Zhong Obstetrics and Gynecology in 2017, IVF in 2019 and 2020, no history of other traumatic surgeries, no history of hepatitis, tuberculosis, heart disease, diabetes, hypertension, etc. No history of drug or food allergies.

[0155] Marital and reproductive history: first marriage 5 years ago, G2P0, IVF in 2019, 13 eggs retrieved, 7 embryos formed, 1 fresh embryo transferred, fetal arrest, 1 FET in June 2020, no implantation, 2 FET in September, 1 biochemical pregnancy, no frozen embryos at the time, IVF in November 2020, 13 eggs retrieved, 9 embryos formed, 2 fresh embryos transferred, fetal arrest, currently have 6 frozen embryos and 1 blastocyst.

[0156] The sex hormone test reported that it was normal, the salpingography reported that both sides were patency, and the fimbria were partially adhered, chromosome examination (2019, Chinese Obstetrics and Gynecology): Female: 46, XX, Male; 46, XY, Gynecological examination: vulva married type, vaginal smoothness, cervix bright, no erosion of cervical opening, uterus anterior, medium texture, no tenderness, bilateral adnexa negative, secretions of medium quantity, white color, and thin texture.

[0157] Ultrasound examination: retroverted uterus, size: 52×46×44mm, endometrium: 10.4mm / AB type, left ovary: size: 28×19mm, AFC: 6-7, right ovary: size: 28×19mm, AFC: 5-6.

[0158] Western medicine diagnosis: recurrent miscarriage

[0159] TCM disease name: miscarriage

[0160] TCM Syndrome Type: Spleen and Kidney Yang Deficiency

[0161] Treatment advice: 1. Adjust lifestyle + exercise, the Chinese medicine is the decoction of Example 4 7 packs

[0162] Follow-up on April 26, 2021: 7 doses of the decoction of Example 4; Follow-up on May 24, 2021: 7 doses of the decoction of Example 4; Follow-up on June 1, 2021: 7 doses of the decoction of Example 4; Follow-up on June 8, 2021: 7 doses of the decoction of Example 4; Follow-up on January 5, 2022: 7 doses of the decoction of Example 4;

[0163] Follow-up on May 16, 2022: 7 doses of the decoction of Example 4; Follow-up on July 9, 2022: Ultrasound showed: intrauterine pregnancy of 12 weeks, NT value: 1.8cm.

[0164] Follow-up: In 2023, a full-term baby boy was born, now 15 months old and in good health.

[0165] 2) Yao#: Chief complaint: No pregnancy for 1 year without contraception, 2 spontaneous abortions

[0166] Current medical history: married for 2 years, amenorrhea for 40+ days in September 2020, spontaneous abortion: 1 biochemical pregnancy in September 2020. No other treatment was performed. After spontaneous abortion, she used contraceptive tools for 3 months, and did not get pregnant again for 1 year without contraception. She is now visiting our department for conditioning and preparation for pregnancy.

[0167] Current symptoms: Current symptoms: Good appetite and sleep, regular urination, easy diarrhea, back pain and fatigue, cold hands and feet, irritable temperament, no special preference for food, usually falls asleep late at night, often after midnight.

[0168] Personal history: Born in Tianjin, lived in Tianjin for a long time, denied smoking and drinking habits, denied contact with infected water, infected areas, toxic and radioactive substances, denied sexually transmitted diseases and travel history

[0169] Past medical history denied any history of trauma or surgery, hepatitis, tuberculosis, heart disease, diabetes, hypertension, etc. No history of drug or food allergy.

[0170] Marital and reproductive history: first marriage for 2 years, G2P0, artificial abortion due to unexpected pregnancy in 2019; amenorrhea for 40+ days in September 2020, spontaneous abortion: 1 biochemical pregnancy in September 2020

[0171] Chromosome examination (April 29, 2021, Central Obstetrics and Gynecology): Female: 46, XX, Male: 46, XY

[0172] Thyroid function (2021-4-18, Central Obstetrics and Gynecology): TSH: 1.320uIU / ml; FT3 3.07pg / ml, FT4: 1.37ng / dl. T3: 0.97ng / ml, T4: 8.00ug / dl

[0173] Five items of eugenics (2021-4-18, Central Obstetrics and Gynecology): Herpes simplex virus IgIlII2.5; other results were negative

[0174] Antiphospholipid antibodies (2021-4-26, Central Obstetrics and Gynecology): Negative

[0175] Homocysteine ​​(2021-4-26, Central Obstetrics and Gynecology): 6.7umol / L

[0176] Anti-B2 glycoprotein antibody 1 (2021-4-26, Central Obstetrics and Gynecology): 2.1U / ml

[0177] Initial diagnosis: recurrent spontaneous abortion

[0178] TCM disease name: infertility / miscarriage

[0179] TCM Syndrome Type: Spleen and Kidney Yang Deficiency Syndrome

[0180] Treatment opinion: 7 doses of the decoction of Example 4, December 25, 2021 Second visit: January 22, 2022 Third visit: February 7, 2022 Fourth visit: February 25, 2022 Fifth visit: April 1, 2022 Sixth visit: 29 days of amenorrhea, HCG was tested positive in this hospital, with vaginal bleeding, anxiety, good appetite, poor sleep, regular bowel movements, pale red tongue, white tongue coating, and thin and stringy pulse. A total of 5 doses of the original prescription of traditional Chinese medicine were given.

