A traditional Chinese medicine composition for treating polycystic ovary syndrome, its preparation method and uses

Abstract

This invention belongs to the field of traditional Chinese medicine and discloses a traditional Chinese medicine composition for treating polycystic ovary syndrome (PCOS), its preparation method, and its uses. The traditional Chinese medicine composition of this invention consists of Cuscuta chinensis, stir-fried Atractylodes macrocephala, Angelica sinensis, and other medicinal ingredients. It has the effects of tonifying the kidney and spleen, nourishing blood, and promoting blood circulation. It has a good therapeutic effect on PCOS of the spleen and kidney deficiency type and the phlegm-dampness obstruction type, and is safe and effective for long-term use.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating polycystic ovary syndrome and its preparation method. Background Technology

[0002] Polycystic ovary syndrome (PCOS) is a chronic endocrine disorder that widely affects women of reproductive age, with a global incidence of approximately 10%, accounting for about 75% of infertile women. my country has one of the fastest-growing PCOS prevalence rates globally, with the prevalence among women of reproductive age rising from 5.61% in 2010 to 8.6% in 2020.

[0003] Polycystic ovary syndrome (PCOS) seriously affects women's quality of life, fertility, and long-term health. Clinically, PCOS is characterized by persistent infrequent or absent ovulation, clinical manifestations of hyperandrogenism or hyperandrogenemia, and polycystic ovarian morphology. It is often accompanied by insulin resistance and obesity, posing a significant threat to health.

[0004] High levels of androgens are a major defect in polycystic ovary syndrome (PCOS). Cholesterol is converted into androgens via a cascade of enzymes common to all steroid-producing organs, but tissue-specific variations lead to different steroid hormone profiles. In PCOS, the increased ovarian androgen production via the classical pathway is driven by increased secretion of luteinizing hormone (LH) from the pituitary gland, the action of insulin as a gonadotropin, and increased hypersensitivity of leukocytes to LH.

[0005] Due to its complex causes, there are currently no specific drugs for PCOS in clinical practice. Clinical treatment methods for PCOS both domestically and internationally mainly focus on symptomatic relief, concentrating on the following five aspects:

[0006] (1) Lifestyle adjustment: Domestic and international guidelines or consensus agree that lifestyle intervention is the preferred basic treatment for PCOS patients. This can increase insulin sensitivity, reduce insulin and testosterone levels, thereby restoring ovulation and fertility;

[0007] (2) Regulate the menstrual cycle: Oral contraceptives or progestin therapy in the second half of the cycle can be used;

[0008] (3) Lowering blood androgen levels: including short-acting COC, spironolactone, flutamide, and finasteride;

[0009] (4) Improve insulin resistance: Metformin has always been the first choice for long-term drug treatment of patients with insulin-resistant PCOS, but clinical findings show that metformin has serious gastrointestinal adverse reactions and some patients cannot tolerate it.

[0010] (5) Inositol: Inositol has a good therapeutic effect on PCOS patients. As an insulin sensitizer, it can improve insulin resistance and hyperinsulinemia in PCOS patients, thereby improving the endocrine and metabolic status of PCOS patients, promoting oocyte maturation in PCOS patients, and improving embryo quality.

[0011] Compared to Western medicines with single treatment mechanisms and adverse reactions, traditional Chinese medicine (TCM) compound prescriptions with multiple treatment pathways have a significant advantage in symptomatic treatment of polycystic ovary syndrome (PCOS). TCM has a long history and rich practice in the diagnosis and treatment of PCOS. Its symptoms and characteristics were first described in the "Huangdi Neijing" and "Jinkui Yaolue," and it was classified into various TCM syndrome differentiation categories.

[0012] Traditional Chinese medicine (TCM) understands the etiology of PCOS by integrating multiple factors, including imbalances in Qi and blood, dysfunction of internal organs, and emotional distress. TCM views the liver as key to regulating emotions and smoothing Qi and blood flow. The TCM principle states that "women's constitution is based on the liver, which is essential for their health, and blood is their primary organ," and that "worry leads to Qi stagnation, and excessive thinking leads to Qi depression." It believes that emotional fluctuations or excessive stress can cause liver Qi stagnation, affecting the circulation of Qi and blood, and consequently interfering with the menstrual cycle and ovarian function, becoming one of the main causes of PCOS. Simultaneously, the spleen is considered the "foundation of acquired constitution," and the concept of spleen deficiency and dampness accumulation emphasizes the importance of the spleen's function of transporting and transforming fluids for maintaining normal metabolism and ovarian function. The kidneys, which "store essence and govern reproduction," are considered the "foundation of innate constitution," and kidney deficiency and essence depletion explain the reproductive system dysfunction and fluid metabolism disorders in PCOS patients from an innate perspective. Furthermore, the saying "obese people often have phlegm" suggests that the internal generation of phlegm and dampness interacts with kidney deficiency, and the blood stasis caused by Qi stagnation and phlegm-dampness obstruction further complicates the etiology. TCM believes that PCOS is a syndrome formed by the intertwining of these multiple pathological factors.

[0013] Based on a comprehensive understanding of the etiology, compared to Western medicine's single symptomatic treatment, Traditional Chinese Medicine (TCM) can act through multiple pathways, comprehensively regulating the various complex causes of PCOS. TCM improves the endocrine environment by adjusting hormone secretion and receptor activity, reducing androgen levels in the ovaries, and increasing estrogen levels. Simultaneously, regarding insulin resistance, a core pathogenesis of PCOS, some TCM components can enhance insulin signaling, improve insulin sensitivity, and effectively alleviate insulin resistance. Furthermore, research has revealed the anti-inflammatory and antioxidant effects of TCM herbs, improving the inflammatory state and oxidative stress in PCOS patients by reducing the release of inflammatory factors and scavenging free radicals.

[0014] In conclusion, it is of great significance to research a new type of traditional Chinese medicine product for the treatment of PCOS that has good therapeutic effects, few toxic side effects, and low price. Summary of the Invention

[0015] The purpose of this invention is to overcome the shortcomings of existing drugs for treating polycystic ovary syndrome, such as poor therapeutic effect, inability to target symptoms, and large toxic side effects. This invention provides a traditional Chinese medicine composition and its preparation method for treating polycystic ovary syndrome of the spleen and kidney deficiency type with phlegm obstruction of ovaries, which tonifies the kidney and spleen, nourishes blood and promotes blood circulation.

[0016] On one hand, the present invention provides a traditional Chinese medicine composition for treating polycystic ovary syndrome, made from the following traditional Chinese medicine raw materials in parts by weight:

[0017] Cuscuta chinensis 30-80 parts, stir-fried Atractylodes macrocephala 30-80 parts, Angelica sinensis 30-80 parts, salt-processed Eucommia ulmoides 30-80 parts, Fritillaria thunbergii 30-80 parts, salt-processed Plantago asiatica 30-70 parts, Curcuma longa 10-50 parts, vinegar-processed Citrus reticulata peel 10-50 parts, Rubia cordifolia 20-60 parts, stir-fried Sophora japonica flower 10-50 parts, Ligusticum chuanxiong 10-50 parts, Cinnamomum cassia twig 10-50 parts.

