A traditional Chinese medicine preparation for nourishing kidney, clearing heat, promoting dampness and removing blood stasis and its application

Abstract

The present invention relates to the field of traditional Chinese medicine and specifically discloses a traditional Chinese medicine preparation for nourishing the kidneys, clearing heat, promoting dampness, and removing blood stasis, and its use. The preparation comprises (i) an extract prepared from the following raw materials in parts by weight: 7-13 parts of Rhizoma Anemarrhenae, 7-13 parts of Rehmannia glutinosa, 12-18 parts of Carapax Trichosanthis, 7-13 parts of Dianthus Dianthus, 7-13 parts of Dendrobium Candidum, 7-13 parts of Semen Persicae, 9-15 parts of Fructus Trichosanthis, 2-7 parts of Rhizoma Coptidis, 7-13 parts of Cortex Phellodendri, 2-7 parts of Cinnamomum cassiae, 7-13 parts of Herba Plantaginis, and 2-12 parts of Radix Glycyrrhizae; and (ii) pharmaceutically acceptable excipients; the mass content of component (ii) in the preparation is 1%-95%. The traditional Chinese medicine preparation for nourishing the kidneys, clearing heat, promoting dampness, and removing blood stasis provided by the present invention can treat polycystic ovary syndrome while significantly improving quality of life and has the effect of preventing and treating depression.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine preparation for nourishing the kidney, clearing away heat, promoting dampness and removing blood stasis, 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] The traditional Chinese medicine formula for nourishing the kidneys, clearing heat, promoting dampness and removing blood stasis has achieved certain efficacy in treating patients with kidney yin deficiency-type polycystic ovary syndrome. For example, Tang Li, "Effects of the Nourishing Kidney, Clearing Heat, Promoting Dampness and Removing Blood Stasis" Method on Negative Emotions in Patients with Kidney Deficiency and Blood Stasis-type Polycystic Ovary Syndrome [D]. Jiangxi University of Traditional Chinese Medicine, 2022. This master's thesis published a formula for nourishing the kidneys, clearing heat, promoting dampness and removing blood stasis (Anemarrhena Rhizoma 10g, Cornus Officinalis 10g, Radix Rehmanniae 10g, Scrophulariae 10g, Radix Ophiopogonis 10g, Plastron 10g, Fructus Lycii 10g, Rhizoma Deer Antlers 10g, Peach Kernel 10g, Carthamus tinctorius 10g, Radix Salviae Miltiorrhizae 10g, Poria 10g, and Semen Coicis 10g), which can improve patients' anxiety, depression, and other negative emotions. However, not all prescriptions with the properties of "nourishing the kidneys, clearing heat, promoting dampness and removing blood stasis" can improve patients' anxiety, depression, and other negative emotions. For example, the present invention's research shows that the Chinese medicine group 1 (the prescription group for nourishing the kidneys, clearing heat, promoting dampness and removing blood stasis) and the Chinese medicine group 2 (the prescription group for nourishing the kidneys, clearing heat, promoting dampness and removing blood stasis) described in Chinese invention CN108403919A did not significantly improve quality of life, especially physiological function, physiological function, emotional function, social function, mental health, and other depression-related emotions. Therefore, the present invention provides a new prescription for nourishing the kidneys, clearing heat, promoting dampness and removing blood stasis, which can significantly improve quality of life while treating polycystic ovary syndrome.

[0006] References:

[0007] [1] Liang Ruining, Sun Xueyan, Li Peishuang, et al. Effect of the 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 Chinese medicine preparation for nourishing the kidney, clearing away heat, promoting dampness and removing blood stasis and its application in view of the deficiencies in the prior art.

[0009] Invention concept: The applicant's research shows that the kidney-nourishing, heat-clearing, dampness-removing and blood-stasis-removing prescription can significantly improve the quality of life while treating polycystic ovary syndrome, and has the effect of preventing and treating depression. This application protects a traditional Chinese medicine preparation that nourishes the kidney, clears heat, dampness and blood-stasis.

