Traditional Chinese medicine preparation for nourishing kidney, clearing heat, promoting diuresis and dispersing blood stasis and application thereof

Abstract

The invention relates to the field of traditional Chinese medicines, and particularly discloses a traditional Chinese medicine preparation for nourishing kidney, clearing heat, promoting diuresis and dispersing blood stasis and application thereof. 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 radix rehmanniae, 12-18 parts of turtle shell, 7-13 parts of dianthus superbus, 7-13 parts of dendrobe, 7-13 parts of peach kernel, 9-15 parts of semen trichosanthis, 2-7 parts of coptis chinensis, 7-13 parts of golden cypress, 2-7 parts of cassia twig, 7-13 parts of plantain herb and 2-12 parts of liquorice; and (ii) a pharmaceutically acceptable auxiliary material; and the mass content of the component (ii) in the preparation is 1-95%. The traditional Chinese medicine preparation for nourishing kidney, clearing heat, promoting diuresis and dispersing blood stasis, provided by the invention, can be used for treating polycystic ovarian syndrome, can also be used for remarkably improving life quality and has the effect of preventing and treating depression.

Description

Technical Field

[0001] The 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 an 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 infertility 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 pressure 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 PCOS treatment plan has not yet been formed. Western medicine treatment plans include laparoscopic ovarian puncture, drug-induced ovulation, and drug anti-androgen, and measures to enhance insulin sensitivity. However, these treatments are mostly staged interventions, and the surgery is traumatic, the drug treatment effect is limited, and there is no active preventive effect on the occurrence of long-term complications. In addition, there are serious side effects, long-term use, and a high recurrence rate after discontinuation of medication. Therefore, these treatments are not the best choice for PCOS patients.

[0004] TCM believes that the pathogenesis of PCOS is kidney, liver and spleen dysfunction, phlegm turbidity and blood stasis, which are mostly symptoms of deficiency of the root and excess of the superficial. The core of TCM treatment of PCOS is syndrome differentiation and treatment. Common syndromes are spleen and kidney yang deficiency, phlegm and blood stasis, kidney deficiency and blood stasis, and kidney yin deficiency. The treatment methods focus on tonifying the kidney, promoting blood circulation and removing blood stasis, and removing dampness and removing phlegm. A few use liver-soothing and spleen-strengthening methods based on syndrome differentiation; the medication focuses on kidney yang tonifying drugs, blood circulation and blood stasis drugs, and warming and removing phlegm and dampness drugs. However, simple TCM treatment is often difficult to solve amenorrhea and menstrual disorders caused by persistent anovulation, hirsutism and acne caused by hyperandrogenism, so the treatment mode of "TCM combined with oral contraceptive drugs" is often used in clinical practice; because it is difficult to achieve the effect of autonomous ovulation, the treatment mode of "TCM combined with Western ovulation-promoting drugs" is often used for those who have fertility requirements.

[0005] In traditional Chinese medicine, the currently adopted formula of nourishing the kidney, clearing heat, promoting diuresis, and removing stasis has achieved certain curative effects in the treatment of patients with polycystic ovary syndrome of kidney yin deficiency type. For example, Tang Li. The influence of the method of "nourishing the kidney, clearing heat, promoting diuresis, and removing stasis" on the negative emotions of patients with polycystic ovary syndrome of kidney deficiency and blood stasis type [D]. Jiangxi University of Traditional Chinese Medicine, 2022. The formula of "nourishing the kidney, clearing heat, promoting diuresis, and removing stasis" disclosed in this master's degree thesis (Anemarrhena Rhizome 10g, Cornus officinalis 10g, Rehmannia glutinosa 10g, Scrophularia ningpoensis 10g, Ophiopogon japonicus 10g, Plastrum Testudinis 10g, Lycium barbarum 10g, Cornu Cervi Parvum 10g, Persica vulgaris 10g, Carthamus tinctorius 10g, Salvia miltiorrhiza 10g, Poria cocos 10g, Coix lacryma-jobi 10g) can improve the negative emotions of patients such as anxiety and depression. However, not all formulas with the functions of "nourishing the kidney, clearing heat, promoting diuresis, and removing stasis" can improve the negative emotions of patients such as anxiety and depression. For example, the research of the present invention shows that in terms of quality of life, especially the improvement of emotions related to depression such as physical function, physiological function, emotional function, social function, and mental health, the traditional Chinese medicine group 1 (the formula group of nourishing the kidney, clearing heat, promoting diuresis, removing stasis, and dredging collaterals) and traditional Chinese medicine group 2 (the formula group of nourishing the kidney, clearing heat, removing stasis, and promoting diuresis) recorded in Chinese invention CN108403919A are not significant. Therefore, the present invention provides a new formula of nourishing the kidney, clearing heat, promoting diuresis, and removing stasis to significantly improve the quality of life while treating polycystic ovary syndrome.

[0006] References: [1] Liang Ruining, Sun Xueyan, Li Peishuang, et al. The influence of the formula of nourishing the kidney, clearing heat, promoting diuresis, and removing stasis on the spontaneous ovulatory menstruation of 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

[0007] Object of the Invention: The technical problem to be solved by the present invention is to provide a traditional Chinese medicine preparation for nourishing the kidney, clearing heat, promoting diuresis, and removing stasis and its application in view of the deficiencies of the prior art.

[0008] Concept of the Invention: The research of the applicant shows that the formula of nourishing the kidney, clearing heat, promoting diuresis, and removing stasis can not only treat polycystic ovary syndrome but also significantly improve the quality of life, and has the function of preventing and treating depression. The present application protects the traditional Chinese medicine preparation for nourishing the kidney, clearing heat, promoting diuresis, and removing stasis.

[0009] In order to solve the above technical problems, the present invention discloses the following technical solutions: In a first aspect, the present invention provides a traditional Chinese medicine preparation for nourishing the kidney, clearing heat, promoting diuresis and removing stasis.

