Traditional Chinese medicine composition for treating polycystic ovary syndrome, traditional Chinese medicine preparation, preparation method and application thereof

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition, preparation, preparation method, and application for treating polycystic ovary syndrome (PCOS). The traditional Chinese medicine composition for treating PCOS comprises the following raw materials in parts by weight: 10-15 parts of Cuscuta chinensis, 10-15 parts of Lycium barbarum, 10-20 parts of Taxillus chinensis, 10-15 parts of Angelica sinensis, 10-15 parts of Achyranthes bidentata, 10-15 parts of Ligusticum chuanxiong, 10-15 parts of Alisma plantago-aquatica, 10-15 parts of Nelumbo nucifera leaf, 10-15 parts of Gynostemma pentaphyllum, 10-20 parts of Salvia miltiorrhiza, 5-10 parts of Euonymus alatus, 5-10 parts of Coptis chinensis, and 5-10 parts of Glycyrrhiza uralensis. Its core treatment principle is to tonify the kidney and spleen, promote blood circulation, and resolve phlegm, and it is used to treat PCOS.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to traditional Chinese medicine compositions, preparations, preparation methods, and applications for treating polycystic ovary syndrome. Background Technology

[0002] Polycystic ovary syndrome (PCOS) is an endocrine and metabolic disorder characterized by long-term anovulation, hyperandrogenemia, and polycystic ovarian morphology. As one of the most common reproductive endocrine disorders in women of reproductive age, PCOS, while not directly life-threatening, significantly impacts reproductive health, metabolic function, and mental well-being, leading to a severe decline in quality of life. Epidemiological surveys indicate that PCOS affects 5% to 20% of women of reproductive age worldwide. PCOS can be mainly classified into classic type (PCOS-A), anovulatory type (PCOS-B), ovulatory type (PCOS-C), and non-hyperandrogenic type (PCOS-D). Classic PCOS is the most common, characterized primarily by polycystic ovarian morphology on ultrasound and clinical manifestations of hyperandrogenemia and / or hyperandrogenemia. PCOS patients often experience psychological abnormalities such as depression and anxiety. Sleep disturbances, weight problems, irregular menstruation, hirsutism, and hair loss are clinical features closely related to emotional disturbances in PCOS patients.

[0003] Currently, the main medications used in clinical treatment of PCOS include: oral contraceptives (such as drospirenone and ethinylestradiol) to regulate the menstrual cycle, metformin to improve insulin resistance and indirectly lower androgen levels, and ovulation-inducing drugs such as clomiphene and letrozole. For patients who do not respond to drug treatment, surgical treatments such as laparoscopic ovarian drilling (LOD) or ovarian wedge resection may also be used. However, Western medicine treatment for PCOS has certain limitations. Treatment strategies are mostly aimed at managing symptoms rather than addressing the underlying cause. Secondly, some medications have side effects; for example, long-term use of hormonal drugs may lead to osteoporosis and increased cardiovascular risk. Finally, Western medicine treatment has a low degree of individualization, making it difficult to meet the diverse needs of different patients.

[0004] The theoretical basis of Traditional Chinese Medicine (TCM) treatment for PCOS is mainly based on the TCM concept of syndrome differentiation and treatment, which holds that the occurrence of PCOS is closely related to pathological factors such as "kidney deficiency," "liver stagnation," "spleen deficiency," "phlegm-dampness," and "blood stasis." TCM emphasizes treatment principles such as "tonifying the kidney and strengthening the spleen," "eliminating dampness and resolving phlegm," "soothing the liver and relieving stagnation," and "activating blood circulation and removing blood stasis," thereby achieving therapeutic goals by regulating organ function and improving the flow of qi and blood. Clinically used TCM formulas and preparations for treating PCOS include Guizhi Fuling Wan, Liuwei Dihuang Tang, Zuogui Wan, Yougui Wan, and Cangfu Daotan Tang, among others. In addition, there are some clinically experienced formulas derived from these formulas with modifications.