[0018] Preferably, the present invention provides a traditional Chinese medicine composition for treating polycystic ovary syndrome, which is made from the following traditional Chinese medicine raw materials in parts by weight:

[0019] Cuscuta chinensis 30-70 parts, stir-fried Atractylodes macrocephala 30-70 parts, Angelica sinensis 30-70 parts, salt-processed Eucommia ulmoides 30-60 parts, Fritillaria thunbergii 30-60 parts, salt-processed Plantago asiatica 30-60 parts, Curcuma longa 20-40 parts, vinegar-processed Citrus reticulata peel 15-40 parts, Rubia cordifolia 20-55 parts, stir-fried Sophora japonica 10-40 parts, Ligusticum chuanxiong 10-30 parts, Cinnamomum cassia 10-30 parts.

[0020] Preferably, the present invention provides a traditional Chinese medicine composition for treating polycystic ovary syndrome, which is made from the following traditional Chinese medicine raw materials in parts by weight:

[0021] Cuscuta chinensis 60 parts, stir-fried Atractylodes macrocephala 50 parts, Angelica sinensis 45 parts, salt-processed Eucommia ulmoides 40 parts, Fritillaria thunbergii 40 parts, salt-processed Plantago asiatica 45 parts, Curcuma longa 25 parts, vinegar-processed Citrus reticulata peel 25 parts, Rubia cordifolia 30 parts, stir-fried Sophora japonica 20 parts, Ligusticum chuanxiong 20 parts, Cinnamomum cassia 10 parts.

[0022] Preferably, the present invention provides a traditional Chinese medicine composition for treating polycystic ovary syndrome, which is made from the following traditional Chinese medicine raw materials in parts by weight:

[0023] 50 parts of Cuscuta chinensis, 50 parts of stir-fried Atractylodes macrocephala, 50 parts of Angelica sinensis, 50 parts of salt-processed Eucommia ulmoides, 50 parts of Fritillaria thunbergii, 40 parts of salt-processed Plantago asiatica, 30 parts of Curcuma longa, 20 parts of vinegar-processed Citrus reticulata peel, 40 parts of Rubia cordifolia, 15 parts of stir-fried Sophora japonica flowers, 15 parts of Ligusticum chuanxiong, and 15 parts of Cinnamomum cassia twig.

[0024] Preferably, the present invention provides a traditional Chinese medicine composition for treating polycystic ovary syndrome, which is made from the following traditional Chinese medicine raw materials in parts by weight:

[0025] Cuscuta chinensis 60 parts, stir-fried Atractylodes macrocephala 60 parts, Angelica sinensis 50 parts, salt-processed Eucommia ulmoides 50 parts, Fritillaria thunbergii 50 parts, salt-processed Plantago asiatica 50 parts, Curcuma longa 30 parts, vinegar-processed Citrus reticulata peel 30 parts, Rubia cordifolia 50 parts, stir-fried Sophora japonica 25 parts, Ligusticum chuanxiong 25 parts, Cinnamomum cassia 15 parts.

[0026] On the other hand, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps:

[0027] Combine all the following ingredients: Cuscuta chinensis, stir-fried Atractylodes macrocephala, Angelica sinensis, salt-processed Eucommia ulmoides, Fritillaria thunbergii, salt-processed Plantago asiatica, Curcuma longa, vinegar-processed Citrus reticulata peel, Rubia cordifolia, stir-fried Sophora japonica flowers, Ligusticum chuanxiong, and Cinnamomum cassia. Add 6-12 times the amount of water and heat under reflux for 1-4 times, each time for 1-4 hours. Combine the extracts, filter, and concentrate the filtrate to a relative density of 1.10-1.30 to obtain a concentrated paste. Dry the concentrated paste under reduced pressure at 50-80℃ to obtain a dry paste, which is then pulverized to obtain the extract.

[0028] Alternatively, combine all the following herbs: Cuscuta chinensis, stir-fried Atractylodes macrocephala, Angelica sinensis, salt-processed Eucommia ulmoides, Fritillaria thunbergii, salt-processed Plantago asiatica, Curcuma longa, vinegar-processed Citrus reticulata peel, Rubia cordifolia, stir-fried Sophora japonica flowers, Ligusticum chuanxiong, and Cinnamomum cassia. Add 6-12 times the amount of water and heat under reflux for 1-4 times, each time for 1-4 hours. Combine the extracts, filter, and concentrate the filtrate to a relative density of 1.10-1.30 to obtain a concentrated paste. Add ethanol to make the concentration 50-80%, perform alcohol precipitation, let stand overnight, filter, take the supernatant, concentrate under reduced pressure to a relative density of 1.10-1.30 to obtain a thick paste, dry under reduced pressure at 50-80℃ to obtain a dry paste, and pulverize to obtain the extract.

[0029] Alternatively, steam distill the stir-fried Atractylodes macrocephala, Angelica sinensis, Curcuma longa, vinegar-processed Citrus reticulata peel, Ligusticum chuanxiong, and Cinnamomum cassia to collect the volatile oils, which are then set aside as aqueous extract 1. The remaining herbs, Cuscuta chinensis, Eucommia ulmoides (processed with salt), Fritillaria thunbergii, Plantago asiatica (processed with salt), Rubia cordifolia, and stir-fried Sophora japonica, are combined with the above-mentioned residues, and 6-12 times the amount of water is added. The mixture is heated and refluxed 1-4 times, each time for 1-4 hours, to obtain aqueous extract 2. Aqueous extract 1 and aqueous extract 2 are combined and concentrated under reduced pressure to a relative density of 1.10-1.30 to obtain a thick paste. The concentrated paste is dried under reduced pressure at 50-80℃ to obtain a dry paste, which is then pulverized. The volatile oils are added and mixed well to obtain the extract.

[0030] Preferably, the preparation method of the traditional Chinese medicine composition of the present invention includes the following steps:

[0031] Combine all the following ingredients: Cuscuta chinensis, stir-fried Atractylodes macrocephala, Angelica sinensis, salt-processed Eucommia ulmoides, Fritillaria thunbergii, salt-processed Plantago asiatica, Curcuma longa, vinegar-processed Citrus reticulata peel, Rubia cordifolia, stir-fried Sophora japonica flowers, Ligusticum chuanxiong, and Cinnamomum cassia. Add 10 times the amount of water and heat under reflux twice, each time for 1.5 hours. Combine the extracts, filter, and concentrate the filtrate to a relative density of 1.10-1.20 to obtain a concentrated paste. Dry the concentrated paste under reduced pressure at 60-70℃ to obtain a dry paste, which is then pulverized to obtain the extract.