[0010] The earliest recognition of polycystic ovary syndrome by traditional Chinese medicine was based on its clinical manifestations of obesity, amenorrhea and other basic characteristics. Traditional Chinese medicine believes that "fat people have more phlegm", and "Golden Chamber" points out that "those with phlegm and fluid should be treated with warm medicine". At the same time, phlegm and dampness can easily block the meridians and cause phlegm and blood stasis. Therefore, traditional Chinese medicine mainly treats with kidney yang-tonifying drugs, blood-activating and blood-stasis-removing drugs, and warming and phlegm-removing drugs. However, after more than 20 years of clinical research, the applicant found that although patients with polycystic ovary syndrome are obese, they also often have symptoms of dampness and heat such as acne, dry mouth, greasy skin, pale red or reddish tongue, and thin yellow and greasy fur. Based on clinical practice combined with the theoretical study of ancient Chinese medicine classics, the applicant determined that the pathogenesis of polycystic ovary syndrome is mainly kidney yin deficiency, endogenous dampness and heat, blood stasis blocking the collaterals, and causing "reversal" of blood and qi in the Chong channel. The main treatment method is formulated as nourishing kidney yin, clearing dampness and heat, and removing blood stasis to calm the Chong channel, and the method and formula of nourishing kidney yin, clearing dampness and heat, and removing blood stasis to calm the Chong channel are created.

[0011] In the present invention, the Chinese medicine preparation for nourishing the kidney, clearing away heat, promoting dampness and removing blood stasis comprises (i) a Chinese medicine extract of the prescription for nourishing the kidney, clearing heat, promoting dampness and removing blood stasis; and (ii) a pharmaceutically acceptable excipient.

[0012] In the present invention, the raw materials of the Chinese medicine extract include rhizoma anemarrhenae, rehmannia root, turtle shell, superbus, dendrobium, peach kernel, trichosanthes seed, coptis root, phellodendron, cassia twig, plantain and liquorice.

[0013] In this Chinese medicine extract, Anemarrhena and Rehmannia nourish kidney yin, clear away heat and purge fire as the main drugs; Coptis chinensis and Phellodendron chinense clear away heat and dampness, Biejia nourishes yin and clears heat, softens and disperses nodules, Dianthus superbus and Prunus persica promote blood circulation, removes blood stasis and dredges the menstruation as the assistant drugs; Fructus Trichosanthis clears heat and resolves phlegm, Dendrobium can benefit the stomach and promote fluid production, nourishes yin and clears heat, Plantago clears heat and promotes urination, and Cinnamon twig calms the adverse and descends the adverse, all of which are 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 dredges the menstruation.

[0014] The effects of these Chinese medicinal materials are as follows: Anemarrhena asphodeloides: bitter and cold in nature, enters the lung, stomach and kidney meridians; Efficacy: nourishes yin and reduces fire, moisturizes dryness and lubricates the intestines.

[0015] Rehmannia root: It can be processed by mixing raw rehmannia root with rice wine, steaming in the sun, etc. It tastes sweet, is warm in nature, and enters the liver and kidney meridians. Efficacy: nourishes blood, replenishes essence and fills the marrow.

[0016] Turtle Shell: salty and cold in nature, enters the liver and kidney meridians; Efficacy: nourishes yin and suppresses yang, softens and disperses lumps.

[0017] Dianthus superbus: bitter and cold in nature, enters the heart and small intestine meridians; Efficacy: diuretic, relieving stranguria, promoting blood circulation and dredging menstruation.

[0018] 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.

[0019] Peach kernel: Bitter, sweet in flavor, neutral in nature, attributing to the heart, liver and large intestine meridians; functions: promoting blood circulation to remove blood stasis, moistening the intestines to relieve constipation, relieving cough and asthma; the seeds of Prunus davidiana.

[0020] Snakegourd seed: Sweet and cold in flavor, attributing to the lung, stomach and large intestine meridians. Functions: moistening the lung to resolve phlegm, moistening the intestines to relieve constipation; the seeds of Trichosanthes kirilowii, alias: snakegourd kernel.

[0021] Coptis root: Bitter and cold in flavor, attributing to the heart, spleen, stomach, liver, gallbladder and large intestine meridians. Functions: clearing heat and drying dampness, purging fire and detoxifying.

[0022] Phellodendron bark: Bitter and cold in flavor, attributing to the kidney, bladder and large intestine meridians. Functions: clearing heat and drying dampness, purging fire and detoxifying, removing heat and relieving steaming.

[0023] Cassia twig: Pungent, sweet in flavor, warm in nature, entering the lung, heart and bladder meridians. Functions: inducing sweating and relieving the exterior syndrome, warming the channels to promote blood circulation, assisting yang to transform qi. Calming the adverse qi rushing upward, being the key medicine for treating adverse qi rushing upward.

[0024] Plantain herb: Sweet and cold in flavor, attributing to the liver, kidney, lung and small intestine meridians. Functions: clearing heat and promoting diuresis, resolving phlegm, cooling blood, detoxifying.

[0025] Licorice root: Sweet and neutral in flavor, attributing to the heart, lung, spleen and stomach meridians. Functions: invigorating the spleen and replenishing qi, clearing heat and detoxifying, coordinating the actions of various drugs.

[0026] In some cases, the traditional Chinese medicine extract is prepared from raw materials including the following parts by weight: anemarrhena rhizome 7 - 13 parts, rehmannia root 7 - 13 parts, turtle shell 12 - 18 parts, dianthus 7 - 13 parts, dendrobium 7 - 13 parts, peach kernel 7 - 13 parts, snakegourd seed 9 - 15 parts, coptis root 2 - 7 parts, phellodendron bark 7 - 13 parts, cassia twig 2 - 7 parts, plantain herb 7 - 13 parts, licorice root 2 - 12 parts.

