Traditional Chinese medicine composition, traditional Chinese medicine preparation and application

Abstract

The invention relates to a traditional Chinese medicine composition for treating polycystic ovarian syndrome. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 5-30 parts of semen cuscutae, 5-30 parts of herba epimedii, 1-20 parts of rhizoma atractylodis, 1-20 parts of poria cocos, 1-20 parts of angelica sinensis, 1-20 parts of ligusticum wallichii and 1-20 parts of fried scutellaria baicalensis. The important composition provided by the invention can effectively treat the polycystic ovarian syndrome, especially infertility and / or menstrual disorder caused by the polycystic ovarian syndrome.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition, a traditional Chinese medicine preparation, and its application. Background Technology

[0002] The continued decline in global fertility rates, leading to negative population growth, has become a major public health crisis threatening sustainable human development. The United Nations points out that the low fertility rate can be partly attributed to the rising incidence of reproductive disorders. Among these, polycystic ovary syndrome (PCOS), the most common reproductive disorder, is the leading cause of female infertility. PCOS is a syndrome characterized by ovulation dysfunction / menstrual irregularities, hyperandrogenemia, and polycystic ovarian changes. Insulin resistance is the core cause of PCOS, with approximately 70% of PCOS cases presenting with insulin resistance. Epidemiological data shows that the global prevalence of PCOS is as high as 6%-10%, with about 80% of patients experiencing ovulation-related infertility, and the incidence of menstrual irregularities far exceeding 90%. Clearly, PCOS poses a significant threat to women's reproductive health. Preventing and treating PCOS is not only a key breakthrough in the medical field to address the reproductive crisis but also an urgent need for national strategies for eugenics and healthy reproduction.

[0003] Western medicine treatment for PCOS mainly focuses on symptomatic treatment or achieving phased goals, such as regulating the menstrual cycle, reducing androgen levels, and improving insulin resistance (IR). These include: 1) promoting ovulation with drugs such as letrozole; 2) hormone therapy to regulate the menstrual cycle; 3) insulin sensitizers to regulate metabolism; and 4) assisted reproductive technology to promote fertility. Despite the consensus on Western medicine treatment strategies for PCOS, certain limitations remain: 1) While ovulation-inducing drugs such as letrozole and clomiphene can increase ovulation rates, they still face the dilemma of "low pregnancy rate and high miscarriage rate," and carry risks such as ovarian hyperstimulation syndrome and multiple pregnancies; 2) While oral contraceptives such as Diane-35 can effectively regulate menstrual cycles, symptoms are prone to recurrence after discontinuation, and long-term use increases the risk of thrombosis; 3) Gastrointestinal adverse reactions are common with insulin sensitizers such as metformin, and they can potentially affect the placenta and fetus, so there is a lack of evidence-based medical evidence regarding their long-term effects on offspring growth and development, metabolism, reproductive function, and neuropsychological development; 4) Assisted reproductive technologies such as IVF-ET can cause enormous physical and mental harm and socioeconomic pressure on patients and their families; in addition, adverse reactions such as weight gain, rebound after drug use, and liver damage are also common.

[0004] Based on the syndromes and symptoms of PCOS, Traditional Chinese Medicine (TCM) categorizes it under "infertility" and "menstrual disorders." The *Danxi Xinfa* states, "If a woman is obese, with a strong constitution, and indulges in excessive food and drink, her menstrual flow will be irregular, preventing conception. This is called 'overflowing body fat, obstructing the uterus.'" "Accumulation of phlegm and dampness in the uterus" is a core aspect of PCOS development. Furthermore, with prolonged PCOS, the *Linzheng Zhinan Yi'an* states, "Prolonged illness inevitably leads to blood stasis." Phlegm is transformed from body fluids, and blood stasis is congealed from blood. Body fluids and blood share the same origin, phlegm and blood stasis mutually transform and become difficult to resolve, ultimately damaging the uterine network and hindering conception. "Phlegm and blood stasis obstructing the uterus" is a key pathological factor in PCOS-related fertility problems. The TCM "Kidney-Tian Gui-Chong Ren-Uterus Axis" corresponds to the modern medical "Hypothalamus-Pituitary-Ovary Axis," both playing important roles in regulating the female reproductive system. TCM has unique advantages in treating infertility and menstrual disorders.

[0005] Therefore, it is of great significance to research and develop traditional Chinese medicine compositions that are reliable in efficacy, safe, have low adverse reactions, and are rationally formulated to treat polycystic ovary syndrome infertility and menstrual disorders. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine composition that is effective, safe, has low adverse reactions, and has a reasonable formulation, which can be used to treat infertility and menstrual disorders caused by polycystic ovary syndrome.

[0007] Solution for solving the problem This invention provides a traditional Chinese medicine composition for treating polycystic ovary syndrome. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: Cuscuta chinensis 5-30 parts, Epimedium brevicornu 5-30 parts, Atractylodes lancea 1-20 parts, Poria cocos 1-20 parts, Angelica sinensis 1-20 parts, Ligusticum chuanxiong 1-20 parts, and Scutellaria baicalensis (fried) 1-20 parts.

