Kidney-nourishing, heat-clearing, dampness-eliminating, and blood-stasis-removing formula, and use thereof

Abstract

A kidney-nourishing, heat-clearing, dampness-eliminating, and blood-stasis-removing traditional Chinese medicine composition, an extract thereof, a pharmaceutical formulation thereof, a preparation method therefor, and use thereof. The traditional Chinese medicine composition comprises the following starting materials in parts by weight: 7-13 parts of Rhizoma Anemarrhenae, 7-13 parts of Radix Rehmanniae, 12-18 parts of Carapax Trionycis, 7-13 parts of Herba Dianthi, 7-13 parts of Herba Dendrobii, 7-13 parts of Semen Persicae, 9-15 parts of Semen Trichosanthis, 2-7 parts of Rhizoma Coptidis, 7-13 parts of Cortex Phellodendri, 2-7 parts of Ramulus Cinnamomi, and 7-13 parts of Herba Plantaginis, and can further comprise 2-12 parts of Radix Glycyrrhizae. The traditional Chinese medicine composition is capable of treating polycystic ovarian syndrome while also significantly improving the quality of life, and has the effect of preventing and treating depression.

Description

A kidney-nourishing, heat-clearing, dampness-removing and blood stasis-removing prescription and its application Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a kidney-nourishing, heat-clearing, dampness-invigorating and blood-stasis-removing prescription and application thereof. Background Art

[0002] Polycystic ovarian syndrome (PCOS) is a common and complex reproductive endocrine and metabolic disease with infrequent ovulation or anovulation, hyperandrogenemia and polycystic ovarian changes as the main clinical manifestations. It is associated with a high risk of serious long-term complications such as diabetes, cardiovascular disease, and endometrial cancer. The incidence rate can reach 5%-10% of women of childbearing age. About 50% of infertile patients are related to PCOS, and 90%-95% of women with infertility and anovulation suffer from this disease. Patients often seek medical treatment due to prolonged menstrual cycles or even amenorrhea or infertility. Menstruation is often a sign for women to self-assess whether their female physiology is healthy. Abnormal menstruation can easily increase the patient's psychological stress and aggravate psychological disorders. In addition, external manifestations such as hirsutism, acne, and obesity can also affect the patient's self-confidence, thereby affecting the patient's physical and mental health. [1] .

[0003] In terms of therapeutics, an ideal treatment plan for PCOS has yet to be established. Western medical treatment options include laparoscopic ovarian puncture, ovarian stimulation with medication, anti-androgen medication, and measures to enhance insulin sensitivity. However, these treatments are often staged interventions, are invasive, and have limited efficacy. They offer no positive preventive effect on long-term complications. Furthermore, they have significant side effects, are contraindicated for long-term use, and have a high recurrence rate after discontinuation. Therefore, they are not optimal options for PCOS patients.

[0004] Traditional Chinese Medicine (TCM) believes that the pathogenesis of PCOS is kidney, liver, and spleen dysfunction, resulting in stagnant phlegm and blood stasis, often constituting a syndrome of underlying deficiency and superficial excess. The core of TCM treatment for PCOS is syndrome differentiation and treatment. Common syndromes include spleen and kidney yang deficiency, phlegm and blood stasis, kidney deficiency and blood stasis, and kidney yin deficiency. Treatment focuses on tonifying the kidney, promoting blood circulation and removing stasis, and dispelling dampness and phlegm. A few, based on syndrome differentiation, utilize liver-soothing and spleen-tonifying methods. Medications focus on tonifying kidney yang, promoting blood circulation and removing stasis, and warming and dissolving phlegm and dampness. However, TCM alone often fails to address amenorrhea and menstrual disorders caused by persistent anovulation, as well as hirsutism and acne caused by hyperandrogenism. Therefore, a combination of TCM and oral contraceptives is often used. Because achieving spontaneous ovulation is difficult, a combination of TCM and Western ovulation-inducing medications is often used for women seeking fertility.

[0005] While traditional Chinese medicine currently uses a formula to nourish the kidneys, clear away heat, promote dampness, and dissipate blood stasis for the treatment of patients with kidney yin deficiency-type polycystic ovary syndrome (PCOS), achieving some efficacy, such as the treatment methods described in CN108403919A, it does not significantly improve quality of life, particularly physiological function, physiological function, emotional function, social function, mental health, and other aspects related to depression. Therefore, the present invention provides a novel formula to nourish the kidneys, clear away heat, promote dampness, and dissipate blood stasis, which can significantly improve quality of life while treating PCOS.

[0006] References:

[0007] [1] Liang Ruining, Sun Xueyan, Li Peishuang, et al. Effect of Zishen Qingre Lishi Huayu Decoction on spontaneous ovulation and menstruation in patients with polycystic ovary syndrome of kidney yin deficiency type [J]. Chinese Journal of Integrated Traditional and Western Medicine, 2021. DOI: 10.7661 / j.cjim.20200813.321. Summary of the Invention

[0008] Purpose of the invention: The technical problem to be solved by the present invention is to provide a kidney-nourishing, heat-clearing, dampness-removing and blood stasis-removing prescription and its application in view of the deficiencies in the prior art.

[0009] In order to solve the above technical problems, the present invention discloses the following technical solutions:

[0010] In a first aspect, the present invention provides a traditional Chinese medicine composition and a traditional Chinese medicine extract.

[0011] Traditional Chinese Medicine (TCM) initially recognized PCOS based on its clinical manifestations, including obesity and amenorrhea. Traditional Chinese Medicine (TCM) believes that "obese individuals are prone to phlegm," and the Golden Chamber states that "those suffering from phlegm and fluid should be treated with warming medicines." Phlegm and dampness can also easily block the meridians, leading to the accumulation of phlegm and blood stasis. Therefore, TCM treatment primarily relies on kidney-yang tonifying drugs, blood-activating and blood-stasis-removing drugs, and phlegm-removing and dampness-removing drugs. However, after more than 20 years of clinical research, the inventors discovered that while PCOS patients present with obesity, they also often experience symptoms of damp-heat, such as acne, dry mouth, oily skin, pale or reddish tongue, and a thin, greasy, yellow tongue coating. Based on clinical practice and theoretical research based on classical TCM texts, the inventors determined that the pathogenesis of PCOS is primarily due to kidney yin deficiency, endogenous damp-heat, and blood stasis blocking the collaterals, resulting in "reversed" blood and qi in the Chong meridian. The inventors formulated a primary treatment strategy of nourishing kidney yin, clearing damp-heat, and resolving blood stasis to soothe the Chong meridian. They established a method and formula for nourishing kidney yin, clearing damp-heat, and resolving blood stasis to soothe the Chong meridian.

