A traditional Chinese medicine composition for treating polycystic ovary syndrome, a preparation method and use thereof

Abstract

The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating polycystic ovary syndrome and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from raw materials of cassia, dogwood, prepared evodia fruit, vinegar Szechwan lovage rhizome, photinia leaf, Chinese angelica root, Chinese toona seed, salted cumin, baizhi, Szechwan rhizoma polygoni multiflori, asarum, honeycomb, and Dolichos biflorus. The traditional Chinese medicine composition takes the treatment principle of 'warming kidney and dredging yang to cultivate the root, dispelling cold and removing blood stasis to dredge collaterals, regulating qi and blood to regulate channels' as the treatment principle, and is mainly used for treating polycystic ovary syndrome, especially cold and blood stasis type polycystic ovary syndrome. Therefore, the traditional Chinese medicine composition has important clinical significance and broad market application prospect.

Description

Technical Field

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

[0002] Polycystic ovary syndrome (PCOS) is the most prevalent endocrine and metabolic disorder among women of reproductive age. Its core clinical features include oligomenorrhea or amenorrhea, hyperandrogenemia, and polycystic ovarian morphology. Most PCOS patients also experience varying degrees of insulin resistance, and their long-term risk of developing type 2 diabetes, hyperlipidemia, and cardiovascular disease is 3 to 6 times higher than that of women of normal reproductive age. PCOS is also the leading cause of ovulatory infertility in women of reproductive age, accounting for more than 30% of all infertility cases, making it a significant public health issue seriously affecting women's reproductive health and long-term quality of life.

[0003] Currently, modern medicine's routine interventions for PCOS mainly fall into three categories: The first category is lifestyle intervention, which involves controlling diet, increasing exercise to reduce weight, and improving insulin sensitivity. However, this approach is poorly suited for adolescent PCOS patients and those under high academic or work pressure who find it difficult to maintain a long-term exercise routine. Furthermore, rapid weight loss may negatively impact the normal gonadal development of adolescent girls. The second category is hormone regulation therapy, which routinely uses oral contraceptives such as ethinylestradiol and cyproterone acetate to regulate the menstrual cycle and improve symptoms related to hyperandrogenism, such as hirsutism and acne. However, long-term use carries potential risks of gastrointestinal irritation and increased risk of thrombosis, and the recurrence rate of menstrual disorders after discontinuation exceeds 60%. The third category is metabolic regulation and ovulation induction therapy, which uses metformin to improve insulin resistance and clomiphene and letrozole to induce ovulation. However, 20% to 30% of patients still experience metformin intolerance and ovulation induction resistance, failing to achieve satisfactory ovulation and pregnancy outcomes.

[0004] Traditional Chinese medicine (TCM) has accumulated thousands of years of clinical experience in treating PCOS. Starting from the theory in the *Huangdi Neijing* (Yellow Emperor's Inner Classic) that "at seven years old, a girl's kidney qi is abundant, her teeth change, and her hair grows longer; at fourteen, her Tian Gui (menstrual blood) arrives, her Ren meridian is open, her Chong meridian is abundant, and her menstruation occurs regularly, thus enabling her to conceive," physicians throughout history have developed a complete system of principles, methods, prescriptions, and medications for menstrual disorders and infertility. Among the publicly available patents and academic literature on TCM compound prescriptions related to PCOS, the vast majority of formulas follow the general treatment principles of "tonifying the kidney and spleen, drying dampness and resolving phlegm, and promoting blood circulation and regulating menstruation." Frequently used herbs include common ones such as Cuscuta chinensis, Epimedium, Lycium barbarum, Salvia miltiorrhiza, Angelica sinensis, Paeonia lactiflora, Poria cocos, and Atractylodes macrocephala. These general compound prescriptions have a certain conditioning effect on mild cases of PCOS caused by phlegm-dampness.