[0010] In order to solve the above technical problems, the present invention discloses the following technical solutions:

[0011] In a first aspect, the present invention provides a traditional Chinese medicine preparation for nourishing the kidney, clearing away heat, promoting dampness and removing blood stasis.

[0012] Traditional Chinese Medicine (TCM) first recognized PCOS based on its clinical manifestations of obesity, amenorrhea, and other basic features. Traditional Chinese Medicine believes that "obese people have more phlegm," and the Golden Chamber states that "those with phlegm and fluid should be treated with warming medicines." Phlegm and dampness can also easily block the meridians, leading to phlegm and blood stasis. Therefore, TCM primarily treats PCOS with drugs that tonify kidney yang, activate blood circulation and dissolve blood stasis, and warm and dissolve phlegm and dampness. However, after more than 20 years of clinical research, the applicant discovered that although PCOS patients present with obesity, they also often experience symptoms of dampness and 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 study of classical TCM texts, the applicant determined that the pathogenesis of PCOS is primarily due to kidney yin deficiency, endogenous dampness and heat, and blood stasis blocking the collaterals, resulting in "reversed" blood and qi in the Chong channel. The applicant formulated the main treatment approach as nourishing kidney yin, clearing dampness and heat, and dissolving blood stasis to soothe the Chong channel. The applicant established a method and formula for nourishing kidney yin, clearing dampness and heat, and dissolving blood stasis to soothe the Chong channel.

[0013] In the present invention, the traditional Chinese medicine preparation for nourishing the kidney, clearing away heat, promoting dampness and removing blood stasis comprises (i) a traditional Chinese medicine extract of the prescription for nourishing the kidney, clearing heat, promoting dampness and removing blood stasis; and (ii) a pharmaceutically acceptable excipient.

[0014] In the present invention, the raw materials of the Chinese medicine extract include rhizoma anemarrhenae, rehmannia root, turtle shell, herba dianthus, dendrobium, peach kernel, fruit of trichosanthes, coptis root, phellodendron amurense, cassia twig, plantain and liquorice.

[0015] In this Chinese herbal extract, Anemarrhena and Rehmannia nourish kidney yin and clear away heat and purge fire as the main herbs; Coptis chinensis and Phellodendron amurense clear away heat and dampness, Carapax trichosanthis nourishes yin and clears heat, softens and disperses nodules, Dianthus chinensis and Prunus persica promote blood circulation, remove blood stasis and promote menstruation as the assistant herbs; Trichosanthes fruit 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 Cinnamon twig calms the stomach and reduces adverse reactions as the adjuvant herbs; Licorice harmonizes all the herbs as the guiding herb. 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 and clears heat, benefits the stomach and produces body fluid; the stem of Dendrobium fringed.

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

[0023] Trichosanthes 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. The seeds of Trichosanthes kirilowii are also known as Trichosanthes kirilowii seeds.

[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] Huang Bai: 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 extract is prepared from the following raw materials in parts by weight: 7-13 parts of Anemarrhena asphodeloides, 7-13 parts of Rehmannia glutinosa, 12-18 parts of Carapax trichosanthis, 7-13 parts of Dianthus bistortae, 7-13 parts of Dendrobium candidum, 7-13 parts of Peach Kernel, 9-15 parts of Trichosanthes fruit, 2-7 parts of Coptis chinensis, 7-13 parts of Phellodendron amurense, 2-7 parts of Cinnamon Twig, 7-13 parts of Plantago, and 2-12 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 Trichosanthis, 7-13 parts of Dianthus bistortae, 7-13 parts of Dendrobium officinale, 7-13 parts of Peach Kernel, 9-15 parts of Trichosanthes Fructus, 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 Trichosanthis, 8-12 parts of Dianthus bistortae, 8-12 parts of Dendrobium officinale, 8-12 parts of Peach Kernel, 10-14 parts of Trichosanthes Fructus, 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 Trichosanthis, 8-12 parts of Dianthus, 8-12 parts of Dendrobium, 8-12 parts of Peach Kernel, 10-14 parts of Trichosanthes, 2-6 parts of Coptis, 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 Trichosanthis, 8-12 parts of Dianthus, 8-12 parts of Dendrobium, 8-12 parts of Peach Kernel, 10-14 parts of Trichosanthes, 2-6 parts of Coptis, 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 Trichosanthis, 10 parts of Dianthus chinensis, 10 parts of Dendrobium officinale, 10 parts of Peach Kernel, 12 parts of Trichosanthes fruit, 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 Rehmannia glutinosa, 15 parts of Carapax Trichosanthis with vinegar, 10 parts of Dianthus chinensis, 10 parts of Dendrobium officinale, 10 parts of Peach Kernel, 12 parts of Trichosanthes fruit, 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. One example of the Rehmannia glutinosa described in the present invention is Rehmannia glutinosa, and one example of the Carapax Trichosanthis with vinegar is Carapax Trichosanthis.

