Kidney-warming and phlegm-removing preparation for polycystic ovarian syndrome and application of kidney-warming and phlegm-removing preparation

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a kidney-warming and phlegm-removing preparation for polycystic ovarian syndrome and application of the kidney-warming and phlegm-removing preparation. The kidney-warming and phlegm-cleaning preparation contains amethyst, cistanche deserticola, semen cuscutae, 5.5-22 parts by weight of rhizoma atractylodis, ginger processed pinellia, angelica sinensis, rhizoma cyperi, rhizoma acori graminei, herba epimedii and ligusticum wallichii, and can effectively improve the condition of a patient suffering from kidney deficiency and phlegm-dampness type PCOS, improve the ovarian reserve function and the serum sex hormone secretion condition of the patient and improve the curative effect of the patient. The traditional Chinese medicine composition has great advantages in the treatment of polycystic ovarian syndrome and irregular menstruation, and has good safety and wide market application prospects.

Description

Technical Field

[0001] The invention relates to the technical field of medicines, and in particular to a kidney-warming and phlegm-clearing preparation for polycystic ovary syndrome and application thereof. Background Art

[0002] Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder in women of childbearing age. The disease is manifested by sparse menstruation or amenorrhea, elevated androgen levels, polycystic ovarian changes, and obesity, hirsutism, acne, insulin resistance and other symptoms. In addition, PCOS may also lead to infertility, depression, anxiety and other emotional disorders, seriously affecting the patient's physical and mental health and family harmony. At present, short-acting oral contraceptives, progesterone, glucocorticoids and other strategies are often used in clinics to regulate PCOS patients, improve patients' sugar and lipid metabolism, and correct menstrual disorders. However, oral hormone products have many adverse reactions and are prone to drug resistance. They are also rejected by young women. Therefore, new strategies are needed to treat PCOS patients. Traditional Chinese medicine believes that the cause of PCOS originates from the kidney and is inseparable from the dysfunction of the kidney-chongren-uterus axis. Kidney deficiency leads to qi and blood deficiency, and qi and blood deficiency leads to poor circulation of qi and fluid, which leads to sparse menstruation and irregular menstruation.

[0003] PCOS ovulation disorders and abnormal endocrine changes cause poor differentiation of the endometrium, affecting embryo implantation, leading to low pregnancy rates and high miscarriage rates; in addition, it also affects the normal cyclical changes of the endometrium, causing the endometrium to have varying degrees of hyperplasia and even an increased risk of developing endometrial cancer.

[0004] Regarding the treatment of PCOS, Western medicine focuses on treating symptoms rather than the root cause. Common Western medical treatments for PCOS mainly use contraceptives or ovulation-inducing drugs, such as: Clomiphene, HMG, GnRH, Gonal-f, Marvelon and Diane. These drugs are not only unable to effectively treat all PCOS, but also have defects such as low pregnancy rate and high miscarriage rate. Surgical puncture technology has also been used in the treatment of PCOS. These therapies may cause damage to the ovaries, or cause pelvic adhesions and potential harm to the fetus; there are also many Chinese medicines, such as:

[0005] Chinese patent CN201810565323.3 provides a drug for treating polycystic ovary syndrome. The technical solution adopted by the present invention is: a drug for treating polycystic ovary syndrome, which is a saline injection containing a PCSK9 inhibitor. The present invention can effectively improve the patient's lipid metabolism index, sex hormone index and ovarian ovulation function, and provides a new drug with low cost, small side effects and significant efficacy for polycystic ovary syndrome. The injection has low adaptability for women taking ginseng and cannot be used on a large scale.

[0006] Chinese patent CN201110270141.1 is a pharmaceutical composition for polycystic ovary syndrome, a pharmaceutical composition for polycystic ovary syndrome, including a Chinese medicine composition and a chemical drug composition, wherein the Chinese medicine composition includes medicinal materials such as Anemarrhena, Fritillaria, Carapax tortoise shell, Polygonum multiflorum, Radix Ophiopogonis and Hippocampus, and the chemical drug includes one or more compound molecules of dexamethasone, spironolactone, ethinylestradiol, estradiol valerate, conjugated estrogen and pharmaceutically acceptable salts. The pharmaceutical composition of the present invention can reduce the level of androgen and androgen receptor in PCOS patients, increase the level of sex hormone binding protein, reduce the level of free testosterone, further increase the level of estrogen in the body, improve the growth and development of follicles, and increase the ovulation rate and pregnancy rate of patients. The combined use of Western medicine and chemistry is difficult to ensure its safety. Summary of the invention

[0007] The invention discloses a kidney-warming and phlegm-clearing preparation for polycystic ovary syndrome and application thereof, solves the problems of polycystic ovary syndrome and irregular menstruation, has good safety, and has broad market application prospects.

[0008] Specifically, the technical objectives of the present invention are achieved through the following technical solutions:

[0009] The invention provides a traditional Chinese medicine composition for preventing or treating diabetic nephropathy. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 9-40 parts by weight of purple quartz, 5.2-23 parts by weight of Cistanche deserticola, 7-32 parts by weight of Cuscuta australis, 5.5-22 parts by weight of Atractylodes macrocephala, 4.5-20 parts by weight of Pinellia ternata, 5.2-22 parts by weight of Angelica sinensis, 5-22 parts by weight of Cyperus rotundus, 3-13 parts by weight of Acorus calamus, 4.5-19 parts by weight of Epimedium brevicornum and 3-13 parts by weight of Ligusticum chuanxiong.

[0010] In a preferred embodiment of the present invention, the Chinese medicine composition is made of the following raw materials in parts by weight: 20 parts by weight of purple quartz, 10 parts by weight of Cistanche deserticola, 15 parts by weight of Cuscuta australis, 10 parts by weight of Atractylodes macrocephala, 9 parts by weight of Pinellia ternata, 10 parts by weight of Angelica sinensis, 10 parts by weight of Cyperus rotundus, 6 parts by weight of Acorus calamus, 9 parts by weight of Epimedium brevicornum, and 6 parts by weight of Ligusticum chuanxiong.