[0005] Although traditional Chinese medicine (TCM) is effective in treating PCOS, the classic formulas commonly used in clinical practice still have some limitations in dealing with this complex disease. For example, the formulas based on syndrome differentiation often target a single pathogenesis or pathological product, making it difficult to cover complex pathogenesis. Furthermore, there is a lack of targeted drugs for the core pathological link of "phlegm and blood stasis." TCM interventions for the metabolic pathological characteristics of this disease are not highly targeted. Summary of the Invention

[0006] The purpose of this invention is to provide a traditional Chinese medicine composition, preparation method and application for treating polycystic ovary syndrome, in order to solve at least one of the problems existing in the prior art.

[0007] According to a first aspect of the present invention, a traditional Chinese medicine composition for treating polycystic ovary syndrome is provided, comprising the following raw materials in parts by weight: 10-15 parts of Cuscuta chinensis, 10-15 parts of Lycium barbarum, 10-20 parts of Taxillus chinensis, 10-15 parts of Angelica sinensis, 10-15 parts of Achyranthes bidentata, 10-15 parts of Ligusticum chuanxiong, 10-15 parts of Alisma plantago-aquatica, 10-15 parts of Nelumbo nucifera leaf, 10-15 parts of Gynostemma pentaphyllum, 10-20 parts of Salvia miltiorrhiza, 5-10 parts of Euonymus alatus, 5-10 parts of Coptis chinensis, and 5-10 parts of Glycyrrhiza uralensis.

[0008] This invention posits that polycystic ovary syndrome (PCOS) primarily affects the uterus (ovaries) and is closely related to dysfunction of the kidneys, liver, and spleen. Its onset is often due to congenital deficiencies or acquired factors such as emotional distress, dietary indiscretions, and overwork, leading to kidney and spleen deficiency, liver qi stagnation, and subsequently, the accumulation of pathological products like blood stasis and phlegm in the uterus, ultimately resulting in clinical manifestations such as menstrual disorders, amenorrhea, infertility, and obesity. The core pathogenesis is that kidney and spleen deficiency is the root cause, while qi stagnation, phlegm, and blood stasis are the manifestations. These three factors interact, creating a complex pathological state of mixed deficiency and excess. Therefore, tonifying the kidneys and spleen, and promoting blood circulation and resolving phlegm are the core treatment principles.

[0009] This invention utilizes the principles of tonifying the liver and kidneys, promoting blood circulation, and eliminating dampness, addressing both the root cause and the symptoms, and employing a combined approach of tonification and purgation. The principal herbs are: Cuscuta chinensis and Lycium barbarum. Cuscuta chinensis is sweet and warm, entering the liver and kidney meridians, tonifying both kidney yang and kidney yin, making it a key herb for mildly tonifying the liver and kidneys; Lycium barbarum is sweet and neutral, effectively nourishing the essence and blood of the liver and kidneys. The two herbs combined work synergistically to replenish essence and blood, and strengthen the lower body, targeting the root cause of liver and kidney deficiency, hence their status as the principal herbs. The assistant herbs are: Taxillus chinensis, Angelica sinensis, Achyranthes bidentata, and Ligusticum chuanxiong. Taxillus chinensis assists the principal herbs in tonifying the liver and kidneys, strengthening tendons and bones, and also dispelling wind and dampness, and calming the fetus; Angelica sinensis nourishes and invigorates blood, acting as a qi-regulating herb within the blood, and when combined with Ligusticum chuanxiong, it combines movement and stillness, nourishing liver blood and removing blood stasis; Achyranthes bidentata removes blood stasis and unblocks the meridians, guiding blood downwards, tonifying the liver and kidneys, and also eliminating dampness. These four herbs serve as assistant herbs, assisting the principal herbs in enhancing their tonifying power, while simultaneously opening the pathways for qi and blood circulation, ensuring that tonification is not stagnant.