[0012] In the present invention, the raw materials of the Chinese medicine composition or Chinese medicine extract are Anemarrhena Rhizoma, Rehmannia glutinosa, Carapax Trionycis, Dianthus bistortae, Dendrobium officinale, Peach Kernel, Cucurbitaceae Seed, Coptis chinensis, Phellodendron amurense, Cinnamomum cassia twig and Plantago.

[0013] The Chinese medicine composition comprises the following raw materials in parts by weight: 7-13 parts of Anemarrhena Rhizoma, 7-13 parts of Rehmannia glutinosa, 12-18 parts of Carapax Trionycis, 7-13 parts of Dianthus dianthus, 7-13 parts of Dendrobium candidum, 7-13 parts of Prunus persica, 9-15 parts of Cucurbitaceae seeds, 2-7 parts of Coptis chinensis, 7-13 parts of Phellodendron amurense, 2-7 parts of Cinnamomum cassia, and 7-13 parts of Plantago asiatica. Furthermore, the raw materials include licorice, preferably 2-12 parts of licorice.

[0014] The Chinese herbal medicine extract is prepared from the following raw materials in parts by weight: 7-13 parts of Anemarrhena Rhizoma, 7-13 parts of Rehmannia glutinosa, 12-18 parts of Carapax Trionycis, 7-13 parts of Dianthus dianthus, 7-13 parts of Dendrobium candidum, 7-13 parts of Prunus persica, 9-15 parts of Cucurbitaceae seeds, 2-7 parts of Coptis chinensis, 7-13 parts of Phellodendron amurense, 2-7 parts of Cinnamomum cassia, and 7-13 parts of Plantago asiatica. Furthermore, the raw materials include licorice, preferably 2-12 parts of licorice.

[0015] In this Chinese medicine composition and Chinese medicine extract, Anemarrhena and Rehmannia nourish kidney yin and clear away heat and purge fire as the main drugs; Coptis chinensis and Phellodendron chinense clear away heat and dampness, Carapax trichosanthis nourishes yin and clears heat, softens and disperses hard masses, Dianthus chinensis and Prunus persica promote blood circulation, removes blood stasis and promotes menstruation as the assistant drugs; Trichosanthes kirilowii seed clears heat and resolves phlegm, Dendrobium candidum nourishes the stomach and promotes fluid production, nourishes yin and clears heat, Plantago asiatica clears heat and promotes urination, and Cinnamomum cassiae calms the stomach and reduces adverse reactions as the adjuvant drugs; Licorice harmonizes all the drugs as the guiding drug. The whole formula works together to nourish kidney yin, clear away dampness and heat, remove blood stasis and promote menstruation.

[0016] The effects of these Chinese herbal medicines are as follows:

[0017] Anemarrhena: bitter and cold in nature, enters the lung, stomach and kidney meridians; Efficacy: nourishes yin and reduces fire, moisturizes dryness and lubricates the intestines.

[0018] Rehmannia root: This can be prepared by mixing raw Rehmannia root with rice wine, then steaming it in the sun. It has a sweet flavor and warm properties, and enters the liver and kidney meridians. Benefits: It nourishes the blood, replenishes the essence, and replenishes the marrow.

[0019] Turtle Shell: salty and cold in nature, enters the Liver and Kidney meridians; Efficacy: nourishes Yin and suppresses Yang, softens and disperses lumps.

[0020] Dianthus superbus: bitter and cold in nature, enters the heart and small intestine meridians; effects: diuretic, relieving stranguria, promoting blood circulation and dredging menstruation.

[0021] Dendrobium: sweet in nature, slightly cold, enters the stomach and kidney meridians; Efficacy: nourishes yin, clears heat, benefits the stomach and promotes fluid production;

[0022] Peach kernel: bitter and sweet in nature, neutral in nature, enters the heart, liver, and large intestine meridians; Efficacy: promotes blood circulation and removes blood stasis, moistens the intestines and promotes bowel movements, relieves cough and asthma.

[0023] Guarana seeds: sweet and cold in nature, enter the lung, stomach and large intestine meridians. Efficacy: moistens the lungs and resolves phlegm, moistens the intestines and promotes bowel movements.

[0024] Coptis chinensis: bitter and cold in nature, enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians. Efficacy: clears heat and dampness, purges fire and detoxifies.

[0025] Phellodendron chinense: bitter and cold in nature, enters the kidney, bladder, and large intestine meridians. Efficacy: clears heat and dampness, purges fire and detoxifies, reduces fever and eliminates steam.

[0026] Cinnamon Twig: Pungent and sweet, warm in nature, enters the Lung, Heart, and Bladder meridians. Benefits: Induces sweating and relaxes muscles, warms and unclogs the meridians, and enhances yang and transforms qi. It calms and relieves adverse reactions, making it a key herb for treating adverse reactions.

[0027] Plantago: Sweet and cold in nature, enters the liver, kidney, lung, and small intestine meridians. Efficacy: clears heat, promotes urination, eliminates phlegm, cools blood, and detoxifies.

[0028] Licorice: Sweet and mild in nature, enters the Heart, Lung, Spleen, and Stomach meridians. Efficacy: Tonifies the spleen and replenishes Qi, clears away heat and detoxifies, and harmonizes various medicines.