[0011] In a preferred embodiment of the present invention, the Chinese medicine composition is made of the following raw materials in parts by weight: 40 parts by weight of purple quartz, 23 parts by weight of Cistanche deserticola, 32 parts by weight of Cuscuta australis, 22 parts by weight of Atractylodes macrocephala, 20 parts by weight of Pinellia ternata, 22 parts by weight of Angelica sinensis, 22 parts by weight of Cyperus rotundus, 13 parts by weight of Acorus calamus, 19 parts by weight of Epimedium brevicornum, and 13 parts by weight of Ligusticum chuanxiong.

[0012] In a preferred embodiment of the present invention, the Chinese medicine composition is made of the following raw materials in parts by weight: 9 parts by weight of purple quartz, 5.2 parts by weight of Cistanche deserticola, 7 parts by weight of Cuscuta australis, 5.5 parts by weight of Atractylodes macrocephala, 4.5 parts by weight of Pinellia ternata, 5.2 parts by weight of Angelica sinensis, 5 parts by weight of Cyperus rotundus, 3 parts by weight of Acorus calamus, 4.5 parts by weight of Epimedium brevicornum, and 3 parts by weight of Ligusticum chuanxiong.

[0013] Furthermore, the second object of the present invention provides a preparation containing the Chinese medicine composition of the present invention, selected from any one of a mixture, a decoction, an oral liquid, a granule, a tablet, a pill, a capsule or an ointment.

[0014] Preferably, the dosage form of the Chinese medicine composition of the present invention is a decoction, and the decoction is Wenshen Ditan Decoction.

[0015] The third object of the present invention is to provide a method for preparing the decoction, that is, the preparation process of the Wenshen Ditan Decoction is as follows:

[0016] (1) Grind the purple quartz into fine powder under vacuum; set aside

[0017] (2) Crush Atractylodes lancea, Angelica sinensis, Ligusticum chuanxiong and Cyperus rotundus, add 70-80% ethanol and reflux extract twice, combine the filtrates and set aside;

[0018] (3) Cuscuta chinensis, Pinellia ternata, Epimedium brevicornum, Acorus calamus and Cistanche deserticola were decocted twice with water. The first decoction was decocted for 40-60 min, and the filtrate and residue were reserved. The second decoction was decocted for 20-40 min, and the two decoctions were combined.

[0019] (4) The fine powder of step 1), the filtrate of step 2) and the decoction obtained in step 3) are combined to obtain a decoction.

[0020] Further, in a preferred embodiment of the present invention, the preparation process of Wenshen Ditan Decoction is as follows:

[0021] (1) Grind the purple quartz into fine powder under vacuum; set aside

[0022] (2) Crush Atractylodes lancea, Angelica sinensis, Ligusticum chuanxiong and Cyperus rotundus, add 75% ethanol and reflux extract twice, combine the filtrates and set aside;

[0023] (3) Cuscuta, Pinellia, Epimedium, Acorus calamus and Cistanche deserticola were decocted twice with water. The first decoction was decocted for 50 min, and the filtrate and residue were reserved. The second decoction was decocted for 30 min, and the two decoctions were combined.

[0024] (4) The fine powder of step 1), the filtrate of step 2) and the decoction obtained in step 3) are combined to obtain a decoction.

[0025] The third object of the present invention is to provide the use of a Chinese medicine composition in the preparation of a drug for preventing or treating polycystic ovary syndrome and irregular menstruation. Furthermore, the use of the Chinese medicine composition in the preparation of a drug for preventing or treating polycystic ovary syndrome. In the prescription, purple quartz is calm and heavy, and its qi is warm and nourishing, which can "warm the blood and nourish, and can open the extraordinary pulse", and the herb of celery, Cistanche deserticola, and Cuscuta chinensis warm the kidney and warm the palace, and nourish the kidney and fill the essence as the main medicine, ginger and Pinellia ternata warm the middle, descend the adverse and resolve phlegm, and Atractylodes macrocephala dries dampness and strengthens the spleen, "resolving the symptoms of phlegm and dampness, and treating the source of phlegm" as the minister medicine, and Angelica sinensis and Chuanxiong replenish blood and activate blood circulation, nourish blood and regulate menstruation, and Cyperus rotundus soothes the liver and relieves depression, regulates qi and regulates menstruation as adjuvants, and Acorus calamus opens the mind and resolves phlegm, and resolves dampness and harmonizes the stomach as the messenger medicine, and the kidney qi is warmed, the dampness evil is eliminated, the Chong and Ren meridians are regulated, and the menstrual water is regulated.

[0026] Compared with the prior art, the present invention has the following advantages:

[0027] (1) The Chinese medicine composition of the present invention has all the main, secondary, adjuvant and guiding ingredients, and the various drugs work together to nourish the kidney and spleen, regulate menstruation and replenish blood, promote the recovery of the patient's renal function, and make the egg cells develop normally and ovulate, so as to achieve the purpose of restoring the patient's menstrual cycle and guide the regularity of menstruation.

[0028] (2) The preparation method of the Chinese medicine composition of the present invention is simple, and the dosage forms such as decoctions and tablets are common clinical dosage forms. The obtained Chinese medicine composition has a definite therapeutic effect on polycystic ovary syndrome and irregular menstruation, and has been confirmed through pharmacodynamic experiments and clinical experiments. It can treat both the symptoms and the root causes, is safe and reliable, and has broad market application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 : The average number of ovulations of the female mice in the embodiments of the present invention, embodiments 1-3 compared with comparative examples 1-5, have significant differences (P<0.05), the number of ovulations in embodiment 1 is better than that in other embodiments, it can be seen that the decoction of embodiment 1 has the best therapeutic effect.

[0030] Figure 2 : The rat ovary weight (g / 100g body weight) of the examples of the present invention, Example 1 and the normal group were significantly different from the model group.

[0031] Figure 3 :Comparison of the average number of corpora lutea and the average number of cystic dilated follicles in each group. The model group had significant differences compared with each group (P<0.000), and the number of corpora lutea in Examples 1-3 was higher than that in Comparative Examples 1-5, and there was a significant difference (P<0.01).

[0032] Figure 4 : Comparison of the results of the cystic dilated follicle rate of each group. The model group had significant differences compared with each group (P<0.000), and the cystic dilated follicle rate of Examples 1-3 was significantly lower than that of Comparative Examples 1-5.

[0033] Figure 5 : Comparison results of serum hormone level testosterone (T) in each group. There are significant differences between Examples 1-3 and Comparative Examples 1-5 (P<0.01).