[0010] The adjuvant herbs are: Alisma plantago-aquatica, lotus leaf, Gynostemma pentaphyllum, Salvia miltiorrhiza, Euonymus alatus, and Coptis chinensis. Alisma plantago-aquatica is sweet and bland, promoting diuresis, eliminating dampness, and clearing heat, preventing the tonifying herbs from becoming cloying and promoting dampness; lotus leaf raises the clear and lowers the turbid, invigorating the spleen and promoting diuresis; Gynostemma pentaphyllum strengthens the spleen and replenishes qi, resolves phlegm and lowers turbidity, and also clears stagnant heat; Salvia miltiorrhiza and Euonymus alatus invigorate blood, remove blood stasis, unblock the meridians, and relieve pain, with Euonymus alatus being particularly effective at breaking up blood stasis and clearing the meridians, specifically targeting the blood to remove obstructions; Coptis chinensis is bitter and cold, clearing heat and drying dampness, thickening the intestines and stopping diarrhea, and also moderating the warming and drying properties of the other herbs. These six herbs together serve as adjuvant herbs, targeting the pathological products of dampness, heat, blood stasis, and turbidity, clearing away the superficial and substantial pathogenic factors. Licorice root in the formula replenishes qi and harmonizes the middle jiao, harmonizing the other herbs and moderating the harshness of the blood-invigorating, dampness-removing, and heat-clearing herbs, serving as the guiding herb. This formula integrates tonification, blood circulation promotion, dampness elimination, and heat clearing into one, targeting the pathogenesis of liver and kidney deficiency and internal obstruction of blood stasis and dampness, while also taking into account the syndrome of mixed deficiency and excess. Together, it achieves the effects of tonifying the liver and kidney, resolving blood stasis and dampness, clearing heat and unblocking the meridians, so that the liver and kidney can be nourished, blood stasis and turbidity can be removed and new blood can be generated, and the meridians can be unblocked and dampness and turbidity can be eliminated.

[0011] All raw materials were prepared in accordance with the Chinese Pharmacopoeia (2020 Edition) and the National Standards for Processing Traditional Chinese Medicine Decoction Pieces (hereinafter referred to as the "National Processing Standards"). Specific sources: Cuscuta: Cuscuta chinensis, a plant in the Convolvulaceae family. Cuscuta australis R. Br. or dodder Dove Chinese Lam. The dried, mature seeds.

[0012] Goji berries: Lycium barbarum, a plant belonging to the Solanaceae family. Lycium barbarum L. The dried, ripe fruit.

[0013] Locust: Loranthaceae plant Loranthaceae Taxillus chinensis (DC.) Danser The dried leafy stems and branches.

[0014] Angelica sinensis: Angelica sinensis, a plant belonging to the Apiaceae family. Angelica sinensis (Oliv.) Diels The dried root.

[0015] Achyranthes bidentata: Achyranthes bidentata, a plant in the Amaranthaceae family. Cyathula officinalis Kuan The dried root.

[0016] Chuanxiong: Ligusticum chuanxiong, a plant of the Apiaceae family. Oak chuanxiong Hort. The dried rhizome.

[0017] Alisma: Alisma orientalis, a plant of the Alismataceae family. Alisma orientale (Sam.) Juzep. or Alisma plantago-aquatica Alisma plantago-aquatica Linn. The dried tubers.

[0018] Lotus leaf: Lotus, a plant in the Nymphaeaceae family. Nelumbo nucifera Gaertn. The dried leaves.

[0019] Gynostemma pentaphyllum: Gynostemma pentaphyllum, a plant of the Cucurbitaceae family Gynoacemma pentaphyllum (Thunb.) Mak The dried whole herb.

[0020] Salvia miltiorrhiza: a plant of the Lamiaceae family. Salvia miltiorrhiza Bge. The dried roots and rhizomes.

[0021] Euonymus alatus: Euonymus japonicus, a plant in the Celastraceae family. Euonymus alatus (Thunb.) Sieb. The wing-like structures of the dried stem.

[0022] Coptis chinensis: a plant of the Ranunculaceae family, Coptis chinensis. Coptis chinensis Franch. Coptis triangularis Copts deltoid CYCheng and Hsiao Or Cloud Link Coptis teeta Wall. The dried rhizome.

[0023] Licorice: Licorice, a plant in the legume family. Glycyrrhiza uralensis Fisch. licorice root Licorice inflated Bat. Or licorice root Glycyrrhiza glabra L. The dried roots and rhizomes.