[0008] Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 9-18 parts of Cuscuta chinensis, 9-18 parts of Epimedium brevicornu, 4-15 parts of Atractylodes lancea, 4-15 parts of Poria cocos, 4-15 parts of Angelica sinensis, 4-15 parts of Ligusticum chuanxiong, and 4-15 parts of Scutellaria baicalensis (fried).

[0009] Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of Cuscuta chinensis, 15 parts of Epimedium brevicornu, 10 parts of Atractylodes lancea, 10 parts of Poria cocos, 10 parts of Angelica sinensis, 10 parts of Ligusticum chuanxiong, and 9 parts of stir-fried Scutellaria baicalensis.

[0010] Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of Cuscuta chinensis, 15 parts of Epimedium brevicornu, 10 parts of Atractylodes lancea, 10 parts of Poria cocos, 10 parts of Angelica sinensis, 10 parts of Ligusticum chuanxiong, and 9 parts of Scutellaria baicalensis (fried).

[0011] This invention provides a traditional Chinese medicine preparation, which comprises the traditional Chinese medicine composition described in any one of the above-mentioned claims.

[0012] Preferably, the traditional Chinese medicine preparation further includes a pharmaceutically acceptable carrier.

[0013] This invention provides a method for preparing a traditional Chinese medicine preparation, wherein the raw materials are prepared in the weight proportions described in any of the above-mentioned claims, with or without the addition of a pharmaceutically acceptable carrier, to form a clinically acceptable preparation.

[0014] The present invention provides the use of the traditional Chinese medicine composition, the traditional Chinese medicine preparation, or the traditional Chinese medicine preparation prepared according to the preparation method described above in the preparation of a drug for treating polycystic ovary syndrome.

[0015] Preferably, the polycystic ovary syndrome includes infertility and / or menstrual disorders caused by the polycystic ovary syndrome.

[0016] Preferably, the drug is an oral formulation.

[0017] Preferably, the oral preparation is selected from one or more of the following: decoction, powder, capsule, tablet, honey pill, water-honey pill, water pill, concentrated pill, paste pill, wax pill, granule, oral liquid or drop pill, and is preferably a decoction, powder, capsule or tablet.

[0018] The effects of the invention This invention provides a traditional Chinese medicine composition for treating polycystic ovary syndrome (PCOS), which is prepared from the following raw materials: Cuscuta chinensis, Epimedium brevicornu, Atractylodes lancea, Poria cocos, Angelica sinensis, Ligusticum chuanxiong, and Scutellaria baicalensis (fried). It is a traditional Chinese medicine composition with reliable efficacy, good safety, low adverse reactions, and reasonable formulation, which can be used to treat infertility and menstrual disorders caused by PCOS. This invention has been verified through extensive clinical practice and multiple studies, and follows the principle of "principal, assistant, adjuvant, and guide" in its formulation. The principal herbs are Cuscuta chinensis and Epimedium, which focus on warming and tonifying kidney yang and replenishing essence and marrow, directly addressing the essence of "kidney deficiency" and promoting follicle development and gonadal axis function. The assistant herbs are Atractylodes lancea and Poria cocos, which strengthen the spleen, dry dampness, resolve phlegm, and promote diuresis, resolving "phlegm and dampness" stagnation and improving insulin resistance and metabolic disorders. The adjuvant herbs are Angelica sinensis and Ligusticum chuanxiong, which nourish blood, invigorate blood circulation, and remove blood stasis, breaking down "blood stasis" obstruction and improving ovarian and endometrial microcirculation. The adjuvant herb is Scutellaria baicalensis, which clears heat and dries dampness, counteracting the warming and drying properties that can damage yin, while also addressing the chronic inflammatory state of PCOS. The combined effects of these herbs tonify the kidneys and strengthen the body's foundation, while resolving phlegm and promoting blood circulation to address the symptoms. This treatment addresses polycystic ovary syndrome (PCOS) infertility characterized by symptoms such as delayed menstruation or amenorrhea, obesity, lower back and knee weakness, chest and rib fullness, acne, acanthosis nigricans, and menstrual irregularities, specifically manifested as "kidney deficiency with phlegm and blood stasis." It simultaneously corrects reproductive metabolic axis disorders and improves the uterine microenvironment (ovaries and uterus), thus promoting menstrual regulation and fertility. The clinical efficacy is definite. The herbal composition provided by this invention has a significant effect on improving the clinical pregnancy rate in PCOS patients (including PCOS-IR), and shows significant differences in reducing body weight, BMI, and TCM syndrome scores in PCOS patients, as well as in LH, LH / FSH, T, FINS, and HOMA-IR. The herbal composition provided by this invention has multi-target effects in treating PCOS, showing good clinical efficacy. It can promote follicular development and gonadal axis function, improve insulin resistance and metabolic disorders, significantly increase the clinical pregnancy rate, and treat / improve infertility and / or menstrual disorders caused by PCOS. Attached Figure Description

[0019] Figure 1 The images show the pathological changes in the ovarian tissue of rats in some animal experimental groups in Test Example 1 of this invention.