[0034] Figure 6 : Comparison results of serum hormone level luteinizing hormone (LH) among each group.

[0035] Figure 7 : Comparison results of fasting blood glucose (FPG) among each group.

[0036] Figure 8 : Comparison results of fasting insulin (FINS) among each group.

[0037] Fig. 9 :It shows the comparison of various indicators of the control group before and after treatment. Luteinizing hormone (LH) and follicle-stimulating hormone (FSH) use the left Y-axis, the unit is (IU / L); pituitary prolactin (PRL), testosterone (T), estradiol (E2) use the right Y-axis, the unit is (ug / L), there are significant differences before and after treatment (P<0.05), indicating that the experimental group can also achieve the same treatment effect.

[0038] Fig.10 :It shows the comparison of luteinizing hormone (LH), follicle stimulating hormone (FSH), pituitary prolactin (PRL), testosterone (T), and estradiol (E2) between the control group and the experimental group after treatment. The luteinizing hormone (LH), follicle stimulating hormone (FSH), pituitary prolactin (PRL), and estradiol (E2) in the experimental group were significantly different from those in the control group (P<0.05).

[0039] Fig.11 : It shows the comparison of insulin (INS), blood glucose content and HOMA-IR indexes between the control group and the experimental group after treatment.

[0040] Fig.12 It shows the BBT measurement results of the control group and the experimental group.

[0041] Fig.13 :Represents the various indicators of inflammatory factors in the control group and the experimental group. After treatment, there was a significant difference between the experimental group and the control group (P<0.05).

[0042] Fig.14 :It shows the comparison of BMI between the control group and the experimental group. Before treatment, the control group and the experimental group were not comparable, but after treatment, there was a significant difference between the experimental group and the control group (P<0.05).

[0043] Fig.15:It represents the menstrual function scores of the control group and the experimental group. It can be seen that the control group and the experimental group before treatment are not comparable, and there is a significant difference between the experimental group and the control group after treatment (P<0.05).

[0044] Fig.16 :It shows the comparison of ovarian volume between the control group and the experimental group. It can be seen that the control group and the experimental group are not comparable before treatment, and there is a significant difference between the experimental group and the control group after treatment (P<0.05). Fig.17 :It shows the comparison of the number of basal follicles between the control group and the experimental group. It can be seen that the control group and the experimental group before treatment are not comparable, and there is a significant difference between the experimental group and the control group after treatment (P<0.05). DETAILED DESCRIPTION

[0045] The technical solution of the present invention will be described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0046] Example 1: A Wenshen Ditan Decoction for polycystic ovary syndrome, the dosage and preparation process are as follows:

[0047] Element (g) Epimedium 9 Cistanche deserticola 10 Cuscuta 15 Atractylodes macrocephala 10 Ginger Pinellia 9 Angelica 10 Cyperus rotundus 10 Chuanxiong 6 Amethyst 20 Acorus 6

[0048] The preparation process is as follows:

[0049] (1) Grind the purple quartz into fine powder under vacuum; set aside

[0050] (2) Crush Atractylodes lancea, Angelica sinensis, Ligusticum chuanxiong and Cyperus rotundus, add 75% ethanol and reflux extract twice, combine the filtrates and set aside;

[0051] (3) Cuscuta, Pinellia, Epimedium, Acorus calamus and Cistanche deserticola were decocted twice with water. The first decoction was decocted for 50 min, and the filtrate and residue were reserved. The second decoction was decocted for 30 min, and the two decoctions were combined.

[0052] (4) The fine powder of step 1), the filtrate of step 2) and the decoction obtained in step 3) are combined to obtain a decoction.

[0053] Example 2: A Wenshen Ditan Decoction for polycystic ovary syndrome, the dosage and preparation process are as follows:

[0054]

[0055]

[0056] The preparation process is as follows

[0057] (1) Grind the purple quartz into fine powder under vacuum; set aside

[0058] (2) Crush Atractylodes lancea, Angelica sinensis, Ligusticum chuanxiong and Cyperus rotundus, add 80% ethanol and reflux extract twice, combine the filtrates and set aside;

[0059] (3) Cuscuta chinensis, Pinellia ternata, Epimedium brevicornum, Acorus calamus and Cistanche deserticola were decocted twice with water. The first decoction was decocted for 60 min, and the filtrate and residue were reserved. The second decoction was decocted for 40 min, and the two decoctions were combined.

[0060] (4) The fine powder of step 1), the filtrate of step 2) and the decoction obtained in step 3) are combined to obtain a decoction.

[0061] Example 3: A Wenshen Ditan Decoction for polycystic ovary syndrome, the dosage and preparation process are as follows:

[0062] Element (g) Epimedium 4.5 Cistanche deserticola 5.2 Cuscuta 7 Atractylodes macrocephala 5.5 Ginger Pinellia 4.5 Angelica 5.2 Cyperus rotundus 5 Chuanxiong 3 Amethyst 9 Acorus 3

[0063] The preparation process is as follows:

[0064] (1) Grind the purple quartz into fine powder under vacuum; set aside

[0065] (2) Crush Atractylodes lancea, Angelica sinensis, Ligusticum chuanxiong and Cyperus rotundus, add 70% ethanol and reflux extract twice, combine the filtrates and set aside;

[0066] (3) Cuscuta chinensis, Pinellia ternata, Epimedium brevicornum, Acorus calamus and Cistanche deserticola were decocted twice with water. The first decoction was decocted for 40 min, and the filtrate and residue were reserved. The second decoction was decocted for 20 min, and the two decoctions were combined.

[0067] (4) The fine powder of step 1), the filtrate of step 2) and the decoction obtained in step 3) are combined to obtain a decoction.

[0068] Example 4: A warming kidney and ditan mixture for polycystic ovary syndrome, the dosage and preparation process are as follows:

[0069] Element (g) Epimedium 9 Cistanche deserticola 10 Cuscuta 15 Atractylodes macrocephala 10 Ginger Pinellia 9 Angelica 10 Cyperus rotundus 10 Chuanxiong 6 Amethyst 20 Acorus 6

[0070] The preparation process is as follows:

[0071] (1)-(3) are the same as in Example 1.

[0072] (4) The fine powder of step 1), the filtrate of step 2) and the decoction obtained in step 3) are combined and subjected to rotary evaporation to obtain a mixture.