[0024] In some embodiments, the traditional Chinese medicine composition for treating polycystic ovary syndrome includes the following raw materials in parts by weight: 12 parts Cuscuta chinensis, 12 parts Lycium barbarum, 15 parts Taxillus chinensis, 12 parts Angelica sinensis, 10 parts Achyranthes bidentata, 10 parts Ligusticum chuanxiong, 15 parts Alisma plantago-aquatica, 10 parts Nelumbo nucifera, 10 parts Gynostemma pentaphyllum, 15 parts Salvia miltiorrhiza, 10 parts Euonymus alatus, 5 parts Coptis chinensis, and 6 parts Glycyrrhiza uralensis.

[0025] In response to the core pathogenesis of polycystic ovary syndrome (PCOS) involving kidney deficiency and blood stasis, as well as phlegm-dampness obstruction, and the common symptoms such as menstrual irregularities, obesity, acne, and insulin resistance, the traditional Chinese medicine composition of this invention can be modified according to the specific symptoms.

[0026] In some implementations, in cases of menstrual disorders (delayed menstruation, amenorrhea, metrorrhagia), lotus leaf, alisma, and gynostemma pentaphyllum in the traditional Chinese medicine composition for treating polycystic ovary syndrome can be replaced with motherwort, peach kernel, and safflower to enhance their blood-activating and menstruation-regulating effects. Among these, motherwort refers to the plant *Leonurus japonicus*, belonging to the Lamiaceae family. Leonurus japonicus Houtt. The fresh or dried aerial parts of the peach kernel, which is the fruit of the Rosaceae family plant *Prunus persica*. Prunus persica(L.)Batsch or mountain peach Prunus davidiana (Carr.) Franch. The dried, mature seeds of safflower (Carthamus tinctorius), a plant in the Asteraceae family. Safflower L. Dried flowers.

[0027] In some implementations, if ovulation disorders (follicle development and ovulation) are encountered, the lotus leaf, alisma, and gynostemma pentaphyllum in the traditional Chinese medicine composition for treating polycystic ovary syndrome can be replaced with 10-15 parts of prepared rehmannia root and 5-10 parts of polygonatum rhizome to enhance the kidney-tonifying and essence-replenishing effects. Prepared rehmannia root is a processed product of raw rehmannia root, and rehmannia root is the plant *Rehmannia glutinosa* of the Scrophulariaceae family. Rehmannia glutinosa Libosch. Fresh or dried tuberous roots; Polygonatum odoratum is the plant Polygonatum yunnanensis of the Liliaceae family. Polygonatum kingianum Coll.et Hemsl. Polygonatum Polygonatum sibiricum Red. Or Polygonatum multiflorum Polygonatum cyrtonema Hua The dried rhizome.

[0028] In some implementations, for patients with obesity, fatigue, and sticky stools (due to spleen deficiency and phlegm dampness), the Achyranthes bidentata and Ligusticum chuanxiong in the traditional Chinese medicine composition for treating polycystic ovary syndrome can be replaced with 5-10 parts Atractylodes lancea, 10-15 parts Poria cocos, 5-10 parts Citrus reticulata peel, and 5-10 parts Crataegus pinnatifida to enhance the effects of drying dampness, strengthening the spleen, regulating qi, and harmonizing the stomach. Atractylodes lancea is a plant of the Asteraceae family. Atractylodes lancea (Thunb.) DC. Or Northern Cangshu Atractylodes chinensis (DC.) Koidz. The dried rhizome of Poria cocos, a fungus belonging to the Polyporaceae family. Poria cocos(Schw.)Wolf The dried sclerotium of the citrus plant, tangerine peel (Chenpi) is a member of the Rutaceae family. Citrus reticulata Blanco The dried, mature pericarp of hawthorn and its cultivated varieties; raw hawthorn is the fruit of the Rosaceae plant Hawthorn. Crataegus pinnatifida Bge.var.major NEBr. Or hawthorn Crataegus pinnatifida Bge. The dried, ripe fruit.

[0029] In some embodiments, for the treatment of polycystic ovary syndrome (PCOS) symptoms such as acne, hirsutism, and hyperandrogenemia, the herbs Alisma plantago-aquatica, Gynostemma pentaphyllum, Angelica sinensis, and Euonymus alatus can be replaced with 5-10 parts of Scutellaria baicalensis, 5-10 parts of Gardenia jasminoides, and 5-10 parts of Morus alba root bark to clear heat from the upper burner; and Coptis chinensis is added in 6-10 parts to enhance the heat-clearing and dampness-drying effects. Scutellaria baicalensis is a plant of the Lamiaceae family. Scutellaria Baikalensis Georgi The dried root of Gardenia jasminoides, a plant of the Rubiaceae family. Gardenia jasminoides Ellis The dried, ripe fruit of the mulberry tree (Morus alba root bark), belonging to the Moraceae family. Mulberry L. The dried root bark.