[0020] Figure 2 The LH and LH / FSH levels in rats of some animal experimental groups in Example 1 of this invention are shown. Among them, * compared with the blank control group, *P<0.05, **P<0.01, ***P<0.001; # compared with the PCOS group, #P<0.05, ##P<0.01, ###P<0.001.

[0021] Figure 3The levels of FINS, HOMA-IR, LH, and LH / FSH in rats in some animal experimental groups in Example 1 of this invention are shown. Among them, * compared with the blank control group, * P < 0.05, ** P < 0.01, *** P < 0.001; # compared with the PCOS group, # P < 0.05, ## P < 0.01, ### P < 0.001. Detailed Implementation

[0022] To make the technical solution and beneficial effects of the present invention more apparent and understandable, a detailed description is provided below by listing specific embodiments. The accompanying drawings are not necessarily drawn to scale, and local features may be enlarged or reduced to more clearly show the details of the local features; unless otherwise defined, the technical and scientific terms used herein have the same meanings as those in the technical field to which this application pertains.

[0023] This invention provides a traditional Chinese medicine composition for treating polycystic ovary syndrome. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: Cuscuta chinensis 5-30 parts, Epimedium brevicornu 5-30 parts, Atractylodes lancea 1-20 parts, Poria cocos 1-20 parts, Angelica sinensis 1-20 parts, Ligusticum chuanxiong 1-20 parts, and Scutellaria baicalensis (fried) 1-20 parts.

[0024] In some embodiments, the weight parts of dodder seed are 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 parts, etc.

[0025] In some embodiments, the weight parts of Epimedium are 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 parts, etc.

[0026] In some embodiments, the weight parts of Atractylodes lancea are 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, etc.

[0027] In some embodiments, the weight parts of Poria cocos are 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, etc.

[0028] In some embodiments, the weight parts of Angelica sinensis are 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, etc.

[0029] In some embodiments, the weight parts of Ligusticum chuanxiong are 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, etc.

[0030] In some embodiments, the weight parts of stir-fried Scutellaria baicalensis are 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, etc.

[0031] In some embodiments, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 9-25 parts of Cuscuta chinensis, 9-25 parts of Epimedium brevicornu, 4-15 parts of Atractylodes lancea, 4-15 parts of Poria cocos, 4-15 parts of Angelica sinensis, 4-15 parts of Ligusticum chuanxiong, and 4-15 parts of Scutellaria baicalensis (fried).

[0032] In some embodiments, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 9-18 parts of Cuscuta chinensis, 9-18 parts of Epimedium brevicornu, 4-15 parts of Atractylodes lancea, 4-15 parts of Poria cocos, 4-15 parts of Angelica sinensis, 4-15 parts of Ligusticum chuanxiong, and 4-15 parts of Scutellaria baicalensis (fried).

[0033] In some embodiments, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 9-18 parts of Cuscuta chinensis, 9-18 parts of Epimedium brevicornu, 4-10 parts of Atractylodes lancea, 4-10 parts of Poria cocos, 4-10 parts of Angelica sinensis, 4-10 parts of Ligusticum chuanxiong, and 4-9 parts of Scutellaria baicalensis (fried).

[0034] In some embodiments, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15-18 parts of Cuscuta chinensis, 15-18 parts of Epimedium brevicornu, 8-10 parts of Atractylodes lancea, 8-10 parts of Poria cocos, 8-10 parts of Angelica sinensis, 8-10 parts of Ligusticum chuanxiong, and 7-9 parts of stir-fried Scutellaria baicalensis.

[0035] In some embodiments, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of Cuscuta chinensis, 15 parts of Epimedium brevicornu, 10 parts of Atractylodes lancea, 10 parts of Poria cocos, 10 parts of Angelica sinensis, 10 parts of Ligusticum chuanxiong, and 9 parts of Scutellaria baicalensis (fried).

[0036] In some embodiments, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts Cuscuta chinensis, 15 parts Epimedium brevicornu, 10 parts Atractylodes lancea, 10 parts Poria cocos, 10 parts Angelica sinensis, 10 parts Ligusticum chuanxiong, and 9 parts Scutellaria baicalensis (fried).

[0037] This invention provides a traditional Chinese medicine preparation, which comprises the traditional Chinese medicine composition described in any one of the above-mentioned claims.

[0038] In some embodiments, the traditional Chinese medicine preparation also includes a pharmaceutically acceptable carrier.

[0039] This invention provides a method for preparing a traditional Chinese medicine preparation, wherein the raw materials are prepared in the weight proportions described in any of the above-mentioned claims, with or without the addition of a pharmaceutically acceptable carrier, to form a clinically acceptable preparation.