[0005] Therefore, it is necessary to develop a traditional Chinese medicine composition that has unique compatibility, definite efficacy, and few side effects to treat polycystic ovary syndrome. Summary of the Invention

[0006] The purpose of this invention is to address the technological gaps and homogeneity in existing traditional Chinese medicine treatments for PCOS by providing a unique, synergistic, safe, and reliable combination of traditional Chinese medicine for warming the kidneys and removing blood stasis. This overcomes the technical bottleneck that conventional compound medicines cannot reach the deep stasis sites in the ovaries, and achieves multi-target precise intervention for refractory PCOS caused by cold and blood stasis. This provides a new and effective treatment option for clinical practice, and also offers new compatibility ideas for the treatment of metabolic endocrine diseases with traditional Chinese medicine compound formulas.

[0007] Specifically, the present invention is achieved through the following technical solutions: In a first aspect, the present invention provides a traditional Chinese medicine composition for treating polycystic ovary syndrome, the composition being made from the following raw materials in parts by weight: 1-10 parts cinnamon, 5-20 parts cornus officinalis, 1-10 parts processed evodia rutaecarpa, 2-18 parts vinegar-processed corydalis yanhusuo, 5-25 parts photinia leaves, 1-15 parts trogopterus xanthipes, 1-10 parts Sichuan chinaberry, 1-10 parts salt-processed fennel, 1-10 parts angelica dahurica, 1-20 parts Sichuan achyranthes bidentata, 1-10 parts asarum, 1-10 parts bee honeycomb, and 1-15 parts fenugreek.

[0008] Alternatively, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 3-5 parts cinnamon, 9-15 parts cornus officinalis, 2-5 parts processed evodia rutaecarpa, 6-12 parts vinegar-processed corydalis yanhusuo, 9-18 parts photinia leaves, 6-10 parts trogopterus xanthipes, 3-6 parts Sichuan chinaberry, 3-6 parts salt-processed fennel, 4.5-9 parts angelica dahurica, 6-15 parts Sichuan achyranthes bidentata, 1-3 parts asarum, 3-5 parts bee honeycomb, and 6-10 parts fenugreek.

[0009] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 4 parts cinnamon, 12 parts cornus officinalis, 3 parts processed evodia rutaecarpa, 9 parts vinegar-processed corydalis yanhusuo, 15 parts photinia leaves, 8 parts trogopterus xanthipes, 5 parts Sichuan chinaberry, 4 parts salt-processed fennel, 6 parts angelica dahurica, 10 parts Sichuan achyranthes bidentata, 2 parts asarum, 4 parts bee honeycomb, and 9 parts fenugreek.

[0010] In a second aspect, the present invention provides a method for preparing the traditional Chinese medicine composition described in the first aspect above, the method comprising the following steps: weighing each raw material in the weight proportions described in the first aspect above, pre-treatment, extraction, and concentration.

[0011] Preferably, in the above preparation method, the traditional Chinese medicine composition of the present invention can be prepared using conventional methods known in the art.

[0012] Preferably, the extraction methods used in this invention include, but are not limited to, decoction extraction, reflux extraction, ultrasonic extraction, and supercritical extraction.

[0013] Preferably, water, commonly used organic solvents in the art, or mixtures thereof can be used to extract the treated active pharmaceutical ingredient.

[0014] Preferably, the organic solvent is methanol, ethanol, propanol, butanol, ethyl acetate, petroleum ether, etc.

[0015] Preferably, the process includes weighing each raw material, pulverizing, extracting, and concentrating.

[0016] Alternatively, in the above preparation method, the preparation method includes the following steps: Step 1: Weigh all 13 raw materials according to the prescription weight, check that the properties of each material meet the quality standards under the 2025 edition of the Chinese Pharmacopoeia, and that there are no signs of insect infestation, mold, or deterioration; Step 2: Put the remaining 12 medicinal materials (excluding cinnamon) into the extraction tank, add 8-10 times the total weight of the medicinal materials in purified water, and soak at room temperature for 30 minutes to allow the medicinal materials to fully absorb water and swell, and the active ingredients to be initially dissolved. Step 3: Heat the extraction tank to a boil, then maintain a gentle boil for 20-30 minutes. After that, add the cinnamon from the prescription and continue to decoct for 3-6 minutes. Filter the first decoction through a 200-mesh sieve and collect the filtrate for later use. Step 4: Add 6-8 times the amount of purified water to the dregs again, heat to boiling, and then simmer for 15-30 minutes. Filter the second decoction through a 200-mesh sieve and combine the two decoctions. Step 5: The combined decoction is put into a vacuum concentration tank and concentrated under reduced pressure at a temperature of 60℃ and a vacuum degree of -0.08~-0.09 MPa to obtain a Chinese herbal extract with a relative density of 1.10~1.20 at 60℃, which is the Chinese herbal composition.