[0030] In some implementations, for cases of emotional fluctuations and liver qi stagnation, the mulberry mistletoe, alisma, and lotus leaf in the traditional Chinese medicine composition for treating polycystic ovary syndrome can be replaced with 5-10 parts of bupleurum, 5-10 parts of turmeric, and 5-10 parts of white peony root to soothe the liver and regulate qi. Bupleurum refers to the bupleurum plant (Apiaceae family). Bupleurum chinense DC. or narrow-leaved Bupleurum Bupleurum scorzonerifolium Willd. The dried root of Curcuma longa, a plant in the ginger family. Curcuma wenyujin Y.H.Chen et C.Ling ,turmeric Curcuma longa L Guangxi Curcuma zedoaria Curcuma kwangsiensis S.G.Lee et C.F.Liang Or Curcuma zedoaria Curcuma phaeocaulis Val. The dried tuberous root of white peony, a plant of the Ranunculaceae family. Paeonia lactiflora Pall. The dried root.

[0031] In some embodiments, for insulin resistance (abnormal glucose metabolism), the traditional Chinese medicine composition for treating polycystic ovary syndrome can be replaced with 5-10 parts of Anemarrhena asphodeloides and 10-15 parts of Pueraria lobata to clear heat and promote fluid production. Anemarrhena asphodeloides is a plant of the Liliaceae family. Anemarrhena asphodeloides Bge. The dried rhizome of kudzu, a legume. Pueraria lobata(Willd.)Ohwi The dried root.

[0032] According to another aspect of the present invention, a traditional Chinese medicine preparation prepared from the above-described traditional Chinese medicine composition for treating polycystic ovary syndrome is provided. The dosage form of the traditional Chinese medicine preparation is a commonly existing dosage form such as decoction, paste, compound, granule, powder, tablet, pill or capsule.

[0033] In some embodiments, pharmaceutically acceptable excipients may be added when traditional Chinese medicine preparations are formulated into common dosage forms. Excipients may include at least one of sustained-release agents, excipients, fillers, binders, wetting agents, disintegrants, absorption promoters, adsorbent carriers, surfactants, lubricants, etc.

[0034] According to another aspect of the present invention, a method for preparing the above-mentioned traditional Chinese medicine preparation is provided, wherein when preparing it into a decoction, the method includes the following steps: Soak the raw materials in 8-10 times their weight of water for 20-30 minutes, then heat to boiling and maintain a gentle boil for 0.5-1 hour. Filter the mixture and boil the residue 1-2 times. Combine the filtrates to obtain the final product.

[0035] According to another aspect of the present invention, the use of the above-mentioned traditional Chinese medicine composition or preparation for treating polycystic ovary syndrome in the preparation of a drug for treating polycystic ovary syndrome is provided.

[0036] The traditional Chinese medicine composition for treating polycystic ovary syndrome (PCOS) provided by this invention constructs a three-dimensional treatment system integrating "tonifying the kidney, promoting blood circulation, and resolving phlegm." It uses Cuscuta chinensis, Lycium barbarum, and Taxillus chinensis to replenish kidney essence and address the root cause; Salvia miltiorrhiza, Euonymus alatus, and Ligusticum chuanxiong to promote blood circulation, remove blood stasis, and unblock the meridians; and Alisma plantago-aquatica, Nelumbo nucifera, and Gynostemma pentaphyllum to eliminate dampness, resolve phlegm, and clear the source of the problem. The combined effects of these herbs simultaneously address the root cause (kidney deficiency), pathological products (blood stasis and phlegm-dampness), and ultimate outcome (enlarged ovaries and irregular menstruation) of PCOS.