[0040] The present invention provides the use of the traditional Chinese medicine composition, the traditional Chinese medicine preparation, or the traditional Chinese medicine preparation prepared according to the preparation method described above in the preparation of a drug for treating polycystic ovary syndrome.

[0041] In some embodiments, the polycystic ovary syndrome includes infertility and / or menstrual disorders caused by the polycystic ovary syndrome.

[0042] In some embodiments, the polycystic ovary syndrome includes infertility caused by the polycystic ovary syndrome.

[0043] In some embodiments, the polycystic ovary syndrome includes menstrual disorders caused by the polycystic ovary syndrome.

[0044] In some embodiments, the drug is formulated as an oral formulation.

[0045] In some embodiments, the oral preparation is selected from one or more of the following: decoction, powder, capsule, tablet, honey pill, water-honey pill, water pill, concentrated pill, paste pill, wax pill, granule, oral liquid, or drop pill.

[0046] In some embodiments, the oral formulation is selected from decoctions, powders, capsules, or tablets.

[0047] The pharmacological effects of each active pharmaceutical ingredient in this invention are as follows: Cuscuta seed: sweet in taste and warm in nature, it enters the liver, spleen, and kidney meridians. It has the effects of tonifying the liver and kidneys, consolidating essence and reducing urination, improving eyesight and calming the fetus. It mainly contains flavonoids, lignans, polysaccharides, and other chemical components. Cuscuta seed is widely used in clinical practice as a commonly used kidney-tonifying traditional Chinese medicine. Modern research shows that it has pharmacological effects such as reproductive protection, anti-oxidation, and anti-tumor activity.

[0048] Epimedium: It has a pungent and sweet taste, is warm in nature, and enters the liver and kidney meridians. It has the effects of tonifying the kidney and strengthening yang, strengthening muscles and bones, and dispelling wind and dampness. It mainly contains flavonoids (such as icariin), alkaloids, polysaccharides and other chemical components. Modern research shows that epimedium has pharmacological effects such as improving reproductive endocrine function, immune regulation, and anti-tumor activity.

[0049] Atractylodes lancea: pungent and bitter in taste, warm in nature, and enters the spleen and stomach meridians. It has the effects of drying dampness and strengthening the spleen, dispelling wind and cold. It mainly contains volatile oils (atractylone, atractylodes glycoside), polysaccharides, sesquiterpenes and other chemical components. Modern research shows that Atractylodes lancea has pharmacological effects such as anti-inflammatory, regulating gastrointestinal motility, promoting digestion, protecting the liver, and anti-tumor effects.

[0050] Poria cocos: sweet and bland in taste, neutral in nature, and enters the heart, lung, spleen, and kidney meridians. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen and calming the mind, and soothing the nerves. It mainly contains polysaccharides (poria polysaccharide), triterpenoids (poria acid), sterols, and proteins. Modern research shows that Poria cocos has pharmacological effects such as diuresis, immune regulation, anti-tumor, sedation, and liver protection.

[0051] Angelica sinensis: sweet and pungent in taste, warm in nature, and enters the liver, heart, and spleen meridians. It has the effects of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain. It mainly contains volatile oil (ligustilide), organic acid (ferulic acid), polysaccharides, and flavonoids. Modern research shows that Angelica sinensis has pharmacological effects such as improving blood circulation, regulating uterine smooth muscle, anti-inflammatory, antioxidant, and immune-enhancing effects.

[0052] Chuanxiong (Ligusticum striatum): pungent and warm in nature, it enters the liver, gallbladder, and pericardium meridians. It has the effects of promoting blood circulation, regulating qi, dispelling wind, and relieving pain. Its main chemical components include alkaloids (chuanxiong azin), phenolic acids (ferulic acid), volatile oils, and lactones. Modern research shows that Chuanxiong has pharmacological effects such as improving microcirculation, inhibiting platelet aggregation, anti-inflammation, analgesia, and protecting the cardiovascular and cerebrovascular systems.

[0053] Stir-fried Scutellaria baicalensis: Bitter in taste and cold in nature, it enters the lung, gallbladder, spleen, large intestine, and small intestine meridians. It has the effects of clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. It mainly contains flavonoids (baicalin, wogonin), phenylethanoid glycosides, and volatile oils, among other chemical components. Modern research shows that stir-fried Scutellaria baicalensis has anti-inflammatory, antibacterial, antiviral, antioxidant, and immunomodulatory pharmacological effects.

[0054] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Experimental methods in the following embodiments, unless otherwise specified, are generally performed under conventional conditions or as recommended by the manufacturer. Unless otherwise stated, percentages and parts are weight percentages and parts by weight.

[0055] Example 1

[0056] A traditional Chinese medicine composition for treating polycystic ovary syndrome comprises the following components by weight: 9 parts Cuscuta chinensis, 9 parts Epimedium brevicornu, 4 parts Atractylodes lancea, 4 parts Poria cocos, 4 parts Angelica sinensis, 4 parts Ligusticum chuanxiong, and 4 parts Scutellaria baicalensis (fried).