[0031] In some cases, the mass content of component (ii) in the preparation is 1%-95%; in some cases, the mass content of component (ii) in the preparation is 2%-90%; in some cases, the mass content of component (ii) in the preparation is 5-85%, such as 10-30%, or 50-85%.

[0032] In some cases, the pharmaceutically acceptable excipients include any one or any two of a solvent and a filler, and the filler includes starch and dextrin.

[0033] In some cases, the Chinese medicine preparation is a non-liquid preparation, further a solid preparation, further a capsule, tablet, powder injection, or granule.

[0034] In some cases, the Chinese medicine preparation is a liquid preparation, further an injection, a suspension, or an aerosol.

[0035] In some cases, the Chinese medicine extract in the Chinese medicine preparation is prepared by the following method: weighing the raw materials according to weight, the raw materials include Anemarrhena asphodeloides, Rehmannia glutinosa, Carapax trichosanthes, Dianthus bistorta, Dendrobium candidum, Peach kernel, Trichosanthes fruit, Coptis chinensis, Phellodendron amurense, Cinnamon twig, Plantago, and Licorice, decocting, filtering, and obtaining a filtrate containing the extract; wherein the decocting is decocting with water; preferably, the mass of the water is 7-10 times the mass of the raw materials, such as 8-10 times; preferably, the number of decoctions is 1-3 times; preferably, the total decoction time is 1-3 hours.

[0036] In some cases, the traditional Chinese medicine preparation contains an extract made from raw materials including the following parts by weight: 7-13 parts of Anemarrhena asphodeloides, 7-13 parts of Rehmannia glutinosa, 12-18 parts of Carapax Trichosanthis, 7-13 parts of Dianthus bistortae, 7-13 parts of Dendrobium candidum, 7-13 parts of Peach Kernel, 9-15 parts of Trichosanthes fruit, 2-7 parts of Coptis chinensis, 7-13 parts of Phellodendron amurense, 2-7 parts of Cinnamon Twig, 7-13 parts of Plantago, and 3-7 parts of Licorice; the preparation is in the form of a non-liquid preparation.

[0037] In some cases, the traditional Chinese medicine preparation comprises (i) an extract prepared from the following raw materials in parts by weight: 8-12 parts of Anemarrhena Rhizoma, 8-12 parts of Rehmannia glutinosa, 13-17 parts of Carapax Trichosanthis, 8-12 parts of Dianthus Verniciflua, 8-12 parts of Dendrobium Candidum, 8-12 parts of Peach Kernel, 10-14 parts of Trichosanthes Fructus, 2-6 parts of Coptis chinensis, 8-12 parts of Phellodendron Amurense, 2-5 parts of Cinnamomum cassia twig, 8-12 parts of Plantago, and 4-6 parts of Glycyrrhiza uralensis; the extract is prepared by the following method: weighing the raw materials according to their parts by weight, decocting them 1-3 times with water (the weight of the water is 7-9 times the weight of the raw materials), decocting them for a total of 1-3 hours, filtering, concentrating the obtained filtrate, and drying; and (ii) pharmaceutically acceptable excipients; the preparation is a solid preparation; and the weight content of component (ii) in the preparation is 1-95%.

[0038] In a second aspect, the present invention provides a method for preparing the Chinese medicine preparation described in the first aspect.