[0037] Especially addressing the difficult issue of "phlegm and blood stasis," the formula combines Euonymus alatus with Salvia miltiorrhiza and Ligusticum chuanxiong. Euonymus alatus is adept at breaking up blood stasis and promoting menstruation, and can also "abort abortion and break up blood stasis," making it highly effective in dispersing gynecological masses and accumulations. Combined with Salvia miltiorrhiza and Ligusticum chuanxiong to invigorate blood and remove blood stasis, and with Alisma plantago-aquatica and Nelumbo nucifera to eliminate dampness and turbidity, this formula focuses on tackling the core pathological link of "phlegm and blood stasis."

[0038] To address the issue of insufficient targeted intervention with traditional Chinese medicine for the metabolic pathological characteristics of this disease, this invention introduces a "hypoglycemic pair"—Coptis chinensis and Gynostemma pentaphyllum—verified by modern pharmacological research. Coptis chinensis clears heat and dries dampness; modern research shows that its active ingredient, berberine, is a recognized natural drug for improving insulin resistance. Gynostemma pentaphyllum resolves phlegm and clears turbidity, significantly regulating blood lipids and blood sugar, and improving metabolism. The addition of these two herbs makes this invention more targeted and advantageous than traditional formulas in improving glucose and lipid metabolism disorders in PCOS patients. Attached Figure Description

[0039] Figure 1The estrous cycle changes in mice from different groups.

[0040] Figure 2 Images of HE staining of ovarian tissue from different groups of mice. Detailed Implementation

[0041] The present invention will be further described in detail below with reference to specific embodiments. It is worth noting that the following embodiments are only for better explaining the content of the present invention and do not limit the scope of protection of the present invention. Process steps not disclosed in the embodiments are prior art. Unless otherwise specified, all raw materials are commercially available. Among them, "slight boiling" refers to the state in which the liquid has just reached the boiling point and a few bubbles are emerging. At this time, the liquid temperature is between 93-100°C (standard atmospheric pressure).

[0042] Example 1 The traditional Chinese medicine composition for treating polycystic ovary syndrome consists of the following ingredients: Cuscuta chinensis 12g, Lycium barbarum 12g, Taxillus chinensis 15g, Angelica sinensis 12g, Achyranthes bidentata 10g, Ligusticum chuanxiong 10g, Alisma plantago-aquatica 15g, Nelumbo nucifera leaf 15g, Gynostemma pentaphyllum 15g, Salvia miltiorrhiza 20g, Euonymus alatus 10g, Coptis chinensis 10g, and Glycyrrhiza uralensis 6g.

[0043] Prepare it into a traditional Chinese medicine preparation (decoction) as follows: Soak the raw materials in water with a weight of about 10 times the total weight of the raw materials for about 30 minutes, then heat to boiling and keep it simmering for about 1 hour. Filter, boil the residue once more, combine the filtrates, and you will get the decoction.

[0044] The traditional Chinese medicine decoction prepared in this embodiment is a single dose, which is approximately 150 mL.

[0045] Example 2 The traditional Chinese medicine composition for treating polycystic ovary syndrome consists of the following ingredients: Cuscuta chinensis 12g, Lycium barbarum 12g, Taxillus chinensis 15g, Angelica sinensis 12g, Achyranthes bidentata 15g, Ligusticum chuanxiong 15g, Alisma plantago-aquatica 15g, Nelumbo nucifera leaf 15g, Gynostemma pentaphyllum 10g, Salvia miltiorrhiza 15g, Euonymus alatus 10g, Coptis chinensis 5g, and Glycyrrhiza uralensis 6g.

[0046] It is prepared into a traditional Chinese medicine preparation according to the following method: Weigh the raw materials according to the formula, add 8 times the total weight of the raw materials in double-distilled water, soak for about 30 minutes, then heat to boiling, keep simmering for about 1 hour, filter, boil the residue once more, combine the filtrates to obtain the extract, and then concentrate the extract to 0.7g crude drug / mL using a vacuum rotary evaporator.

[0047] In order to verify the therapeutic effect of the traditional Chinese medicine composition for treating polycystic ovary syndrome of the present invention on polycystic ovary syndrome, the traditional Chinese medicine preparation prepared in Example 2 was used as the research drug for animal experiments, and the results were recorded.

[0048] 1. Laboratory animals Healthy female C57 mice, 4 weeks old, weighing 18±4g, were housed in an SPF environment (temperature 22±2℃, humidity 50±10%), provided with food and water.

