Use of tongren wuji baifeng pills and pharmaceutical composition in preparation of drug for treating premature ovarian failure, pharmaceutical preparation comprising tongren wuji baifeng pills, method for preparing same, and method for preparing drug for treating premature ovarian failure

Abstract

The present application belongs to the technical field of pharmaceutical preparations, and specifically relates to the new use of Tongren Wuji Baifeng Pills and a pharmaceutical composition in the preparation of a drug for treating premature ovarian failure, a pharmaceutical preparation comprising Tongren Wuji Baifeng Pills, a method for preparing same, and a method for preparing a drug for treating premature ovarian failure. In the present application, a rat model of chemotherapy-induced premature ovarian failure via intraperitoneal injection of cisplatin and a mouse model of immune-mediated premature ovarian failure via multi-point subcutaneous injection of mouse zona pellucida peptide 3 (pZP3) are established. By means of observing the effects of Tongren Wuji Baifeng Pills on the estrous cycles, organ coefficients, serum sex hormone levels, and ovarian histopathological changes in animals in both models, the therapeutic effect of Tongren Wuji Baifeng Pills on premature ovarian failure is verified and clarified. This expands the new clinical use of the drug and provides a new therapeutic drug and means for treating premature ovarian failure, thereby offering technical support for clinical precision medication.

Description

Use of tongren wuji baifeng pill and pharmaceutical composition for preparing a medicine for treating premature ovarian failure, medicine preparation comprising tongren wuji baifeng pill, method for preparing the same, and method for treating premature ovarian failure

[0001] Cross-reference to related applications

[0002] The present application claims priority to the Chinese patent application No. 202411159891.5, filed on August 22, 2024, entitled "Use of Tongren Wuji Baifeng Pill for Preparing a Medicine for Treating Premature Ovarian Failure", the entire contents of which are incorporated herein by reference. TECHNICAL FIELD

[0003] The present application belongs to the technical field of pharmaceutical preparations, and specifically relates to a new use of tongren wuji baifeng pill for preparing a medicine for treating premature ovarian failure. BACKGROUND

[0004] Premature ovarian failure (POF) refers to the phenomenon that the ovarian function is exhausted, leading to amenorrhea before the age of 40, which is characterized by primary or secondary amenorrhea accompanied by elevated blood gonadotropin levels and decreased estrogen levels. POF not only reduces the fertility of women, but also causes osteoporosis, cardiovascular disease, decreased immunity and other diseases, seriously affecting the physical and mental health of women. Epidemiological surveys show that the prevalence of POF in the general population is 1%-3%, in patients with primary amenorrhea is 10%-28%, in patients with secondary amenorrhea is 4%-18%, the incidence before the age of 40 is 1%, and the incidence before the age of 30 is 0.1%, and in recent years, the incidence of POF has shown an increasing trend year by year and a younger trend.

[0005] Premature ovarian failure is an important cause of female infertility, but its etiology and pathogenesis are not very clear. Most premature ovarian failure patients have unknown causes, and once the ovarian function is exhausted, it is mostly irreversible, and there is a lack of effective prevention and treatment methods in clinical practice. Recent research results show that the causes of POF include genetic factors, immune factors, iatrogenic factors (ovarian surgery, chemotherapy damage), metabolic abnormalities and environmental factors, etc.

[0006] Currently, there is no clear treatment plan for premature ovarian failure in Western medicine clinical practice, and the main treatment is hormone replacement therapy (HRT). Hormone replacement therapy periodically supplements estrogen and progesterone, which is negatively feedback regulated by the hypothalamic-pituitary-ovarian gonadal axis, reduces FSH levels, and restores the sensitivity of follicles to gonadotropins. However, long-term use of hormone therapy can increase the incidence of endometrial cancer, breast cancer, cardiovascular and cerebrovascular diseases, and pulmonary embolism. Moreover, HRT can only simply supplement estrogen and progesterone, and cannot truly restore the endocrine function of the ovary, and is prone to relapse after drug withdrawal.

[0007] TCM emphasizes the "holistic concept" and "treatment based on syndrome differentiation", and has unique therapeutic advantages and broad application prospects by using traditional Chinese medicine flexibly from multiple angles, links and targets. There is no clear name for premature ovarian failure in TCM, but it can be classified into the categories of "blood deficiency", "amenorrhea", "early discontinuation of menstrual water" and "blood barrier" according to its clinical manifestations. POF is equivalent to the premature failure of the uterus, and kidney deficiency is often considered as the primary cause. It is said in the "Discussion of the Origin of Life" that "when a girl is seven years old, the kidney qi is full, the teeth are replaced and the hair is grown, the heavenly chi arrives at 27, the conception vessel is connected, the chong and ren vessels are full, and the monthly period comes down at the right time …… At 49, the conception vessel is empty, the chong and ren vessels are weak, the heavenly chi is exhausted, and the earth channel is not connected, so the body is damaged and there is no child." Due to the weakness of kidney qi, the kidney essence is insufficient, the heavenly chi is gradually exhausted, the chong and ren vessels are damaged, and the kidney qi-heavenly chi-chong and ren vessels-uterus lose the normal regulation and feedback function, so that the production of menstrual blood is blocked, and the uterus is malnourished, resulting in infertility. Among the five zang organs, liver blood and kidney essence are homologous and complementary, and the functions of dispersion and storage are mutually restricted. If the liver blood is sufficient and the dispersion function of the liver is normal, the chong and ren vessels are unobstructed, and the ovum can be discharged. It is recorded in "Fu Nv Ke" that "the spleen is the postnatal, and the kidney is the prenatal. The spleen cannot transform the postnatal qi without the prenatal qi, and the kidney cannot generate the prenatal without the postnatal qi." The kidney stores essence, governs bone and marrow, and the spleen governs transportation and transformation, which is the source of qi and blood. Although the heavenly chi is derived from the prenatal, it must be nourished by the postnatal fine essence of food and drink. If the spleen function is normal, the qi and blood are abundant, and the chong and ren vessels are nourished. In addition, blood stasis will obstruct the chong and ren vessels, and the uterus, vessels and collaterals will lose nourishment, and the blood sea will not be full and overflow, resulting in amenorrhea. Therefore, the treatment of premature ovarian failure with traditional Chinese medicine should be mainly supplemented with kidney essence, supplemented with blood tonification and blood activation, liver soothing, spleen strengthening and heart calming, which reflects the advantages of TCM in the diagnosis and treatment of premature ovarian failure. SUMMARY

[0008] To this end, the technical problem to be solved by the present application is to provide a new use of Tongren Wujibi Baifeng Pills for preparing a medicine for treating premature ovarian failure.

[0009] The second technical problem to be solved by the present application is to provide a medicine composition for treating premature ovarian failure.

[0010] To solve the above technical problems, the present application discloses a use of Tongren Wujibi Baifeng Pills for preparing a medicine for treating premature ovarian failure.