[0027] In some cases, the traditional Chinese medicine extract is prepared from raw materials including the following parts by weight: Anemarrhena Rhizome 7 - 13 parts, Rehmannia Root 7 - 13 parts, Turtle Shell 12 - 18 parts, Dianthus Superbus 7 - 13 parts, Dendrobium Stem 7 - 13 parts, Peach Kernel 7 - 13 parts, Trichosanthis Fruit 9 - 15 parts, Coptis Rhizome 2 - 7 parts, Phellodendron Bark 7 - 13 parts, Cinnamon Twig 2 - 7 parts, Asiatic Plantain Herb 7 - 13 parts, Licorice Root 2 - 12 parts; preferably, the parts by weight of each raw material are as follows: Anemarrhena Rhizome 8 - 12 parts, Rehmannia Root 8 - 12 parts, Turtle Shell 13 - 17 parts, Dianthus Superbus 8 - 12 parts, Dendrobium Stem 8 - 12 parts, Peach Kernel 8 - 12 parts, Trichosanthis Fruit 10 - 14 parts, Coptis Rhizome 2 - 6 parts, Phellodendron Bark 8 - 12 parts, Cinnamon Twig 2 - 7 parts, Asiatic Plantain Herb 8 - 12 parts, Licorice Root 2 - 12 parts; preferably, the parts by weight of each raw material are as follows: Anemarrhena Rhizome 8 - 12 parts, Rehmannia Root 8 - 12 parts, Turtle Shell 13 - 17 parts, Dianthus Superbus 8 - 12 parts, Dendrobium Stem 8 - 12 parts, Peach Kernel 8 - 12 parts, Trichosanthis Fruit 10 - 14 parts, Coptis Rhizome 2 - 6 parts, Phellodendron Bark 8 - 12 parts, Cinnamon Twig 2 - 5 parts, Asiatic Plantain Herb 8 - 12 parts, Licorice Root 4 - 10 parts; preferably, the parts by weight of each raw material are as follows: Anemarrhena Rhizome 10 parts, Rehmannia Root 8 - 12 parts, Turtle Shell 13 - 17 parts, Dianthus Superbus 8 - 12 parts, Dendrobium Stem 8 - 12 parts, Peach Kernel 8 - 12 parts, Trichosanthis Fruit 10 - 14 parts, Coptis Rhizome 2 - 6 parts, Phellodendron Bark 8 - 12 parts, Cinnamon Twig 2 - 5 parts, Asiatic Plantain Herb 8 - 12 parts, Licorice Root 4 - 10 parts. One case is: Anemarrhena Rhizome 10 parts, Rehmannia Root 10 parts, Turtle Shell 15 parts, Dianthus Superbus 10 parts, Dendrobium Stem 10 parts, Peach Kernel 10 parts, Trichosanthis Fruit 12 parts, Coptis Rhizome 3 parts, Phellodendron Bark 10 parts, Cinnamon Twig 3 parts, Asiatic Plantain Herb 10 parts, Licorice Root 6 parts. One case is: Anemarrhena Rhizome 10 parts, Prepared Rehmannia Root 10 parts, Vinegar-processed Turtle Shell 15 parts, Dianthus Superbus 10 parts, Dendrobium Stem 10 parts, Peach Kernel 10 parts, Trichosanthis Fruit 12 parts, Coptis Rhizome 3 parts, Phellodendron Bark 10 parts, Cinnamon Twig 3 parts, Asiatic Plantain Herb 10 parts, Licorice Root 6 parts. One case of the Rehmannia Root in the present invention is Prepared Rehmannia Root; one case of the Turtle Shell is Vinegar-processed Turtle Shell.

[0028] 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%.

[0029] In some cases, the pharmaceutically acceptable excipients include any one or any two of solvents and fillers, and the fillers include starch and dextrin.

[0030] In some cases, the traditional Chinese medicine preparation is a non - liquid preparation, further a solid preparation, and further a capsule, tablet, powder for injection, or granule.

[0031] In some cases, the traditional Chinese medicine preparation is a liquid preparation, further an injection, suspension, or aerosol.

[0032] In some cases, the traditional Chinese medicine extract in the traditional Chinese medicine preparation is prepared by the following method: weighing raw materials according to parts by weight, the raw materials including Anemarrhena Rhizome, Rehmannia Root, Turtle Shell, Dianthus Superbus, Dendrobium, Peach Kernel, Trichosanthes Seed, Coptis Rhizome, Phellodendron Bark, Cinnamon Twig, Plantain Herb, and Licorice Root, decocting, and filtering to obtain a filtrate containing the extract; wherein, the decocting is carried out by adding water for decocting; 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 decocting times is 1 - 3 times; preferably, the total decocting duration is 1 - 3 h.

[0033] In some cases, the traditional Chinese medicine preparation contains an extract prepared from raw materials including the following parts by weight: 7 - 13 parts of Anemarrhena Rhizome, 7 - 13 parts of Rehmannia Root, 12 - 18 parts of Turtle Shell, 7 - 13 parts of Dianthus Superbus, 7 - 13 parts of Dendrobium, 7 - 13 parts of Peach Kernel, 9 - 15 parts of Trichosanthes Seed, 2 - 7 parts of Coptis Rhizome, 7 - 13 parts of Phellodendron Bark, 2 - 7 parts of Cinnamon Twig, 7 - 13 parts of Plantain Herb, and 3 - 7 parts of Licorice Root; the preparation is in a non - liquid preparation form.

[0034] In some cases, the traditional Chinese medicine preparation comprises (i) an extract prepared from raw materials including the following parts by weight: 8 - 12 parts of Anemarrhena Rhizome, 8 - 12 parts of Rehmannia Root, 13 - 17 parts of Turtle Shell, 8 - 12 parts of Dianthus Superbus, 8 - 12 parts of Dendrobium, 8 - 12 parts of Peach Kernel, 10 - 14 parts of Trichosanthes Seed, 2 - 6 parts of Coptis Rhizome, 8 - 12 parts of Phellodendron Bark, 2 - 5 parts of Cinnamon Twig, 8 - 12 parts of Plantain Herb, and 4 - 6 parts of Licorice Root; the extract is prepared by the following method: weighing raw materials according to parts by weight, adding water for decocting 1 - 3 times, the mass of the water being 7 - 9 times the mass of the raw materials, decocting for a total of 1 - 3 h, filtering, and concentrating and drying the obtained filtrate; and (ii) a pharmaceutically acceptable excipient; the preparation is a solid preparation; the mass content of component (ii) in the preparation is 1 - 95%.