[0073] Example 5: A kidney-warming and phlegm-digesting oral liquid for polycystic ovary syndrome, the dosage and preparation process are as follows:

[0074] Element (g) Epimedium 9 Cistanche deserticola 10 Cuscuta 15 Atractylodes macrocephala 10 Ginger Pinellia 9 Angelica 10 Cyperus rotundus 10 Chuanxiong 6 Amethyst 20 Acorus 6

[0075] The preparation process is as follows:

[0076] (1)-(3) are the same as in Example 1.

[0077] (4) The fine powder of step 1), the filtrate of step 2) and the decoction obtained in step 3) are combined, and a pharmaceutically acceptable excipient is added by rotary evaporation to obtain an oral solution.

[0078] Example 6: A Wenshen Ditan granule for polycystic ovary syndrome, the dosage and preparation process are as follows:

[0079] Element (g) Epimedium 9 Cistanche deserticola 10 Cuscuta 15 Atractylodes macrocephala 10 Ginger Pinellia 9 Angelica 10 Cyperus rotundus 10 Chuanxiong 6 Amethyst 20 Acorus 6

[0080] The preparation process is as follows:

[0081] (1)-(3) are the same as in Example 1.

[0082] (4) The fine powder of step 1), the filtrate of step 2) and the decoction obtained in step 3) are combined, and a clear paste is obtained by rotary evaporation. A pharmaceutically acceptable excipient is added, and granulation is performed to obtain a granule.

[0083] Example 7: A kidney-warming and phlegm-digesting tablet for polycystic ovary syndrome, the dosage and preparation process are as follows:

[0084]

[0085]

[0086] The preparation process is as follows:

[0087] (1)-(3) are the same as in Example 1.

[0088] (4) The fine powder of step 1), the filtrate of step 2) and the decoction obtained in step 3) are combined, and rotary evaporated to obtain a clear paste, and then 95% ethanol is added and evaporated to obtain a thick paste, and then pharmaceutically acceptable excipients are added and tableted to obtain tablets.

[0089] Example 8: A Wenshen Ditan Capsule for polycystic ovary syndrome, the dosage and preparation process are as follows:

[0090] Element (g) Epimedium 9 Cistanche deserticola 10 Cuscuta 15 Atractylodes macrocephala 10 Ginger Pinellia 9 Angelica 10 Cyperus rotundus 10 Chuanxiong 6 Amethyst 20 Acorus 6

[0091] The preparation process is as follows:

[0092] (1)-(3) are the same as in Example 1.

[0093] (4) The fine powder of step 1), the filtrate of step 2) and the decoction obtained in step 3) are combined, and a clear paste is obtained by rotary evaporation. 95% ethanol is then added and further evaporated to obtain a thick paste. Pharmaceutically acceptable excipients are then added and the mixture is filled into capsules.

[0094] Comparative Example 1: A Wenshen Ditan Decoction for polycystic ovary syndrome, the dosage and preparation process are as follows:

[0095]

[0096]

[0097] The preparation process is the same as in Example 1.

[0098] Comparative Example 2: A Wenshen Ditan Decoction for polycystic ovary syndrome, the dosage and preparation process are as follows:

[0099] Element (g) Cuscuta 15 Atractylodes macrocephala 10 Ginger Pinellia 9 Angelica 10 Cyperus rotundus 10 Chuanxiong 6 Amethyst 20 Acorus 6

[0100] The preparation process is the same as in Example 1.

[0101] Comparative Example 3: A Wenshen Ditan Decoction for polycystic ovary syndrome, the dosage and preparation process are as follows:

[0102] Element (g) Epimedium 9 Actinolite 10 Epimedium 15 Atractylodes macrocephala 10 Ginger Pinellia 9 Angelica 10 Cyperus rotundus 10 Chuanxiong 6 Amethyst 20 Acorus 6

[0103] The preparation process is the same as in Example 1.

[0104] Comparative Example 4: A Wenshen Ditan Decoction for polycystic ovary syndrome, the dosage and preparation process are as follows:

[0105] Element (g) Epimedium 9 Cistanche deserticola 10 Cuscuta 15 Atractylodes macrocephala 10 French Pinellia 9 Astragalus 10 Zeeland 10 Salvia miltiorrhiza 6 Red Peony Root 20 Citrus aurantium 6

[0106] The preparation process is the same as in Example 1.

[0107] Comparative Example 5: A Wenshen Ditan Decoction for polycystic ovary syndrome, the dosage and preparation process are as follows:

[0108] Element (g) Epimedium 30 Cistanche deserticola 5 Cuscuta 6 Atractylodes macrocephala 5 Ginger Pinellia 26 Angelica 25 Cyperus rotundus 3 Chuanxiong 3 Amethyst 17 Acorus 15

[0109] The preparation process is the same as in Example 1.

[0110] 1. The pharmacodynamics and clinical experimental design of the decoction of the present invention are as follows:

[0111] 1. Pharmacodynamics study of Wenshen Ditan Decoction

[0112] 1.1 Construction of PCOS-IR rat model

[0113] One hundred female SD rats were adaptively reared for one week and then examined for estrous cycle. 96 SD rats with normal estrous cycle were randomly divided into blank control group (n=8) and model group (n=88). The rat model of PCOS with IR was established according to relevant literature: daily oral administration of letrozole solution [letrozole 1 mg / (kg·d) dissolved in 0.5% (mass fraction) sodium carboxymethyl cellulose] combined with high-fat diet [casein 800 kcaL, L-cystine 12 kcaL, corn starch 291 kcaL, maltodextrin 400 kcaL, sucrose 691 kcaL, soybean oil 225 kcaL, lard 1598 kcaL, multivitamins 40 kcaL] for 4 consecutive weeks.

[0114] Rats in the blank control group were fed with regular feed and gavaged with an equal volume of pure water every day during this period. After 4 weeks, blood was collected from the orbital vein of rats after fasting for 12 hours to measure blood hormones, insulin and blood sugar levels. Vaginal smears were performed on all modeling rats for 7 consecutive days: first use a marker to mark the mouse, then grab the rat and fix it in the palm of your hand, gently insert a fine cotton swab moistened with saline into the rat's vagina about 0.5 cm, and slowly rotate it to remove it. The vaginal contents on the cotton swab were evenly spread on the slide, and the slide was numbered and dried naturally. As a result, vaginal epithelial cells with continuous keratinization were seen on the vaginal smears of all rats, indicating that the rats completely lost the estrous cycle changes. When the estrous cycle and sex hormone levels of rats are disturbed at the same time, it indicates that the PCOS-IR rat model has been successfully established.