[0011] Specifically, the raw material of Tongren Wuchili Baifeng Pill is composed of: Radix et Rhizoma Ligustici Wallichii 130-160 parts by weight, Radix et Rhizoma Rehmanniae 240-260 parts by weight, Radix Paeoniae Alba 110-140 parts by weight, Radix Salviae Miltiorrhizae 110-140 parts by weight, Rhizoma Cyperi 110-140 parts by weight, Radix Angelicae Sinensis 130-160 parts by weight, Concha Ostreae 30-55 parts by weight, Cornu Cervi Pantotrichum 130-180 parts by weight, Carapax Trunculae Aeolis 30-55 parts by weight, Radix Glycyrrhizae 20-40 parts by weight, Herba Artemisiae Annuae 20-30 parts by weight, Radix Asparagi 50-75 parts by weight, Radix Rehmanniae Preparata 240-260 parts by weight, Radix Rehmanniae 240-260 parts by weight, Rhizoma Chuanxiong 50-75 parts by weight, Radix Astragali 20-40 parts by weight, Radix Bupleuri 20-35 parts by weight, Semen Bambusae 50-75 parts by weight, Rhizoma Dioscoreae 110-140 parts by weight.

[0012] Specifically, the raw material of Tongren Wuchili Baifeng Pill is composed of: Radix et Rhizoma Ligustici Wallichii 130-160 parts by weight, Radix et Rhizoma Rehmanniae 240-260 parts by weight, Radix Paeoniae Alba 110-140 parts by weight, Radix Salviae Miltiorrhizae 110-140 parts by weight, Rhizoma Cyperi 110-140 parts by weight, Radix Angelicae Sinensis 130-160 parts by weight, Concha Ostreae 30-55 parts by weight, Cornu Cervi Pantotrichum 130-180 parts by weight, Carapax Trunculae Aeolis 30-55 parts by weight, Radix Glycyrrhizae 20-40 parts by weight, Herba Artemisiae Annuae 20-30 parts by weight, Radix Asparagi 50-75 parts by weight, Radix Rehmanniae Preparata 240-260 parts by weight, Radix Rehmanniae 240-260 parts by weight, Rhizoma Chuanxiong 50-75 parts by weight, Radix Astragali 20-40 parts by weight, Radix Bupleuri 20-35 parts by weight, Semen Bambusae 50-75 parts by weight, Rhizoma Dioscoreae 110-140 parts by weight.

[0013] Specifically, the Tongren Wuchili Baifeng Pill is administered orally.

[0014] Specifically, the administration dose of the Tongren Wuchili Baifeng Pill is 0.9-3.6 g·kg -1 .

[0015] Specifically, the administration dose of the Tongren Wuchili Baifeng Pill is 0.9 g·kg -1 , 1.0 g·kg -1 , 1.1 g·kg -1 , 1.2 g·kg -1 , 1.3 g·kg -1 , 1.4 g·kg -1 , 1.5 g·kg -1 , 1.6 g·kg -1 , 1.7 g·kg -1 , 1.8 g·kg -1 , 1.9 g·kg -1 , 2.0 g·kg -1 , 2.1 g·kg -1 , 2.2 g·kg -1 , 2.3 g·kg-1 , 2.4 g·kg -1 , 2.5 g·kg -1 , 2.6 g·kg -1 , 2.7 g·kg -1 , 2.8 g·kg -1 , 2.9 g·kg -1 , 3.0 g·kg -1 , 3.1 g·kg -1 , 3.2 g·kg - 1 , 3.3 g·kg -1 , 3.4 g·kg -1 , 3.5 g·kg -1 , 3.6 g·kg -1 .

[0016] The application also discloses a use of a medicine composition for preparing a medicine for treating premature ovarian failure, and raw material composition of the medicine composition comprises: 610-660 parts by weight of black-bone chicken, 110-140 parts by weight of red ginseng, 110-140 parts by weight of white peony root, 110-140 parts by weight of salvia miltiorrhiza, 110-140 parts by weight of cyperus rotundus, 130-160 parts by weight of angelica sinensis, 30-55 parts by weight of calcined concha mallei, 130-180 parts by weight of antler, 30-55 parts by weight of soft-shelled turtle egg, 20-40 parts by weight of licorice, 20-30 parts by weight of artemisia annua, 50-75 parts by weight of asparagus cochinchinensis, 240-260 parts by weight of prepared rehmannia, 240-260 parts by weight of rehmannia glutinosa, 50-75 parts by weight of chuanxiong, 20-40 parts by weight of astragalus, 20-35 parts by weight of radix scophulariae, 50-75 parts by weight of gorgon, and 110-140 parts by weight of yam.

[0017] Optionally, the raw material composition of the medicine composition comprises: 620-650 parts by weight of black-bone chicken, 120-130 parts by weight of red ginseng, 120-130 parts by weight of white peony root, 120-130 parts by weight of salvia miltiorrhiza, 120-130 parts by weight of cyperus rotundus, 140-150 parts by weight of angelica sinensis, 35-45 parts by weight of calcined concha mallei, 140-170 parts by weight of antler, 35-50 parts by weight of soft-shelled turtle egg, 25-34 parts by weight of licorice, 22-28 parts by weight of artemisia annua, 55-70 parts by weight of asparagus cochinchinensis, 245-255 parts by weight of prepared rehmannia, 245-255 parts by weight of rehmannia glutinosa, 55-70 parts by weight of chuanxiong, 25-35 parts by weight of astragalus, 25-30 parts by weight of radix scophulariae, 55-70 parts by weight of gorgon, and 120-130 parts by weight of yam.

[0018] Specifically, the medicine composition is administered orally.

[0019] Specifically, the medicine composition is administered at a dose of 0.9-3.6 g·kg -1 .

[0020] In particular, the pharmaceutical composition is administered at a dose of 0.9 g·kg -1 , 1.0 g·kg -1 , 1.1 g·kg -1 , 1.2 g·kg -1 , 1.3 g·kg -1 , 1.4 g·kg -1 , 1.5 g·kg -1 , 1.6 g·kg -1 , 1.7 g·kg -1 , 1.8 g·kg -1 , 1.9 g·kg -1 , 2.0 g·kg -1 , 2.1 g·kg -1 , 2.2 g·kg -1 , 2.3 g·kg - 1 , 2.4 g·kg -1 , 2.5 g·kg -1 , 2.6 g·kg -1 , 2.7 g·kg -1 , 2.8 g·kg -1 , 2.9 g·kg -1 , 3.0 g·kg -1 , 3.1 g·kg -1 , 3.2 g·kg -1 , 3.3 g·kg -1 , 3.4 g·kg -1 , 3.5 g·kg -1 , 3.6 g·kg -1 .

[0021] The application also discloses a medicine preparation for treating premature ovarian failure, which comprises the Tongren Wuyi Baifeng Pill.

[0022] The application also discloses a medicine preparation for treating premature ovarian failure, which comprises the Tongren Wuyi Baifeng Pill.

[0022] The application also discloses a medicine preparation for treating premature ovarian failure, which comprises the Tongren Wuyi Baifeng Pill.

[0023] Optionally, the raw material composition of the pharmaceutical preparation comprises: 620-650 parts by weight of black-bone chicken, 120-130 parts by weight of red ginseng, 120-130 parts by weight of white peony root, 120-130 parts by weight of salvia miltiorrhiza, 120-130 parts by weight of cyperus rotundus, 140-150 parts by weight of angelica sinensis, 35-45 parts by weight of calcined concha mallei, 140-170 parts by weight of deer antler, 35-50 parts by weight of soft-shelled turtle egg, 25-34 parts by weight of licorice, 22-28 parts by weight of artemisia annua, 55-70 parts by weight of asparagus cochinchinensis, 245-255 parts by weight of prepared rehmannia, 245-255 parts by weight of rehmannia glutinosa, 55-70 parts by weight of chuanxiong rhizome, 25-35 parts by weight of astragalus, 25-30 parts by weight of radix scophulariae, 55-70 parts by weight of gordon euryale, and 120-130 parts by weight of dioscorea opposita.