[0035] In a second aspect, the present invention provides a preparation method of the traditional Chinese medicine preparation described in the first aspect above.

[0036] In some cases, the preparation method of the traditional Chinese medicine preparation includes: weighing raw materials according to parts by weight, the raw materials including Anemarrhena Rhizome, Rehmannia Root, Turtle Shell, Dianthus Superbus, Dendrobium, Peach Kernel, Trichosanthes Seed, Coptis Rhizome, Phellodendron Bark, Cinnamon Twig, Plantain Herb, and Licorice Root, decocting, and filtering to obtain a filtrate containing the extract.

[0037] Wherein, the decocting is carried out by adding water for decocting; 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 decocting times is 1 - 3 times; preferably, the total decocting duration is 1 - 3 h.

[0038] Among them, the obtained extract can also be added with different excipients such as solvents and fillers according to the needs of clinical use, and made into various preparations by conventional preparation processes. Among them, the filtrate of the obtained extract can be further concentrated and dried to obtain an extract powder, and then different excipients such as solvents and fillers are added, and various preparations are made by conventional preparation processes.

[0039] Among them, the traditional Chinese medicine preparation uses the traditional Chinese medicine composition for treating polycystic ovary syndrome as an active ingredient, and this traditional Chinese medicine preparation is prepared into a commonly used pharmaceutical dosage form by a conventional preparation method in the art.

[0040] The traditional Chinese medicine preparation of the present invention can be prepared by the following method: (A) Weigh the above-mentioned various medicinal material components, mix them to obtain a mixture; (B) Add a pharmaceutically acceptable carrier to the mixture and prepare it by a conventional preparation method in the art.

[0041] In some cases, in step (A), the obtained mixture can be made into an extract, such as decocting and filtering to obtain a filtrate containing the extract, and the filtrate of the obtained extract can be further concentrated and dried to obtain an extract powder. Among them, 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 decocting times is 1-3 times; preferably, the total duration of decocting is 1-3 h.

[0042] In a third aspect, the present invention provides a product for treating polycystic ovary syndrome and / or depression, which comprises the traditional Chinese medicine preparation described in the first aspect above, and the traditional Chinese medicine preparation prepared by the method described in the second aspect. ​

[0043] Among them, the product includes drugs or health foods.

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

[0045] The dosage of the traditional Chinese medicine preparation in the present invention can be determined according to the amount of the drug contained in the final preparation to meet the requirements of a therapeutically effective dose and complete the preventive and / or therapeutic effects of the present invention.

[0046] The traditional Chinese medicine extract in the present invention is a traditional Chinese medicine extract for treating polycystic ovary syndrome and / or depression.

[0047] The traditional Chinese medicine preparation in the present invention is a traditional Chinese medicine preparation for treating polycystic ovary syndrome and / or depression.

[0048] The improvement of the quality of life in the present invention includes: Increase the scores of any one or more dimensions among physical function, role physical, bodily pain, general health, vitality, social function, role emotional, and mental health in the Short Form-36 (SF-36) health questionnaire; And / or, Increase the scores of any one or more dimensions among hirsutism, mood, weight, infertility, and menstruation in the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ).

[0049] Beneficial effects: The extract of the Zishen Qingre Lishi Huayu formula and its preparation provided by the present invention can not only significantly improve the quality of life while treating polycystic ovary syndrome, but also have the effect of preventing and treating depression. It solves the problem that the Zishen Qingre Lishi Huayu Tongluo formula and the Zishen Qingre Huayu Lishi formula in the prior art such as Chinese invention CN108403919A have insignificant improvement in the quality of life. In particular, the extract of the Zishen Qingre Lishi Huayu formula and its preparation provided by the present invention have an extremely significant difference in improving the quality of life and having the effect of preventing and treating depression compared with the control group (P<0.01), and have a better improvement effect compared with the significant effect (P<0.05) of the prior art (Tang Li, "The influence of the method of tonifying the kidney, clearing heat, promoting diuresis and removing stasis" on the negative emotions of patients with polycystic ovary syndrome of kidney deficiency and blood stasis type [D]. Jiangxi University of Traditional Chinese Medicine).

[0050] The extract of the Zishen Qingre Lishi Huayu formula and its preparation provided by the present invention can not only help PCOS patients restore ovarian function, promote ovulation, and be beneficial to pregnancy, but also have small side effects, no drug dependence, and good safety.

[0051] The traditional Chinese medicine preparation for treating polycystic ovary syndrome provided by the present invention uses inexpensive raw materials, is simple to prepare, convenient to use, has small side effects, and can be taken for a long time. After years of clinical application research, it has good curative effects on treating polycystic ovary syndrome. In view of the large number of patients with polycystic ovary syndrome and the poor clinical hormone treatment effect at present, the traditional Chinese medicine compound preparation provided by the present invention has good application prospects. Detailed implementation manners

[0052] In the following examples, the experimental methods are all conventional methods unless otherwise specified; the reagents and materials can be obtained from commercial channels unless otherwise specified. The medicinal materials meet the requirements of the current (2020 edition) Chinese Pharmacopoeia. Unless otherwise noted, they are all Chinese medicinal material decoction pieces, which can be obtained from sales companies or processed after obtaining.

[0053] Example 1: The effect of the Zishen Qingre Lishi Huayu formula on spontaneous ovulatory menstruation in PCOS patients: A multi-center, double-blind, randomized placebo-controlled trial 1.1 Experimental design This study was a multicenter, double-blind, randomized, placebo-controlled trial. The study was conducted in accordance with the Declaration of Helsinki and was reviewed and approved by the medical ethics committees of the participating institutions.

[0054] 1.2 Subjects The subjects were patients with polycystic ovarian syndrome (PCOS). All the included patients met the criteria and signed the informed consent form.