[0029] In some cases, the Chinese medicine composition includes the following raw materials in parts by weight: 7-13 parts of Anemarrhena, 7-13 parts of Rehmannia, 12-18 parts of Carapax Trionycis, 7-13 parts of Dianthus, 7-13 parts of Dendrobium, 7-13 parts of Peach Kernel, 9-15 parts of Cucurbita, 2-7 parts of Coptis, 7-13 parts of Phellodendron, 2-7 parts of Cinnamon Twig, 7-13 parts of Plantago, and 2-12 parts of Licorice; preferably, the weight parts of each raw material are as follows: 8-12 parts of Anemarrhena, 8-12 parts of Rehmannia, 13-17 parts of Carapax Trionycis, 8-12 parts of Dianthus, 8-12 parts of Dendrobium, 8-12 parts of Peach Kernel, 10-14 parts of Cucurbita, 2-6 parts of Coptis, 8-12 parts of Phellodendron, 2-7 parts of Cinnamon Twig, 8-12 parts of Plantago, and 2-12 parts of Licorice. 2-12 parts; preferably, the weight portions of each raw material are as follows: 8-12 parts of Anemarrhena, 8-12 parts of Rehmannia, 13-17 parts of Carapax Trionycis, 8-12 parts of Dianthus, 8-12 parts of Dendrobium, 8-12 parts of Peach Kernel, 10-14 parts of Cucurbita wilt kernel, 2-6 parts of Coptis chinensis, 8-12 parts of Phellodendron, 2-5 parts of Cinnamon Twig, 8-12 parts of Plantago, and 4-10 parts of Licorice; preferably, the weight portions of each raw material are as follows: 10 parts of Anemarrhena, 8-12 parts of Rehmannia, 13-17 parts of Carapax Trionycis, 8-12 parts of Dianthus, 8-12 parts of Dendrobium, 8-12 parts of Peach Kernel, 10-14 parts of Cucurbita wilt kernel, 2-6 parts of Coptis chinensis, 8-12 parts of Phellodendron, 2-5 parts of Cinnamon Twig, 8-12 parts of Plantago, and 4-10 parts of Licorice. One example is: 10 parts of Anemarrhena Rhizoma, 10 parts of Rehmannia glutinosa, 15 parts of Carapax Trionycis, 10 parts of Dianthus Root, 10 parts of Dendrobium Officinale, 10 parts of Peach Kernel, 12 parts of Cucurbitaceae Seed, 3 parts of Coptis chinensis, 10 parts of Phellodendron Amurense, 3 parts of Cinnamon Twig, 10 parts of Plantago asiatica, and 6 parts of Licorice. Another example is: 10 parts of Anemarrhena Rhizoma, 10 parts of Prepared Rehmannia Glutinosa, 15 parts of Carapax Trionycis, 10 parts of Dianthus Root, 10 parts of Dendrobium Officinale, 10 parts of Peach Kernel, 12 parts of Cucurbitaceae Seed, 3 parts of Coptis chinensis, 10 parts of Phellodendron Amurense, 3 parts of Cinnamon Twig, 10 parts of Plantago asiatica, and 6 parts of Licorice.

[0030] In some cases, the Chinese medicine extract is prepared from the following raw materials in parts by weight: 7-13 parts of Anemarrhena Rhizoma, 7-13 parts of Rehmannia glutinosa, 12-18 parts of Carapax Trionycis, 7-13 parts of Dianthus bistortae, 7-13 parts of Dendrobium officinale, 7-13 parts of Peach Kernel, 9-15 parts of Cucurbitaceae, 2-7 parts of Coptis chinensis, 7-13 parts of Phellodendron amurense, 2-7 parts of Cinnamon Twig, 7-13 parts of Plantago asiatica, and 2-12 parts of Licorice; preferably, the weight parts of each raw material are as follows: 8-12 parts of Anemarrhena Rhizoma, 8-12 parts of Rehmannia glutinosa, 13-17 parts of Carapax Trionycis, 8-12 parts of Dianthus bistortae, 8-12 parts of Dendrobium officinale, 8-12 parts of Peach Kernel, 10-14 parts of Cucurbitaceae, 2-6 parts of Coptis chinensis, 8-12 parts of Phellodendron amurense, 2-7 parts of Cinnamon Twig, 8-12 parts of Plantago asiatica, 2-12 parts of licorice; preferably, the weight parts of each raw material are as follows: 8-12 parts of Anemarrhena, 8-12 parts of Rehmannia, 13-17 parts of Carapax Trionycis, 8-12 parts of Dianthus, 8-12 parts of Dendrobium, 8-12 parts of Peach Kernel, 10-14 parts of Cucurbita wilt kernel, 2-6 parts of Coptis chinensis, 8-12 parts of Phellodendron, 2-5 parts of Cinnamon Twig, 8-12 parts of Plantago, and 4-10 parts of licorice; preferably, the weight parts of each raw material are as follows: 10 parts of Anemarrhena, 8-12 parts of Rehmannia, 13-17 parts of Carapax Trionycis, 8-12 parts of Dianthus, 8-12 parts of Dendrobium, 8-12 parts of Peach Kernel, 10-14 parts of Cucurbita wilt kernel, 2-6 parts of Coptis chinensis, 8-12 parts of Phellodendron, 2-5 parts of Cinnamon Twig, 8-12 parts of Plantago, and 4-10 parts of licorice. One example is: 10 parts of Anemarrhena Rhizoma, 10 parts of Rehmannia glutinosa, 15 parts of Carapax Trionycis, 10 parts of Dianthus Root, 10 parts of Dendrobium Officinale, 10 parts of Peach Kernel, 12 parts of Cucurbitaceae Seed, 3 parts of Coptis chinensis, 10 parts of Phellodendron Amurense, 3 parts of Cinnamon Twig, 10 parts of Plantago asiatica, and 6 parts of Licorice. Another example is: 10 parts of Anemarrhena Rhizoma, 10 parts of Prepared Rehmannia Glutinosa, 15 parts of Carapax Trionycis, 10 parts of Dianthus Root, 10 parts of Dendrobium Officinale, 10 parts of Peach Kernel, 12 parts of Cucurbitaceae Seed, 3 parts of Coptis chinensis, 10 parts of Phellodendron Amurense, 3 parts of Cinnamon Twig, 10 parts of Plantago asiatica, and 6 parts of Licorice.

[0031] The Chinese medicine composition and Chinese medicine extract are prepared by the following method: weighing raw materials in parts by weight, the raw materials including Anemarrhena Rhizoma, Rehmannia glutinosa, Carapax Trionycis, Dianthus ferox, Dendrobium candidum, Peach Kernel, Cucurbitaceae Seed, Coptis chinensis, Phellodendron amurense, Cinnamomum cassia twig, Plantago, and further the raw materials including Licorice, decocting and filtering to obtain a filtrate containing the Chinese medicine composition or the Chinese medicine extract; wherein the decocting is decocting with water; preferably, the mass of the water is 8-10 times the mass of the raw materials; preferably, the number of decocting is 1-3 times; preferably, the total decocting time is 1-3 hours.

[0032] In a second aspect, the present invention provides a method for preparing the Chinese medicine composition and Chinese medicine extract described in the first aspect.

[0033] The preparation method of the traditional Chinese medicine composition and the traditional Chinese medicine extract comprises: weighing raw materials according to weight, the raw materials comprising rhizoma anemarrhenae, rehmannia root, turtle shell, herba dianthus, dendrobium, peach kernel, cucurbita wilt seed, coptis root, phellodendron amurense, cassia twig, and plantain, and further comprising liquorice, decocting, filtering, and obtaining a filtrate containing the traditional Chinese medicine composition or the traditional Chinese medicine extract.