[0032] Alternatively, combine all of the following herbs: Cuscuta chinensis, stir-fried Atractylodes macrocephala, Angelica sinensis, salt-processed Eucommia ulmoides, Fritillaria thunbergii, salt-processed Plantago asiatica, Curcuma longa, vinegar-processed Citrus reticulata peel, Rubia cordifolia, stir-fried Sophora japonica flowers, Ligusticum chuanxiong, and Cinnamomum cassia. Add 10 times the amount of water and heat under reflux twice, each time for 1.5 hours. Combine the extracts, filter, and concentrate the filtrate to a relative density of 1.10-1.20 to obtain a concentrated paste. Add ethanol to make the concentration 60%, perform alcohol precipitation, let stand overnight, filter, take the supernatant, concentrate under reduced pressure to a relative density of 1.10-1.20 to obtain a thick paste, dry under reduced pressure at 60-70℃ to obtain a dry paste, and pulverize to obtain the extract.

[0033] Alternatively, stir-fried Atractylodes macrocephala, Angelica sinensis, Curcuma longa, vinegar-processed Citrus reticulata peel, Ligusticum chuanxiong, and Cinnamomum cassia twig can be steam distilled to collect the volatile oils, which are then set aside as water extract 1. The remaining herbs, Cuscuta chinensis, salt-processed Eucommia ulmoides, Fritillaria thunbergii, salt-processed Plantago asiatica, Rubia cordifolia, and stir-fried Sophora japonica flowers, can be combined with the above-mentioned residues, and 10 times the amount of water can be added. The mixture can be heated and refluxed twice, each time for 1.5 hours, to obtain water extract 2. Water extract 1 and water extract 2 can be combined and concentrated under reduced pressure to a relative density of 1.10~1.20 to obtain a thick paste. The concentrated paste can be dried under reduced pressure at 60~70℃ to obtain a dry paste, which can then be pulverized. The volatile oils can be dissolved in ethanol, sprayed onto the dry powder, and mixed well to obtain the extract.

[0034] Alternatively, combine all the following ingredients: Cuscuta chinensis, stir-fried Atractylodes macrocephala, Angelica sinensis, salt-processed Eucommia ulmoides, Fritillaria thunbergii, salt-processed Plantago asiatica, Curcuma longa, vinegar-processed Citrus reticulata peel, Rubia cordifolia, stir-fried Sophora japonica flowers, Ligusticum chuanxiong, and Cinnamomum cassia. Heat and reflux to extract three times, adding 12, 10, and 8 times the amount of water each time, and reflux for 1.5 hours each time. Combine the extracts, filter, and concentrate the filtrate to a relative density of 1.10~1.18 to obtain a concentrated paste. Take the concentrated paste and vacuum dry it at 65℃ to obtain a dry paste, which can be pulverized to obtain the extract.

[0035] On the other hand, the above-mentioned traditional Chinese medicine composition provided by the present invention can be formulated into any pharmaceutically acceptable oral dosage form; the dosage form is selected from tablets, hard capsules, soft capsules, oral liquids, granules, honey pills, water pills, drop pills or ointments.

[0036] The oral dosage form is prepared using conventional methods in the pharmaceutical field, and pharmaceutically acceptable excipients may be added as needed. These pharmaceutically acceptable excipients are selected from dextrin, starch, lactose, micronized silica gel, mannitol, magnesium stearate, hydroxypropyl cellulose, microcrystalline cellulose, calcium phosphate, sodium carboxymethyl starch, crospovidone, talc, hydroxypropyl methylcellulose, citric acid, ethyl cellulose, etc.

[0037] On the other hand, the present invention provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating polycystic ovary syndrome.

[0038] This prescription consists of Cuscuta chinensis, stir-fried Atractylodes macrocephala, Angelica sinensis, salt-processed Eucommia ulmoides, Fritillaria thunbergii, salt-processed Plantago asiatica, Curcuma longa, vinegar-processed Citrus reticulata peel, Rubia cordifolia, stir-fried Sophora japonica flower, Ligusticum chuanxiong, and Cinnamomum cassia twig, and is used to treat polycystic ovary syndrome (PCOS) of the spleen and kidney deficiency type with phlegm obstructing the uterus. Symptoms include irregular menstruation (delayed menstruation, scanty and pale menstrual flow, amenorrhea), soreness and weakness of the lower back and knees, fatigue, dizziness and tinnitus, thin and clear vaginal discharge, heaviness in the limbs, pale and swollen tongue with teeth marks, and a deep, thready, and weak pulse. Cuscuta chinensis and stir-fried Atractylodes macrocephala are the principal herbs in the prescription. Cuscuta chinensis enters the liver and kidney meridians, and has the function of tonifying the liver and kidneys and replenishing essence and marrow. Stir-fried Atractylodes macrocephala enters the spleen and stomach meridians, and has the effects of tonifying qi and strengthening the spleen, drying dampness and promoting diuresis. The two herbs combined tonify both the congenital and acquired constitutions. The formula uses Angelica sinensis, which invigorates and replenishes blood, with both tonification and movement. The *Jingyue Quanshu* states that it is "truly a qi-regulating medicine within the blood, and also a sacred medicine within the blood." Salt-processed Eucommia ulmoides tonifies the liver and kidneys, strengthens tendons and bones, and assists Cuscuta chinensis in warming and tonifying kidney qi. Fritillaria thunbergii clears heat and resolves phlegm, dissipates nodules and eliminates masses without harming the qi mechanism. Salt-processed Plantago asiatica promotes urination, eliminates dampness and resolves phlegm, removing dampness from the body and treating the symptoms. Rubia cordifolia is added to promote blood circulation, remove blood stasis, and generate new blood, thus advancing the flow of qi and blood; vinegar-processed Citrus reticulata peel soothes the liver, breaks up qi stagnation, eliminates accumulations and stagnation, and strengthens the phlegm-resolving effect; Curcuma longa promotes qi circulation, relieves depression, invigorates blood, removes blood stasis, and clears heat from the heart and liver; Sophora japonica flower enters the liver and large intestine meridians, clearing heat, cooling blood, resolving turbidity, and lowering lipids. Ligusticum chuanxiong and Cinnamomum cassia are used as guiding herbs. Cinnamomum cassia moves through the qi aspect, warms and unblocks the meridians, and assists yang qi transformation; Ligusticum chuanxiong moves through the blood aspect, invigorates blood, removes blood stasis, and guides the blood to the uterus. The formula works synergistically to tonify the kidneys and spleen, nourish the blood and promote smooth flow of qi, thereby promoting normal follicle development and ovulation, achieving both symptomatic and root-cause treatment.