[0017] In a third aspect, the present invention provides the use of the traditional Chinese medicine composition described in the first aspect above, or the traditional Chinese medicine composition prepared by the preparation method described in the second aspect above, in the preparation of a medicament for treating polycystic ovary syndrome.

[0018] Alternatively, in the above-described uses, the polycystic ovary syndrome is the cold-blood stasis type polycystic ovary syndrome.

[0019] Alternatively, in the above-described uses, the drug can simultaneously improve patients' sex hormone disorders, polycystic ovarian changes, insulin resistance, and ovulation disorders.

[0020] Alternatively, in the above-described uses, the drug may be in oral dosage form.

[0021] Alternatively, in the above-described uses, the drug may be a decoction, powder, oral liquid, ointment, granules, tablet, or capsule.

[0022] Compared with the prior art, the present invention has the following beneficial effects: First, this invention is the first to incorporate two rare ingredients in the PCOS field, namely, photinia leaves and honeycomb, into the formulation, thus avoiding the homogeneous compatibility of existing conventional compound formulations. This technical solution cannot be obtained by non-technical personnel through conventional ingredient selection and simple substitution, and has outstanding substantive features.

[0023] Secondly, by using photinia leaves and honeycomb, this invention achieves the dual effects of "improving deep ovarian microcirculation" and "softening and thickening the ovarian capsule". Animal experimental results have confirmed that the efficacy of the taste-deficient control group after removing the honeycomb was significantly reduced, proving that the synergistic effect of the two brings technical effects far superior to conventional compound prescriptions, and can significantly improve the ovulation success rate of patients with refractory PCOS.

[0024] Third, the traditional Chinese medicine composition of this invention can not only regulate the secretion rhythm of sex hormones in the hypothalamus-pituitary-gonadal axis, but also target and activate the LKB1 / AMPK signaling pathway, improve insulin resistance at the molecular level, and cover both the reproductive endocrine and glucose and lipid metabolism systems, thus achieving both symptomatic and root-cause treatment.

[0025] Fourth, the dosage of all medicinal ingredients in this invention strictly complies with the safe dosage guidelines of the 2025 edition of the Chinese Pharmacopoeia. The results of long-term animal toxicity experiments have confirmed that after three months of continuous oral administration, there were no abnormal changes in the liver and kidney function or blood routine of rats, and no obvious toxic side effects. It is suitable for long-term use and conditioning for PCOS patients. Detailed Implementation

[0026] This invention's herbal composition is based on long-term clinical practice and summarization of the pathogenesis of PCOS in Traditional Chinese Medicine. It innovatively establishes the core treatment principle of "warming the kidneys and promoting yang to nourish the root, dispelling cold and removing blood stasis to unblock the collaterals, and regulating qi and blood to regulate the meridians." This is completely different from the common approach of existing conventional compound prescriptions that "emphasize resolving phlegm and dampness while lightly warming and removing blood stasis." The combination of principal, assistant, adjuvant, and guide herbs is logically linked, with no redundant herbs. The synergistic effect of each herb forms a complete intervention system. The principal ingredient, cinnamon, plays a unique role in warming the kidneys and replenishing fire, as well as warming and unblocking the Chong and Ren meridians. It directly clears the cold stagnation and blockage in the lower abdomen and uterus, providing yang energy for subsequent ovulation and menstrual flow.