[0024] Specifically, the pharmaceutical preparation for treating premature ovarian failure, the dosage form of the pharmaceutical preparation comprises a pharmaceutically acceptable preparation.

[0025] Optionally, the dosage form comprises at least one of tablets, pills, capsules, powders, drops, lyophilized products, granules, suspensions, syrups, or oral solutions.

[0026] Specifically, the pharmaceutical preparation for treating premature ovarian failure, the pharmaceutical preparation further comprises a pharmaceutically acceptable excipient.

[0027] Optionally, the excipient comprises one or a combination of several of solvents, fillers, solubilizers, co-solvents, emulsifiers, colorants, binders, disintegrants, stabilizers, flavorings, preservatives, suspending agents, sweeteners, lubricants, coating materials, fragrances, or thickening agents.

[0028] Specifically, the pharmaceutical preparation is administered orally.

[0029] Specifically, the pharmaceutical preparation is administered at a dose of 0.9-3.6 g·kg -1 .

[0030] Specifically, the pharmaceutical preparation is administered at a dose of 0.9 g·kg -1 , 1.0 g·kg -1 , 1.1 g·kg -1 , 1.2 g·kg -1 , 1.3 g·kg -1 , 1.4 g·kg - 1 , 1.5 g·kg -1 , 1.6 g·kg -1 , 1.7 g·kg -1 , 1.8 g·kg -1 , 1.9 g·kg -1 , 2.0 g·kg-1 2.1 g·kg -1 2.2 g·kg -1 2.3 g·kg -1 2.4 g·kg -1 2.5 g·kg -1 2.6 g·kg -1 2.7 g·kg -1 2.8 g·kg -1 2.9 g·kg -1 3.0 g·kg -1 3.1 g·kg -1 3.2 g·kg -1 3.3 g·kg -1 3.4 g·kg -1 3.5 g·kg -1 3.6 g·kg -1 .

[0031] The application also discloses a method for preparing the medicine preparation for treating premature ovarian failure, which comprises the steps of selecting a quantitative raw material component or extracting an active component of the raw material component.

[0032] The application also discloses a method for treating premature ovarian failure, which is characterized by comprising the steps of administering the Tongren Wuyifeng Pill, the medicine composition, the medicine preparation or the medicine preparation prepared by the method to a subject in need.

[0033] Specifically, the Tongren Wuyifeng Pill, the raw medicine component of the medicine composition or the raw medicine component of the medicine preparation comprises: 610-660 parts by weight of black-bone chicken, 110-140 parts by weight of red ginseng, 110-140 parts by weight of white peony root, 110-140 parts by weight of salvia miltiorrhiza, 110-140 parts by weight of cyperus rotundus, 130-160 parts by weight of angelica sinensis, 30-55 parts by weight of calcined oyster shell, 130-180 parts by weight of deer antler, 30-55 parts by weight of soft-shelled turtle egg, 20-40 parts by weight of licorice, 20-30 parts by weight of artemisia vulgaris, 50-75 parts by weight of asparagus, 240-260 parts by weight of prepared rehmannia, 240-260 parts by weight of rehmannia, 50-75 parts by weight of chuanxiong, 20-40 parts by weight of astragalus, 20-35 parts by weight of radix scophulariae, 50-75 parts by weight of gordon euryale, and 110-140 parts by weight of yam.

[0034] Optionally, the raw material composition of Tong Ren Wuji Baifeng Pill, the raw material composition of the pharmaceutical composition or the raw material composition of the pharmaceutical preparation comprises: Radix Asparagi 620-650 parts by weight, Radix Ginseng 120-130 parts by weight, Radix Paeoniae Alba 120-130 parts by weight, Radix Salviae Miltiorrhizae 120-130 parts by weight, Rhizoma Cyperi 120-130 parts by weight, Radix Angelicae Sinensis 140-150 parts by weight, Oyster Shell 35-45 parts by weight, Cornu Cervi 140-170 parts by weight, Soft-shelled Turtle Egg 35-50 parts by weight, Radix Glycyrrhizae 25-34 parts by weight, Artemisia Annua 22-28 parts by weight, Radix Asparagi 55-70 parts by weight, Radix Rehmanniae Preparata 245-255 parts by weight, Radix Rehmanniae 245-255 parts by weight, Rhizoma Chuanxiong 55-70 parts by weight, Radix Astragali 25-35 parts by weight, Radix Scutellariae 25-30 parts by weight, Semen Euryale 55-70 parts by weight, Rhizoma Dioscoreae 120-130 parts by weight.

[0035] Specifically, the Tong Ren Wuji Baifeng Pill, the pharmaceutical composition or the pharmaceutical preparation is administered orally.

[0036] Specifically, the administration dose of the Tong Ren Wuji Baifeng Pill, the pharmaceutical composition or the pharmaceutical preparation is 0.9-3.6 g·kg -1 .

[0037] Specifically, the administration dose of the Tong Ren Wuji Baifeng Pill, the pharmaceutical composition or the pharmaceutical preparation is 0.9 g·kg -1 , 1.0 g·kg -1 , 1.1 g·kg -1 , 1.2 g·kg -1 , 1.3 g·kg -1 , 1.4 g·kg -1 , 1.5 g·kg -1 , 1.6 g·kg -1 , 1.7 g·kg -1 , 1.8 g·kg -1 , 1.9 g·kg -1 , 2.0 g·kg - 1 , 2.1 g·kg -1 , 2.2 g·kg -1 , 2.3 g·kg -1 , 2.4 g·kg -1 , 2.5 g·kg -1 , 2.6 g·kg -1 , 2.7 g·kg -1 , 2.8 g·kg -1 , 2.9 g·kg -1 , 3.0 g·kg -1 , 3.1 g·kg -1 , 3.2 g·kg -1 , 3.3 g·kg-1 3.4 g·kg -1 3.5g·kg -1 3.6 g·kg -1 .

[0038] Tongren Wuji Baifeng Wan (a traditional Chinese medicine formula) has the effects of replenishing qi and blood, regulating menstruation and stopping leukorrhea. It is used for menstrual disorders, menstrual cramps, lower abdominal pain, weakness, fatigue, and soreness in the waist and legs caused by deficiency of both qi and blood. In the formula, black-boned chicken nourishes the liver, kidneys, and spleen; deer antler nourishes the kidneys, invigorates yang, and promotes blood circulation; angelica, chuanxiong, white peony root, and prepared rehmannia root are combined in the Siwu Decoction, supplemented by danshen, to replenish blood, invigorate blood, and regulate menstruation; red ginseng, astragalus, yam, and licorice are all qi-tonifying herbs, replenishing the middle jiao, invigorating qi, strengthening the spleen, and benefiting the lungs; raw rehmannia root, artemisia annua, stellaria dichotoma, and asparagus root work together to clear heat, cool blood, nourish yin, and generate fluids; oyster shell, mantis egg case, and euryale seed are added to have a calming and astringent effect, and to stop leukorrhea; the formula also includes cyperus rhizome, which can soothe the liver, relieve depression, regulate menstruation, and relieve pain, making it an essential medicine for regulating menstruation in gynecology. The entire formula works synergistically to tonify the kidneys, soothe the liver, strengthen the spleen, replenish blood, promote blood circulation, and regulate menstruation, which aligns with traditional Chinese medicine's treatment of premature ovarian failure. Therefore, to further clarify and expand the clinical indications of Tongren Wuji Baifeng Wan and to deeply explore the drug's application potential, a pharmacodynamic study of Tongren Wuji Baifeng Wan in the treatment of premature ovarian failure was conducted.