[0055] 1.3 Inclusion Criteria Patients diagnosed with PCOS according to the modified Rotterdam diagnostic criteria: Oligomenorrhea (menstrual cycle ≥ 35 days) or amenorrhea (absence of menstruation for 6 months) is a necessary condition; additional conditions are a. ≥ 12 antral follicles with a diameter of less than 10 mm or ovarian volume greater than 10 cm³ detected by transvaginal / rectal ultrasound; or b. clinical or biochemical hyperandrogenism (clinical hyperandrogenism includes hirsutism, acne, and androgenetic alopecia; biochemical hyperandrogenism refers to elevated serum testosterone levels).

[0056] ② Patients aged 18 - 40 years without current fertility requirements.

[0057] ③ Willing to be treated according to the treatment plan specified in this trial.

[0058] 1.4 Exclusion Criteria ① Hyperprolactinemia: Serum prolactin (PRL) levels ≥ 25 ng / ml in at least two measurements taken at least one week apart; ② Serum follicle-stimulating hormone (FSH) > 15 IU / L; ③ Patients with thyroid diseases, serum thyroid-stimulating hormone (TSH) < 0.2 mIU / mL or > 5.5 mIU / mL; ④ Poorly controlled type II diabetes patients; ⑤ Patients suspected of having Cushing's syndrome; ⑥ Patients suspected of having adrenal or ovarian tumors secreting androgens; ⑦ Hypertensive patients with poor blood pressure control, systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg; ⑧ Patients who have taken hormonal or other medications within the last 3 months that may affect the results; ⑨ Pregnant or lactating women; ⑩ Patients with severe or acute diseases in the heart, liver, kidneys, or blood, etc.

[0059] 1.5 Randomization and blinding Eligible subjects were randomly assigned to the traditional Chinese medicine group or the placebo group at a ratio of 1:1. The random sequence was generated by an independent researcher who did not participate in treatment, data collection, and evaluation using a computer, and the random numbers and grouping information were provided to each sub-center. The serial numbers of the subjects were printed on the outer packaging of the corresponding drug or placebo according to the determined grouping scheme. The study adopted a double-blind method, and the subjects, researchers, and doctors were unaware of the intervention measures. The researchers distributed the study drugs with the same numbers as those on the packaging boxes in the order of subject enrollment.

[0060] 1.6 Intervention measures The treatment group (traditional Chinese medicine group) was treated with the traditional Chinese medicine compound formula Zishen Qingre Lishi Huayu Decoction. Zishen Qingre Lishi Huayu Decoction was composed of 10 g of Anemarrhena asphodeloides, 10 g of Rehmannia glutinosa, 15 g of vinegar-processed turtle shell, 10 g of Dianthus superbus, 10 g of Dendrobium officinale, 10 g of Prunus persica, 12 g of Trichosanthes kirilowii Maxim., 3 g of Coptis chinensis, 10 g of Phellodendron amurense, 3 g of Cinnamomum cassia, 10 g of Plantago asiatica, and 6 g of Glycyrrhiza uralensis Fisch., a total of 12 herbs. It was decocted twice with 8 times the amount of water and concentrated, 1.5 h each time. The control group was treated with a placebo. The two drugs were packaged uniformly with the same appearance, smell, and color. The subjects took the medicine starting from the first day of inclusion, 1 prescription dose per day, 2 times a day, once in the morning and once in the evening, for a total of 3 months.

[0061] 1.7 Outcome measures 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 the basal body temperature measurement showed a biphasic body temperature, the serum progesterone level was measured on the 2 - 4th day of the high temperature phase.

[0062] Secondary outcome measures included: 1) Menstrual status, including the number of menstrual periods and the average number of days in the menstrual cycle during the 3-month treatment period. 2) Anthropometric characteristics, including body weight, body mass index, and waist-to-hip ratio. 3) Hair: Assessed using the Ferriman-Gallwey questionnaire, the hair scores for nine body areas (upper lip, chin, chest, arm, upper abdomen, lower abdomen, upper back, lower back, and thigh) ranged from 0 (none) to 4 (equivalent to a hairy man). 4) Acne: Using the criteria proposed by Rosenfield, with the nature and number of skin lesions as the scoring criteria, divided into 0 - 5 points. 5) Glucose and lipid metabolism indicators, including total cholesterol, triglycerides, fasting blood glucose, insulin, 2-hour blood glucose and insulin levels during the oral glucose tolerance test, and the insulin resistance index calculated according to the formula (Insulin resistance, IR = fasting glucose mmol / l × fasting insulin mIU / L / 22.5). 6) Quality of life: Assessed using the Short Form-36 (SF-36) health questionnaire and the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ). The SF-36 is the most commonly used general tool for measuring quality of life. It consists of 8 dimensions (physical function, role physical, bodily pain, general health, vitality, social function, role emotional, mental health), a total of 36 items. The score range for each dimension is from 0 to 100, and the higher the score, the better the condition. The PCOSQ is a specific tool for measuring the quality of life in PCOS. It consists of 5 dimensions (body hair, mood, weight, infertility, menstruation), a total of 26 items. Each item is scored from 1 (always) to 7 (never) with 7 options. The higher the score, the better the function. 7) Adverse events related to the study drug: Record all adverse events that occurred during the treatment of the subjects and evaluate and determine the relevance to the study treatment.

[0063] 1.8 Statistical analysis After preliminary pre-study, we found that the monthly ovulation rate of the traditional Chinese medicine compound Zishen Qingre Lishi Huayu formula in the treatment of PCOS was 40.3%, and the monthly ovulation rate of the placebo after acting on PCOS was 15.8%. α is the probability of type I error, β is the probability of type II error. Considering a 25% dropout rate, 63 eligible subjects were calculated to be included in each group, and the total sample size of the two groups was 126 cases.

[0064] Data analysis was performed by statisticians who were unclear about the grouping settings. In the intention-to-treat (ITT) analysis, all randomized participants were included, and unobserved outcome events were uniformly recorded as "anovulation". The per-protocol (PP) analysis included study subjects who received complete intervention treatment, that is, study subjects who were lost to follow-up, withdrew, aborted, or interrupted medication for various reasons were excluded. In addition, we conducted a sensitivity analysis, that is, we compared the differences in secondary outcome indicators after excluding 12 study subjects with interrupted medication (5 in the control group and 7 in the treatment group). Continuous variables that conform to the normal distribution were expressed as mean ± standard deviation, and the independent samples t-test was used to compare the differences between groups. Continuous variables that do not conform to the normal distribution were expressed as median (quartiles), and the Wilcoxon rank sum test was used to compare the differences between groups. Categorical variables were expressed as frequency and frequency (%), and the chi-square test was used to compare the differences between groups. All statistical analyses were completed in SAS 9.4 software, and two-sided tests were used. P A P value < 0.05 was considered statistically significant.