[0027] The assistant herbs, the kidney-warming and cold-dispersing group: Cornus officinalis, Trigonella foenum-graecum, processed Evodia rutaecarpa, and Photinia serratifolia leaves, not only replenish the essence of the liver and kidneys but also disperse the deep-seated cold in the lower burner, enhancing the kidney-warming and yang-tonifying effects of the principal herbs. The qi-regulating and stagnation-relieving group: Salt-processed fennel seeds and Melia toosendan fruit, which are pungent and dispersing to soothe the liver, preventing the kidney-warming herbs from causing stagnation and internal heat, allowing yang qi to be smoothly distributed to the uterus.

[0028] The adjuvant herbs, including vinegar-processed Corydalis, Trogopterus xanthipes, bee honeycomb, and Angelica dahurica, promote blood circulation, remove blood stasis, unblock meridians, and relieve pain. They specifically improve local blood circulation in the ovaries and the hypercoagulable state in the pelvic cavity, while also relieving symptoms such as lower abdominal pain and breast tenderness during menstruation.

[0029] The guiding herbs, Achyranthes bidentata and Asarum heterotropoides, act as meridian guides to precisely direct the medicinal power of the entire formula to the lower abdomen, the Chong and Ren meridians, and the uterus. At the same time, Asarum heterotropoides can penetrate the exterior and warm the interior, helping to dispel deep-seated cold pathogens.

[0030] The formula, consisting of 13 herbs, is warm but not drying, and promotes circulation without causing damage. It balances the regulation of qi and blood circulation with the nourishment and protection of yin. The formula does not use any strong, pungent, or hot herbs. The astringent properties of Cornus officinalis can counteract excessive warming and dispersing, preventing excessive heat and damage to yin. It fully complies with the principle of consistency between theory, method, formula, and medicine in traditional Chinese medicine. It forms a complete synergistic intervention system targeting the three core pathological links of PCOS with cold and blood stasis.

[0031] In the pharmaceutical applications described above, the timing, frequency, and duration of administration of the traditional Chinese medicine composition need to be determined based on the specific diagnostic results of the patient's condition, which is within the technical scope of those skilled in the art. For example, when applying a treatment regimen for mice or rats to humans, the effective dose of all drugs for humans can be converted from the effective dose of the drug for mice or rats, which is easily achievable by those skilled in the art.

[0032] The present invention will be further described below with reference to specific embodiments. It should be understood that the specific embodiments described herein are for illustrative purposes only and are not intended to limit the scope of the invention.

[0033] Where specific techniques or conditions are not specified in the examples, they shall be performed in accordance with the techniques or conditions described in the literature in this field, or in accordance with the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased through legitimate channels.

[0034] Unless otherwise specified, the experimental methods used in the following embodiments are conventional methods. Unless otherwise specified, the experimental materials used in the following embodiments are commercially available products.

[0035] Unless otherwise stated, all percentages and parts in this invention refer to weight percentages and weight parts.

[0036] Preparation Example: Example 1: A traditional Chinese medicine composition for treating polycystic ovary syndrome, the composition being made from the following raw materials: 4 g cinnamon, 12 g cornus officinalis, 3 g processed evodia rutaecarpa, 9 g vinegar-processed corydalis yanhusuo, 15 g photinia leaves, 8 g trogopterus xanthipes, 5 g Sichuan pepper, 4 g salt-processed fennel, 6 g angelica dahurica, 10 g Sichuan achyranthes bidentata, 2 g asarum, 4 g bee honeycomb, and 9 g fenugreek.

[0037] The preparation method of the traditional Chinese medicine composition includes the following steps: Step 1: Weigh all 13 raw materials according to the prescription weight, check that the properties of each material meet the quality standards under the 2025 edition of the Chinese Pharmacopoeia, and that there are no signs of insect infestation, mold, or deterioration; Step 2: Put the remaining 12 herbs (excluding cinnamon) into the extraction tank, add purified water at 9 times the total weight of the herbs, and soak at room temperature for 30 minutes to allow the herbs to fully absorb water and swell, and the active ingredients to be initially dissolved. Step 3: Heat the extraction tank to a boil, then maintain a gentle boil for 25 minutes. After that, add the cinnamon from the prescription and continue to decoct for 5 minutes. Filter the first decoction through a 200-mesh sieve and collect the filtrate for later use. Step 4: Add 7 times the amount of purified water to the dregs again, heat to boiling, then keep simmering for 20 minutes. Filter the second decoction through a 200-mesh sieve and combine the two decoctions. Step 5: The combined decoction is put into a vacuum concentration tank and concentrated under reduced pressure at a temperature of 60℃ and a vacuum degree of -0.08~-0.09 MPa to obtain a Chinese herbal extract with a relative density of 1.10~1.20 at 60℃, which is the Chinese herbal composition.