[0039] This application extends the pharmacodynamic study based on the prescription of Tongren Wuji Baifeng Wan (a traditional Chinese medicine formula). Tongren Wuji Baifeng Wan uses black-boned chicken to nourish yin and blood, tonify the liver and kidneys, and clear deficiency heat; deer antler warms kidney yang and benefits essence and blood, serving as the principal herbs. Red ginseng, astragalus, and yam invigorate qi and strengthen the spleen; angelica, white peony root, prepared rehmannia root, chuanxiong rhizome, and salvia miltiorrhiza nourish and invigorate blood, serving as the assistant herbs. Ophiopogon japonicus, rehmannia root, stellaria root, and artemisia annua nourish yin, clear heat, and relieve irritability; mantis egg case, calcined oyster shell, and euryale seed calm the mind and stabilize the will, and also have astringent effects; cyperus rhizome soothes the liver and regulates qi, preventing excessive tonification from causing qi stagnation and yin stagnation, serving as the adjuvant herbs. Tongren Wuji Baifeng Wan (a traditional Chinese medicine formula) has the effects of replenishing qi and blood, regulating menstruation and stopping leukorrhea. It is used for qi and blood deficiency, emaciation, soreness and weakness of the waist and knees, irregular menstruation, metrorrhagia and leukorrhea. Its main functions and indications are to replenish qi and blood, regulate menstruation and stop leukorrhea. It is often used for irregular menstruation, menstrual cramps, lower abdominal pain, weakness and fatigue, and soreness and weakness of the waist and legs caused by qi and blood deficiency. Based on the formulation analysis and clinical reports of the drug, this application is the first to conduct a pharmacodynamic study on the treatment of premature ovarian failure with Tongren Wuji Baifeng Wan. Through pharmacodynamic experimental methods, the therapeutic effect of Tongren Wuji Baifeng Wan on premature ovarian failure was clarified.

[0040] According to the functions of Tong Ren Wuji Baifeng Pill in tonifying qi and nourishing blood, regulating menstruation and stopping leucorrhea, and according to the functions of drugs and modern pharmacological research, the pharmacodynamic study of Tong Ren Wuji Baifeng Pill in treating premature ovarian failure is carried out. The chemotherapy-induced premature ovarian failure rat model is established by intraperitoneal injection of cisplatin, and the immune premature ovarian failure mouse model is established by subcutaneous injection of mouse zona pellucida polypeptide 3 (pZP3). The effects of Tong Ren Wuji Baifeng Pill on the estrous cycle, organ coefficient, serum sex hormone level and ovarian histopathological changes of the two model animals are observed, the therapeutic effect of Tong Ren Wuji Baifeng Pill on premature ovarian failure is verified and clarified, the new clinical use of the drug is expanded, a new therapeutic drug and means for treating premature ovarian failure are provided, and technical support for precise clinical drug use is provided. BRIEF DESCRIPTION OF DRAWINGS

[0041] In order to make the content of the present application more easily understood, the present application will be further described in detail below according to specific embodiments of the present application and in conjunction with the drawings, wherein,

[0042] Figure 1 is the effect of Tong Ren Wuji Baifeng Pill on the ovarian histopathology of cisplatin-induced chemotherapy-induced premature ovarian failure model rats in Example 1;

[0043] Figure 2 is the effect of Tong Ren Wuji Baifeng Pill on the ovarian histopathology of immune premature ovarian failure model mice in Example 2. DETAILED DESCRIPTION

[0044] Example 1

[0045] In this example, Tong Ren Wuji Baifeng Pill with product batch number 21010516 is selected, which is produced by Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory. It is a secret formula, and the raw material composition includes chicken (dehairing and intestine), red ginseng, white peony root, salvia miltiorrhiza, vinegar fragrant, angelica, calcined oyster shell, deer horn, sand worm, licorice, green wormwood, asparagus, prepared rehmannia, radix rehmanniae, chuanmiao, astragalus, silver radix scutellariae, bran-fried gordonii and yam. The effects of different batches of products are basically consistent.

[0046] The taking mode of Tong Ren Wuji Baifeng Pill in this example is oral, one pill at a time, twice a day.

[0047] Example 2

[0048] The medicine for treating premature ovarian failure in the embodiment is a pill, and the raw medicine comprises: 610 parts by weight of black-bone chicken (with hair and intestine removed), 140 parts by weight of red ginseng, 110 parts by weight of white peony root, 140 parts by weight of salvia miltiorrhiza, 110 parts by weight of vinegar-flavored cyperus rotundus, 160 parts by weight of angelica sinensis, 30-55 parts by weight of calcined concha murex, 180 parts by weight of deer antler, 30-55 parts by weight of soft-shelled turtle egg, 40 parts by weight of licorice, 20 parts by weight of Chinese mugwort, 75 parts by weight of yam of heaven, 240 parts by weight of prepared rehmannia, 260 parts by weight of rehmannia, 50 parts by weight of chuanxiong, 40 parts by weight of astragalus, 20 parts by weight of silver radix scutellariae, 75 parts by weight of fried morinda officinalis, and 110 parts by weight of Chinese yam.

[0049] The preparation method of the pill for treating premature ovarian failure in the embodiment comprises the steps of compounding the selected raw medicine and adding conventional dosage of excipient to process into a pill.

[0050] Embodiment 3

[0051] The medicine for treating premature ovarian failure in the embodiment is a pill, and the raw medicine comprises: 610 parts by weight of black-bone chicken (with hair and intestine removed), 140 parts by weight of red ginseng, 110 parts by weight of white peony root, 140 parts by weight of salvia miltiorrhiza, 110 parts by weight of vinegar-flavored cyperus rotundus, 160 parts by weight of angelica sinensis, 30-55 parts by weight of calcined concha murex, 180 parts by weight of deer antler, 30-55 parts by weight of soft-shelled turtle egg, 40 parts by weight of licorice, 20 parts by weight of Chinese mugwort, 75 parts by weight of yam of heaven, 240 parts by weight of prepared rehmannia, 260 parts by weight of rehmannia, 50 parts by weight of chuanxiong, 40 parts by weight of astragalus, 20 parts by weight of silver radix scutellariae, 75 parts by weight of fried morinda officinalis, and 110 parts by weight of Chinese yam.

[0052] The preparation method of the pill for treating premature ovarian failure in the embodiment comprises the steps of compounding the selected raw medicine and adding conventional dosage of excipient to process into a pill.