[0115] 1.2 Medication administration and specimen collection

[0116] The 88 rats with successful modeling were randomly divided into model group, metformin group [positive control, 0.135g / (kg·d), Example 1 group, Example 2 group, Example 3 group and Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group, Comparative Example 5 group and Comparative Example 6 group, 8 rats in each group. On the second day after successful modeling, rats in each drug group began to be gavaged (the drug was prepared into the corresponding drug solution with normal saline), once a day, and the drug was continuously administered for 28 days; the blank control group and model group rats were gavaged with an equal volume of normal saline in the same way. After the end of the drug administration, the rats in each group fasted for 12h (drinking water was normal) and then anesthetized by intraperitoneal injection of 0.3% sodium pentobarbital at 50mg / kg. After anesthesia, the rats were fixed on the operating board, and blood was collected from the aorta to separate the serum for later use. The ovarian tissue and ileal tissue of the female rats were removed from both sides, fixed with 4% paraformaldehyde or frozen in liquid nitrogen after weighing, and then stored at -80℃.

[0117] 1.3 Observation and detection of relevant indicators

[0118] a. Observation of ovarian tissue morphology: HE staining was used to observe the ovulation of female mice under a light microscope (ovulation was determined by the formation of corpus luteum), and the average number of ovulations of female mice was recorded = total number of corpora lutea / number of female mice; ovarian weight (g / 100g body weight); average cystic dilated follicle rate = average number of cystic dilated follicles / total number of follicles × 100%.

[0119] b. Serum index detection: Enzyme-linked immunosorbent assay (ELISA) was used to detect the reproductive endocrine indexes FSH, LH, T, fasting blood glucose (FPG) and fasting insulin (FINS) of rats in each group.

[0120] 1.4 Data Analysis

[0121] SPSS 19.0 statistical software was used for data processing. The measurement data were expressed as mean ± standard deviation (X ± S). The paired t test was used to compare the differences between groups. The Kruskal-Wallis rank sum test was used for intra-group comparisons between multiple groups. If the data did not conform to the normal distribution, the one-way analysis of variance was used if the data conformed to the normal distribution and the variance was homogeneous. The Wilcoxon rank sum test was used to compare the distribution of paired and single samples. The linear discriminant analysis (LDA) was used to distinguish the main classification of the samples. The non-parametric multivariate analysis of variance (PERMANOVA) was used to compare the differences in community composition and structure. The count data were analyzed by X 2 The difference was statistically significant when p < 0.05.

[0122] 1.5 Results Analysis

[0123] Figure 1 : represents the average ovulation number of female mice in the embodiments of the present invention. Compared with comparative examples 1-5, embodiments 1-3 have significant differences (P<0.05). The ovulation number of embodiment 1 is better than that of other embodiments. It can be seen that the decoction of embodiment 1 has the best therapeutic effect.

[0124] Figure 2 : Rat ovary weight (g / 100g body weight), it can be seen that there is not much change in body weight, only Example 1 and the normal group have significant differences compared with the model group, but it can also be seen from the bar graph that the rat ovary weight of Comparative Examples 1-5 is higher than that of Example 1-3.

[0125] Figure 3:The average number of corpora lutea and the average number of cystic dilated follicles in each group. It can be seen that the model group has significant differences compared with each group (P<0.000), the number of corpora lutea in Examples 1-3 is higher than that in Comparative Examples 1-5, and there is a significant difference (P<0.01). The embodiments are more likely to secrete progesterone than the comparative examples, which helps to maintain the thickness of the endometrium, making it suitable for embryo implantation, thereby increasing the possibility of conception. The increase in the number of cystic dilated follicles affects normal ovulation, leading to irregular menstrual cycles or no ovulation. The decoction of Comparative Examples 1-5 makes the number of cystic dilated follicles significantly higher than that of Examples 1-3, indicating that the probability of conception in Comparative Examples 1-5 is reduced.

[0126] Figure 4 :Comparison of the results of the cystic dilated follicle rate of each group. It can be seen that the increase in the cystic dilated follicle rate is closely related to polycystic ovary syndrome (PCOS), and the increase in cystic follicles may interfere with the normal ovulation process, thereby leading to irregular menstrual cycles or amenorrhea and cystic dilated follicles, ultimately leading to difficulty in conception or infertility. The model group showed significant differences compared with each group (P<0.000), and the cystic dilated follicle rate of Examples 1-3 was significantly lower than that of Comparative Examples 1-5. It also illustrates that the decoction prepared in Examples 1-3 is more conducive to reducing the cystic dilated follicle rate and improving the conception rate than the decoction of Comparative Examples 1-5.

[0127] Figure 5 : Comparison results of serum hormone level testosterone (T) in each group. It can be seen that Examples 1-3 have significant differences compared with Comparative Examples 1-5 (P<0.01).

[0128] Figure 6 : Comparison results of serum hormone level luteinizing hormone (LH) in each group. It can be seen that Examples 1-3 have significant differences compared with Comparative Examples 1-5 (P<0.01).

[0129] Figure 7 : Comparison results of fasting blood glucose (FPG) of each group. There was no significant difference between the comparative example 1-5 group and the example 1-3 group (P>0.05).

[0130] Figure 8 : Comparison results of fasting insulin (FINS) in each group. It can be seen that Examples 1-3 have significant differences compared with Comparative Examples 1-5 (P<0.01).

[0131] 2.1 Research content

[0132] (1) Research subjects

[0133] A total of 76 patients with PCOS with kidney deficiency and phlegm-dampness and insulin resistance who visited Hangzhou Hospital of Traditional Chinese Medicine from January 1, 2025 to May 31, 2026 were enrolled. They were randomly divided into an observation group and a control group, 38 cases in each group. There was no significant difference in the baseline data of the two groups, such as age, menarche, menstruation, and BMI (P>0.05). The study was approved by the Ethics Committee of Hangzhou Hospital of Traditional Chinese Medicine.