[0039] In some cases, the preparation method of the traditional Chinese medicine preparation includes: weighing the raw materials according to weight, the raw materials include Anemarrhena asphodeloides, Rehmannia glutinosa, Carapax trichosanthis, Dianthus chinensis, Dendrobium candidum, Peach kernel, Trichosanthes kirilowii, Coptis chinensis, Phellodendron amurense, Cinnamon twig, Plantago, and Licorice, decocting, filtering, and obtaining a filtrate containing the extract.

[0040] Wherein, the decoction is performed by adding water; preferably, the mass of the water is 7-10 times, such as 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.

[0041] The extract obtained can be further prepared into various preparations by adding different excipients such as solvents and fillers according to the needs of clinical use using conventional preparation processes. The filtrate of the extract obtained can be further concentrated and dried to obtain an extract powder, which can then be prepared into various preparations by adding different excipients such as solvents and fillers using conventional preparation processes.

[0042] The Chinese medicine preparation adopts the Chinese medicine composition for treating polycystic ovary syndrome as an active ingredient, and the Chinese medicine preparation is prepared into a common dosage form in pharmacy by conventional preparation methods in the art.

[0043] The Chinese medicine preparation of the present invention can be prepared by the following method:

[0044] (A) weighing the medicinal components, mixing them, and obtaining a mixture;

[0045] (B) A pharmaceutically acceptable carrier is added to the mixture and prepared by conventional preparation methods in the art.

[0046] In some cases, the mixture obtained in step (A) can be prepared into an extract, such as by decocting and filtering to obtain a filtrate containing the extract. The filtrate obtained can be further concentrated and dried to obtain an extract powder. The decocting step is performed by adding water; preferably, the mass of the water is 7-10 times, such as 8-10 times, the mass of the raw material; preferably, the decocting step is repeated 1-3 times; and preferably, the total decocting time is 1-3 hours.

[0047] In a third aspect, the present invention provides a product for treating polycystic ovary syndrome and / or depression, which comprises the above The Chinese medicine preparation described in the first aspect, and the Chinese medicine preparation prepared by the method described in the second aspect.

[0048] Wherein, the product includes medicine or health food.

[0049] Wherein, the treatment of polycystic ovary syndrome is to improve the quality of life while treating polycystic ovary syndrome.

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

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

[0052] The traditional Chinese medicine preparation described in the present invention is a traditional Chinese medicine preparation for treating polycystic ovary syndrome and / or depression.

[0053] Improving the quality of life in the present invention includes:

[0054] 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;

[0055] and / or,

[0056] Improve scores on any one or more of the PCOS Quality of Life Questionnaire (PCOSQ) dimensions of body hair, mood, weight, infertility, and menstruation.

[0057] Beneficial effects:

[0058] The extract and preparation of the Zishen Qingre Lishi Huayu Recipe provided by the present invention not only treat polycystic ovary syndrome (PCOS), but also significantly improve quality of life and prevent and treat depression. This addresses the problem of existing technologies, such as the Zishen Qingre Lishi Huayu Tongluo Recipe and the Zishen Qingre Huayu Lishi Recipe in Chinese invention CN108403919A, which lack significant improvement in quality of life. Specifically, the extract and preparation of the Zishen Qingre Lishi Huayu Recipe provided by the present invention demonstrated a highly significant difference (P < 0.01) in improving quality of life and preventing and treating depression compared to the control group. This improvement surpasses the significant effect (P < 0.05) of the existing technology (Tang Li, Effects of the "Zishen Qingre, Lishi Huayu Recipe" Method on Negative Emotions in Patients with Kidney Deficiency and Blood Stasis Polycystic Ovary Syndrome [D]. Jiangxi University of Traditional Chinese Medicine).

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

[0060] The traditional Chinese medicine preparation 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 a good therapeutic effect in treating PCOS. Given the large number of PCOS patients and the poor efficacy of current clinical hormone 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 meet the requirements of the current (2020 edition) Chinese Pharmacopoeia and, unless otherwise noted, are prepared from Chinese herbal medicine slices. These slices can be obtained from distributors or processed after purchase.