[0053] Embodiment 4

[0054] The medicine for treating premature ovarian failure in the embodiment is a pill, and the raw medicine comprises: 610 parts by weight of black-bone chicken (with hair and intestine removed), 140 parts by weight of red ginseng, 110 parts by weight of white peony root, 140 parts by weight of salvia miltiorrhiza, 110 parts by weight of vinegar-flavored cyperus rotundus, 160 parts by weight of angelica sinensis, 30-55 parts by weight of calcined concha murex, 180 parts by weight of deer antler, 30-55 parts by weight of soft-shelled turtle egg, 40 parts by weight of licorice, 20 parts by weight of Chinese mugwort, 75 parts by weight of yam of heaven, 240 parts by weight of prepared rehmannia, 260 parts by weight of rehmannia, 50 parts by weight of chuanxiong, 40 parts by weight of astragalus, 20 parts by weight of silver radix scutellariae, 75 parts by weight of fried morinda officinalis, and 110 parts by weight of Chinese yam.

[0055] Embodiment 5

[0056] The medicine for treating premature ovarian failure in the embodiment is a powder, and the raw material composition of the medicine is as follows: 650 parts by weight of black-bone chicken (with hair and claws removed), 120 parts by weight of red ginseng, 130 parts by weight of white peony root, 120 parts by weight of salvia miltiorrhiza, 130 parts by weight of rhizoma zedoariae, 140 parts by weight of angelica sinensis, 45 parts by weight of calcined concha murex, 140 parts by weight of deer antler, 50 parts by weight of soft-shelled turtle egg, 25 parts by weight of licorice, 28 parts by weight of Chinese mugwort, 55 parts by weight of asparagus cochinchinensis, 255 parts by weight of prepared rehmannia, 245 parts by weight of rehmannia glutinosa, 70 parts by weight of chuanxiong rhizome, 25 parts by weight of astragalus, 30 parts by weight of radix scutellariae, 55 parts by weight of torrefied morinda officinalis, and 130 parts by weight of dioscorea opposita.

[0057] Experimental Example

[0058] In the following experimental example scheme of the present application, the Tongren Wujia Baifeng Pill product in Example 1 is used as the experimental medicine.

[0059] In the following experimental example scheme of the present application, a chemotherapy-induced premature ovarian failure rat model is established by intraperitoneal injection of cisplatin, and an immune-induced premature ovarian failure mouse model is established by subcutaneous injection of mouse zona pellucida polypeptide 3 (pZP3), and the effects of the Tongren Wujia Baifeng Pill on the estrous cycle, organ coefficients, serum sex hormone levels, and ovarian histopathological changes of the two types of model animals are observed, and the therapeutic effects of the medicine on premature ovarian failure are evaluated.

[0060] Experimental Example 1

[0061] The present experimental example verifies the effects of the Tongren Wujia Baifeng Pill on premature ovarian failure based on a cisplatin-induced chemotherapy-induced premature ovarian failure model rat.

[0062] (I) Preparation of a cisplatin-induced chemotherapy-induced premature ovarian failure model and administration method

[0063] SD rats, female, were selected and randomly divided into 6 groups according to body weight after adaptive feeding, 10 rats in each group, namely: a blank group, a model group, a progynova tablet group, a Tongren Wujia Baifeng Pill high-dose group, a Tongren Wujia Baifeng Pill middle-dose group, and a Tongren Wujia Baifeng Pill low-dose group. The rats in each administration group were respectively given corresponding medicines by gavage, and the rats in the blank group and the model group were given the same volume of purified water by gavage. The specific administration doses are shown in Table 1 below.

[0064] Table 1: Administration doses and preparation concentrations of the rats in each group

[0065] After 14 days of prophylactic administration, the premature ovarian failure animal models of the rats in each group except the blank group were established, and cisplatin (dissolved in physiological saline to prepare a 1 mg / mL solution) was intraperitoneally injected at 4 mg / kg on the 14th day and the 21st day. The rats in each administration group were continuously given medicines by gavage until the end of the experiment. At the end of the experiment, the rats were anesthetized by intraperitoneal injection of 10% chloral hydrate at 3 mL / kg, blood was taken from the abdominal aorta, centrifuged at 3500 r / min for 10 min, and the serum was stored in a-80℃ refrigerator. The model was successfully constructed.

[0066] In the following experimental examples, the rat uterus and bilateral ovaries were further dissected, weighed and the organ coefficient was calculated. The ovaries were placed in paraformaldehyde fixative and histopathological examination was performed by HE staining, and the number of follicles at each stage was counted.

[0067] (II) Effect on cisplatin-induced chemotherapy-induced premature ovarian failure model rats

[0068] (1) Effect on the estrous cycle of rats

[0069] In this experimental example, the estrous cycle of rats was detected: after the second injection of cisplatin, vaginal cytology smears were taken every morning at 9 o'clock for 10 consecutive days. The changes in the estrous cycle of rats were observed and recorded under a light microscope. The experimental results are shown in Table 2 below.

[0070] Table 2 Effect of Tong Ren Wuji Baifeng Pills on the estrous cycle of cisplatin-induced chemotherapy-induced premature ovarian failure model rats

[0071] The experimental results showed that the model group of rats showed obvious estrous cycle disorder, manifested as no estrus period or prolonged diestrus period, which was significantly different from the blank group (p<0.01). The number of rats with estrous cycle disorder in the high and low dose groups of Tong Ren Wuji Baifeng Pills was significantly reduced compared with the model group, and the difference was significant (p<0.01). The results suggest that Tong Ren Wuji Baifeng Pills has obvious improvement effect on the estrous cycle disorder caused by cisplatin-induced chemotherapy-induced premature ovarian failure.

[0072] (2) Effect on the organ coefficient of rats

[0073] In this experimental example, the organ coefficient was detected: the rat uterus and bilateral ovaries were taken, the surrounding adipose tissue was removed, and the organ coefficient was calculated by precise weighing with an electronic balance [organ coefficient (%) = organ wet weight (g) / body weight (g) x 100%]. The experimental results are shown in Table 3 below.

[0074] Table 3 Effect of Tong Ren Wuji Baifeng Pills on the organ coefficient of cisplatin-induced chemotherapy-induced premature ovarian failure model rats

[0075] The experimental results showed that the ovarian and uterine coefficients of the model group of rats were significantly reduced, which was significantly different from the blank group (p<0.05), indicating that the model rats had ovarian and uterine damage. The uterine coefficient of the high dose group of Tong Ren Wuji Baifeng Pills was significantly increased compared with the model group, with a significant difference (p<0.05); the ovarian and uterine coefficients of the rats in the other drug groups were not significantly different from those of the model group (p>0.05). The results suggest that Tong Ren Wuji Baifeng Pills has no obvious improvement effect on the reduction of ovarian coefficient in model rats, but has a certain protective effect on the uterus of model rats.

[0076] (3) Effects on serum sex hormone levels in rats

[0077] In this experimental example, serum hormone levels were detected: ELISA method was used, and the operation was strictly in accordance with the kit instructions. The levels of related hormones such as estrogen and gonadotropin in serum were determined, and the experimental results are shown in Table 4.