[0038] Comparative Example 1: A traditional Chinese medicine composition, said composition being made from the following raw materials: 8 g cinnamon, 12 g cornus officinalis, 3 g processed evodia rutaecarpa, 9 g vinegar-processed corydalis yanhusuo, 15 g photinia leaves, 8 g trogopterus xanthipes, 5 g Sichuan pepper, 4 g salt-processed fennel, 6 g angelica dahurica, 10 g Sichuan achyranthes bidentata, 2 g asarum, and 9 g fenugreek.

[0039] The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0040] Comparative Example 2: A traditional Chinese medicine composition, said composition being made from the following raw materials: 4 g cinnamon, 12 g cornus officinalis, 3 g processed evodia rutaecarpa, 9 g vinegar-processed corydalis yanhusuo, 15 g white peony root, 8 g trogopterus xanthipes, 5 g Sichuan pepper, 4 g salt-processed fennel, 6 g angelica dahurica, 10 g Sichuan achyranthes bidentata, 2 g asarum, 4 g bee honeycomb, and 9 g fenugreek.

[0041] The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0042] Comparative Example 3.

[0043] A traditional Chinese medicine composition, said composition being made from the following raw materials: 4 g cinnamon, 12 g cornus officinalis, 3 g processed evodia rutaecarpa, 9 g vinegar-processed corydalis yanhusuo, 15 g white peony root, 8 g trogopterus xanthipes, 5 g Sichuan pepper, 4 g salt-processed fennel, 6 g angelica dahurica, 10 g Sichuan achyranthes bidentata, 2 g asarum, 4 g leech, and 9 g fenugreek.

[0044] The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0045] Example of efficacy: Pharmacodynamic verification experiment of the traditional Chinese medicine composition of the present invention on letrozole-induced PCOS model rats. This experiment used the letrozole-induced PCOS model in SD rats, which is recognized in the biomedical field. The pathological features of this model are highly similar to those of human PCOS patients, such as sex hormone disorders, polycystic ovarian changes, and insulin resistance. It is currently the most widely used classic animal model in PCOS drug development.

[0046] The specific experimental methods, steps, and results are as follows: 1. Laboratory animals and their housing conditions: Healthy, sexually mature, nonpregnant female SD rats, aged 6 weeks and weighing 180–200 g, were selected and provided by Beijing Vital River Laboratory Animal Technology Co., Ltd. All rats were housed in a barrier-level animal facility at a temperature controlled at 22±2℃ and a relative humidity of 50%–60%, maintaining a 12-hour light / 12-hour dark cycle. They had free access to standard feed and sterile drinking water. Formal experiments began after one week of acclimatization.

[0047] 2. PCOS model establishment method: After the adaptation period, 9 rats were randomly assigned to the normal control group, while the remaining 50 rats were administered letrozole suspension at a dose of 1 mg / kg via gavage at 9:00 AM daily for 21 consecutive days. During the modeling period, daily vaginal smear examinations were performed: a sterile cotton swab dipped in a small amount of physiological saline was gently inserted into the rat's vagina and rotated once to evenly smear the secretions onto a glass slide. After Georgieshtam staining, cell morphology was observed under a light microscope to determine the estrous cycle. After 21 days of modeling, rats that remained in the interestrous phase for more than 10 consecutive days, with only a large number of white blood cells and irregular keratinocyte-epithelial cell cycle transitions in the vaginal smear, were considered to have successfully established the model. Finally, 45 successfully modeled rats were selected for subsequent grouping and drug administration experiments.