[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] PCOS was diagnosed according to the modified Rotterdam diagnostic criteria: oligomenorrhea (menstrual cycles ≥ 35 days) or amenorrhea (missing menstruation for 6 months) was a prerequisite; additional requirements included a. 12 or more antral follicles with a diameter less than 10 mm or an ovarian volume greater than 10 cm³ as determined by transvaginal / rectal ultrasound; 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 years old 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: serum prolactin (PRL) levels ≥ 25 ng / ml on two occasions at least one week apart;

[0073] ② Serum follicle-stimulating hormone (FSH) > 15 IU / 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 2 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] ⑧ Those who have taken hormones or other drugs in the last 3 months that may affect the results;

[0080] ⑨ Pregnant or breastfeeding women;

[0081] ⑩ Severe 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 (Zi Shen Qingre Lishi Huayu) (Zi Shen Qingre Lishi Huayu) consisting of 12 ingredients: Anemarrhena Rhizoma 10g, Rehmannia Glutinosa 10g, Carapax Trichosanthis 15g, Herba Dioscoreae 10g, Dendrobium 10g, Semen Persicae 10g, Fructus Trichosanthis 12g, Coptis chinensis 3g, Phellodendron chinense 10g, Cinnamomum cassiae 3g, Herba Plantaginis 10g, and Radix Glycyrrhizae 6g. These ingredients were decocted twice with 8-fold water and concentrated, with a 1.5-hour infusion. 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, starting on 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 a 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 three-month treatment period. 2) anthropometric characteristics, including weight, body mass index, and waist-to-hip ratio. 3) hair: assessed using the Ferriman-Gallwey questionnaire, with hair on nine body areas (upper lip, chin, chest, arms, upper abdomen, lower abdomen, upper back, lower back, and thighs) scored from 0 (absent) to 4 (equivalent to a hairy man). 4) acne: scored using the Rosenfield criteria, based on the nature and number of lesions, on a scale of 0 to 5. 5) 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 quality of life tool. It consists of 36 items across 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 functioning. The PCOSQ is a tool specific for measuring quality of life in PCOS. It consists of 26 items across five dimensions (body hair, mood, weight, infertility, and menstruation). Each item is scored from 1 (always) to 7 (never), with higher scores indicating better functioning. 7) Adverse Events Related to Study Drug: All adverse events occurring during treatment were recorded and assessed to determine their relevance to study treatment.

[0089] 1.8 Statistical analysis

[0090] In a preliminary pilot study, we found that the monthly ovulation rate for PCOS treated with the traditional Chinese medicine formula Zishen Qingre Lishi Huayu (Zishen Qingre Lishi Huayu) was 40.3%, compared to 15.8% for placebo. α represents the type I error rate, and β represents the type II error rate. 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 statisticians who were not aware of the group settings. All randomized participants were included in the intention-to-treat (ITT) analysis, and unobserved outcome events were uniformly recorded as "non-ovulation". The per-protocol (PP) analysis included subjects who received the complete intervention treatment, that is, subjects who were lost to follow-up, withdrew, discontinued or discontinued medication for various reasons were excluded. In addition, we conducted a sensitivity analysis, that is, excluding 12 subjects who discontinued medication (5 in the control group and 7 in the treatment group) to compare the differences in secondary outcome indicators. Continuous variables that conform to the normal distribution are expressed as mean ± standard deviation, and two independent sample t-tests are used to compare differences between groups. Continuous variables that are not normally distributed are expressed as medians (quartiles), and the Wilcoxon rank sum test is used to compare differences between groups. Categorical variables are expressed as frequencies and frequencies (%), and the chi-square test is used to compare differences between groups. All statistical analyses were completed in SAS 9.4 software, using two-sided tests. P A value <0.05 was 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, and one became pregnant. Additionally, seven subjects in the treatment group and five subjects in the control group interrupted their medication during treatment. 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 Chinese medicine 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 3 months of treatment, there was no significant difference in weight, body mass index, waist-to-hip ratio, and Ferriman-Gallwey hair score between the two groups. The acne score in the Chinese medicine group decreased by 0.6±0.81, which was statistically significant compared with the control group ( P There was no statistically significant difference in glucose and lipid metabolism between the two groups (Table 3).