[0034] Wherein, the decoction is performed by adding water; preferably, the mass of the water is 8-10 times the mass of the raw material; preferably, the decoction is performed 1-3 times; preferably, the total decoction time is 1-3 hours.

[0035] In a third aspect, the present invention provides a pharmaceutical preparation.

[0036] The traditional Chinese medicine composition and the traditional Chinese medicine extract obtained by the present invention can also be prepared into various preparations by adding different auxiliary materials and adopting conventional preparation processes according to the needs of clinical use.

[0037] The pharmaceutical preparation comprises (i) the Chinese medicine composition or Chinese medicine extract described in the first aspect, or the Chinese medicine composition or Chinese medicine extract prepared by the method described in the second aspect, or a combination of the foregoing; and (ii) pharmaceutically acceptable excipients.

[0038] The pharmaceutical preparation uses the traditional Chinese medicine composition for treating polycystic ovary syndrome as an active ingredient, and the pharmaceutical preparation is prepared into a common dosage form in pharmacy by conventional preparation methods in the art.

[0039] The pharmaceutical preparation of the present invention can be prepared by the following method:

[0040] (A) weighing the medicinal material components, mixing them, and obtaining a mixture;

[0041] (B) A pharmaceutically acceptable carrier is added to the mixture and prepared by conventional preparation methods in the art.

[0042] In a fourth aspect, the present invention provides the Chinese medicine composition and Chinese medicine extract described in the first aspect, the Chinese medicine composition and Chinese medicine extract prepared by the method described in the second aspect, and the use of the pharmaceutical preparation described in the third aspect in the preparation of products for treating polycystic ovary syndrome and / or depression.

[0043] Wherein, the product includes medicine or health food.

[0044] Wherein, the treatment of polycystic ovary syndrome is to improve the quality of life while treating polycystic ovary syndrome.

[0045] In a fifth aspect, the present invention provides a drug for treating polycystic ovary syndrome, wherein the drug uses the Chinese medicine composition and Chinese medicine extract described in the first aspect, the Chinese medicine composition and Chinese medicine extract prepared by the method described in the second aspect, or the pharmaceutical preparation described in the third aspect as an active ingredient.

[0046] In a sixth aspect, the present invention provides a product for treating polycystic ovary syndrome and / or depression, which comprises the Chinese medicine composition and Chinese medicine extract described in the first aspect, the Chinese medicine composition and Chinese medicine extract prepared by the method described in the second aspect, and the pharmaceutical preparation described in the third aspect.

[0047] Wherein, the product includes medicine or health food.

[0048] Wherein, the treatment of polycystic ovary syndrome is to improve the quality of life while treating polycystic ovary syndrome.

[0049] An example of the Rehmannia root described in the present invention is Rehmannia root prepared from cooked Rehmannia root; an example of the Carapace of Turtle is Carapace of Turtle with Vinegar.

[0050] The dosage of the pharmaceutical preparation of the present invention can be determined based on the amount of the drug contained in the final preparation to achieve the therapeutically effective dose and achieve the preventive and / or therapeutic effects of the present invention.

[0051] The traditional Chinese medicine composition of the present invention is a traditional Chinese medicine composition for treating polycystic ovary syndrome and / or depression.

[0052] The traditional Chinese medicine extract of the present invention is a traditional Chinese medicine extract used for treating polycystic ovary syndrome and / or depression.

[0053] The pharmaceutical preparation of the present invention is a pharmaceutical preparation for treating polycystic ovary syndrome and / or depression.

[0054] Improving the quality of life in the present invention includes:

[0055] Improvement in scores on any one or more of the Short Form-36 (SF-36) health questionnaire dimensions of physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health;

[0056] and / or,

[0057] Improve the scores on any one or more of the following dimensions of body hair, mood, weight, infertility, and menstruation in the PCOS Quality of Life Questionnaire (PCOSQ). Beneficial effects:

[0058] The kidney-nourishing, heat-clearing, dampness-removing and blood-stasis-removing prescription provided by the present invention can not only treat polycystic ovary syndrome but also significantly improve the quality of life and has the effect of preventing and treating depression.

[0059] The kidney-nourishing, heat-clearing, dampness-removing and blood-stasis-removing prescription provided by the present invention can not only help PCOS patients restore ovarian function, promote ovulation and facilitate pregnancy, but also has few side effects, no drug dependence and good safety.

[0060] The traditional Chinese medicine composition provided by the present invention for treating polycystic ovary syndrome (PCOS) uses inexpensive raw materials, is simple to prepare, easy to use, has minimal side effects, and can be taken long-term. Years of clinical application research have shown that it has good efficacy in treating PCOS. Given the large number of PCOS patients and the poor efficacy of current clinical hormonal treatments, the traditional Chinese medicine compound preparation provided by the present invention has promising application prospects. DETAILED DESCRIPTION

[0061] The experimental methods described in the following examples are conventional methods unless otherwise specified. The reagents and materials described are commercially available unless otherwise specified. The medicinal materials described are all prepared slices of Chinese herbal medicines, which can be obtained from sales companies or processed after purchase, unless otherwise specified.

[0062] Example 1: Effect of the Zishen Qingre Lishi Huayu Recipe on Spontaneous Ovulatory Menstruation in PCOS Patients: A Multicenter, Double-Blind, Randomized Placebo-Controlled Trial

[0063] 1.1 Experimental design

[0064] This study was a multicenter, double-blind, randomized, placebo-controlled trial conducted in accordance with the Declaration of Helsinki and approved by the medical ethics committees of the participating institutions.

[0065] 1.2 Subjects

[0066] The subjects were patients with polycystic ovarian syndrome (PCOS). All included patients met the criteria and signed informed consent.

[0067] 1.3 Inclusion criteria

[0068] ① PCOS was diagnosed according to the modified Rotterdam diagnostic criteria: oligomenorrhea (menstrual cycle ≥ 35 days) or amenorrhea (no menstruation for 6 months) was a necessary condition; additional conditions were a. transvaginal / rectal ultrasound examination showed ≥12 antral follicles with a diameter less than 10 mm or an ovarian volume greater than 10 cm. 3 ; or b. clinical or biochemical hyperandrogenism (clinical hyperandrogenism includes hirsutism, acne, and androgenic alopecia; biochemical hyperandrogenism refers to elevated serum testosterone levels).