[0048] 3. Grouping and Dosing Regimens for Laboratory Animals: The 45 successfully modeled rats were randomly divided into 5 groups of 9 rats each: model control group, Example 1 group, Comparative Example 1 group, Comparative Example 2 group, and Comparative Example 3 group. The dosing regimen was set as follows: Normal control group and model control group: The same volume of physiological saline was administered by gavage at a dose of 10 mL / kg per day for 21 consecutive days; Example 1 and Comparative Examples 1-3: The corresponding drug solution prepared in the preparation example was administered by gavage daily at a concentration of 10 g / kg of crude drug, which is equivalent to 1 times the clinical adult equivalent dose, for 21 consecutive days.

[0049] 4. Sample collection and indicator detection methods: Twenty-four hours after the last administration, all rats were fasted for 12 hours and anesthetized by intraperitoneal injection of 6% chloral hydrate at a dose of 3 mL / kg. Blood was collected by abdominal aortic puncture, and after standing for 2 hours, the whole blood was centrifuged at 3000 rpm for 15 minutes. The supernatant serum was separated, aliquoted into cryovials, and stored at -80°C for later analysis. Serum levels of sex hormones, including testosterone (T), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and estradiol (E2), were detected by radioimmunoassay. Fasting blood glucose was detected by glucose oxidase method, and fasting insulin level was detected by enzyme-linked immunosorbent assay (ELISA). The insulin resistance index (HOMA-IR = fasting blood glucose × fasting insulin / 22.5) was calculated.

[0050] After sacrifice, both ovaries were quickly removed from the rats. The ovarian coefficient (ovarian weight / rat body weight × 100) was calculated by weighing the ovaries using an electronic balance. One ovary was fixed in 10% neutral formaldehyde solution for 24 hours. After routine dehydration, clearing, paraffin embedding, serial sectioning, and hematoxylin-eosin (HE) staining, the pathological morphology of the ovarian tissue was observed under a light microscope. The proportion of cystic follicles and the number of mature corpora lutea in the ovaries of each group of rats were statistically analyzed. Total protein was extracted from the other ovary tissue, and the relative expression levels of LKB1, p-LKB1, AMPK, and p-AMPK proteins were detected by Western blotting.

[0051] 5. Statistical Analysis: Data statistical analysis was performed using GraphPad Prism 8.0.2 software. Data are expressed as mean ± standard deviation (x ± s). One-way ANOVA was used for comparisons among multiple groups, and P < 0.05 was considered statistically significant.

[0052] 6. Experimental Results: As shown in Tables 1 and 2 below, the traditional Chinese medicine composition of the present invention (Example 1 group) can significantly improve the sex hormone disorder in PCOS model rats, reduce serum hyperandrogen levels, restore disordered gonadotropin ratios, reduce the number of cystic follicles in the ovaries, promote corpus luteum formation, significantly improve insulin resistance, and upregulate the phosphorylation activity of the LKB1 / AMPK signaling pathway.

[0053] In contrast, the results of Comparative Examples 1 and 2 were significantly worse than those of Example 1, indicating that each herb in the invented Chinese herbal composition plays an important role in its efficacy in treating polycystic ovary syndrome. For example, removing the honeycomb from the composition or replacing the photinia leaves with other Chinese herbal medicines such as white peony root significantly reduced its efficacy.

[0054] In addition, the efficacy of the traditional Chinese medicine composition of the present invention (Example 1 group) in treating polycystic ovary syndrome is also superior to that of Guixiang Wenjing Zhitong Granules (Comparative Example 3 group), which is currently commonly used in clinical practice to treat this disease.

[0055] Table 1. Comparison of sex hormones and ovarian morphology indices in different groups of rats (n=9, x±s) Note: ## This indicates that compared with the normal control group, P<0.01. This indicates that P < 0.05 compared to the model control group. This indicates that the result is P<0.01 compared to the model control group.

[0056] Table 2 Comparison of insulin resistance and pathway protein expression indices in rats of different groups (n=9, x±s) Note: ## This indicates that compared with the normal control group, P<0.01. This indicates that P < 0.05 compared to the model control group. This indicates that the result is P<0.01 compared to the model control group.