[0134] (2) Diagnostic criteria

[0135] a. Western medicine diagnostic criteria:

[0136] 1) PCOS diagnostic criteria:

[0137] Refer to the PCOS diagnostic criteria of the 2003 Rotterdam Conference in the Netherlands: ① infrequent ovulation or anovulation; ② hyperandrogenemia or clinical manifestations of hyperandrogenism; ③ polycystic ovarian changes under ultrasound (one or both ovaries have more than 12 follicles with a diameter of 2-9mm and / or an ovarian volume greater than 10ml); meet any two of the above three items.

[0138] After meeting the above-mentioned suspected PCOS diagnostic conditions, the following conditions must be excluded in order to confirm PCOS: ① Diseases that cause hyperandrogenism: tumors of the ovaries or adrenal glands that secrete androgens, drug-induced hyperandrogenism, Cushing's syndrome, and non-classical congenital adrenal hyperplasia; ② Diseases that cause ovulatory disorders: functional hypothalamic amenorrhea, premature ovarian insufficiency, hyperprolactinemia, and thyroid dysfunction, etc.; ③ Others: drug-induced hyperandrogenism must have a history of medication, idiopathic hirsutism must have a positive family history, and blood testosterone levels and ultrasound examinations are normal.

[0139] 2) Diagnostic criteria for insulin resistance:

[0140] Since there is no diagnostic standard for IR in China, this study refers to the "Endocrinology" to formulate: ① fasting insulin ≥ 8.5mmol / L; ② insulin value 1 hour after meal is more than 10 times the fasting insulin value; ③ insulin value 2 hours after meal is higher than insulin value 1 hour after meal; ④ insulin resistance index HOMA-IR (insulin resistance index = fasting blood sugar × insulin / 22.5) ≥ 2.69. If any one of these items is met, the diagnosis can be made.

[0141] b. TCM diagnostic criteria:

[0142] Kidney deficiency and phlegm dampness type: refer to the syndrome differentiation criteria of kidney deficiency and phlegm dampness in the "Guidelines for Clinical Research of New Chinese Medicines (Part II Clinical Research Trial)", the syndrome differentiation criteria of kidney deficiency and phlegm dampness are as follows:

[0143] Main symptoms: amenorrhea, late menstruation, scanty menstruation or irregular menstruation;

[0144] Secondary symptoms: Kidney deficiency: ① Weakness of waist and knees; ② Dizziness and tinnitus; ③ Decreased libido; ④ Fear of cold and cold limbs;

[0145] Phlegm dampness: ①Heavy head and body; ②Chest tightness and nausea; ③Fatigue and lethargy; ④Sticky mouth with a lot of phlegm; ⑤Greasy stool;

[0146] ⑥ Obesity; Tongue and pulse: pale and dark or pale and fat tongue with teeth marks on the edges, greasy white tongue coating, deep, fine and smooth pulse.

[0147] Syndrome diagnosis requirements: The above main symptoms must be present, and any one or more of the symptoms of kidney deficiency and phlegm dampness must be present at the same time. Combined with the tongue and pulse, it can be diagnosed as kidney deficiency and phlegm dampness syndrome. Two doctors with senior professional titles must perform syndrome differentiation respectively, and only when both of them diagnose it as kidney deficiency and phlegm dampness can the syndrome be confirmed.

[0148] (3) Inclusion criteria

[0149] ① Patients who meet the diagnosis of PCOS of kidney deficiency and phlegm-dampness type and insulin resistance; ② Women of childbearing age, aged 18-40 years old; ③ Those who have not taken any medications that affect menstruation (such as: contraceptives, hormones or other drugs that affect insulin, blood sugar, sex hormones and blood lipid metabolism) and have not adopted related treatment methods within 3 months, and have no record of artificial abortion; ④ Gynecological examination and auxiliary examination: no organic lesions of internal and external reproductive organs, and no other primary diseases; ⑤ Those who have signed the informed consent form and are willing to bear the possible consequences and risks.

[0150] (4) Exclusion criteria

[0151] ① Patients aged <18 years and >40 years will be excluded. ② Patients with congenital deficiencies in the reproductive system that cannot meet the needs of this study. ③ Patients with congenital hereditary mental illness will be excluded. ④ Patients with organ failure such as liver, heart, kidney, and hematopoietic system. ⑤ Patients with special physiques and a history of severe allergies to drugs. ⑥ Patients who cannot follow this study plan. ⑦ Patients who need other treatments in addition to this disease, which will affect this study.

[0152] (5) Elimination criteria

[0153] ① Misdiagnosis and misacceptance; ② Poor compliance (the medication rate is less than 80% or greater than 120% of the subjects); ③ Those without any relevant test records; ④ Those who use hormones, hypoglycemic and lipid-lowering drugs other than those in this regimen during the trial, and those who take Chinese medicine prescriptions with a medicinal overlap rate of more than 50% with the prescriptions used in this trial; ⑤ Those who use other methods to treat polycystic ovary syndrome during the trial (such as acupuncture, massage therapy, etc.).

[0154] (6) Shedding standard

[0155] Those who failed to complete one month of treatment due to subjective or objective reasons were considered dropouts.

[0156] (7) Termination criteria

[0157] ① The researcher determines that the trial is harmful to the subjects. ② The clinical trial is cancelled by the relevant national authorities. ③ Most subjects have serious adverse reactions, or patients have serious adverse events.

[0158] If the above situation occurs, the researcher has the right to terminate the experiment without obtaining the subject's consent.

[0159] 2.2 Research Methods

[0160] (1) Research design: This study was a prospective randomized controlled clinical trial.

[0161] (2) Sample size calculation: This was a small sample exploratory study, and a total of 76 patients with kidney deficiency and phlegm-dampness type PCOS and insulin resistance were included, with 38 cases in the control group and 38 cases in the experimental group.

[0162] (3) Random grouping: Statistical professionals use the random number table method to conduct a random design, and randomly assign the subjects to the control group and the experimental group in a 1:1 ratio.

[0163] (4) Treatment options:

[0164] ① Control group: Metformin hydrochloride tablets twice a day, 500 mg each time; the first dose starts on the 5th day of menstruation or the 5th day of progesterone withdrawal bleeding.

[0165] ② Experimental group: taking the Wenshen Ditan Decoction of the embodiment, one dose per day, twice a day, 1 bag each time.