[0057] Example 2

[0058] A traditional Chinese medicine composition for treating polycystic ovary syndrome comprises the following components by weight: 18 parts of Cuscuta chinensis, 18 parts of Epimedium brevicornu, 8 parts of Atractylodes lancea, 8 parts of Poria cocos, 8 parts of Angelica sinensis, 8 parts of Ligusticum chuanxiong, and 7 parts of Scutellaria baicalensis (fried).

[0059] Example 3

[0060] A traditional Chinese medicine composition for treating polycystic ovary syndrome comprises the following components by weight: 15 parts of Cuscuta chinensis, 15 parts of Epimedium brevicornu, 10 parts of Atractylodes lancea, 10 parts of Poria cocos, 10 parts of Angelica sinensis, 10 parts of Ligusticum chuanxiong, and 9 parts of Scutellaria baicalensis (fried).

[0061] Preparation method and administration: Prepare the raw materials according to the above weight components, mix the raw materials, soak them in a clay pot for 30 minutes, then add water to cover the medicine, and then decoct over medium heat until the liquid is about 200 mL. Pour out the liquid, add water again to cover the medicine, decoct until about 200 mL, pour out the liquid, mix with the first liquid, and take orally once a day.

[0062] Test Example 1 The traditional Chinese medicine compositions prepared in Examples 1-3 above were subjected to animal experiments to test the therapeutic effect of the traditional Chinese medicine compositions of the present invention on polycystic ovary syndrome and the synergistic effect of the components. A key control group was also set up, with the specific groupings as follows: All-round group: Formula 1: Formula from Example 1 (9 parts Cuscuta chinensis, 9 parts Epimedium, 4 parts Atractylodes lancea, 4 parts Poria cocos, 4 parts Angelica sinensis, 4 parts Ligusticum chuanxiong, 4 parts Scutellaria baicalensis (fried)). Formula 2: Formula from Example 2 (18 parts Cuscuta chinensis, 18 parts Epimedium, 8 parts Atractylodes lancea, 8 parts Poria cocos, 8 parts Angelica sinensis, 8 parts Ligusticum chuanxiong, 7 parts Scutellaria baicalensis (fried)). Formula Group 3: Formula from Example 3 (15 parts Cuscuta chinensis, 15 parts Epimedium, 10 parts Atractylodes lancea, 10 parts Poria cocos, 10 parts Angelica sinensis, 10 parts Ligusticum chuanxiong, 9 parts stir-fried Scutellaria baicalensis); Group lacking stir-fried Scutellaria baicalensis: Formula of Example 3, which does not include stir-fried Scutellaria baicalensis (15 parts of Cuscuta chinensis, 15 parts of Epimedium brevicornu, 10 parts of Atractylodes lancea, 10 parts of Poria cocos, 10 parts of Angelica sinensis, and 10 parts of Ligusticum chuanxiong).

[0063] 1. PCOS Modeling Twenty-one-day-old SPF-grade female SD rats were acclimatized for 3 days and then randomly divided into a normal group and a model group according to body weight. Rats in the model group were fed a 45% high-fat diet for 7 weeks, and for the last 4 weeks, they were administered letrozole (1 mg / 10 mL / kg / d) in CMC-Na suspension daily by gavage. Rats in the normal group were fed a normal diet for 7 weeks, and for the last 4 weeks, they were administered an equal volume of 0.5% CMC-Na solution daily by gavage. The model group rats exhibited irregular estrous cycles, with a significantly prolonged interestrous period compared to the normal group, confirming the successful establishment of the PCOS model.

[0064] 2. Experimental grouping and drug administration According to Table 1, each experimental group was administered the drug according to the corresponding dosing regimen.

[0065] Table 1 Experimental Groups and Dosing Regimens

[0066] 3. Sample collection and indicator detection Blood was drawn from the orbital vein, allowed to stand at room temperature for 30 minutes, and then centrifuged at 3000 rpm for 15 minutes at 4°C. Serum was separated, and the levels of fasting insulin (FINS), follicle-stimulating hormone (FSH), and luteinizing hormone (LH) in the serum were detected by ELISA. Fasting blood glucose (FBG) levels were measured using a fully automated biochemical analyzer.

[0067] ELISA testing steps: (1) Sample pretreatment: The serum sample was thawed at room temperature for later use; (2) Reagent preparation: Place the kit at room temperature for 40 minutes to equilibrate, and shake gently before use; (3) Preparation of standards: Set up 10 wells for standards on the microplate, and add 50 μL of sample to each well; (4) Sample addition: First add 40 μL of sample diluent to the sample well, then add 10 μL of serum to be tested (the final dilution factor of the sample is 5 times). (5) Incubation: After sealing, incubate at 37°C for 30 minutes; (6) Preparation of washing solution: Dilute the 30-fold concentrated washing solution with distilled water according to the ratio to prepare the working solution; Washing steps: Remove the sealing film, discard the liquid in the well, pat dry, fill each well with washing solution, let stand for 30 seconds and then discard, repeat the washing 5 times, and finally pat dry. (7) Add enzyme: Add 50 μL of enzyme-labeled reagent to each well, except for the blank wells; (8) Second incubation: Same as step (5); (9) Second wash: Same as step (6); (10) Color development: Add 50 μL of color developer A and color developer B to each well in sequence, mix gently, and react at 37°C in the dark for 15 minutes; (11) Termination: Add 50 μL of termination solution to each well (the color changes from blue to yellow); (12) Detection: The absorbance (OD value) of each well is measured at a wavelength of 450 nm. Instrument calibration is required before detection. (13) Data processing: Plot a standard curve with the concentration of the standard as the x-axis and the OD value as the y-axis and calculate the regression equation. Substitute the OD value of the sample into the equation to obtain the concentration, and then multiply it by the dilution factor to obtain the actual concentration of the sample.