[0069] ② Patients aged 18-40 who have no fertility requirements.

[0070] ③ Willing to follow the treatment plan specified in this trial.

[0071] 1.4 Exclusion criteria

[0072] ① Hyperprolactinemia: The serum prolactin (PRL) level is ≥25 ng / ml on two occasions at least one week apart;

[0073] ② Serum follicle-stimulating hormone (FSH)>15IU / L;

[0074] ③ Patients with thyroid disease, serum thyroid stimulating hormone (TSH) <0.2mIU / mL or >5.5mIU / mL;

[0075] ④ Patients with poorly controlled type II diabetes;

[0076] ⑤ Patients suspected of Cushing's syndrome;

[0077] ⑥ Patients suspected of having adrenal or ovarian tumors secreting androgens;

[0078] ⑦ Hypertensive patients with poorly controlled blood pressure, systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg;

[0079] ⑧Those who have taken hormones or other drugs in the last 3 months that may affect the results;

[0080] ⑨ Pregnant or breastfeeding women;

[0081] ⑩Serious or acute diseases of the heart, liver, kidney, or blood.

[0082] 1.5 Randomization and blinding

[0083] Eligible subjects were randomly assigned in a 1:1 ratio to either the traditional Chinese medicine (TCM) or placebo group. The randomization sequence was computer-generated by an independent researcher not involved in treatment, data collection, or assessment. The randomization number and group assignment were provided to each subcenter. The study was then printed with the subject number on the outer packaging of the corresponding medication or placebo according to the defined group assignment scheme. The study was double-blind, with subjects, investigators, and physicians unaware of the intervention. The investigators distributed the study medications according to the order in which the subjects were enrolled, corresponding to the number on the packaging.

[0084] 1.6 Intervention measures

[0085] The treatment group (TCM group) received the traditional Chinese medicine formula "Zishen Qingre Lishi Huayu" (Zishen Qingre Lishi Huayu) for 12 ingredients: 10g of Anemarrhena Rhizoma, 10g of Rehmanniae Preparata, 15g of Vinegar-sweetened Carapace of Turtle, 10g of Dianthus Dianthus, 10g of Dendrobium Candidum, 10g of Prunus Persicae, 12g of Cucurbitaceae Semen, 3g of Coptis Chinensis, 10g of Phellodendron Amurense, 3g of Cinnamomum Cassiae, 10g of Plantago, and 6g of Licorice Root. The formula was decocted twice with 8 times the amount of water, administered every 1.5 hours. The control group received a placebo. Both drugs were packaged identically, with the same appearance, odor, and color. Participants took the prescribed dose twice daily, morning and evening, from the first day of enrollment for three months.

[0086] 1.7 Outcome Measures

[0087] The primary outcome measure was the monthly ovulation rate (total number of ovulations in each group during the 3-month treatment period / number of samples in each group × 3). Ovulation was defined as a progesterone level >3 ng / mL. When basal body temperature measurement indicated biphasic temperature, serum progesterone levels were measured after the high temperature persisted for 2-4 days.

[0088] Secondary outcome measures included: 1) Menstrual status, including the number of menstrual periods and average menstrual cycle length during the 3-month treatment period. 2) Anthropometric characteristics, including weight, body mass index, and waist-to-hip ratio. 3) Hair: The Ferriman-Gallwey questionnaire was used to assess hair on nine body areas (upper lip, chin, chest, arms, upper abdomen, lower abdomen, upper back, lower back, and thighs), with a score ranging from 0 (absent) to 4 (equivalent to a hairy man). 4) Acne: The Rosenfield criteria were used to score acne on a scale of 0 to 5 based on the nature and number of lesions. 5) Glucose and lipid metabolism indicators, including total cholesterol, triglycerides, fasting blood glucose, insulin, 2-hour blood glucose and insulin levels after an oral glucose tolerance test, and insulin resistance (IR) calculated using the formula (basal glucose mmol / l × basal insulin mIU / L / 22.5). 6) Quality of Life: The Short Form-36 (SF-36) health questionnaire and the PCOS Quality of Life Questionnaire (PCOSQ) were used to assess quality of life. The SF-36 is the most commonly used general tool for measuring quality of life. It consists of 8 dimensions (physical function, physical role, bodily pain, general health, vitality, social function, emotional role, and mental health), with a total of 36 items. The score for each dimension ranges from 0 to 100, with higher scores indicating better conditions. The PCOSQ is a specific tool for measuring quality of life in PCOS. It consists of 5 dimensions (body hair, mood, weight, infertility, and menstruation), with a total of 26 items. Each item is scored from 1 (always) to 7 (never), with higher scores indicating better function. 7) Adverse Events Related to Study Drug: All adverse events occurring during the subject's treatment were recorded and assessed to determine their relevance to the study treatment.

[0089] 1.8 Statistical analysis

[0090] In a preliminary pilot study, we found that the monthly ovulation rate for the traditional Chinese medicine formula Zishen Qingre Lishi Huayu (Zishen Qingre Lishi Huayu) in PCOS was 40.3%, compared with a monthly ovulation rate of 15.8% for placebo. α is the type I error probability, and β is the type II error probability. Taking into account a 25% dropout rate, we calculated that 63 eligible subjects were required to be included in each group, for a total sample size of 126 subjects across both groups.

[0091] Data analysis was performed by a statistician who was blinded to the group assignments. Intention-to-treat (ITT) analyses included all randomized participants, with unobserved outcome events uniformly recorded as "non-ovulation." Per-protocol (PP) analyses included participants who received the entire intervention, excluding those who were lost to follow-up, withdrew, discontinued, or intermittently took medication for various reasons. Furthermore, a sensitivity analysis was performed to compare secondary outcome measures after excluding 12 participants (5 in the control group and 7 in the treatment group) who had intermittent medication. Continuous variables with a normal distribution were expressed as mean ± standard deviation, and differences between groups were compared using two-sample t-tests. Continuous variables with non-normal distributions were expressed as medians (interquartile ranges), and differences between groups were compared using the Wilcoxon rank-sum test. Categorical variables were expressed as frequencies and percentages, and differences between groups were compared using the chi-square test. All statistical analyses were performed in SAS 9.4 software, using two-sided tests, with P < 0.05 considered statistically significant.