[0078] Table 4 Effects of Tongrentang White-Cooked Chicken with White Phoenix Pill on serum hormone levels in rats with chemotherapy-induced premature ovarian failure caused by cisplatin

[0079] The experimental results showed that the serum E2 and AMH levels of the model group rats were significantly decreased, and the FSH and LH levels were significantly increased, which had significant differences compared with the blank group (all p<0.01), indicating that the serum hormone levels of rats with chemotherapy-induced premature ovarian failure caused by cisplatin were disordered, and the ovarian reserve function decreased. Compared with the model group, the serum E2 and AMH levels of the estradiol valerate tablet group rats were significantly increased, and the FSH and LH levels were significantly decreased, which had significant differences (all p<0.01). The serum E2 and AMH levels of the high and medium dose groups of Tongrentang White-Cooked Chicken with White Phoenix Pill were significantly increased, and the FSH and LH levels were significantly decreased, which had significant differences compared with the model group (p<0.05, p<0.01, respectively). The serum AMH level of the low dose group of Tongrentang White-Cooked Chicken with White Phoenix Pill was significantly increased, and the FSH level was significantly decreased, which had significant differences compared with the model group (p<0.01). The results suggested that Tongrentang White-Cooked Chicken with White Phoenix Pill had obvious regulating effect on the hormone level disorder caused by chemotherapy-induced premature ovarian failure caused by cisplatin, and could improve the ovarian reserve function.

[0080] (4) Effects on ovarian histopathology in rats

[0081] In this experimental example, ovarian histopathology examination: after the ovary was fixed in paraformaldehyde fixing solution for 48 h, dehydration, transparency, wax immersion, embedding, sectioning, dewaxing, HE staining, and then the morphological changes of ovarian tissue were observed under an optical microscope, and the number of follicles at each stage was counted. The experimental results are shown in Table 5 below.

[0082] In this experimental example, the effects of Tongrentang White-Cooked Chicken with White Phoenix Pill on ovarian histopathology in rats with chemotherapy-induced premature ovarian failure caused by cisplatin are shown in Figure 1.

[0083] Table 5 Number of follicles at each stage in ovarian tissue of animals in each group

[0084] The experimental results show that the pathological changes of the ovarian tissue of the model rats occur, mainly manifested as the decrease of the granulosa cell layer of the ovary, the abnormality of the follicle lumen structure, the significant decrease of the total follicle, primary follicle and secondary follicle in the ovary, and the increase of the atretic follicle. Tongren Wujibaifeng Pill can significantly reduce the pathological damage of the ovarian tissue of the model rats, mainly manifested as the richness of the granulosa cell layer of the ovary and the normality of the follicle lumen structure. The number of the ovarian follicles of each level of the rats in the high-dose group of Tongren Wujibaifeng Pill is significantly increased, and the atretic follicle is reduced, which has a significant difference (p<0.05, p<0.01, respectively) compared with the model group. It is indicated that Tongren Wujibaifeng Pill has a certain improvement effect on the chemotherapy-induced premature ovarian failure caused by cisplatin.

[0085] Experimental Example 2

[0086] The present experimental example verifies the influence of Tongren Wujibaifeng Pill on premature ovarian failure based on the immune premature ovarian failure model mice.

[0087] (I) Preparation of immune premature ovarian failure model and administration method

[0088] BALB / c mice were selected, female, and after adaptive feeding, they were randomly divided into 12 blank groups according to the body weight, and the rest were model groups. 10 mg pZP3 powder was added to 10 mL of normal saline to prepare a solution, which was prepared into an immune reagent with Freund's complete adjuvant at a ratio of 1:1, and an immune enhancer reagent with Freund's incomplete adjuvant at a ratio of 1:1. The model group was injected with 0.15 mL of the immune reagent subcutaneously at the back of the foot and the abdomen of each mouse on day 0, and was given 0.15 mL of the immune enhancer reagent again to strengthen the immunity at the back of the foot and the abdomen subcutaneously on day 14 to establish an immune premature ovarian failure model. All mice were subjected to vaginal exfoliative cell smears for 10 consecutive days, and the change of the estrous cycle of the mice was observed under an optical microscope. The model was successfully prepared when the estrous cycle disorder occurred. On day 21 of the experiment, the successfully modeled mice were randomly divided into a model group, a estradiol valerate tablet group, a high-dose, a medium-dose and a low-dose Tongren Wujibaifeng Pill group according to the body weight, with 12 mice in each group. The mice in each administration group were respectively given corresponding drugs by gavage, and the mice in the blank and model groups were given the same volume of purified water by gavage. The administration was continuously given for 8 weeks, and the specific administration dose was shown in Table 1 in the experimental example 1.

[0089] After the last administration, the mice were anesthetized by intraperitoneal injection of 4% chloral hydrate 10 mL / kg, blood was taken through the portal vein, centrifuged at 3500 r / min for 10 min, and the serum was stored in a-80℃ refrigerator. The model was successfully constructed.

[0090] In the following experimental examples, the uterus, ovary, spleen and thymus of the mice were further dissected, weighed and calculated for the organ coefficient. The ovary was placed in a paraformaldehyde fixing solution, and histopathological examination was performed by HE staining, and the number of follicles of each level was counted.

[0091] (II) Influence on immune premature ovarian failure model mice

[0092] (1) Effect on estrous cycle of mice

[0093] In this experimental example, estrous cycle detection: at the end of the experiment, daily at 9 am, vaginal exfoliative cell smear was performed, for 10 consecutive days, and the changes in estrous cycle of mice were observed and recorded under an optical microscope. The experimental results are shown in Table 6 below.

[0094] Table 6 Effect of Tongren Wujibaifeng Pill on estrous cycle of immune premature ovarian failure model mice

[0095] The experimental results showed that the number of animals with estrous cycle disorder in the model group was higher than that in the blank group, showing no estrous period or prolonged diestrus period, but no significant difference was observed (p>0.05). The number of animals with estrous cycle disorder in the estradiol valerate tablet group had a certain decreasing trend compared with the model group, but no significant difference was observed (p>0.05), and the estrous cycle disorder of mice in the Tongren Wujibaifeng Pill groups was not obviously improved. Due to the influence of the physiological structure of the mouse vagina, the cotton swab head was relatively large during the vaginal smear process, which might stimulate the vaginal mucosa, affect the mood and vaginal exfoliative cells of the mice, and interfere with the judgment of the estrous cycle results, so the results were only for reference.

[0096] (2) Effect on organ coefficients of mice

[0097] In this experimental example, organ coefficient detection: the uterus, ovary, spleen, and thymus of mice were taken, the surrounding adipose tissue was removed, and the organs were precisely weighed using an electronic balance. The organ coefficient [organ coefficient (g / 10g) = organ wet weight (g) / body weight (g) x 10] was calculated, and the experimental results are shown in Table 7 below.

[0098] Table 7 Effect of Tongren Wujibaifeng Pill on organ coefficients of immune premature ovarian failure model mice g / 10g)

[0099] The experimental results showed that the spleen coefficient of mice in the model group was significantly increased, and there was a significant difference compared with the blank group (p<0.01), indicating that the immune function of the immune premature ovarian failure model mice was abnormal. The ovary, uterus, and thymus coefficients of mice in the model group were not significantly different from those in the blank group (all p>0.05). Compared with the model group, the spleen coefficient of the high-dose Tongren Wujibaifeng Pill group was significantly reduced, and there was a significant difference (p<0.01). The organ coefficients of mice in the other drug groups were not significantly different from those in the model group (all p>0.05). The results suggested that Tongren Wujibaifeng Pill might have a certain improvement effect on the immune dysfunction of immune premature ovarian failure model mice.

[0100] (3) Effect on serum sex hormone levels of mice

[0101] In this experimental example, serum hormone levels were detected by ELISA according to the kit instructions. The levels of estrogen, gonadotropin and other related hormones in serum were determined. The results are shown in Table 8.