[0039] Cuscuta seed is the dried, mature seed of *Cuscuta australis* R. Br. or *Cuscutachinensis* Lam., both belonging to the Convolvulaceae family. The plants are harvested in autumn when the fruits are ripe, dried, and the seeds are threshed and impurities removed. It has a pungent, sweet, and neutral flavor. It enters the liver, kidney, and spleen meridians. It has the effects of tonifying the liver and kidneys, consolidating essence and reducing urination, calming the fetus, improving eyesight, and stopping diarrhea; externally, it is used to dispel wind and remove blemishes. It is used for liver and kidney deficiency, soreness and weakness of the lower back and knees, impotence, seminal emission, enuresis, frequent urination, kidney deficiency with threatened abortion, threatened miscarriage, blurred vision and tinnitus, and diarrhea due to spleen and kidney deficiency; externally, it is used to treat vitiligo.

[0040] Atractylodes macrocephala is the dried rhizome of the plant Atractylodes macrocephala Koidz., belonging to the Asteraceae family. It is harvested in winter when the lower leaves turn yellow and the upper leaves become brittle. After removing the soil and sand, it is dried by baking or sun-drying, and then the fibrous roots are removed. It has a bitter and sweet taste, and is warm in nature. It enters the spleen and stomach meridians. It has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. It is used for spleen deficiency with poor appetite, abdominal distension and diarrhea, phlegm retention with dizziness and palpitations, edema, spontaneous sweating, and threatened abortion.

[0041] Angelica sinensis is the dried root of Angelica sinensis (Oliv.) Diels, a plant belonging to the Apiaceae family. It is harvested in late autumn, with the fibrous roots and soil removed. After the moisture has partially evaporated, it is bundled into small bunches, placed on a shed, and slowly dried by smoking; alternatively, it can be air-dried or low-temperature dried. It has a sweet and pungent taste, and is warm in nature. It enters the liver, heart, and spleen meridians. It has the effects of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. It is used for blood deficiency and chlorosis, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic arthralgia, traumatic injuries, carbuncles and sores, and constipation due to intestinal dryness. Angelica sinensis infused with wine promotes blood circulation and regulates menstruation. It is used for amenorrhea and dysmenorrhea, rheumatic arthralgia, and traumatic injuries.

[0042] Eucommia ulmoides Oliv., a plant in the Eucommaceae family, is the dried bark of the tree. It is harvested from April to June, the outer bark is scraped off, and the bark is piled up to "sweat" until the inner bark turns purplish-brown, then sun-dried. It has a sweet and warm taste and enters the liver and kidney meridians. It has the effects of tonifying the liver and kidneys, strengthening tendons and bones, and calming the fetus. It is used for liver and kidney deficiency, lower back and knee pain, weakness of tendons and bones, dizziness, threatened abortion, and fetal restlessness.

[0043] Fritillaria thunbergii Miq., a plant belonging to the Liliaceae family, is a dried bulb. It is harvested in early summer when the plant withers, washed, and separated by size. Larger bulbs, with the core bud removed, are commonly called "large bulbs"; smaller bulbs, with the core bud intact, are commonly called "pearl bulbs." Each bulb is rubbed to remove the outer skin, mixed with calcined shell powder, and the sap extracted during rubbing is absorbed before drying. Alternatively, the bulbs are separated by size, washed, the core bud removed, and while still fresh, sliced ​​into thick pieces, washed, and dried; these are commonly called "fritillaria slices." It has a bitter and cold nature. It enters the lung and heart meridians. It has the effects of clearing heat, resolving phlegm, relieving cough, detoxifying, dispersing nodules, and reducing swelling. It is used for wind-heat cough, phlegm-fire cough, lung abscess, mastitis, scrofula, and carbuncles.

[0044] Plantain seeds are the dried, mature seeds of *Plantago asiatica* L. or *Plantago depressa* Willd., belonging to the Plantaginaceae family. The fruit spikes are harvested in summer and autumn when the seeds are mature, dried in the sun, and the seeds are extracted by rubbing to remove impurities. They are sweet and cold in nature. They enter the liver, kidney, lung, and small intestine meridians. They have the effects of clearing heat and promoting diuresis, relieving strangury, eliminating dampness and stopping diarrhea, improving eyesight, and resolving phlegm. They are used for painful urination due to heat, edema and abdominal distension, summer-heat diarrhea, red and swollen eyes, and cough with phlegm and heat.

[0045] Turmeric is the dried tuberous root of *Curcuma wenyujin* YH Chen et C. Ling, *Curcuma longa* L., *Curcuma kwangsiensis* SG Lee et CF Liang, or *Curcuma phaeocaulis* Val., all belonging to the ginger family. The first two are commonly known as "Wenyujin" and "Huangsiyujin," respectively, while the others are known as "Guiyujin" or "Lvsiyujin" depending on their characteristics. It is harvested in winter after the stems and leaves wither, and the soil and fine roots are removed. It is then steamed or boiled until thoroughly cooked and dried. It has a pungent, bitter, and cold nature. It enters the liver, heart, and lung meridians. It has the effects of promoting blood circulation and relieving pain, regulating qi and relieving depression, clearing the heart and cooling the blood, and promoting bile secretion and reducing jaundice. It is used for chest and rib pain, chest pain, amenorrhea and dysmenorrhea, breast distension and pain, delirium due to fever, epilepsy, hematemesis due to blood heat, and jaundice with dark urine.

[0046] Green peel is the dried peel of the young or immature fruit of Citrus reticulata Blanco and its cultivated varieties, belonging to the Rutaceae family. Young fruits that have fallen naturally are collected in May and June, dried in the sun, and are commonly called "individual green peel"; immature fruits are harvested in July and August, and the peel is longitudinally split into four segments to the base, the pulp is removed, and then dried, commonly called "four-flower green peel". It has a bitter and pungent taste, and is warm in nature. It enters the liver, gallbladder, and stomach meridians. It has the effects of soothing the liver and regulating qi, eliminating stagnation and resolving masses. It is used for chest and rib pain, hernia pain, mastopathy, breast abscess, food stagnation and qi stagnation, and abdominal distension and pain.

[0047] Madder root refers to the dried root and rhizome of *Rubia cordifolia* L., a plant in the Rubiaceae family. It is harvested in spring and autumn, cleaned of dirt, and dried. It has a bitter and cold nature. It enters the liver meridian. It has the effects of cooling the blood, removing blood stasis, stopping bleeding, and regulating menstruation. It is used for hematemesis, epistaxis, metrorrhagia, traumatic bleeding, amenorrhea due to blood stasis, joint pain, and swelling and pain from falls.

[0048] Sophora japonica flowers are the dried flowers and buds of the legume Sophora japonica L. They are harvested in summer when the flowers open or the buds form, dried promptly, and the branches, stems, and impurities removed. The former is commonly known as "Sophora japonica flowers," and the latter as "Sophora japonica buds." They are bitter and slightly cold in nature. They enter the liver and large intestine meridians. They have the effects of cooling the blood and stopping bleeding, clearing liver heat and purging fire. They are used for hematochezia, hemorrhoidal bleeding, bloody dysentery, metrorrhagia, hematemesis, epistaxis, red eyes due to liver heat, headache, and dizziness.