[0166] The intervention lasted for 12 weeks, and the clinical efficacy was observed. During the treatment, the patients in the observation group were especially told to take Chinese and Western medicines two hours apart to avoid unexpected interactions. The patients were also told to pay attention to hygiene during menstruation, keep warm, eat light food at regular times and quantitatively, and keep a happy mood.

[0167] The patients were followed up after stopping treatment, and the menstrual cycles for three consecutive months and the insulin resistance index three months later were recorded, and the average values ​​were taken for comparison.

[0168] 2.3 Observation indicators and efficacy evaluation criteria

[0169] (1) Main outcome measures

[0170] Comprehensive efficacy evaluation:

[0171] The standard refers to the efficacy standard of new Chinese medicine for the treatment of menstrual disorders, amenorrhea, etc. in the "Guidelines for Clinical Research of New Chinese Medicines". Calculation formula (Nimodipine method): efficacy index = (symptom score before treatment - symptom score after treatment) / symptom score before treatment × 100%;

[0172] ① Clinical recovery: the score and reduction ratio of symptoms and signs n≥95%, BBT showed biphasic changes for 2 months, and the indicators related to insulin resistance were normal;

[0173] ② Significantly effective: The symptom and sign scores and reduction ratios are 70%<n<95% and the BBT shows a biphasic change for at least 1 month, and 3 or more insulin resistance-related indicators are normal;

[0174] ③ Effective: The proportion of symptom and sign scores reduced by 30%<n<70% or BBT showed biphasic changes for 1 month, and at least one of the insulin resistance-related indicators was normal;

[0175] ④ Ineffective: No change or worsening of symptoms, symptom and sign scores and reduction ratio n < 30%, BBT is monophasic, and there is no improvement in insulin resistance-related indicators.

[0176] Comprehensive effective rate = (total number of people - number of ineffective people) / total number of people * 100%

[0177] (2) Secondary outcome measures

[0178] ①Main symptom score:

[0179] A quantitative scoring standard for TCM symptoms was formulated with reference to the Guiding Principles for Clinical Research of New Chinese Medicines. The symptoms before treatment and 12 weeks after treatment were scored as 0, 2, 4, and 6 points according to the main symptoms; the menstrual cycle score was (0 points for a menstrual cycle of 35 days ≥ ≥ 21 days, 2 points for a menstrual cycle of 60 days ≥ 35 days, 4 points for a menstrual cycle of 90 days ≥ 60 days, and 6 points for a menstrual cycle of 90 days). The changes in TCM symptom scores before and after treatment were observed and compared between the two groups of patients.

[0180] ②BBT determination:

[0181] All patients should be informed of the need to maintain a regular work and rest schedule during treatment, sleep for 6-8 hours, take sublingual temperature immediately after getting up in the morning, and keep relevant records every day. BBT type classification: ① Single-phase BBT: no obvious fluctuation in body temperature. ② Atypical biphasic BBT: The high temperature phase of the luteal phase increases by <0.3℃ and lasts for <12 days. ③ Typical biphasic BBT: The high temperature of the luteal phase increases by 0.3-0.5℃ compared to the previous one. Record the number of biphasic BBTs during the patient's treatment.

[0182] ③Insulin (INS), blood sugar content and HOMA-IR index:

[0183] When testing patients before and after treatment, the fasting blood glucose level and fasting insulin level of the patients were measured 12 hours after meals, during which the patients did not eat anything, and the HOMA-IR index was calculated.

[0184] ④ Hormone level detection:

[0185] The hormone levels of patients were tested before treatment and 12 weeks after treatment, including luteinizing hormone (LH), follicle-stimulating hormone (FSH), pituitary prolactin (PRL), testosterone (T), estradiol (E2), etc. The testing time was 2-4 days of menstrual bleeding before treatment and 2-4 days of the most recent menstrual bleeding after treatment, and fasting peripheral venous blood was drawn from 8 am to 8 pm.

[0186] ⑤ Serum inflammatory factor detection:

[0187] The serum inflammatory factors of patients were tested before and after treatment, including CRP, LPS, IL-6, IL-1β, TNF-α, etc.

[0188] (4) Safety indicators

[0189] Record the patient's general vital signs including respiration, pulse, body temperature, and blood pressure, which are recorded at the 0th, 4th, 8th, and 12th weeks of treatment. At the same time, blood routine and biochemical tests are performed on the patients before and after treatment, and the drug-related adverse reactions that occur during the treatment are observed, such as drowsiness, dizziness, gastric discomfort, nausea, vomiting, rash, skin itching, and constipation. The adverse reactions that occur clinically are recorded truthfully, including symptoms, degree, time of occurrence, duration, treatment measures, etc., and the relevance to the test drug is evaluated, and a descriptive analysis is performed according to irrelevant, possibly related, very likely related, definitely related, and undetermined. If a serious adverse event occurs (such as death, direct threat to life safety, permanent or significant disability, need for hospitalization or prolonged hospitalization, etc.), the observing physician should immediately stop the drug for treatment and report to the principal investigator in a timely manner.

[0190] (5) Observation time point

[0191] ① From enrollment to before treatment: collect data on general biological indicators; safety indicators; serum sex hormone levels; basal body temperature; insulin resistance indicators; inflammatory factor levels; TCM symptoms and symptom scores; menstrual cycle;

[0192] ②After treatment begins: continue to monitor BBT until treatment ends; monitor weight, waist circumference, hip circumference, and vital signs every month;

[0193] ③ End of treatment: review all data before treatment;

[0194] ④ Follow-up: Follow-up for 3 months after leaving the group, record the average menstrual cycle for 3 months, BBT biphasic rate, insulin resistance index after 3 months, and pregnancy status.

[0195] 2.4 Statistical methods

[0196] Graphad prism 9.0 statistical software was used for data statistical processing. When the data satisfied the normal distribution, the mean ± standard deviation (X ± S) was selected, and the t-test was used for analysis of differences between groups. When the data did not satisfy the normal distribution or were rank data, the rank-sum test was used for analysis of differences between groups. The X2 test was used for comparative analysis of count data.

[0197] 2.5 Results Analysis

[0198] Fig. 9 :It shows the comparison of various indicators of the control group before and after treatment. Luteinizing hormone (LH) and follicle-stimulating hormone (FSH) use the left Y-axis, the unit is (IU / L); pituitary prolactin (PRL), testosterone (T), estradiol (E2) use the right Y-axis, the unit is (ug / L). It can be seen that there are significant differences before and after treatment (P<0.05), indicating that the experimental group can also achieve the same treatment effect.