[0057] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

Claims

1. A traditional Chinese medicine composition for treating polycystic ovary syndrome, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 1-10 parts cinnamon, 5-20 parts cornus officinalis, 1-10 parts processed evodia rutaecarpa, 2-18 parts vinegar-processed corydalis yanhusuo, 5-25 parts photinia leaves, 1-15 parts trogopterus xanthipes, 1-10 parts Sichuan chinaberry, 1-10 parts salt-processed fennel, 1-10 parts angelica dahurica, 1-20 parts Sichuan achyranthes bidentata, 1-10 parts asarum, 1-10 parts bee honeycomb, and 1-15 parts fenugreek.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 3-5 parts cinnamon, 9-15 parts cornus officinalis, 2-5 parts processed evodia rutaecarpa, 6-12 parts vinegar-processed corydalis yanhusuo, 9-18 parts photinia leaves, 6-10 parts trogopterus dung, 3-6 parts Sichuan chinaberry, 3-6 parts salt-processed fennel, 4.5-9 parts angelica dahurica, 6-15 parts Sichuan achyranthes bidentata, 1-3 parts asarum, 3-5 parts bee honeycomb, and 6-10 parts fenugreek.

3. The traditional Chinese medicine composition according to claim 2, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 4 parts cinnamon, 12 parts cornus officinalis, 3 parts processed evodia rutaecarpa, 9 parts vinegar-processed corydalis yanhusuo, 15 parts photinia leaves, 8 parts trogopterus xanthipes, 5 parts Sichuan chinaberry, 4 parts salt-processed fennel, 6 parts angelica dahurica, 10 parts Sichuan achyranthes bidentata, 2 parts asarum, 4 parts bee honeycomb, and 9 parts fenugreek.

4. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The preparation method includes the following steps: weighing each raw material according to the weight proportions of any one of claims 1 to 3, pre-treating, extracting, and concentrating.

5. The preparation method according to claim 4, characterized in that: The preparation method includes the following steps: Step 1: Weigh all 13 raw materials according to the prescription weight, check that the properties of each material meet the quality standards under the 2025 edition of the Chinese Pharmacopoeia, and that there are no signs of insect infestation, mold, or deterioration; Step 2: Put the remaining 12 medicinal materials (excluding cinnamon) into the extraction tank, add 8-10 times the total weight of the medicinal materials in purified water, and soak at room temperature for 30 minutes to allow the medicinal materials to fully absorb water and swell, and the active ingredients to be initially dissolved. Step 3: Heat the extraction tank to a boil, then maintain a gentle boil for 20-30 minutes. After that, add the cinnamon from the prescription and continue to decoct for 3-6 minutes. Filter the first decoction through a 200-mesh sieve and collect the filtrate for later use. Step 4: Add 6-8 times the amount of purified water to the dregs again, heat to boiling, and then simmer for 15-30 minutes. Filter the second decoction through a 200-mesh sieve and combine the two decoctions. Step 5: The combined decoction is put into a vacuum concentration tank and concentrated under reduced pressure at a temperature of 60℃ and a vacuum degree of -0.08~-0.09 MPa to obtain a Chinese herbal extract with a relative density of 1.10~1.20 at 60℃, which is the Chinese herbal composition.

6. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3, or the traditional Chinese medicine composition prepared by the preparation method according to claim 4 or claim 5, in the preparation of a medicament for treating polycystic ovary syndrome.

7. The use according to claim 6, characterized in that: The polycystic ovary syndrome mentioned is the cold-blood stasis type polycystic ovary syndrome.

8. The use according to claim 7, characterized in that: The drug can simultaneously improve patients' sex hormone disorders, polycystic ovarian changes, insulin resistance, and ovulation disorders.

9. The use according to claim 6, characterized in that: The drug is an oral dosage form.

10. The use according to claim 9, characterized in that: The medicine is in the form of decoction, powder, oral liquid, ointment, granules, tablets or capsules.

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