[0102] Table 8 Effect of Tong Ren Wuji Baifeng Pills on serum hormone levels of immune premature ovarian failure model mice

[0103] The results showed that the serum E2 and AMH levels of the model group mice were significantly decreased, and the LH level was significantly increased, which had significant differences compared with the blank group (p<0.05, p<0.01, respectively), indicating that the serum sex hormone levels of immune premature ovarian failure model mice were disordered, and the ovarian reserve function was decreased. Compared with the model group, the serum E2 and AMH levels of the estradiol valerate tablet group mice were significantly increased, and the LH level was significantly decreased, which had significant differences (p<0.01). The high dose of Tong Ren Wuji Baifeng Pills could significantly reduce the serum LH level of the model mice and increase the AMH level. The medium and low doses of Tong Ren Wuji Baifeng Pills could significantly increase the serum E2 and AMH levels and decrease the LH level of the model mice, which had significant differences compared with the model group (p<0.05, p<0.01, respectively). The results suggested that Tong Ren Wuji Baifeng Pills had obvious regulatory effect on the estrogen and gonadotropin disorder caused by immune premature ovarian failure, and could increase the anti-Mullerian hormone, indicating that Tong Ren Wuji Baifeng Pills could improve the ovarian reserve function of the model mice.

[0104] (4) Effect on ovarian histopathology of mice

[0105] In this experimental example, ovarian histopathology was examined. After the ovary was fixed in paraformaldehyde fixing solution for 48 h, it was dehydrated, transparent, immersed in wax, embedded, sectioned, deparaffinated, HE stained, and then observed under an optical microscope for morphological changes of the ovarian tissue, and the number of follicles at each level was counted. The results are shown in Table 9 below.

[0106] In this experimental example, the effect of Tong Ren Wuji Baifeng Pills on the ovarian histopathology of immune premature ovarian failure model mice is shown in Figure 2.

[0107] Table 9 Number of follicles at each level of ovarian tissue of animals in each group

[0108] The above histopathology results show that subcutaneous multi-point injection of mouse zona pellucida polypeptide 3 can cause pathological changes in the ovarian tissue of the model mice, mainly manifested as a decrease in granulosa cells in the ovary, abnormal morphology of follicle lumen, a significant decrease in the number of total follicles, primary follicles and secondary follicles in the ovary, and an increase in atretic follicles. Tongren Wujibaifeng Pills can significantly reduce the pathological damage to the ovarian tissue of the model mice, mainly manifested as relatively abundant granulosa cells in the ovary and basically normal morphology of follicle lumen. The number of ovarian follicles at all levels in the high-dose group of mice was significantly increased, and the atretic follicles were reduced, which had a significant difference (p<0.01) compared with the model group. It is suggested that Tongren Wujibaifeng Pills have a certain therapeutic effect on immune premature ovarian failure and can improve the ovarian reserve function.

[0109] In summary, the present application carries out pharmacodynamic study of Tongren Wujibaifeng Pills in the treatment of premature ovarian failure, establishes a chemotherapy-induced premature ovarian failure rat model by intraperitoneal injection of cisplatin and an immune premature ovarian failure mouse model by subcutaneous multi-point injection of mouse zona pellucida polypeptide 3 (pZP3), observes the effects of Tongren Wujibaifeng Pills on the estrous cycle, organ coefficient, serum sex hormone level and histopathological changes of the ovarian tissue of the two model animals, and determines the therapeutic effect of Tongren Wujibaifeng Pills on premature ovarian failure, thereby providing a new therapeutic drug and means for treating premature ovarian failure.

[0110] Obviously, the above examples are only examples for clearly illustrating but not limiting the embodiments. Based on the above description, other different forms of changes or variations can be made by those skilled in the art. Here, all the embodiments need not and cannot be exhausted. The obvious changes or variations derived therefrom are still within the protection scope of the present application.

Claims

1. Use of Tong Ren Wuji Baifeng Pills in the preparation of a medicament for treating premature ovarian failure.

2. Use according to claim 1, characterized in that, The raw material composition of the Tong Ren Wuji Baifeng Pills comprises: 610-660 parts by weight of black-bone chicken, 110-140 parts by weight of red ginseng, 110-140 parts by weight of white peony root, 110-140 parts by weight of salvia miltiorrhiza, 110-140 parts by weight of cyperus rotundus, 130-160 parts by weight of angelica sinensis, 30-55 parts by weight of calcined concha margaritiferae, 130-180 parts by weight of deer antler, 30-55 parts by weight of soft-shelled turtle egg, 20-40 parts by weight of licorice, 20-30 parts by weight of Chinese mugwort, 50-75 parts by weight of yam of heaven, 240-260 parts by weight of prepared rehmannia, 240-260 parts by weight of rehmannia, 50-75 parts by weight of chuanxiong, 20-40 parts by weight of astragalus, 20-35 parts by weight of radix scophulariae, 50-75 parts by weight of gordon euryale, and 110-140 parts by weight of Chinese yam.

3. Use according to claim 1 or 2, characterized in that, The raw material composition of the Tong Ren Wuji Baifeng Pills comprises: 610-660 parts by weight of black-bone chicken, 110-140 parts by weight of red ginseng, 110-140 parts by weight of white peony root, 110-140 parts by weight of salvia miltiorrhiza, 110-140 parts by weight of cyperus rotundus, 130-160 parts by weight of angelica sinensis, 30-55 parts by weight of calcined concha margaritiferae, 130-180 parts by weight of deer antler, 30-55 parts by weight of soft-shelled turtle egg, 20-40 parts by weight of licorice, 20-30 parts by weight of Chinese mugwort, 50-75 parts by weight of yam of heaven, 240-260 parts by weight of prepared rehmannia, 240-260 parts by weight of rehmannia, 50-75 parts by weight of chuanxiong, 20-40 parts by weight of astragalus, 20-35 parts by weight of radix scophulariae, 50-75 parts by weight of gordon euryale, and 110-140 parts by weight of Chinese yam.

4. Use according to any one of claims 1 to 3, characterized in that, The Tong Ren Wuji Baifeng Pills are administered orally.

5. Use according to any one of claims 1 to 3, characterized in that, The Tongren Wuji Baifeng Pill administration dose is 0.9-3.6g·kg -1 .

6. Use of a pharmaceutical composition for the manufacture of a medicament for the treatment of premature ovarian failure, characterized in that, The raw material composition of the pharmaceutical composition comprises: 610-660 parts by weight of black-bone chicken, 110-140 parts by weight of red ginseng, 110-140 parts by weight of white peony root, 110-140 parts by weight of salvia miltiorrhiza, 110-140 parts by weight of cyperus rotundus, 130-160 parts by weight of angelica sinensis, 30-55 parts by weight of calcined concha margaritiferae, 130-180 parts by weight of deer antler, 30-55 parts by weight of soft-shelled turtle egg, 20-40 parts by weight of licorice, 20-30 parts by weight of Chinese mugwort, 50-75 parts by weight of yam of heaven, 240-260 parts by weight of prepared rehmannia, 240-260 parts by weight of rehmannia, 50-75 parts by weight of chuanxiong, 20-40 parts by weight of astragalus, 20-35 parts by weight of radix scophulariae, 50-75 parts by weight of gordon euryale, and 110-140 parts by weight of Chinese yam.