[0068] The formula for calculating the insulin resistance index (HOMA-IR) is as follows: HOMA IR = Fasting blood glucose (FBG) × Fasting insulin (FINS) / 22.5.

[0069] After euthanizing the rats, both ovarian tissues were completely removed. The left ovarian tissue was fixed in 4% paraformaldehyde solution, embedded in paraffin, and then sectioned (approximately 4 μm) for subsequent HE staining.

[0070] Steps for HE staining of ovarian tissue: (1) Dewaxing and washing paraffin sections: The sections were placed in xylene I for 20 min, xylene II for 20 min, anhydrous ethanol I for 5 min, anhydrous ethanol II for 5 min, and 75% ethanol for 5 min in sequence, and then washed with PBS; (2) Hematoxylin staining: Immerse the sections in hematoxylin staining solution for 3-5 min, wash with PBS, differentiate with differentiation solution, wash with tap water, blue back solution, and rinse with running water. (3) Eosin staining: Immerse the sections directly in eosin staining solution for 1-2 minutes; (4) Dehydration and mounting: The sections were placed in anhydrous ethanol I for 5 min, anhydrous ethanol II for 5 min, anhydrous ethanol III for 5 min, xylene I for 5 min, and xylene II for 5 min in sequence for clearing and mounting with neutral resin; (5) Microscopic examination, image acquisition and analysis.

[0071] 4. Results Analysis like Figure 1 As shown, the PCOS group exhibited a high number of cystic follicles in the ovarian tissue, with follicular atresia and a small number of necrotic granulosa cells within the follicles, showing nuclear condensation and fragmentation; numerous follicles showed dilation, and the number of granulosa cells decreased. In the complete formula group 3, the number of cystic follicles in the ovarian cortex decreased, while the number of corpora lutea increased. The group lacking roasted Scutellaria baicalensis had a higher number of cystic follicles and fewer corpora lutea than the complete formula group 3; a small number of follicles showed necrosis of granulosa cells, with nuclear condensation and fragmentation; a small number of follicles showed dilation, and the number of granulosa cells decreased. The complete formula group 3, including roasted Scutellaria baicalensis, improved the pathological changes in the ovaries of PCOS model rats. The raw material roasted Scutellaria baicalensis had a synergistic effect with the other raw materials in the complete formula group 3, with roasted Scutellaria baicalensis playing a key role.

[0072] like Figure 2As shown, LH: After 2 weeks of administration, the LH level in the whole formula group 1 was significantly lower than that in the PCOS group (P<0.05), the LH level in the whole formula group 2 was significantly lower than that in the PCOS group (P<0.05), and the LH level in the whole formula group 3 was significantly lower than that in the PCOS group (P<0.01); LH / FSH: After 2 weeks of administration, the LH / FSH level in the whole formula group 1 was significantly lower than that in the PCOS group (P<0.05), the LH / FSH level in the whole formula group 2 was significantly lower than that in the PCOS group (P<0.05), and the LH / FSH level in the whole formula group 3 was significantly lower than that in the PCOS group (P<0.001).

[0073] like Figure 3 As shown, FINS: After 2 weeks of administration, the FINS of the whole formula group 3 was significantly lower than that of the PCOS group (P<0.05) and also lower than that of the group without stir-fried Scutellaria baicalensis; HOMA-IR: After 2 weeks of administration, the HOMA-IR of the whole formula group 3 was significantly lower than that of the PCOS group (P<0.01) and also lower than that of the group without stir-fried Scutellaria baicalensis; LH: After 2 weeks of administration, the LH of the whole formula group 3 was significantly lower than that of the PCOS group (P<0.01) and also lower than that of the group without stir-fried Scutellaria baicalensis; LH / FSH: After 2 weeks of administration, the LH / FSH of the whole formula group 3 was significantly lower than that of the PCOS group (P<0.001) and also lower than that of the group without stir-fried Scutellaria baicalensis.

[0074] Test Example 2 Based on the results of animal experiments, we conducted a clinical efficacy observation test on the traditional Chinese medicine composition prepared in Example 3.