[0181] Follow-up: A healthy baby girl was born at full term, now 17 months old.

[0182] In summary, there are 17 cases with similar conditions to Sun## and Yao#, with 3-7 consultations. Currently, 11 cases have successfully delivered babies, including 6 full-term deliveries. Another 4 cases have successfully conceived.

[0183] 4. The pharmacodynamics and clinical experimental design of the granules of the present invention are as follows:

[0184] 1. Pharmacological study of Zhongyu granules

[0185] 1.1 Construction of PCOS-IR rat model

[0186] Several female SD rats were adaptively fed for 1 week and then examined for estrous cycle. The SD female rats with normal estrous cycle were randomly divided into a blank control group (n=8) and a model group (n=56). The PCOS rat model with IR was established according to relevant literature: daily intragastric administration of letrozole solution [letrozole 1 mg / (kg·d) dissolved in 0.5% (mass fraction) sodium carboxymethyl cellulose] combined with high-fat diet [casein 800 kcaL, L-cystine 12 kcaL, corn starch 291 kcaL, maltodextrin 400 kcaL, sucrose 691 kcaL, soybean oil 225 kcaL, lard 1598 kcaL, multivitamins 40 kcaL] for 4 consecutive weeks.

[0187] Rats in the blank control group were fed with regular feed and gavaged with an equal volume of pure water every day during this period. After 4 weeks, blood was collected from the orbital vein of rats after fasting for 12 hours to measure blood hormones, insulin and blood sugar levels. Vaginal smears were performed on all modeling rats for 7 consecutive days: first use a marker to mark the mouse, then grab the rat and fix it in the palm of your hand, gently insert a fine cotton swab moistened with saline into the rat's vagina about 0.5 cm, and slowly rotate it to remove it. The vaginal contents on the cotton swab were evenly spread on the slide, and the slide was numbered and dried naturally. As a result, vaginal epithelial cells with continuous keratinization were seen on the vaginal smears of all rats, indicating that the rats completely lost the estrous cycle changes. When the estrous cycle and sex hormone levels of rats are disturbed at the same time, it indicates that the PCOS-IR rat model has been successfully established.

[0188] 1.2 Medication administration and specimen collection

[0189] The 64 rats with successful modeling were randomly divided into model group, embodiment 1 group, comparative example 1 group, comparative example 2 group, comparative example 3 group, comparative example 4 group and comparative example 5 group by random number table method, 8 rats in each group. On the second day after successful modeling, rats in each drug group began to be gavaged (the drug was prepared into the corresponding solution with normal saline), once a day, and continued to be administered for 28 days; the blank control group and model group rats were gavaged with equal volume of normal saline in the same way. After the end of the administration, the rats in each group fasted for 12h (drinking water was normal) and then anesthetized by intraperitoneal injection of 0.3% sodium pentobarbital at 50mg / kg. After anesthesia, they were fixed on the operating board, and blood was taken from the aorta to separate serum for standby use. The ovarian tissue and ileal tissue of the female rats were removed, and after weighing, they were fixed with 4% paraformaldehyde or frozen in liquid nitrogen and stored at -80℃.

[0190] 1.3 Observation and detection of relevant indicators

[0191] a. Observation of ovarian tissue morphology: HE staining was used to observe the ovulation of female mice under a light microscope (ovulation was determined by the formation of corpus luteum), and the average number of ovulations of female mice was recorded = total number of corpora lutea / number of female mice; average rate of cystic dilated follicles = average number of cystic dilated follicles / total number of follicles × 100%.

[0192] b. Serum index detection: Enzyme-linked immunosorbent assay (ELISA) was used to detect the reproductive endocrine indexes FSH, LH, T, fasting blood glucose (FPG) and fasting insulin (FINS) of rats in each group.

[0193] 1.4 Data Analysis

[0194] SPSS 19.0 statistical software was used for data processing, and the measurement data were expressed as mean ± standard deviation (X ± S). The difference was statistically significant when p < 0.05.