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

[0100]

[0101] 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 indicators are presented as means ± standard deviations with two-independent-sample t-tests. All P values ​​were greater than 0.05, indicating that the two groups were comparable at baseline.

[0102] Table 2 Comparison of ovulation rate and menstrual frequency, n (%)

[0103]

[0104] Notice:

[0105] 1. In ITT and PP analyses, n(%) represents the number of outcomes (frequency), not the number of samples.

[0106] 2. The total ITT sample size was 63 in the control group and 63 in the treatment group. The PP sample size was 55 in the control group and 50 in the treatment group (excluding all participants who did not receive the full intervention).

[0107] 3. P values ​​were calculated using the chi-square test.

[0108] Table 3 Comparison of other secondary outcome indicators

[0109]

[0110] Notice:

[0111] The difference in effect before and after the intervention was the difference between the indicators at three months after the intervention and the indicators at the baseline (reflecting the treatment effect). The difference conformed to the normal distribution (sample size ≥ 50) and was expressed as mean ± standard deviation. Two independent sample t-tests were used to compare whether there was any difference in the mean of the difference between the treatment group and the control group.

[0112] Example 2

[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 Kernel, 12 parts of Trichosanthes Fructus, 3 parts of Coptis chinensis, 10 parts of Phellodendron Amurense, 3 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, 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.

[0115] Example 3

[0116] 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 Candidum, 8 parts of Peach Kernel, 14 parts of Trichosanthes Fructus, 2 parts of Coptis chinensis, 8 parts of Phellodendron Amurense, 3 parts of Cinnamon Twig, 8 parts of Plantago, and 6 parts of Licorice.

[0117] 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.

[0118] Example 4

[0119] 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 Kernel, 12 parts of Trichosanthes Fructus, 3 parts of Coptis chinensis, 10 parts of Phellodendron Amurense, 3 parts of Cinnamon Twig, 10 parts of Plantago, and 10 parts of Licorice.

[0120] 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.

[0121] Example 5

[0122] 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 Trichosanthes Fructus, 3 parts of Coptis chinensis, 10 parts of Phellodendron Amurense, 5 parts of Cinnamon Twig, 10 parts of Plantago, and 6 parts of Licorice.

[0123] 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.

[0124] Example 6

[0125] 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 Candidum, 12 parts of Peach Kernel, 10 parts of Trichosanthes Fructus, 6 parts of Coptis chinensis, 12 parts of Phellodendron Amurense, 2 parts of Cinnamon Twig, 12 parts of Plantago, and 4 parts of Licorice.

[0126] 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.

[0127] 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.

[0128] Example 7: Depression Treatment Effect Case

[0129] 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.

[0130] 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.

[0131] Example 8: Preparation of granules

[0132] Add 12 ingredients (12 ingredients total) to 10g of Anemarrhena Rhizoma, 10g of Rehmannia glutinosa, 15g of Vinegar-sweetened Carapace of Trichosanthes, 10g of Dianthus Root, 10g of Dendrobium Candidum, 10g of Peach Kernel, 12g of Trichosanthes Fructus, 3g of Coptis chinensis, 10g of Phellodendron Amurense, 3g of Cinnamomum cassia twig, 10g of Plantago asiatica, and 6g of Licorice Root. Add 8 times the amount of water and decoct twice, 1.5 hours each time, to obtain an extract. The resulting extract is concentrated under reduced pressure, and the concentrate is dried under reduced pressure to obtain an extract powder, which is crushed and sieved for later use.

[0133] Granules were prepared according to the following formula:

[0134] Dextrin 10.00g

[0135] Extract powder 20.00g

[0136] 85% ethanol (appropriate amount)

[0137] Take dextrin and extract powder and mix them evenly, add appropriate amount of 85% ethanol and knead them evenly, squeeze them through a 20-mesh sieve, put them in an oven to dry at 60°C, and sieve them with a 16-mesh sieve to obtain granules.