[0049] Chuanxiong (Ligusticum chuanxiong Hort.) is the dried rhizome of the plant, belonging to the Apiaceae family. It is harvested in summer when the nodes on the stem are prominently protruding and slightly purplish. After removing the soil and sand, it is sun-dried and then oven-dried, and the fibrous roots are removed. It has a pungent and warm flavor. It enters the liver, gallbladder, and pericardium meridians. It has the effects of promoting blood circulation, regulating qi, dispelling wind, and relieving pain. It is used for chest pain, stabbing pain in the chest and hypochondrium, swelling and pain from falls, irregular menstruation, amenorrhea and dysmenorrhea, abdominal masses and pain, headache, and rheumatic pain.

[0050] Cinnamon twigs are the dried tender branches of *Cinnamomum cassia* Presl., a plant in the Lauraceae family. They are harvested in spring and summer, the leaves are removed, and they are sun-dried, or sliced ​​and sun-dried. They are pungent, sweet, and warm in nature. They enter the heart, lung, and bladder meridians. They have the effects of inducing sweating and relieving muscle tension, warming and unblocking the meridians, assisting yang and promoting qi circulation, and calming and descending qi. They are used for wind-cold type common cold, cold pain in the epigastrium and abdomen, amenorrhea due to blood stasis, joint pain, phlegm retention, edema, palpitations, and sudden abdominal pain. Attached Figure Description

[0051] Figure 1 The images show pathological photographs of the ovaries in rats with polycystic ovary syndrome induced by spironolactone, as described in the following figures: A. Control group; B. Model group; C. Example 2, 5g crude drug / kg group; D. Example 2, 20g crude drug / kg group; E. Example 3, 5g crude drug / kg group; F. Example 3, 20g crude drug / kg group; J. Example 6, 5g crude drug / kg group; H. Example 6, 20g crude drug / kg group; I. Spironolactone, 20g crude drug / kg group. Detailed Implementation

[0052] The present invention will be further described in detail through the following embodiments, but the scope of protection of the present invention is not limited to any specific embodiments. Other embodiments obtained by those skilled in the art based on the embodiments described in the embodiments, and in conjunction with the experimental design of traditional Chinese medicine compound prescriptions, without inventive effort, are all within the scope of protection of the present invention.

[0053] Example 1:

[0054] Cuscuta chinensis 60 parts, stir-fried Atractylodes macrocephala 60 parts, Angelica sinensis 50 parts, salt-processed Eucommia ulmoides 50 parts, Fritillaria thunbergii 50 parts, salt-processed Plantago asiatica 50 parts, Curcuma longa 30 parts, vinegar-processed Citrus reticulata 30 parts, Rubia cordifolia 50 parts, stir-fried Sophora japonica 25 parts, Ligusticum chuanxiong 25 parts, Cinnamomum cassia 15 parts.

[0055] Combine all the above medicinal ingredients, add 10 times the amount of water, heat and reflux twice, reflux for 1.5 hours each time, combine the extracts, filter, concentrate the filtrate to a relative density of 1.10~1.20 to obtain a concentrated paste, take the concentrated paste and dry it under reduced pressure at 60~70℃ to obtain a dry paste, pulverize it to obtain the sample of Example 1, with a yield of 27.47%.

[0056] Example 2:

[0057] Cuscuta chinensis 60 parts, stir-fried Atractylodes macrocephala 60 parts, Angelica sinensis 50 parts, salt-processed Eucommia ulmoides 50 parts, Fritillaria thunbergii 50 parts, salt-processed Plantago asiatica 50 parts, Curcuma longa 30 parts, vinegar-processed Citrus reticulata 30 parts, Rubia cordifolia 50 parts, stir-fried Sophora japonica 25 parts, Ligusticum chuanxiong 25 parts, Cinnamomum cassia 15 parts.

[0058] Combine all the above medicinal ingredients, add 10 times the amount of water, and heat under reflux twice, refluxing for 1.5 hours each time. Combine the extracts, filter, and concentrate the filtrate to a relative density of 1.10-1.20 to obtain a concentrated paste. Add ethanol to make the concentration 60%, perform alcohol precipitation, let stand overnight, filter, take the supernatant, concentrate under reduced pressure to a relative density of 1.10-1.20 to obtain a thick paste, dry under reduced pressure at 60-70℃ to obtain a dry paste, pulverize to obtain the sample of Example 2, with a yield of 15.69%.

[0059] Example 3:

[0060] Cuscuta chinensis 60 parts, stir-fried Atractylodes macrocephala 60 parts, Angelica sinensis 50 parts, salt-processed Eucommia ulmoides 50 parts, Fritillaria thunbergii 50 parts, salt-processed Plantago asiatica 50 parts, Curcuma longa 30 parts, vinegar-processed Citrus reticulata 30 parts, Rubia cordifolia 50 parts, stir-fried Sophora japonica 25 parts, Ligusticum chuanxiong 25 parts, Cinnamomum cassia 15 parts.

[0061] Steam distillation was performed on stir-fried Atractylodes macrocephala, Angelica sinensis, Curcuma longa, vinegar-processed Citrus reticulata peel, Ligusticum chuanxiong, and Cinnamomum cassia to collect the volatile oils, which were then set aside as aqueous extract 1. The remaining herbs, Cuscuta chinensis, Eucommia ulmoides (processed with salt), Fritillaria thunbergii, Plantago asiatica (processed with salt), Rubia cordifolia, and stir-fried Sophora japonica, were combined with the above-mentioned residues, and 10 times the amount of water was added. The mixture was heated and refluxed twice, each time for 1.5 hours, to obtain aqueous extract 2. Aqueous extract 1 and aqueous extract 2 were combined and concentrated under reduced pressure to a relative density of 1.10-1.20 to obtain a thick paste. The concentrated paste was dried under reduced pressure at 60-70°C to obtain a dry paste, which was then pulverized. The volatile oils were dissolved in ethanol and sprayed onto the dry powder. The mixture was then stirred to obtain the sample of Example 3, with a yield of 26.21%.

[0062] Example 4:

[0063] Cuscuta chinensis 60 parts, stir-fried Atractylodes macrocephala 50 parts, Angelica sinensis 45 parts, salt-processed Eucommia ulmoides 40 parts, Fritillaria thunbergii 40 parts, salt-processed Plantago asiatica 45 parts, Curcuma longa 25 parts, vinegar-processed Citrus reticulata 25 parts, Rubia cordifolia 30 parts, stir-fried Sophora japonica 20 parts, Ligusticum chuanxiong 20 parts, Cinnamomum cassia 10 parts.