[0065] 1.9 Results A total of 126 eligible subjects were included in this study. Among them, 117 completed all treatments and follow-ups. Two subjects in the treatment group withdrew midway for personal reasons, two were pregnant, and two were lost to follow-up. Two subjects in the control group withdrew for personal reasons, one was pregnant, and in addition, seven subjects in the treatment group had interrupted medication during treatment, and five subjects in the control group had interrupted medication during treatment. The baseline characteristics before treatment were comparable between the two groups (see Table 1).

[0066] Regarding ovulation, during the 3-month treatment period, both the ITT and PP analyses showed that the monthly spontaneous ovulation rate in the traditional Chinese medicine group was significantly higher than that in the control group (ITT: 36.5% vs. 14.3%, P P < 0.001, RR 2.56, 95% CI 1.72 to 3.80; PP: 38.0% vs. 14.6%, P P < 0.001, RR 2.61, 95% CI 1.71 to 3.99, see Table 2).

[0067] Regarding menstruation, during the 3-month treatment period, both the ITT and PP analyses showed that the number of menstruations in the traditional Chinese medicine group was significantly higher than that in the control group (ITT: 27.0% vs. 11.6%, P 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 traditional Chinese medicine group was shortened by 8.66 ± 28.71 days, with a significant difference compared to the control group ( P <0.001) (see Table 3).

[0068] After 3 months of treatment, there were no significant differences in body weight, body mass index, waist-to-hip ratio, and Ferriman-Gallwey hair score between the two groups. The acne score in the traditional Chinese medicine group decreased by 0.6 ± 0.81, with a statistically significant difference compared to the control group ( P <0.001). There were no statistically significant differences in the glycolipid metabolism indexes between the two groups (see Table 3).

[0069] In terms of quality of life, after 3 months of treatment, the PCOSQ and SF-36 scores in the traditional Chinese medicine group were significantly higher than those at baseline. The scores of the parts of PCOSQ related to body hair, mood, menstruation, weight, and infertility in the traditional Chinese medicine group all increased to varying degrees, with a statistically significant difference compared to the control group ( P <0.001), and the mood part was the most obvious (increased by 2.13 ± 1.60). The traditional Chinese medicine group had great improvements in physical function, physical role, emotional role, social function, mental health, vitality, bodily pain, and general health in SF-36 compared to baseline, with a significant difference compared to the control group ( P <0.001) (see Table 3).

[0070] During the study period, there were no drug-related adverse events, and there were no abnormalities in the safety tests such as blood routine and liver and kidney functions after the treatment ended.

[0071] Table 1 Baseline characteristics

[0072] Note: The indexes of hair, acne, total cholesterol, fasting insulin, HOMA-IR, and SF-36 health questionnaire did not conform to the normal distribution, and were presented as median (25th percentile, 75th percentile), and the rank sum test was used. The rest were presented as mean ± standard deviation, and the two independent sample T test was used. After testing, all P values were greater than 0.05, indicating that the two groups were comparable at baseline.

[0073] Table 2 Comparison of ovulation rate and menstrual frequency, n (%)

[0074] Note: 1. In the ITT and PP analyses, n(%) represents the number of times (frequency) of the occurrence of the outcome, rather than the sample size.

[0075] 2. The total ITT sample size was 63 in the control group and 63 in the treatment group. The PP control group had 55 people, and the treatment group had 50 people (excluding all those who did not receive the complete intervention).

[0076] 3. The chi-square test was used for P-value calculation.

[0077] Table 3 Comparison of Other Secondary Outcome Measures

[0078] Note: The difference in effect before and after the intervention was the difference between each index three months later and each baseline index (reflecting the treatment effect). The differences conformed to a normal distribution (sample size ≥ 50), were expressed as mean ± standard deviation, and the independent samples t-test was used to compare whether there were differences in the means of the indices between the treatment group and the control group.

[0079] Example 2 Formula: 10 parts of Anemarrhena asphodeloides, 10 parts of Rehmannia glutinosa, 15 parts of vinegar-processed turtle shell, 10 parts of Dianthus superbus, 10 parts of Dendrobium officinale, 10 parts of peach kernel, 12 parts of Trichosanthes kirilowii Maxim. seed, 3 parts of Coptis chinensis, 10 parts of Phellodendron amurense, 3 parts of Cinnamomum cassia, 10 parts of Plantago asiatica, 6 parts of licorice.

[0080] Preparation process: Weigh each component according to the formula, add 8 times the total raw material mass of water, decoct 2 times, each decoction for 1 h, filter to obtain the filtrate; the obtained filtrate is concentrated to obtain a concentrated solution, and the concentrated solution is further concentrated and dried, and made into a preparation according to the conventional method.

[0081] Example 3 Formula: 8 parts of Anemarrhena asphodeloides, 12 parts of Rehmannia glutinosa, 13 parts of vinegar-processed turtle shell, 12 parts of Dianthus superbus, 12 parts of Dendrobium officinale, 8 parts of peach kernel, 14 parts of Trichosanthes kirilowii Maxim. seed, 2 parts of Coptis chinensis, 8 parts of Phellodendron amurense, 3 parts of Cinnamomum cassia, 8 parts of Plantago asiatica, 6 parts of licorice.

[0082] Preparation process: Weigh each component according to the formula, add 8 times the total raw material mass of water, decoct 1 time, decoct for 2 h, filter to obtain the filtrate; the obtained filtrate is concentrated to obtain a concentrated solution, and the concentrated solution can be further concentrated and dried, and made into a preparation according to the conventional method.