[0075] 1. Research Subjects Sixty patients with PCOS-IR of kidney deficiency and phlegm stasis type who visited the gynecology outpatient clinic were collected, totaling 60 subjects. They were randomly divided into two groups using a random number table: Treatment group: 30 cases, who were given oral administration of the traditional Chinese medicine decoction of Example 3 (15 parts of Cuscuta chinensis, 15 parts of Epimedium brevicornu, 10 parts of Atractylodes lancea, 10 parts of Poria cocos, 10 parts of Angelica sinensis, 10 parts of Ligusticum chuanxiong, and 9 parts of stir-fried Scutellaria baicalensis). Control group: 30 cases, who received oral metformin tablets.

[0076] 2. Treatment Plan Basic treatment includes: developing an individualized healthy lifestyle (diet, exercise, reducing sedentary behavior, and behavioral strategies); engaging in at least 60 minutes of moderate to vigorous physical activity daily, including at least three muscle- and bone-strengthening exercises per week; scientifically and rationally adjusting the diet, setting calorie intake goals, and maintaining a dietary record; and incorporating cognitive behavioral interventions that include goal setting, self-monitoring, cognitive restructuring, problem-solving, and relapse prevention strategies. The treatment and follow-up periods are both 3 months.

[0077] Group treatment: Treatment group: The traditional Chinese medicine composition decoction of Example 3 of this invention was administered orally, one dose per day, decocted in water and taken warm twice a day, morning and evening, for a course of 3 months.

[0078] Control group: Metformin tablets were administered orally, 500 mg each time, 3 times a day, for 3 months.

[0079] 3. Evaluation Indicators The pregnancy status of patients in the control group and the treatment group were statistically analyzed and compared, as well as their body weight, body mass index (BMI), TCM syndrome scores, sex hormone levels [testosterone (T), luteinizing hormone (LH), follicle-stimulating hormone (FSH), LH / FSH], glucose metabolism indicators [fasting plasma glucose (FPG), fasting insulin (FINS), insulin resistance index (HOMA-IR)] and adverse reactions before and after treatment.

[0080] BMI = Body mass (kg) / Height (m) 2 .

[0081] Traditional Chinese Medicine (TCM) syndrome scoring method: Referencing the "Guiding Principles for Clinical Research of New Chinese Medicine Drugs" and the TCM diagnostic criteria for menstrual disorders of the kidney deficiency and phlegm stasis type in the 7th edition of the textbook "Traditional Chinese Medicine Gynecology": Score the symptoms such as delayed menstruation / amenorrhea, heaviness in the head and body, soreness and weakness in the waist and knees, fullness and discomfort in the chest and ribs, loose stools, grayish-brown pigmentation on the skin of the neck, back and labia, tongue and pulse, etc. 0 points are no symptoms, 2 points are mild symptoms, 4 points are moderate symptoms, and 6 points are severe symptoms, and TCM syndrome scores are calculated.

[0082] Fasting blood glucose (FBG) before and after treatment was measured using a fully automated biochemical analyzer.

[0083] Fasting insulin (FINS), testosterone (T), luteinizing hormone (LH), and follicle-stimulating hormone (FSH) levels before and after treatment were measured using the ELISA method.

[0084] ELISA testing steps: (1) Sample pretreatment: The serum sample was thawed at room temperature for later use; (2) Reagent preparation: Place the kit at room temperature for 40 minutes to equilibrate, and shake gently before use; (3) Preparation of standards: Set up 10 wells for standards on the microplate, and add 50 μL of sample to each well; (4) Sample addition: First add 40 μL of sample diluent to the sample well, then add 10 μL of serum to be tested (the final dilution factor of the sample is 5 times). (5) Incubation: After sealing, incubate at 37°C for 30 minutes; (6) Preparation of washing solution: Dilute the 30-fold concentrated washing solution with distilled water according to the ratio to prepare the working solution; Washing steps: Remove the sealing film, discard the liquid in the well, pat dry, fill each well with washing solution, let stand for 30 seconds and then discard, repeat the washing 5 times, and finally pat dry. (7) Add enzyme: Add 50 μL of enzyme-labeled reagent to each well, except for the blank wells; (8) Second incubation: Same as step (5); (9) Second wash: Same as step (6); (10) Color development: Add 50 μL of color developer A and color developer B to each well in sequence, mix gently, and react at 37°C in the dark for 15 minutes; (11) Termination: Add 50 μL of termination solution to each well (the color changes from blue to yellow); (12) Detection: The absorbance (OD value) of each well is measured at a wavelength of 450 nm. Instrument calibration is required before detection. (13) Data processing: Plot a standard curve with the concentration of the standard as the x-axis and the OD value as the y-axis and calculate the regression equation. Substitute the OD value of the sample into the equation to obtain the concentration, and then multiply it by the dilution factor to obtain the actual concentration of the sample.

[0085] 4. Results Analysis The clinical pregnancy rates of the two groups of PCOS-IR patients after treatment are shown in Table 2. The comparison of clinical pregnancy rates between the two groups showed *P<0.05.