[0049] 2. Grouping These were the blank group, model group, positive control group, low-dose group of the patented formula, medium-dose group of the patented formula, and high-dose group of the patented formula.

[0050] 3. Modeling methods The model was established by subcutaneous injection of dehydroepiandrosterone (DHEA) 75 mg / kg / day for 28 consecutive days. The blank control group mice were subcutaneously injected with anhydrous ethanol 0.5 mL / kg / day and sesame oil 4.5 mL / kg / day for 28 days. From day 14 to day 21 of modeling, vaginal smears were performed on the mice. The presence of persistent keratinized epithelial cells in the vaginal epithelium indicated estrous cycle disorder, suggesting successful modeling.

[0051] 4. Administration Mice were administered the traditional Chinese medicine preparation prepared in Example 2 and Diane-35 by gavage. The crude drug content in the low-dose, medium-dose, and high-dose groups was 7 g / kg / d, 10.5 g / kg / d, and 14 g / kg / d, respectively, and the Diane-35 dosage by gavage was 4.5 mg / kg / d. The blank control group and the model group were administered an equal volume of physiological saline by gavage once daily for 21 consecutive days.

[0052] 5. Evaluation Indicators (1) General situation Observe the changes in fur color, activity level, demeanor, activity level, and feces of the mice.

[0053] (2) Weight Regularly measure rat body weight to understand weight changes and assess metabolic disorders associated with PCOS, especially obesity tendency.

[0054] (3) Ovarian pathology Directly observe changes in the ovarian tissue structure to confirm whether a typical "polycystic" morphology has appeared.

[0055] (4) Erosive cycle By observing the keratinization of vaginal epithelial cells in vaginal smears, the regularity of the estrous cycle in mice can be determined, thus reflecting ovulation function. A large number of white blood cells are consistently observed, characteristic of the interestrous phase; a lack of keratinized epithelial cells suggests the absence of estrogen peaks and ovulation.

[0056] (5) Sex hormones Testosterone (T): Excessively high T levels can inhibit follicle maturation, leading to follicular atresia and polycystic ovarian changes. Hyperandrogenemia is one of the most prominent pathophysiological features of PCOS.

[0057] Follicle-stimulating hormone (FSH): FSH is a key hormone that stimulates the proliferation of granulosa cells in follicles and promotes follicle development and maturation. Insufficient FSH prevents the activation of aromatase, leading to the inability of androgens within the follicle to be converted into estrogens, thus causing follicle development arrest.

[0058] Luteinizing hormone (LH): LH binds to receptors on theca cells, promoting the activity of cytochrome P450c17α enzyme, leading to excessive production of androstenedione and testosterone. High levels of LH can induce premature luteinization of granulosa cells in follicles, causing follicle development to stop and preventing the release of a mature egg.

[0059] 6. Experimental Results (1) General situation Mice in the normal group were in good spirits, active, and showed no abnormalities in fur, diet, or bowel movements. Mice in the model group exhibited increased spontaneous activity, increased aggression, disheveled and less lustrous fur, were easily startled by noise, and showed an initial increase followed by a decrease in food intake, occasionally excreting brownish-green loose stools. Compared to the model group, mice in the traditional Chinese medicine group and the positive control group showed near-normal spontaneous activity, preferred to huddle together, exhibited decreased aggression, had smooth and glossy fur, normalized food intake, and slightly formed, dark brown stools.

[0060] (2) Weight At Week 1, compared with the model group, mice in the normal group, high-dose group, medium-dose group, low-dose group and positive drug group had lower body weights, and the differences were statistically significant (P < 0.05).

[0061] At Week 2, compared with the model group, mice in the normal group, high-dose group, medium-dose group, and low-dose group had lower body weights, and the differences were statistically significant (P < 0.05). Compared with the model group, mice in the positive drug group had lower body weights, but the difference was not statistically significant (P > 0.05).

[0062] At Week 3, compared with the model group, mice in the normal group, high-dose group, medium-dose group, low-dose group and positive drug group had lower body weights, and the differences were statistically significant (P < 0.05).