[0064] All the above medicinal ingredients were combined and extracted by heating and reflux three times, with 12, 10 and 8 times the amount of water added each time, and refluxed for 1.5 hours each time. The extracts were combined, filtered, and the filtrate was concentrated to a relative density of 1.10~1.18 to obtain a concentrated paste. The concentrated paste was vacuum dried at 65°C to obtain a dry paste, which was then pulverized to obtain the sample of Example 4, with a yield of 32.61%.

[0065] Example 5:

[0066] 50 parts of Cuscuta chinensis, 50 parts of stir-fried Atractylodes macrocephala, 50 parts of Angelica sinensis, 50 parts of salt-processed Eucommia ulmoides, 50 parts of Fritillaria thunbergii, 40 parts of salt-processed Plantago asiatica, 30 parts of Curcuma longa, 20 parts of vinegar-processed Citrus reticulata peel, 40 parts of Rubia cordifolia, 15 parts of stir-fried Sophora japonica flowers, 15 parts of Ligusticum chuanxiong, and 15 parts of Cinnamomum cassia twig.

[0067] All the above medicinal ingredients were combined and extracted by heating and reflux three times, with 12, 10, and 8 times the amount of water added each time, and refluxed for 1.5 hours each time. The extracts were combined, filtered, and the filtrate was concentrated to a relative density of 1.10~1.18 to obtain a concentrated paste. The concentrated paste was vacuum dried at 65°C to obtain a dry paste, which was then pulverized to obtain the sample of Example 5, with a yield of 34.22%.

[0068] Example 6: Comparative Example - Kidney-tonifying, Spleen-strengthening, Blood-nourishing, and Diuretic Formula

[0069] The preparation was carried out according to the extraction process described in Chinese patent CN115845012B.

[0070] Cuscuta chinensis 12 parts, stir-fried Atractylodes macrocephala 10 parts, Angelica sinensis 10 parts, Ligusticum chuanxiong 5 parts, Cinnamomum cassia 3 parts, Fritillaria thunbergii 10 parts, Rubia cordifolia 10 parts, Eucommia ulmoides 10 parts, Curcuma longa 6 parts, Dianthus superbus 6 parts, Plantago asiatica 10 parts, Dipsacus asper 12 parts, Platycodon grandiflorus 10 parts, Benincasa hispida peel 15 parts, Lycopus lucidus 10 parts, Nelumbo nucifera leaf 10 parts, Morus alba 10 parts, Morinda officinalis 3 parts, raw malt 10 parts, Cnidium monnieri 3 parts, Adenophora stricta 15 parts, Pseudostellaria heterophylla 10 parts, Albizia julibrissin bark 10 parts.

[0071] Add 10 times the amount of water and decoct twice, one hour each time. Combine the filtrates and concentrate them. Dry under reduced pressure at 60°C to obtain a concentrated paste. Take the concentrated paste and dry it under vacuum at 65°C to obtain a dry paste. Pulverize it to obtain the sample of Example 6, with a yield of 35.74%.

[0072] Example 7: The therapeutic effect of the composition of the present invention on letrozole-induced polycystic ovary syndrome in rats.

[0073] 1. Model making

[0074] 120 female SD rats were used, with 10 reserved as the control group. The rest were administered 0.1 mg / mL letrozole solution by gavage at a dose of 1 mg / kg once a day for 30 consecutive days, with the day of the first modeling being recorded as day 1.

[0075] 2. Experimental Grouping

[0076] On day 30, the rats were fasted overnight. On the morning of day 31, blood was collected from the orbital venous plexus. Serum testosterone was measured using an ELISA kit, and the rats were grouped according to the results: control group, model group, Example 2 group (5, 20 g crude drug / kg), Example 3 group (5, 20 g crude drug / kg), Example 6 group (5, 20 g crude drug / kg), and positive control drug spironolactone group (20 mg / kg). A total of 7 groups were formed, with 10 rats in each group.

[0077] 3. Administration

[0078] After the model was successfully established, the drugs were administered to the groups once a day for three consecutive weeks. The control group and the model group were given the corresponding volume of solvent by gavage.

[0079] For specific group settings and dosing information, please refer to Table 1.

[0080]

[0081] Note: The control and model groups were administered ultrapure water by gavage.

[0082] 4. Detection Indicators

[0083] (1) Sex hormone levels: After administration for 1 and 3 weeks, blood was collected from the orbital venous plexus of rats 1 hour after administration. The supernatant was collected by centrifugation at 3000 rpm for 15 min and stored at -70℃. Serum T, E2, FSH and LH were measured by ELISA kit and LH / FSH was calculated.

[0084] (2) Ovarian histopathological examination: After the last blood collection, the rats were sacrificed, the ovaries were dissected, fixed in 10% neutral formalin, sectioned, stained with HE, and the histological changes of follicles, granulosa cell layer and corpus luteum were observed.

[0085] 5. Test Results

[0086] 1) Serum hormone levels

[0087] One week after administration: Compared with the control group, the serum T and LH levels in the model group were significantly increased (P≤ 0.01, P≤ 0.01), E2 was significantly decreased (P≤ 0.01), and the LH / FSH ratio was significantly increased (P≤ 0.01); compared with the model group, the LH level in the 20 g crude drug / kg group of Example 3 was significantly decreased, and the LH / FSH ratio in the positive drug spironolactone group was significantly decreased (P≤0.01), while there were no significant differences in the other groups (P>0.05), as detailed in Table 2.

[0088] After 3 weeks of administration: Compared with the control group, serum T and LH levels in the model group were significantly increased (P≤ 0.01), and E2 levels were significantly decreased (P≤ 0.01); compared with the model group, T levels in the 5 g crude drug / kg group of Example 2 were significantly decreased (P≤ 0.05), and T and LH levels in the 20 g crude drug / kg group were significantly decreased (P≤ 0.01); T and LH levels in the 5 g crude drug / kg group of Example 3 were significantly decreased (P≤ 0.01, P≤ 0.05), and T and LH levels in the 20 g crude drug / kg group were significantly decreased (P≤ 0.01, P≤ 0.01); T and LH levels in the positive control drug spironolactone group were significantly decreased (P≤ 0.01, P≤ 0.01); there were no significant differences among the other administration groups (P>0.05), as detailed in Table 3. The above results indicate that the composition of the present invention has a significant improvement effect on hormones compared with the prior art (Example 6) and has a lower effective dose. In Examples 2 and 3, the effective dose is 5 g crude drug / kg or lower.

[0089] Table 2. Effects of test drug administration on serum hormone levels in rats after 1 week (Mean±SEM, n=10)

[0090]

[0091] Note: Compared with the control group, ΔΔ P ≤ 0.01, compared with the model group, * P ≤ 0.05, ** P ≤ 0.01, where n is the number of animals.