7. Use according to claim 6, characterized in that, The raw material composition of the medicine preparation comprises: 610-660 parts by weight of black-bone chicken, 110-140 parts by weight of red ginseng, 110-140 parts by weight of white peony root, 110-140 parts by weight of salvia miltiorrhiza, 110-140 parts by weight of cyperus rotundus, 130-160 parts by weight of angelica sinensis, 30-55 parts by weight of calcined concha mactrae, 130-180 parts by weight of deer antler, 30-55 parts by weight of dried soft-shelled turtle egg, 20-40 parts by weight of licorice, 20-30 parts by weight of artemisia annua, 50-75 parts by weight of asparagus cochinchinensis, 240-260 parts by weight of prepared rehmannia, 240-260 parts by weight of rehmannia glutinosa, 50-75 parts by weight of chuanxiong rhizome, 20-40 parts by weight of astragalus, 20-35 parts by weight of radix stellariae dichotomae, 50-75 parts by weight of gordon euryale, 110-140 parts by weight of rhizoma dioscoreae.

8. Use according to claim 6 or 7, characterized in that, The medicine composition is administered orally.

9. Use according to claim 6 or 7, characterized in that, The pharmaceutical composition is administered at a dose of 0.9-3.6 g·kg -1 .

10. A pharmaceutical preparation for the treatment of premature ovarian failure, characterized in that, The medicine preparation comprises Tongren Wuchili Baifeng Pills.

11. A pharmaceutical preparation for the treatment of premature ovarian failure, characterized in that, The raw material composition of the medicine preparation comprises: 610-660 parts by weight of black-bone chicken, 110-140 parts by weight of red ginseng, 110-140 parts by weight of white peony root, 110-140 parts by weight of salvia miltiorrhiza, 110-140 parts by weight of cyperus rotundus, 130-160 parts by weight of angelica sinensis, 30-55 parts by weight of calcined concha mactrae, 130-180 parts by weight of deer antler, 30-55 parts by weight of dried soft-shelled turtle egg, 20-40 parts by weight of licorice, 20-30 parts by weight of artemisia annua, 50-75 parts by weight of asparagus cochinchinensis, 240-260 parts by weight of prepared rehmannia, 240-260 parts by weight of rehmannia glutinosa, 50-75 parts by weight of chuanxiong rhizome, 20-40 parts by weight of astragalus, 20-35 parts by weight of radix stellariae dichotomae, 50-75 parts by weight of gordon euryale, 110-140 parts by weight of rhizoma dioscoreae. Preferably, the raw material composition of the medicine preparation comprises: 620-650 parts by weight of black-bone chicken, 120-130 parts by weight of red ginseng, 120-130 parts by weight of white peony root, 120-130 parts by weight of salvia miltiorrhiza, 120-130 parts by weight of cyperus rotundus, 140-150 parts by weight of angelica sinensis, 35-45 parts by weight of calcined concha mactrae, 140-170 parts by weight of deer antler, 35-50 parts by weight of dried soft-shelled turtle egg, 25-34 parts by weight of licorice, 22-28 parts by weight of artemisia annua, 55-70 parts by weight of asparagus cochinchinensis, 245-255 parts by weight of prepared rehmannia, 245-255 parts by weight of rehmannia glutinosa, 55-70 parts by weight of chuanxiong rhizome, 25-35 parts by weight of astragalus, 25-30 parts by weight of radix stellariae dichotomae, 55-70 parts by weight of gordon euryale, 120-130 parts by weight of rhizoma dioscoreae.

12. The pharmaceutical preparation for the treatment of premature ovarian failure according to claim 10 or 11, characterized in that, The dosage form of the medicine preparation comprises a pharmaceutically acceptable preparation; Optionally, the dosage form comprises at least one of a tablet, a pill, a capsule, a powder, a drop, a lyophilizate, a granule, a suspension, a syrup or an oral solution.

13. The pharmaceutical preparation for the treatment of premature ovarian failure according to claim 12, characterized in that, The medicine preparation further comprises a pharmaceutically acceptable excipient; Optionally, the excipient comprises a combination of one or more of a solvent, a filler, a solubilizer, a cosolvent, an emulsifier, a coloring agent, a binder, a disintegrant, a stabilizer, a flavoring agent, a preservative, a suspending agent, a sweetening agent, a lubricant, a coating material, an aromatic agent or a thickening agent.

14. A method of preparing a pharmaceutical preparation for the treatment of premature ovarian failure according to any one of claims 10 to 13, characterized in that, The method comprises the step of compounding or extracting active ingredients from the selected raw material components.

15. A method of treating premature ovarian failure comprising administering to a subject in need thereof a therapeutically effective amount of a compound of claim 1. A method for preparing a pharmaceutical preparation comprising administering to a subject in need of the Tong Ren Wu Ji Bai Feng Pill of any one of claims 1-3, the pharmaceutical composition of claim 6 or 7, the pharmaceutical preparation of claim 10, the pharmaceutical preparation of any one of claims 11-13, or the pharmaceutical preparation of claim 14.

16. The method of claim 15, wherein, The Tong Ren Wu Ji Bai Feng Pill, the raw material composition of the pharmaceutical composition, or the raw material composition of the pharmaceutical preparation comprises: Wuji 610-660 parts by weight, red ginseng 110-140 parts by weight, white peony root 110-140 parts by weight, Danshen 110-140 parts by weight, Xiangfu 110-140 parts by weight, Angelica 130-160 parts by weight, calcined oyster shell 30-55 parts by weight, antler 130-180 parts by weight, Sangpaojiao 30-55 parts by weight, licorice 20-40 parts by weight, Artemisia annua 20-30 parts by weight, Yatsum 50-75 parts by weight, Renshen 240-260 parts by weight, Dihuang 240-260 parts by weight, Chuanqiong 50-75 parts by weight, Huangqi 20-40 parts by weight, Yinchaixu 20-35 parts by weight, Qianshi 50-75 parts by weight, Shanyao 110-140 parts by weight.

17. The method of claim 16, wherein, The Tong Ren Wu Ji Bai Feng Pill, the raw material composition of the pharmaceutical composition, or the raw material composition of the pharmaceutical preparation comprises: Wuji 620-650 parts by weight, red ginseng 120-130 parts by weight, white peony root 120-130 parts by weight, Danshen 120-130 parts by weight, Xiangfu 120-130 parts by weight, Angelica 140-150 parts by weight, calcined oyster shell 35-45 parts by weight, antler 140-170 parts by weight, Sangpaojiao 35-50 parts by weight, licorice 25-34 parts by weight, Artemisia annua 22-28 parts by weight, Yatsum 55-70 parts by weight, Renshen 245-255 parts by weight, Dihuang 245-255 parts by weight, Chuanqiong 55-70 parts by weight, Huangqi 25-35 parts by weight, Yinchaixu 25-30 parts by weight, Qianshi 55-70 parts by weight, Shanyao 120-130 parts by weight.

18. The method of claim 15, wherein, The Tong Ren Wu Ji Bai Feng Pill, the pharmaceutical composition, or the pharmaceutical preparation is administered orally.

19. The method of claim 15, wherein, The administration dose of the Tongren Wuji Baifeng Pill, the pharmaceutical composition or the pharmaceutical preparation is 0.9-3.6 g·kg -1 .

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