[0086] Table 2

[0087] Table 3 shows the results of body weight, BMI and TCM syndrome scores (x±s) before and after treatment in the two groups of PCOS-IR patients. Compared with the pre-treatment values ​​in the same group, *P<0.05 and **P<0.01.

[0088] Table 3

[0089] Table 4 shows the results of luteinizing hormone (LH) (x±s) before and after treatment in the two groups of PCOS-IR patients. *P<0.05 compared with the pre-treatment values ​​in the same group.

[0090] Table 4

[0091] Table 5 shows the results of follicle-stimulating hormone (FSH) (x±s) before and after treatment in the two groups of PCOS-IR patients. Among them, compared with the pre-treatment values ​​in the same group, *P<0.05.

[0092] Table 5

[0093] Table 6 shows the LH / FSH ratio (x±s) and testosterone (T) (x±s) before and after treatment in the two groups of PCOS-IR patients. *P<0.05 compared with the pre-treatment values ​​in the same group.

[0094] Table 6

[0095] Table 7 shows the fasting insulin (FINS) and insulin resistance index (HOMA-IR) (x±s) before and after treatment in the two groups of PCOS-IR patients. Compared with the pre-treatment values ​​in the same group, *P<0.05 and **P<0.01.

[0096] Table 7

[0097] Clinical trials showed that the traditional Chinese medicine composition provided by this invention significantly improved the clinical pregnancy rate in PCOS-IR patients compared to the control group (Table 2), and also demonstrated significant differences in reducing body weight, BMI, and TCM syndrome scores, as well as in LH, LH / FSH, FINS, and HOMA-IR (Tables 3-7). The traditional Chinese medicine composition provided by this invention has multi-target efficacy in treating PCOS-IR, exhibiting good clinical results. It can promote follicular development and gonadal axis function, improve insulin resistance and metabolic disorders, significantly increase the clinical pregnancy rate, and treat / improve infertility and / or menstrual disorders caused by polycystic ovary syndrome.

[0098] It should be understood that the above embodiments are exemplary and are not intended to encompass all possible implementations included in the claims. Various modifications and changes can be made to the above embodiments without departing from the scope of this disclosure. Similarly, the various technical features of the above embodiments can be arbitrarily combined to form other embodiments of the present invention that may not be explicitly described. Therefore, the above embodiments only illustrate several implementations of the present invention and do not limit the scope of protection of this patent.

Claims

1. A traditional Chinese medicine composition for treating polycystic ovary syndrome, characterized in that, The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: Cuscuta chinensis 5-30 parts, Epimedium brevicornu 5-30 parts, Atractylodes lancea 1-20 parts, Poria cocos 1-20 parts, Angelica sinensis 1-20 parts, Ligusticum chuanxiong 1-20 parts, and Scutellaria baicalensis (fried) 1-20 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: Cuscuta chinensis 9-18 parts, Epimedium brevicornu 9-18 parts, Atractylodes lancea 4-15 parts, Poria cocos 4-15 parts, Angelica sinensis 4-15 parts, Ligusticum chuanxiong 4-15 parts, and Scutellaria baicalensis (fried) 4-15 parts.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts Cuscuta chinensis, 15 parts Epimedium brevicornu, 10 parts Atractylodes lancea, 10 parts Poria cocos, 10 parts Angelica sinensis, 10 parts Ligusticum chuanxiong, and 9 parts Scutellaria baicalensis (fried).

4. The traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts Cuscuta chinensis, 15 parts Epimedium brevicornu, 10 parts Atractylodes lancea, 10 parts Poria cocos, 10 parts Angelica sinensis, 10 parts Ligusticum chuanxiong, and 9 parts Scutellaria baicalensis (fried).

5. A traditional Chinese medicine preparation, characterized in that, The traditional Chinese medicine preparation includes the traditional Chinese medicine composition according to any one of claims 1 to 4.

6. The traditional Chinese medicine preparation according to claim 5, characterized in that, The traditional Chinese medicine preparations also include pharmaceutically acceptable carriers.

7. A method for preparing a traditional Chinese medicine preparation, characterized in that, The active pharmaceutical ingredient, in any one of claims 1 to 4, is prepared into a clinically acceptable formulation with or without the addition of a pharmaceutically acceptable carrier.

8. The use of the traditional Chinese medicine composition according to any one of claims 1 to 4, the traditional Chinese medicine preparation according to claim 5 or 6, or the traditional Chinese medicine preparation prepared by the preparation method according to claim 7 in the preparation of a drug for treating polycystic ovary syndrome; Preferably, the polycystic ovary syndrome includes infertility and / or menstrual disorders caused by the polycystic ovary syndrome.

9. The application according to claim 8, characterized in that, The drug is an oral formulation.

10. The application according to claim 9, characterized in that, The oral preparation is selected from one or more of the following: decoction, powder, capsule, tablet, honey pill, water-honey pill, water pill, concentrated pill, paste pill, wax pill, granule, oral liquid or drop pill, preferably decoction, powder, capsule or tablet.

Images