[0138] Example 9

[0139] 12 ingredients (10 parts Anemarrhena Rhizoma, 10 parts Rehmannia glutinosa, 15 parts Vinegar-sweetened Carapace of Trichosanthes, 10 parts Dianthus Root, 10 parts Dendrobium Candidum, 10 parts Peach Kernel, 12 parts Trichosanthes Fructus, 3 parts Coptis Rhizome, 10 parts Phellodendron Amurense, 3 parts Cinnamomum Cassiae Twig, 10 parts Plantago, and 6 parts Licorice Root) are added to 8-fold the amount of water and decocted twice, 1.5 hours each time. Filter and combine the filtrates; concentrate the resulting filtrates to obtain a concentrate, which is then added with starch at a 1:2 ratio of extract to form granules. A portion of the granules is filled into capsule shells to obtain capsules, while a portion is compressed to produce tablets.

[0140] Comparative Example 1

[0141] 1.1 Treatment methods

[0142] The treatment group received the existing CPOS formula (composition: Rhizoma Anemarrhenae 10g, Fructus Corni 10g, Radix Salviae Miltiorrhizae 10g, Rhizoma Pruni 10g, Rhizoma Coicis 15g, Semen Coicis 10g, Semen Sinapis Albiflora 10g, Cortex Phellodendri 10g, Radix Scrophulariae 10g, and Radix Glycyrrhizae 6g, each bag containing 12.6g, containing 45.5g of the raw herbs; 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; the CPOS formula and placebo were identical in weight and packaging and had similar appearance, odor, and color; manufactured by Guangdong Yifang Pharmaceutical Co., Ltd., placebo batch number: 2014101609). Patients were taken one packet daily, morning and evening, with boiled water, for three consecutive months. Throughout the study, patients were required to maintain a normal diet and physical activity, 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.

[0143] 1.2 Observation indicators

[0144] 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.

[0145] 1.3 Statistical analysis

[0146] 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.

[0147] 1.4 Results

[0148] 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).

[0149] 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).

[0150] Table 4 Baseline characteristics

[0151]

[0152] 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.

[0153] Table 5 Comparison of indicators before and after intervention

[0154]

[0155] Comparative Example 2

[0156] 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 removing dampness 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.

[0157] 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 preparation for nourishing the kidney, clearing away heat, promoting dampness and removing blood stasis, characterized in that: The invention comprises (i) an extract prepared from the following raw materials in parts by weight: 8-12 parts of Anemarrhena Rhizoma, 8-12 parts of Rehmannia glutinosa, 13-17 parts of Carapax Trichosanthis, 8-12 parts of Dianthus Dianthus, 8-12 parts of Dendrobium Candidum, 8-12 parts of Peach Kernel, 10-14 parts of Trichosanthes Fructus, 2-6 parts of Coptis chinensis, 8-12 parts of Phellodendron Amurense, 2-7 parts of Cinnamomum cassia twig, 8-12 parts of Plantago, and 2-12 parts of Licorice; and (ii) pharmaceutically acceptable excipients; the mass content of component (ii) in the preparation is 1%-95%.

2. The Chinese medicine preparation according to claim 1, characterized in that 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 Trichosanthis, 8-12 parts of Dianthus, 8-12 parts of Dendrobium, 8-12 parts of Peach Kernel, 10-14 parts of Trichosanthes Fruit, 2-6 parts of Coptis, 8-12 parts of Phellodendron, 2-5 parts of Cinnamon Twig, 8-12 parts of Plantago, and 4-10 parts of Licorice.

3. The Chinese medicine preparation according to claim 1, characterized in that The weight proportions of the raw materials are as follows: 10 parts of Anemarrhena, 8-12 parts of Rehmannia, 13-17 parts of Carapax Trichosanthis, 8-12 parts of Dianthus, 8-12 parts of Dendrobium, 8-12 parts of Peach Kernel, 10-14 parts of Trichosanthes Fruit, 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.