[0083] Example 4 Formula: 10 parts of Anemarrhena asphodeloides, 10 parts of Rehmannia glutinosa, 15 parts of vinegar-processed turtle shell, 10 parts of Dianthus superbus, 10 parts of Dendrobium officinale, 10 parts of peach kernel, 12 parts of Trichosanthes kirilowii Maxim. seed, 3 parts of Coptis chinensis, 10 parts of Phellodendron amurense, 3 parts of Cinnamomum cassia, 10 parts of Plantago asiatica, 10 parts of licorice.

[0084] Preparation process: Weigh each component according to the formula, add 10 times the total raw material mass of water, decoct 1 time, decoct for 1.5 h, filter to obtain the filtrate; the obtained filtrate is concentrated to obtain a concentrated solution, and the concentrated solution is further concentrated and dried, and made into a preparation according to the conventional method.

[0085] Example 5 Formula: 10 parts of Anemarrhena Rhizome, 10 parts of Rehmannia Root, 15 parts of Vinegar-processed Turtle Shell, 10 parts of Dianthus superbus, 10 parts of Dendrobium officinale, 10 parts of peach, 12 parts of Trichosanthes kirilowii Maxim. seeds, 3 parts of Coptis chinensis, 10 parts of Phellodendron amurense, 5 parts of Cinnamon Twig, 10 parts of Plantago asiatica, 6 parts of Licorice Root.

[0086] Preparation process: Weigh each component according to the formula, add 8 times the mass of the total raw materials of water, decoct twice for 1 hour each time, filter to obtain the filtrate; concentrate the obtained filtrate to obtain a concentrated solution, further concentrate and dry the concentrated solution, and make it into a preparation according to the conventional method.

[0087] Example 6 Formula: 12 parts of Anemarrhena Rhizome, 8 parts of Rehmannia Root, 17 parts of Vinegar-processed Turtle Shell, 8 parts of Dianthus superbus, 8 parts of Dendrobium officinale, 12 parts of peach kernel, 10 parts of Trichosanthes kirilowii Maxim. seeds, 6 parts of Coptis chinensis, 12 parts of Phellodendron amurense, 2 parts of Cinnamon Twig, 12 parts of Plantago asiatica, 4 parts of Licorice Root.

[0088] Preparation process: Weigh each component according to the formula, add 10 times the mass of the total raw materials of water, decoct three times for 1 hour, 3 hours, and 2 hours respectively, filter, and combine the filtrates; concentrate the obtained filtrate to obtain a concentrated solution, further concentrate and dry the concentrated solution, and make it into a preparation according to the conventional method.

[0089] The products provided in Examples 2 - 6 and Example 1 can all significantly improve the quality of life while treating polycystic ovary syndrome, and have the effect of preventing and treating depression.

[0090] Example 7: Case of depression treatment effect Case 1: Li, female, 35 years old, with normal menstruation, suffering from severe depression for 7 months, having difficulty falling asleep, feeling inferior and desperate, and often having suicidal thoughts when negative. After taking the drug of this Example 1 personally for 12 weeks, all clinical symptoms disappeared, and the patient's sleep evaluation was over 7.5 hours per night, and there was no change in the following six months.

[0091] Case 2: Chen, female, 46 years old, with normal menstruation, suffering from severe depression for 12 months, having difficulty falling asleep, feeling inferior and desperate, and often having suicidal thoughts when negative. After taking the traditional Chinese medicine formula of this Example 5 personally for 10 weeks, all clinical symptoms basically disappeared, and the patient's sleep evaluation was over 7 hours per night, and there was no change in the following one year.

[0092] Example 8: Preparation of granules 10 g of Anemarrhena Rhizome, 10 g of Rehmannia Root, 15 g of Vinegar-processed Turtle Shell, 10 g of Dianthus superbus, 10 g of Dendrobium officinale, 10 g of peach kernel, 12 g of Trichosanthes kirilowii Maxim. seeds, 3 g of Coptis chinensis, 10 g of Phellodendron amurense, 3 g of Cinnamon Twig, 10 g of Plantago asiatica, 6 g of Licorice Root, a total of 12 flavors, prepared by adding 8 times the amount of water and decocting twice for 1.5 hours each time to obtain the extract. The obtained extract is concentrated under reduced pressure, and the concentrated solution is dried under reduced pressure to obtain an extract powder, which is pulverized and sieved for standby.

[0093] Prepare granules according to the following prescription: Dextrin 10.00g Extract powder 20.00g 85% ethanol appropriate amount 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 use a 16-mesh sieve to get granules.

[0094] Example 9 10 parts of Rhizoma Anemarrhenae, 10 parts of Radix Rehmanniae Preparata, 15 parts of Carapax Trichosanthis, 10 parts of Dianthus Superbus, 10 parts of Dendrobium Officinale, 10 parts of Semen Persicae, 12 parts of Fructus Trichosanthis, 3 parts of Rhizoma Coptidis, 10 parts of Cortex Phellodendri, 3 parts of Cinnamomum cassiae, 10 parts of Herba Plantaginis, 6 parts of Radix Glycyrrhizae, a total of 12 flavors, add 8 times amount of water and boil twice, 1.5h / time. Filter and combine the filtrate; the obtained filtrate is concentrated to obtain a concentrate, starch with a mass ratio of 1:2 is added to prepare granules. A part of the granules is filled into a capsule shell to obtain a capsule, and a part of the granules is compressed to prepare a tablet.

[0095] Comparative Example 1 1.1 Treatment methods The treatment group used the CPOS prescription in the prior art (drug composition: 10g of Anemarrhena Rhizoma, 10g of Cornus Officinalis, 10g of Salvia Miltiorrhiza, 10g of Peach Kernel, 15g of Coix Seed, 10g of White Mustard Seed, 10g of Phellodendron Amurense, 10g of Scrophulariae, 6g of Licorice, 12.6g per bag, containing 45.5g of raw drugs, produced by Guangdong Yifang Pharmaceutical Co., Ltd., CPOS prescription production batch number: 2014101602), and the placebo group used placebo (composed of starch, pigment, bitter element and ginseng essence, the weight and packaging of CPOS prescription and placebo are consistent, and the appearance, smell and color are similar, produced by Guangdong Yifang Pharmaceutical Co., Ltd., placebo production batch number: 2014101609), once a day in the morning and evening, 1 pack each time, taken with boiled water, for 3 consecutive months. During the entire study period, patients were required to maintain normal diet and physical activities, and any other drugs that may affect the results were not allowed. The observation subject serial number was printed on the outer packaging of the corresponding drug or simulant according to the grouping. The researcher distributed the drug with the same serial number on the packaging box. The researcher and the patient were unaware of the grouping and the medication they were taking.