[0092] Table 3. Effects of test drug administration on serum hormone levels in rats after 3 weeks (Mean±SEM, n=10)

[0093]

[0094] Note: Compared with the control group, ΔΔ P ≤ 0.01, compared with the model group, * P ≤ 0.05, ** P ≤ 0.01, where n is the number of animals.

[0095] 2) Pathological tissue examination

[0096] The control group showed intact ovarian cortex and medulla structures, with follicles at different developmental stages and a small number of corpora lutea, neatly arranged granulosa cells, and no obvious abnormalities in the stroma.

[0097] In the model group, the granulosa cell layer of some follicles was reduced, and significantly dilated cystic follicles were visible. The number of immature small follicles was significantly reduced, and oocytes disappeared in some follicles, while the number of corpora lutea increased.

[0098] Compared with the model group, the 5g crude drug / kg group and the 20g crude drug / kg group in Example 6 showed slight relief; compared with the model group, both groups in Example 2 and both groups in Example 3 showed relief, and the 20g crude drug / kg group was more effective than the 5g crude drug / kg group; the spironolactone group also showed relief. These results indicate that Examples 2 and 3 have a significant improvement effect on pathology compared with the prior art (Example 6), with an effective dose of 5g crude drug / kg or lower.

[0099] The examination results are summarized in Table 4. Pathological photographs for each group are shown below. Figure 1 .

[0100] Table 4 Summary of Microscopic Examinations (n=10)

[0101]

[0102] Note: - No lesions observed; ± Slight; + Mild lesions; ++ Moderate lesions; +++ Severe lesions. n is the number of animals.

[0103] Example 8 Acute toxicity test of the composition of the present invention

[0104] 1. Dosage setting

[0105] Setting principle: Calculations are based on the maximum soluble amount of extract powder in each embodiment. Since the total amount of extract powder and its equivalent amount per unit of crude drug differ in different embodiments, the dosage group settings also differ in each embodiment.

[0106] Blank control group: deionized water, 0 g crude drug / kg;

[0107] Example 2 Low-dose group: 47.8 g crude drug / kg;

[0108] Example 2 High-dose group: 177.8 g crude drug / kg;

[0109] Example 3 Low-dose group: 33.3 g crude drug / kg;

[0110] Example 3 High-dose group: 47.8 g crude drug / kg.

[0111] 2. Administration method

[0112] Administer by gavage, twice daily.

[0113] 3. Inspection Indicators

[0114] Day 1: Observe continuously for about 4 hours after each dose. Day 2 to Day 15: Observe once a day. Check the weight once on Day 1, Day 2, Day 4, Day 8, and Day 15. Perform gross necropsy on the surviving rats on Day 16.

[0115] 4. Test Results

[0116] Under the conditions of this experiment, SD rats were administered Example 2 via gavage at doses of 47.8 g crude drug / kg and 177.8 g crude drug / kg. Only in the 177.8 g crude drug / kg group were some animals exhibiting mild salivation, prone position, reduced activity, and mild prickly prickles after administration; all abnormal signs returned to normal within 3 hours. Apart from this, no other significant abnormalities were observed in any of the groups. The maximum tolerated dose (MTD) of Example 2 administered to SD rats via single gavage was >177.8 g crude drug / kg.

[0117] Under the experimental conditions, SD rats were administered Example 3 via gavage at doses of 33.3 g crude drug / kg and 47.8 g crude drug / kg. During the experiment, no significant abnormalities were observed in any of the examination indicators of the animals in each treatment group. The maximum tolerated dose (MTD) of Example 3 administered to SD rats via single gavage was >47.8 g crude drug / kg.

[0118] No abnormalities were observed in SD rats after gavage administration of drugs from Examples 2 and 3 at the same dose (47.8 g crude drug / kg). The toxicity of both drugs was consistent after a single gavage administration under the same dosage conditions. These results indicate that the composition of the present invention has good safety. It also exhibits a relatively high tolerable dose and thus high safety.

Claims

1. A traditional Chinese medicine composition for treating polycystic ovary syndrome, made from the following traditional Chinese medicine raw materials in parts by weight: Cuscuta chinensis 30-80 parts, stir-fried Atractylodes macrocephala 30-80 parts, Angelica sinensis 30-80 parts, salt-processed Eucommia ulmoides 30-80 parts, Fritillaria thunbergii 30-80 parts, salt-processed Plantago asiatica 30-70 parts, Curcuma longa 10-50 parts, vinegar-processed Citrus reticulata peel 10-50 parts, Rubia cordifolia 20-60 parts, stir-fried Sophora japonica flower 10-50 parts, Ligusticum chuanxiong 10-50 parts, Cinnamomum cassia twig 10-50 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following Chinese medicinal materials in parts by weight: Cuscuta chinensis 30-70 parts, stir-fried Atractylodes macrocephala 30-70 parts, Angelica sinensis 30-70 parts, salt-processed Eucommia ulmoides 30-60 parts, Fritillaria thunbergii 30-60 parts, salt-processed Plantago asiatica 30-60 parts, Curcuma longa 20-40 parts, vinegar-processed Citrus reticulata peel 15-40 parts, Rubia cordifolia 20-55 parts, stir-fried Sophora japonica flower 10-40 parts, Ligusticum chuanxiong 10-30 parts, and Cinnamomum cassia twig 10-30 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, Made from the following parts by weight of traditional Chinese medicine raw materials: Cuscuta chinensis 60 parts, stir-fried Atractylodes macrocephala 50 parts, Angelica sinensis 45 parts, salt-processed Eucommia ulmoides 40 parts, Fritillaria thunbergii 40 parts, salt-processed Plantago asiatica 45 parts, Curcuma longa 25 parts, vinegar-processed Citrus reticulata 25 parts, Rubia cordifolia 30 parts, stir-fried Sophora japonica 20 parts, Ligusticum chuanxiong 20 parts, Cinnamomum cassia 10 parts. Or, 50 parts of Cuscuta chinensis, 50 parts of stir-fried Atractylodes macrocephala, 50 parts of Angelica sinensis, 50 parts of salt-processed Eucommia ulmoides, 50 parts of Fritillaria thunbergii, 40 parts of salt-processed Plantago asiatica, 30 parts of Curcuma longa, 20 parts of vinegar-processed Citrus reticulata peel, 40 parts of Rubia cordifolia, 15 parts of stir-fried Sophora japonica flowers, 15 parts of Ligusticum chuanxiong, and 15 parts of Cinnamomum cassia twig. Alternatively, use 60 parts of Cuscuta chinensis, 60 parts of stir-fried Atractylodes macrocephala, 50 parts of Angelica sinensis, 50 parts of salt-processed Eucommia ulmoides, 50 parts of Fritillaria thunbergii, 50 parts of salt-processed Plantago asiatica, 30 parts of Curcuma longa, 30 parts of vinegar-processed Citrus reticulata peel, 50 parts of Rubia cordifolia, 25 parts of stir-fried Sophora japonica flowers, 25 parts of Ligusticum chuanxiong, and 15 parts of Cinnamomum cassia twigs.

4. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-3, comprising the following steps: Combine all the following ingredients: Cuscuta chinensis, stir-fried Atractylodes macrocephala, Angelica sinensis, salt-processed Eucommia ulmoides, Fritillaria thunbergii, salt-processed Plantago asiatica, Curcuma longa, vinegar-processed Citrus reticulata peel, Rubia cordifolia, stir-fried Sophora japonica flowers, Ligusticum chuanxiong, and Cinnamomum cassia. Add 6-12 times the amount of water and heat under reflux for 1-4 times, each time for 1-4 hours. Combine the extracts, filter, and concentrate the filtrate to a relative density of 1.10-1.30 to obtain a concentrated paste. Dry the concentrated paste under reduced pressure at 50-80℃ to obtain a dry paste, which is then pulverized to obtain the extract. Alternatively, combine all the following herbs: Cuscuta chinensis, stir-fried Atractylodes macrocephala, Angelica sinensis, salt-processed Eucommia ulmoides, Fritillaria thunbergii, salt-processed Plantago asiatica, Curcuma longa, vinegar-processed Citrus reticulata peel, Rubia cordifolia, stir-fried Sophora japonica flowers, Ligusticum chuanxiong, and Cinnamomum cassia. Add 6-12 times the amount of water and heat under reflux for 1-4 times, each time for 1-4 hours. Combine the extracts, filter, and concentrate the filtrate to a relative density of 1.10-1.30 to obtain a concentrated paste. Add ethanol to make the concentration 50-80%, perform alcohol precipitation, let stand overnight, filter, take the supernatant, concentrate under reduced pressure to a relative density of 1.10-1.30 to obtain a thick paste, dry under reduced pressure at 50-80℃ to obtain a dry paste, and pulverize to obtain the extract. Alternatively, steam distill the stir-fried Atractylodes macrocephala, Angelica sinensis, Curcuma longa, vinegar-processed Citrus reticulata peel, Ligusticum chuanxiong, and Cinnamomum cassia to collect the volatile oils, which are then set aside as aqueous extract 1. The remaining herbs, Cuscuta chinensis, Eucommia ulmoides (processed with salt), Fritillaria thunbergii, Plantago asiatica (processed with salt), Rubia cordifolia, and stir-fried Sophora japonica, are combined with the above-mentioned residues, and 6-12 times the amount of water is added. The mixture is heated and refluxed 1-4 times, each time for 1-4 hours, to obtain aqueous extract 2. Aqueous extract 1 and aqueous extract 2 are combined and concentrated under reduced pressure to a relative density of 1.10-1.30 to obtain a thick paste. The concentrated paste is dried under reduced pressure at 50-80℃ to obtain a dry paste, which is then pulverized. The volatile oils are added and mixed well to obtain the extract.

5. The method for preparing the traditional Chinese medicine composition according to claim 4, comprising the following steps: Combine all the following ingredients: Cuscuta chinensis, stir-fried Atractylodes macrocephala, Angelica sinensis, salt-processed Eucommia ulmoides, Fritillaria thunbergii, salt-processed Plantago asiatica, Curcuma longa, vinegar-processed Citrus reticulata peel, Rubia cordifolia, stir-fried Sophora japonica flowers, Ligusticum chuanxiong, and Cinnamomum cassia. Add 10 times the amount of water and heat under reflux twice, each time for 1.5 hours. Combine the extracts, filter, and concentrate the filtrate to a relative density of 1.10-1.20 to obtain a concentrated paste. Dry the concentrated paste under reduced pressure at 60-70℃ to obtain a dry paste, which is then pulverized to obtain the extract. Alternatively, combine all of the following herbs: Cuscuta chinensis, stir-fried Atractylodes macrocephala, Angelica sinensis, salt-processed Eucommia ulmoides, Fritillaria thunbergii, salt-processed Plantago asiatica, Curcuma longa, vinegar-processed Citrus reticulata peel, Rubia cordifolia, stir-fried Sophora japonica flowers, Ligusticum chuanxiong, and Cinnamomum cassia. Add 10 times the amount of water and heat under reflux twice, each time for 1.5 hours. Combine the extracts, filter, and concentrate the filtrate to a relative density of 1.10-1.20 to obtain a concentrated paste. Add ethanol to make the concentration 60%, perform alcohol precipitation, let stand overnight, filter, take the supernatant, concentrate under reduced pressure to a relative density of 1.10-1.20 to obtain a thick paste, dry under reduced pressure at 60-70℃ to obtain a dry paste, and pulverize to obtain the extract. Alternatively, stir-fried Atractylodes macrocephala, Angelica sinensis, Curcuma longa, vinegar-processed Citrus reticulata peel, Ligusticum chuanxiong, and Cinnamomum cassia twig can be steam distilled to collect the volatile oils, which are then set aside as water extract 1. The remaining herbs, Cuscuta chinensis, salt-processed Eucommia ulmoides, Fritillaria thunbergii, salt-processed Plantago asiatica, Rubia cordifolia, and stir-fried Sophora japonica flowers, can be combined with the above-mentioned residues, and 10 times the amount of water can be added. The mixture can be heated and refluxed twice, each time for 1.5 hours, to obtain water extract 2. Water extract 1 and water extract 2 can be combined and concentrated under reduced pressure to a relative density of 1.10~1.20 to obtain a thick paste. The concentrated paste can be dried under reduced pressure at 60~70℃ to obtain a dry paste, which can then be pulverized. The volatile oils can be dissolved in ethanol, sprayed onto the dry powder, and mixed well to obtain the extract. Alternatively, combine all the following ingredients: Cuscuta chinensis, stir-fried Atractylodes macrocephala, Angelica sinensis, salt-processed Eucommia ulmoides, Fritillaria thunbergii, salt-processed Plantago asiatica, Curcuma longa, vinegar-processed Citrus reticulata peel, Rubia cordifolia, stir-fried Sophora japonica flowers, Ligusticum chuanxiong, and Cinnamomum cassia. Heat and reflux to extract three times, adding 12, 10, and 8 times the amount of water each time, and reflux for 1.5 hours each time. Combine the extracts, filter, and concentrate the filtrate to a relative density of 1.10~1.18 to obtain a concentrated paste. Take the concentrated paste and vacuum dry it at 65℃ to obtain a dry paste, which can be pulverized to obtain the extract.

6. The traditional Chinese medicine composition according to any one of claims 1-3 can be formulated into any pharmaceutically acceptable oral dosage form.

7. The traditional Chinese medicine composition according to claim 6, characterized in that, The dosage form is selected from tablets, hard capsules, soft capsules, oral liquids, granules, honey pills, water pills, drop pills, or ointments.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for treating polycystic ovary syndrome.

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