4. The Chinese medicine preparation according to claim 1, characterized in that The weight proportions of the raw materials are as follows: 10 parts of Anemarrhena Rhizoma, 10 parts of Rehmannia glutinosa, 15 parts of Carapax Trichosanthis, 10 parts of Dianthus Root, 10 parts of Dendrobium Candidum, 10 parts of Peach Kernel, 12 parts of Trichosanthes Fructus, 3 parts of Coptis chinensis, 10 parts of Phellodendron Amurense, 3 parts of Cinnamon Twig, 10 parts of Plantago, and 6 parts of Licorice.

5. The Chinese medicine preparation according to any one of claims 1 to 4, characterized in that The Rehmannia root is Rehmannia root prepared from cooked herbs; and the turtle shell is turtle shell prepared from vinegar.

6. The Chinese medicine preparation according to any one of claims 1 to 4, characterized in that The mass content of component (ii) in the preparation is 10-30%, or 50-85%.

7. The Chinese medicine preparation according to any one of claims 1 to 4, characterized in that The pharmaceutically acceptable excipients include any one or a combination of solvents and fillers; the traditional Chinese medicine preparation is a non-liquid preparation or a liquid preparation.

8. The Chinese medicine preparation according to claim 7, characterized in that The non-liquid preparations include capsules, tablets, powder injections, and granules; the liquid preparations include injections, suspensions, and aerosols.

9. The Chinese medicine preparation according to any one of claims 1 to 4, characterized in that: The extract is prepared by the following method: weighing raw materials according to weight, decocting, filtering, and obtaining a filtrate containing the extract.

10. The Chinese medicine preparation according to claim 9, characterized in that: The decoction is performed by adding water; the mass of the water is 7-10 times the mass of the raw material; the number of decoctions is 1-3 times; and the total decoction time is 1-3 hours.

11. A method for preparing the traditional Chinese medicine preparation according to any one of claims 1 to 8, characterized in that: include: The raw materials are weighed according to weight, decocted, and filtered to obtain a filtrate containing the extract.

12. The preparation method according to claim 11, characterized in that: The decoction is performed by adding water; the mass of the water is 7-10 times the mass of the raw material; the number of decoctions is 1-3 times; and the total decoction time is 1-3 hours.

13. A Chinese medicine preparation for nourishing the kidney, clearing away heat, promoting dampness and removing blood stasis, characterized in that: The invention contains an extract 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 Trichosanthis, 7-13 parts of Dianthus dianthus, 7-13 parts of Dendrobium candidum, 7-13 parts of Peach Kernel, 9-15 parts of Trichosanthes fruit, 2-7 parts of Coptis chinensis, 7-13 parts of Phellodendron amurense, 2-7 parts of Cinnamomum cassia twig, 7-13 parts of Plantago, and 3-7 parts of Licorice. The preparation is in the form of a non-liquid preparation.

14. A Chinese medicinal preparation for nourishing the kidney, clearing away heat, promoting dampness and removing blood stasis, characterized in that: The invention comprises (i) an extract prepared from the following raw materials in parts by weight: 8-12 parts of Anemarrhena Rhizoma, 8-12 parts of Rehmannia glutinosa, 13-17 parts of Carapax Trichosanthis, 8-12 parts of Dianthus Dianthus, 8-12 parts of Dendrobium Candidum, 8-12 parts of Peach Kernel, 10-14 parts of Trichosanthes Fructus, 2-6 parts of Coptis chinensis, 8-12 parts of Phellodendron Amurense, 2-5 parts of Cinnamomum cassia twig, 8-12 parts of Plantago, and 4-6 parts of Licorice; the extract is prepared by the following method: weighing the raw materials according to parts by weight, decocting them 1-3 times with water (the weight of the water is 7-9 times that of the raw materials), decocting them for a total of 1-3 hours, filtering, concentrating the obtained filtrate, and drying; and (ii) pharmaceutically acceptable excipients; the preparation is a solid preparation; and the weight content of component (ii) in the preparation is 1-95%.

15. A product for treating polycystic ovary syndrome and / or depression, characterized in that: The invention comprises the Chinese medicine preparation according to any one of claims 1 to 10 or claim 13 or 14.

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