[0096] 1.2 Observation indicators Quality of life: Assessed using the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ) and the Short Form-36 (SF-36) Health Questionnaire. The PCOSQ is a specific tool for measuring the 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 7 options. The higher the score, the better the function. The SF-36 is the most commonly used general tool for measuring quality of life. It consists of 8 dimensions (physical function, role physical, bodily pain, general health, vitality, social function, role emotional, mental health), with a total of 36 items. The score range for each dimension is from 0 to 100, and the higher the score, the better the quality of life.

[0097] 1.3 Statistical analysis The data were processed using SAS 9.4 statistical software. Continuous variables that conform to a normal distribution were expressed as mean ± standard deviation, and the independent samples t-test was used to compare the differences between groups. Continuous variables with a non-normal distribution were expressed as median (interquartile range), and the Wilcoxon rank-sum test was used to compare the differences between groups. Categorical variables were expressed as frequency and frequency (%), and the chi-square test was used to compare the differences between groups. A two-sided test was used, and P < 0.05 was considered statistically significant.

[0098] 1.4 Results A total of 50 subjects meeting the PCOS criteria were included in this study. Among them, 48 subjects completed all treatments and follow-up. Two subjects in the control group dropped out midway for personal reasons, one was lost to follow-up, and one withdrew from the trial due to hyperthyroidism discovered during treatment. The baseline characteristics of the two groups were comparable before treatment (see Table 4).

[0099] In terms of quality of life, after 3 months of treatment, there were no significant differences between the CPOS formula and the control group in terms of physical function, role physical, role emotional, social function, mental health, vitality, bodily pain, and general health of the SF-36 (P > 0.05) (see Table 5).

[0100] Table 4 Baseline characteristics

[0101] Note: Data are presented as mean ± standard deviation, and the independent samples T-test was used. After testing, all P values were greater than 0.05, indicating that the two groups were comparable at baseline.

[0102] Table 5 Comparison of indicators before and after intervention

[0103] Comparative Example 2 During the process of conducting PCOS research on the first group of oral traditional Chinese medicine (TCM) prescriptions for nourishing the kidney, clearing heat, promoting diuresis, removing dampness, promoting blood circulation to remove stasis and dredging collaterals, and the second group of oral TCM prescriptions for nourishing the kidney, clearing heat, promoting blood circulation to remove stasis and promoting diuresis to remove dampness, with the Chinese invention patent No. 201810536499.6, the research results showed that there were no significant differences between the first group of TCM and the second group of TCM compared with the control group in terms of various indicators of quality of life, such as physical function, physical role, emotional role, social function, mental health, vitality, bodily pain and general health.

[0104] The above embodiments merely represent several implementation manners of the present invention. The description thereof is relatively specific and detailed, but it should not be construed as a limitation to the scope of the invention patent of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the invention patent of the present invention shall be subject to 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 Superbus, 8-12 parts of Dendrobium Officinale, 8-12 parts of Semen Persicae, 10-14 parts of Fructus Trichosanthis, 2-6 parts of Coptis chinensis, 8-12 parts of Cortex Phellodendri, 2-7 parts of Cinnamomum cassiae, 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 Carapace of Turtle, 8-12 parts of Dianthus Superbus, 8-12 parts of Dendrobium, 8-12 parts of Peach Kernel, 10-14 parts of Trichosanthes Seed, 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.

3. The Chinese medicine preparation according to claim 1, characterized in that: The weight proportions of each raw material are as follows: 10 parts of Anemarrhena asphodeloides, 8-12 parts of Rehmannia glutinosa, 13-17 parts of Carapax trichosanthis, 8-12 parts of Dianthus superbus, 8-12 parts of Dendrobium candidum, 8-12 parts of Prunus persica, 10-14 parts of Trichosanthes fruit, 2-6 parts of Coptis chinensis, 8-12 parts of Phellodendron amurense, 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: 10 parts of Rhizoma Anemarrhenae, 10 parts of Rehmannia Glutinosa, 15 parts of Carapax Trichosanthis, 10 parts of Dianthus Superbus, 10 parts of Herba Dendrobii, 10 parts of Semen Persicae, 12 parts of Fructus Trichosanthis, 3 parts of Rhizoma Coptidis, 10 parts of Cortex Phellodendri, 3 parts of Ramulus Cinnamomi, 10 parts of Herba Plantaginis, and 6 parts of Radix Glycyrrhizae.

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 cooking; 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 are capsules, tablets, powder injections, and granules; the liquid preparations are 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 Chinese medicine preparation according to any one of claims 1 to 8, characterized in that: include: The raw materials are weighed according to weight, boiled, filtered, and a filtrate containing the extract is obtained.

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 Superbus, 7-13 parts of Dendrobium Officinale, 7-13 parts of Semen Persicae, 9-15 parts of Fructus Trichosanthis, 2-7 parts of Coptis Chinensis, 7-13 parts of Phellodendron Aucklandiae, 2-7 parts of Cinnamomum Cinnamomum, 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 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 Superbus, 8-12 parts of Dendrobium Officinale, 8-12 parts of Semen Persicae, 10-14 parts of Fructus Trichosanthis, 2-6 parts of Coptis chinensis, 8-12 parts of Cortex Phellodendri, 2-5 parts of Cinnamomum cassiae, 8-12 parts of Plantago, and 4-6 parts of Licorice; the extract is prepared by the following method: weighing the raw materials in parts by weight, decocting them 1-3 times with water having a mass of 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; the mass content of component (ii) in the preparation is 1-95%.

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

Images