[0092] 1.9 Results

[0093] This study enrolled 126 eligible subjects, of whom 117 completed all treatment and follow-up visits. Two subjects in the treatment group withdrew for personal reasons, two became pregnant, and two were lost to follow-up. Two subjects in the control group withdrew for personal reasons, one became pregnant. Additionally, seven subjects in the treatment group and five subjects in the control group interrupted their medication during treatment due to home quarantine due to Covid-19. Baseline characteristics before treatment were comparable between the two groups (see Table 1).

[0094] In terms of ovulation, during the 3-month treatment period, both ITT and PP analyses showed that the monthly spontaneous ovulation rate in the TCM group was significantly higher than that in the control group (ITT: 36.5% vs. 14.3%, P < 0.001, RR 2.56, 95% CI 1.72 to 3.80; PP: 38.0% vs. 14.6%, P < 0.001, RR 2.61, 95% CI 1.71 to 3.99, see Table 2).

[0095] In terms of menstruation, during the 3-month treatment period, both ITT and PP analyses showed that the number of menstrual cramps in the TCM group was significantly higher than that in the control group (ITT: 27.0% vs. 11.6%, P < 0.001, RR 2.32, 95% CI 1.47 to 3.66; PP: 29.3% vs. 12.1%, P < 0.001, RR 2.42, 95% CI 1.50 to 3.91, see Table 2). The average menstrual cycle length in the TCM group was shortened by 8.66 ± 28.71 days, which was significantly different from that in the control group (P < 0.001) (see Table 3).

[0096] After three months of treatment, there were no significant differences in body weight, body mass index, waist-to-hip ratio, or Ferriman-Gallwey hair score between the two groups. The acne score in the TCM group decreased by 0.6±0.81, a statistically significant difference compared with the control group (P<0.001). There were no statistically significant differences in glucose and lipid metabolism between the two groups (see Table 3).

[0097] In terms of quality of life, after three months of treatment, the PCOSQ and SF-36 scores in the TCM group were significantly higher than at baseline. The scores for body hair, mood, menstruation, weight, and infertility in the TCM group increased to varying degrees, with statistically significant differences compared to the control group (P < 0.001), with the mood score being the most significant (an increase of 2.13 ± 1.60). The TCM group also showed significant improvements in the SF-36 scores for physical function, physical role, emotional role, social function, mental health, vitality, bodily pain, and overall health compared to baseline, with significant differences compared to the control group (P < 0.001) (Table 3).

[0098] No drug-related adverse events occurred during the study, and after the end of treatment, there were no abnormalities in safety tests such as routine blood tests and liver and kidney function tests.

[0099] Table 1 Baseline characteristics Note: Hair, acne, total cholesterol, fasting insulin, HOMA-IR, and the SF-36 health questionnaire did not conform to a normal distribution and are presented as medians (25th and 75th percentiles) with a rank sum test. All other parameters are presented as mean ± standard deviation with a two-sample t-test. All P values ​​were greater than 0.05, indicating that the two groups were comparable at baseline.

[0100] Table 2 Comparison of ovulation rate and menstrual frequency, n (%). Note: 1. In ITT and PP analyses, n (%) represents the number of outcomes (frequency), not the number of participants in the sample. 2. The total sample size for ITT was 63 participants in the control group and 63 participants in the treatment group. The total sample size for PP was 55 participants in the control group and 50 participants in the treatment group (excluding all participants who did not receive the full intervention).

[0101] 3. P values ​​were calculated using the chi-square test.

[0102] Table 3 Comparison of other secondary outcome indicators Note: The difference in effect before and after the intervention is the difference between the indicators three months later and the baseline indicators (reflecting the treatment effect). The difference conforms to the normal distribution (sample size ≥ 50) and is expressed as mean ± standard deviation. Two independent sample t-tests are used to compare whether there is any difference in the mean of the difference between the treatment group and the control group.

[0103] Example 2

[0104] Recipe: 10 parts of Anemarrhena Rhizoma, 10 parts of Rehmannia glutinosa, 15 parts of Vinegar-soaked Turtle Shell, 10 parts of Dianthus Root, 10 parts of Dendrobium, 10 parts of Peach Kernel, 12 parts of Cucurbitacin Kernel, 3 parts of Coptis Rhizome, 10 parts of Phellodendron Amurense, 3 parts of Cinnamon Twig, 10 parts of Plantago, and 6 parts of Licorice.

[0105] Preparation process: Weigh each component according to the formula, add water 8 times the total mass of the raw materials, decoct twice, each decoction for 1 hour, filter to obtain the filtrate; the obtained filtrate is concentrated to obtain a concentrated solution, the concentrated solution is further concentrated and dried, and prepared into a preparation according to a conventional method.

[0106] Example 3

[0107] Recipe: 8 parts of Anemarrhena Rhizoma, 12 parts of Rehmannia glutinosa, 13 parts of Vinegar-soaked Turtle Shell, 12 parts of Dianthus Root, 12 parts of Dendrobium, 8 parts of Peach Kernel, 14 parts of Cucurbitacin Kernel, 2 parts of Coptis Rhizome, 8 parts of Phellodendron Amurense, 3 parts of Cinnamon Twig, 8 parts of Plantago, and 6 parts of Licorice.

[0108] Preparation process: Weigh each component according to the formula, add water 8 times the total mass of the raw materials, decoct once, decoct for 2 hours, filter to obtain a filtrate; the obtained filtrate is concentrated to obtain a concentrated solution, which can be further concentrated and dried, and prepared into a preparation according to conventional methods.

[0109] Example 4

[0110] Recipe: 10 parts of Anemarrhena Rhizoma, 10 parts of Rehmannia glutinosa, 15 parts of Vinegar-soaked Turtle Shell, 10 parts of Dianthus Root, 10 parts of Dendrobium, 10 parts of Peach Kernel, 12 parts of Cucurbitacin Kernel, 3 parts of Coptis Rhizome, 10 parts of Phellodendron Amurense, 3 parts of Cinnamon Twig, 10 parts of Plantago, and 10 parts of Licorice.

[0111] Preparation process: Weigh each component according to the formula, add water 10 times the total mass of the raw materials, decoct once, decoct for 1.5 hours, filter to obtain the filtrate; concentrate the filtrate to obtain a concentrated solution, further concentrate and dry the concentrated solution, and prepare the preparation according to the conventional method.

[0112] Example 5

[0113] Recipe: 10 parts of Anemarrhena Rhizoma, 10 parts of Rehmannia glutinosa, 15 parts of Vinegar-soaked Turtle Shell, 10 parts of Dianthus Root, 10 parts of Dendrobium Candidum, 10 parts of Peach, 12 parts of Cucurbitacin Semen, 3 parts of Coptis Rhizome, 10 parts of Phellodendron Amurense, 5 parts of Cinnamon Twig, 10 parts of Plantago, and 6 parts of Licorice.