[0195] 1.5 Results Analysis

[0196] Among them: #The blank control group has a significant difference compared with the model group (P<0.01); @The embodiment 1 group has a significant difference compared with the comparative example 1-5 groups (P<0.05 or P<0.01).

[0197] Figure 2 : It represents the average ovulation number of female mice in the relevant examples. Compared with the comparative examples 1-5, Example 1 has a significant difference (P<0.05). The ovulation number of Example 1 is better than that of other comparative examples. It can be seen that the granules of Example 1 have the best therapeutic effect.

[0198] Figure 3 :Comparison of the average number of cystic dilated follicles in each group. It can be seen that the model group has significant differences compared with each group (P<0.01), the increase in the number of cystic dilated follicles affects normal ovulation and reduces the probability of pregnancy. The number of cystic dilated follicles in Example 1 is significantly lower than that in Comparative Examples 1-5.

[0199] Figure 4 : Comparison results of serum hormone level testosterone (T) in each group. It can be seen that Example 1 has significant difference compared with Comparative Examples 1-5 (P<0.01).

[0200] Figure 5 : Comparison results of serum hormone level luteinizing hormone (LH) in each group. It can be seen that Example 1 has significant difference compared with Comparative Examples 1-5 (P<0.01).

[0201] Figure 6 : Comparison results of fasting blood glucose (FPG) of each group. There was no significant difference between the comparative example 1-5 groups and the example 1 group (P>0.05).

[0202] Figure 7 : Comparison results of fasting insulin (FINS) in each group. It can be seen that Examples 1-3 have significant differences compared with Comparative Examples 1-5 (P<0.01).

Claims

1. A Chinese medicine composition for treating gynecological diseases, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 213-370 parts of astragalus, 142-247 parts of tuckahoe, 142-247 parts of stir-fried atractylodes, 285-494 parts of stir-fried coix seeds, 142-247 parts of papaya, 285-494 parts of antler frost, 142-247 parts of salt eucommia, 142-247 parts of dipsacus root, 142-247 parts of bupleurum, 142-247 parts of tangerine peel, 285-494 parts of yam, 42-74 parts of phellodendron, 42-74 parts of anemarrhena, 142-247 parts of vinegar-cooked cyperus, 42-74 parts of amomum, and 71-123 parts of patchouli.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 285 parts of astragalus, 190 parts of poria, 190 parts of stir-fried atractylodes, 380 parts of stir-fried coix seeds, 190 parts of papaya, 380 parts of antler frost, 190 parts of salt eucommia, 190 parts of dipsacus, 190 parts of bupleurum, 190 parts of tangerine peel, 380 parts of yam, 57 parts of phellodendron, 57 parts of anemarrhena, 190 parts of vinegar-cooked cyperus, 57 parts of amomum, and 95 parts of patchouli.

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is prepared from the following raw materials in parts by weight: 213 parts of astragalus, 142 parts of poria, 142 parts of stir-fried atractylodes, 285 parts of stir-fried coix seeds, 142 parts of papaya, 285 parts of antler frost, 142 parts of salt eucommia, 142 parts of dipsacus root, 142 parts of bupleurum, 142 parts of tangerine peel, 285 parts of yam, 42 parts of phellodendron, 42 parts of anemarrhena, 142 parts of vinegar-cooked cyperus, 42 parts of amomum, and 71 parts of patchouli.

4. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 370 parts of astragalus, 247 parts of poria, 247 parts of stir-fried atractylodes, 494 parts of stir-fried coix seeds, 247 parts of papaya, 494 parts of antler frost, 247 parts of salt eucommia, 247 parts of dipsacus, 247 parts of bupleurum, 247 parts of tangerine peel, 494 parts of yam, 74 parts of phellodendron, 74 parts of anemarrhena, 247 parts of vinegar-cooked cyperus, 74 parts of amomum, and 123 parts of patchouli.

5. The Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The traditional Chinese medicine composition is prepared into a clinically acceptable dosage form with pharmaceutically acceptable excipients.

6. The Chinese medicine composition according to claim 5, characterized in that: The dosage form is any one of granules, mixtures, decoctions, oral liquids, tablets, pills, capsules or pastes.

7. The Chinese medicine composition according to claim 6, characterized in that: The dosage form of the traditional Chinese medicine composition is granules, and the granules are Zhongyu granules.

8. The Chinese medicine composition according to claim 1, characterized in that: The gynecological diseases include one or more of infertility, polycystic ovary syndrome, recurrent miscarriage, repeated implantation failure, and endometriosis.

9. The Chinese medicine composition according to claim 1, characterized in that: The gynecological disease described is the cause of repeated implant failure.

10. The Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The gynecological diseases are gynecological diseases caused by spleen and kidney yang deficiency, dampness, turbidity and blood stasis.

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