[0199] Fig.10 :It shows the comparison of luteinizing hormone (LH), follicle stimulating hormone (FSH), pituitary prolactin (PRL), testosterone (T), and estradiol (E2) between the control group and the experimental group after treatment. The luteinizing hormone (LH), follicle stimulating hormone (FSH), pituitary prolactin (PRL), and estradiol (E2) in the experimental group were significantly different from those in the control group (P<0.05).

[0200] Fig.11 :It shows the comparison of insulin (INS), blood glucose content and HOMA-IR index between the control group and the experimental group after treatment. The 2h blood glucose (2hPG) (mmol / L), fasting insulin (FINS) (μU / mL), and insulin resistance index (HOMA-IR) of the experimental group were significantly different from those of the control group (P<0.05).

[0201] Fig.12 The figure shows the BBT measurement of the control group and the experimental group. The typical biphasic BBT of the experimental group was 28 cases. The change in body temperature further indicates that the possibility of ovulation is greatly increased, thereby increasing the probability of pregnancy.

[0202] Fig.13 :Represents the various indicators of inflammatory factors in the control group and the experimental group. After treatment, there was a significant difference between the experimental group and the control group (P<0.05).

[0203] Fig.14 :It shows the comparison of BMI between the control group and the experimental group. It can be seen that the control group and the experimental group are not comparable before treatment, but there is a significant difference between the experimental group and the control group after treatment (P<0.05).

[0204] Fig.15 :It represents the menstrual function scores of the control group and the experimental group. It can be seen that the control group and the experimental group before treatment are not comparable, and there is a significant difference between the experimental group and the control group after treatment (P<0.05).

[0205] Fig.16 :It shows the comparison of ovarian volume between the control group and the experimental group. It can be seen that the control group and the experimental group are not comparable before treatment, and there is a significant difference between the experimental group and the control group after treatment (P<0.05). Fig.17 :It shows the comparison of the number of basal follicles between the control group and the experimental group. It can be seen that the control group and the experimental group before treatment are not comparable, and there is a significant difference between the experimental group and the control group after treatment (P<0.05).

[0206] The above embodiments are merely examples for clear explanation and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description, and the obvious changes or modifications derived therefrom are still within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for polycystic ovary syndrome, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 9-40 parts by weight of purple quartz, 5.2-23 parts by weight of Cistanche deserticola, 7-32 parts by weight of Cuscuta australis, 5.5-22 parts by weight of Atractylodes macrocephala, 4.5-20 parts by weight of Pinellia ternata, 5.2-22 parts by weight of Angelica sinensis, 5-22 parts by weight of Cyperus rotundus, 3-13 parts by weight of Acorus calamus, 4.5-19 parts by weight of Epimedium brevicornum and 3-13 parts by weight of Ligusticum chuanxiong.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20 parts by weight of purple quartz, 10 parts by weight of Cistanche deserticola, 15 parts by weight of Cuscuta australis, 10 parts by weight of Atractylodes macrocephala, 9 parts by weight of Pinellia ternata, 10 parts by weight of Angelica sinensis, 10 parts by weight of Cyperus rotundus, 6 parts by weight of Acorus calamus, 9 parts by weight of Epimedium brevicornum, and 6 parts by weight of Ligusticum chuanxiong.

3. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 40 parts by weight of purple quartz, 23 parts by weight of Cistanche deserticola, 32 parts by weight of Cuscuta australis, 22 parts by weight of Atractylodes macrocephala, 20 parts by weight of Pinellia ternata, 22 parts by weight of Angelica sinensis, 22 parts by weight of Cyperus rotundus, 13 parts by weight of Acorus calamus, 19 parts by weight of Epimedium brevicornum and 13 parts by weight of Ligusticum chuanxiong.

4. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 9 parts by weight of purple quartz, 5.2 parts by weight of Cistanche deserticola, 7 parts by weight of Cuscuta australis, 5.5 parts by weight of Atractylodes macrocephala, 4.5 parts by weight of Pinellia ternata, 5.2 parts by weight of Angelica sinensis, 5 parts by weight of Cyperus rotundus, 3 parts by weight of Acorus calamus, 4.5 parts by weight of Epimedium brevicornum, and 3 parts by weight of Ligusticum chuanxiong.

5. The Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The preparation method of the decoction is as follows: 1) Grind the purple quartz into fine powder under vacuum; set aside 2) Crush Atractylodes lancea, Angelica sinensis, Ligusticum chuanxiong and Cyperus rotundus, add 70-80% ethanol and reflux extract twice, combine the filtrates and set aside; 3) Cuscuta, Pinellia, Herba Epimedii, Acorus calamus and Herba Cistanches are decocted twice with water. The first decoction is 40-60 min, and the filtrate and residue are reserved. The second decoction is 20-40 min, and the two decoctions are combined. 4) The fine powder of step 1), the filtrate of step 2) and the decoction obtained in step 3) are combined to obtain a decoction.

6. The Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The preparation method of the decoction is as follows: 1) Grind the purple quartz into fine powder under vacuum; set aside 2) Crush Atractylodes lancea, Angelica sinensis, Ligusticum chuanxiong and Cyperus rotundus, add 75% ethanol and reflux extract twice, combine the filtrates and set aside; 3) Cuscuta, Pinellia, Herba Epimedii, Acorus calamus and Herba Cistanches were decocted twice with water. The first decoction was decocted for 50 min, and the filtrate and residue were reserved. The second decoction was decocted for 30 min, and the two decoctions were combined. 4) The fine powder of step 1), the filtrate of step 2) and the decoction obtained in step 3) are combined to obtain a decoction.

7. The Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The dosage form of the Chinese medicine composition is mixture, decoction, oral liquid, granule, tablet, pill, capsule or paste.

8. The Chinese medicine composition according to claim 7, characterized in that: The decoction is the Wenshen Ditan Decoction.

9. Use of the Chinese medicine composition according to claim 7 in preparing medicines for preventing or treating polycystic ovary syndrome and irregular menstruation.

10. Use of the Chinese medicine composition according to claim 7 in preparing a drug for preventing or treating polycystic ovary syndrome.

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