[0114] Preparation process: Weigh each component according to the formula, add water 8 times the total mass of the raw materials, decoct twice, decoct for 1 hour, filter to obtain the filtrate; concentrate the filtrate to obtain a concentrated solution, further concentrate and dry the concentrated solution, and prepare the preparation according to the conventional method.

[0115] Example 6

[0116] Recipe: 12 parts of Anemarrhena Rhizoma, 8 parts of Rehmannia glutinosa, 17 parts of Vinegar-soaked Turtle Shell, 8 parts of Dianthus Root, 8 parts of Dendrobium, 12 parts of Peach Kernel, 10 parts of Cucurbitacin Kernel, 6 parts of Coptis Rhizome, 12 parts of Phellodendron Amurense, 2 parts of Cinnamon Twig, 12 parts of Plantago, and 4 parts of Licorice.

[0117] Preparation process: Weigh each component according to the formula, add water 10 times the total mass of the raw materials, decoct three times, decoct for 1h, 3h, and 2h respectively, filter, and combine the filtrate; the obtained filtrate is concentrated to obtain a concentrated solution, the concentrated solution is further concentrated and dried, and prepared into a preparation according to conventional methods.

[0118] The products provided in Examples 2-6, like those in Example 1, can treat polycystic ovary syndrome while significantly improving the quality of life and have the effect of preventing and treating depression.

[0119] Example 7: Depression Treatment Effect Case

[0120] Case 1: Ms. Li, 35 years old, with normal menstruation, had suffered from severe depression for 7 months, difficulty sleeping, low self-esteem, despair, and frequent suicidal thoughts. After taking the drug of Example 1 for 12 weeks, all clinical symptoms disappeared. The patient's sleep evaluation exceeded 7.5 hours per night, and there was no change in the following six months.

[0121] Case 2: Chen, female, 46 years old, with normal menstruation, suffered from severe depression for 12 months, difficulty falling asleep, low self-esteem, despair, and frequent suicidal thoughts. After taking the Chinese medicine formula of Example 5 for 10 weeks, the clinical symptoms basically disappeared. The patient's sleep evaluation per night exceeded 7 hours, and there was no change in the following year.

[0122] Comparative Example 1:

[0123] 1.1 Treatment methods

[0124] The treatment group received the existing CPOS formula (composition: Rhizoma Anemarrhenae 10g, Fructus Corni 10g, Radix Salviae Miltiorrhizae 10g, Semen Persicae 10g, Semen Coicis 15g, Semen Sinapis Albiflora 10g, Cortex Phellodendri 10g, Radix Scrophulariae 10g, and Radix Glycyrrhizae 6g, each 12.6g bag containing 45.5g of crude drugs, manufactured by Guangdong Yifang Pharmaceutical Co., Ltd., CPOS batch number: 2014101602). The placebo group received a placebo (composition: starch, pigment, bitter element, and ginseng essence; CPOS and placebo were identical in weight and packaging, and similar in appearance, odor, and color; manufactured by Guangdong Yifang Pharmaceutical Co., Ltd., placebo batch number: 2014101609). One packet was taken daily, morning and evening, with boiled water, for three consecutive months. Patients were required to maintain a normal diet and physical activity throughout the study and were not permitted to take any other medications that could affect the results. The study subjects were assigned a serial number on the outer packaging of the corresponding drug or sham. The investigators distributed the drug according to the serial number on the packaging. Neither the investigators nor the patients knew about the group assignments or medications they were taking.

[0125] 1.2 Observation indicators

[0126] Quality of life was assessed using the PCOS Quality of Life Questionnaire (PCOSQ) and the Short Form-36 (SF-36) health questionnaire. The PCOSQ is a specific tool for measuring quality of life in PCOS. It consists of 26 items in five dimensions: body hair, mood, weight, infertility, and menstruation. Each item is scored on a scale from 1 (always) to 7 (never), with higher scores indicating better function. The SF-36 is the most commonly used general quality of life tool. It consists of 36 items in eight dimensions (physical function, role physical function, bodily pain, general health, vitality, social function, role emotional function, and mental health). Scores for each dimension range from 0 to 100, with higher scores indicating better quality of life.

[0127] 1.3 Statistical analysis

[0128] Data were processed using SAS 9.4 statistical software. Continuous variables with a normal distribution were expressed as mean ± standard deviation, and differences between groups were compared using two independent sample t-tests. Continuous variables with non-normal distributions were expressed as medians (interquartile ranges), and differences between groups were compared using the Wilcoxon rank-sum test. Categorical variables were expressed as frequency and percentage, and differences between groups were compared using the chi-square test. Two-sided tests were used, and P < 0.05 was considered statistically significant.

[0129] 1.4 Results

[0130] This study enrolled 50 subjects with PCOS, of whom 48 completed all treatment and follow-up. Two subjects in the control group withdrew for personal reasons, one was lost to follow-up, and one withdrew from the trial due to hyperthyroidism during treatment. Baseline characteristics before treatment were comparable between the two groups (see Table 4).

[0131] In terms of quality of life, after 3 months of treatment, there was no significant difference between the CPOS prescription and the control group in SF-36 physical function, physical role, emotional role, social function, mental health, vitality, bodily pain and overall health (P>0.05) (see Table 5).

[0132] Table 4 Baseline characteristics Note: Data are presented as mean ± standard deviation and tested using two independent sample T-tests. All P values ​​were greater than 0.05, indicating that the two groups were comparable at baseline.

[0133] Table 5 Comparison of indicators before and after intervention Note: The difference in effect before and after the intervention is the difference between the indicators three months later and the baseline indicators (reflecting the treatment effect). The difference conforms to the normal distribution and is expressed as mean ± standard deviation. Two independent sample t-tests are used to compare whether there is any difference in the mean difference of the indicators between the treatment group and the control group.

[0134] Comparative Example 2:

[0135] The inventors of this application conducted a study on PCOS using the Chinese medicine group 1 oral nourishing kidney, clearing heat, promoting dampness, removing blood stasis and unblocking meridians prescription, which is Chinese invention number 201810536499.6, and the Chinese medicine group 2 oral nourishing kidney, clearing heat, promoting dampness, removing blood stasis and unblocking meridians prescription. The research results showed that in terms of various indicators of quality of life such as physiological function, physiological function, emotional function, social function, mental health, vitality, physical pain and overall health, there was no significant difference between the Chinese medicine group 1 and the Chinese medicine group 2 and the control group.

[0136] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the present invention shall be determined by the appended claims.

Claims

1. A Chinese medicine composition, characterized in that: The invention comprises the following raw materials in parts by weight: 7-13 parts of Anemarrhena asphodeloides, 7-13 parts of Rehmannia glutinosa, 12-18 parts of Carapace of Turtle, 7-13 parts of Dianthus superbus, 7-13 parts of Dendrobium officinale, 7-13 parts of Peach Kernel, 9-15 parts of Cucurbitacinum aviculare, 2-7 parts of Coptis chinensis, 7-13 parts of Phellodendron amurense, 2-7 parts of Cinnamomum cassia twig and 7-13 parts of Plantago.

2. A Chinese medicine extract, characterized in that: The invention is prepared from the following raw materials in parts by weight: 7-13 parts of Anemarrhena Rhizoma, 7-13 parts of Rehmannia Glutinosa, 12-18 parts of Carapace of Trionycis, 7-13 parts of Dianthus Superbus, 7-13 parts of Dendrobium Officinale, 7-13 parts of Peach Kernel, 9-15 parts of Cucurbitacin Semen, 2-7 parts of Coptis Chinensis, 7-13 parts of Phellodendron Amurense, 2-7 parts of Cinnamomum Cassia Twig and 7-13 parts of Plantago.

3. The Chinese medicine composition according to claim 1 or the Chinese medicine extract according to claim 2, characterized in that: The raw materials include licorice, and the licorice is preferably 2-12 parts; further, the weight proportions of each raw material are as follows: 8-12 parts of Anemarrhena, 8-12 parts of Rehmannia, 13-17 parts of Carapax Trionycis, 8-12 parts of Dianthus Superbus, 8-12 parts of Dendrobium, 8-12 parts of Peach Kernel, 10-14 parts of Cucurbitacin, 2-6 parts of Coptis, 8-12 parts of Phellodendron, 2-7 parts of Cinnamon Twig, 8-12 parts of Plantago, and 2-12 parts of Licorice; preferably, the weight proportions of each raw material are as follows: 8-12 parts of Anemarrhena, 8-12 parts of Rehmannia, 13-17 parts of Carapax Trionycis, 8-12 parts of Dianthus Superbus, 8-12 parts of Dendrobium, 8-12 parts of Peach Kernel, 10-14 parts of Cucurbitacin, 2-6 parts of Coptis, 8-12 parts of Phellodendron, 2-5 parts of cinnamon twig, 8-12 parts of plantain, and 4-10 parts of licorice; preferably, the weight proportions of each raw material are as follows: 10 parts of Anemarrhena, 8-12 parts of Rehmannia, 13-17 parts of Carapax Trionycis, 8-12 parts of Dianthus Superbus, 8-12 parts of Dendrobium, 8-12 parts of Peach Kernel, 10-14 parts of Cucurbitacin, 2-6 parts of Coptis, 8-12 parts of Phellodendron, 2-5 parts of cinnamon twig, 8-12 parts of Plantain, and 4-10 parts of licorice; further, 10 parts of Anemarrhena, 10 parts of Rehmannia, 15 parts of Carapax Trionycis, 10 parts of Dianthus Superbus, 10 parts of Dendrobium, 10 parts of Peach Kernel, 12 parts of Cucurbitacin, 3 parts of Coptis, 10 parts of Phellodendron, 3 parts of cinnamon twig, 10 parts of Plantain, and 6 parts of licorice.

4. The Chinese medicine composition according to claim 1 or 3 or the Chinese medicine extract according to claim 2 or 3, characterized in that: The preparation method is as follows: weighing raw materials according to weight, decocting, filtering, and obtaining a filtrate containing the traditional Chinese medicine composition or the traditional Chinese medicine extract.

5. A method for preparing the Chinese medicine composition according to claim 1 or 3 or the Chinese medicine extract according to claim 2 or 3, characterized in that: include: The raw materials are weighed according to weight, decocted, and filtered to obtain a filtrate containing the Chinese medicine composition or the Chinese medicine extract.

6. The Chinese medicine composition or Chinese medicine extract according to claim 4 or the preparation method according to claim 5, characterized in that: The decoction is performed by adding water; preferably, the mass of the water is 8-10 times the mass of the raw material; preferably, the decoction is performed 1-3 times; preferably, the total decoction time is 1-3 hours.

7. A pharmaceutical preparation, characterized in that The invention comprises (i) a Chinese medicine composition as described in any one of claims 1, 3-4, or a Chinese medicine extract as described in any one of claims 2-4, or a Chinese medicine composition or Chinese medicine extract prepared by the method described in claim 5 or 6, or a combination of the foregoing; and (ii) a pharmaceutically acceptable excipient.

8. Use of the Chinese medicine composition according to any one of claims 1, 3-4, or the Chinese medicine extract according to any one of claims 2-4, or the Chinese medicine composition or Chinese medicine extract prepared by the method according to claim 5 or 6, or the pharmaceutical preparation according to claim 7 in the preparation of products for treating polycystic ovary syndrome and / or depression; preferably, the product includes a medicine or a health food; preferably, the treatment of polycystic ovary syndrome is to improve the quality of life while treating polycystic ovary syndrome.

9. A product for treating polycystic ovary syndrome and / or depression, characterized in that: Including the Chinese medicine composition as described in any one of claims 1, 3-4, or the Chinese medicine extract as described in any one of claims 2-4, or the Chinese medicine composition or Chinese medicine extract prepared by the method described in claim 5 or 6, or the pharmaceutical preparation as described in claim 7; preferably, the product includes a medicine or a health food; preferably, the treatment of polycystic ovary syndrome is to improve the quality of life while treating polycystic ovary syndrome.

10. A drug for treating polycystic ovary syndrome, characterized in that: The drug uses the Chinese medicine composition described in any one of claims 1, 3-4, or the Chinese medicine extract described in any one of claims 2-4, or the Chinese medicine composition or Chinese medicine extract prepared by the method described in claim 5 or 6 as an active ingredient.

11. The Chinese medicine composition, Chinese medicine extract, method, pharmaceutical preparation or use according to any one of claims 1 to 10, characterized in that: The Rehmannia root is Rehmannia glutinosa; preferably, the turtle shell is vinegar turtle shell.

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