[0063] At Week 4, compared with the model group, mice in the normal group, high-dose group, medium-dose group, and low-dose group had lower body weights, and the differences were statistically significant (P < 0.05). Compared with the model group, mice in the positive drug group had lower body weights, but the difference was not statistically significant (P > 0.05).

[0064] Table 1 Comparison of mouse body weight before and after treatment in each group

[0065] Note: * indicates that the weight difference compared with the model group was statistically significant at Week 1. ▲ indicates that the weight difference compared with the model group was statistically significant at Week 2. # indicates that the weight difference compared with the model group was statistically significant at Week 3. ■ indicates that the weight difference compared with the model group was statistically significant at Week 4.

[0066] (3) Sex hormones Compared with the model group mice, the serum testosterone concentrations in the normal group, positive drug group, and high-dose group were lower, and the differences were statistically significant (P < 0.05). Compared with the model group mice, the serum testosterone concentrations in the medium-dose group and low-dose group of the patented formula were lower, but the differences were not statistically significant (P > 0.05).

[0067] Compared with the model group mice, the serum follicle-stimulating hormone (FSH) concentration in the positive control group was lower, and the difference was statistically significant (P < 0.05). Compared with the model group mice, the serum FSH concentrations in the normal group, the high-dose group, the medium-dose group, and the low-dose group of the patented formula were higher, but the differences were not statistically significant (P > 0.05).

[0068] Compared with the model group mice, the serum progesterone concentrations in the normal group, positive drug group, and high-dose group were lower, and the differences were statistically significant (P < 0.05). Compared with the model group mice, the serum progesterone concentrations in the medium-dose group and low-dose group of the patented formula were lower, but the differences were not statistically significant (P > 0.05).

[0069] Table 2. Serum testosterone, follicle-stimulating hormone, and progesterone concentrations in mice before and after treatment.

[0070] Note: * indicates a statistically significant difference in testosterone concentration compared to the model group. # indicates a statistically significant difference in follicle-stimulating hormone concentration compared to the model group. ▲ indicates a statistically significant difference in progesterone concentration compared to the model group.

[0071] (4) Erosive cycle Mice in the normal group exhibited an estrous cycle, with regular changes observed in the interestrous, proestrous, estrous, and metestrous phases, lasting approximately 5 days. Mice in the model group only showed proestrous or estrous phases without cyclical changes; mice in the positive control group and each traditional Chinese medicine treatment group recovered their estrous cycle.

[0072] (5) Ovarian pathology In the normal control group, follicles and corpora lutea at different developmental stages were observed in the ovaries of mice. In the model group, the number of primary and secondary follicles increased, while mature follicles and corpora lutea were less common. In the positive control group and each Chinese medicine treatment group, follicles at different developmental stages were observed in the ovaries of mice, and the number of corpora lutea was less than that in the normal control group.

[0073] The above descriptions are merely some specific embodiments of the present invention. For those skilled in the art, various modifications and improvements can be made without departing from the inventive concept of the present invention, and all such modifications and improvements fall within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating polycystic ovary syndrome, characterized in that, It comprises the following ingredients in parts by weight: Cuscuta chinensis 10-15 parts, Lycium barbarum 10-15 parts, Taxillus chinensis 10-20 parts, Angelica sinensis 10-15 parts, Achyranthes bidentata 10-15 parts, Ligusticum chuanxiong 10-15 parts, Alisma plantago-aquatica 10-15 parts, Nelumbo nucifera leaf 10-15 parts, Gynostemma pentaphyllum 10-15 parts, Salvia miltiorrhiza 10-20 parts, Euonymus alatus 5-10 parts, Coptis chinensis 5-10 parts, Glycyrrhiza uralensis 5-10 parts.

2. The traditional Chinese medicine composition for treating polycystic ovary syndrome according to claim 1, characterized in that, It includes the following ingredients by weight: 12 parts Cuscuta chinensis, 12 parts Lycium barbarum, 15 parts Taxillus chinensis, 12 parts Angelica sinensis, 10 parts Achyranthes bidentata, 10 parts Ligusticum chuanxiong, 15 parts Alisma plantago-aquatica, 10 parts Nelumbo nucifera, 10 parts Gynostemma pentaphyllum, 15 parts Salvia miltiorrhiza, 10 parts Euonymus alatus, 5 parts Coptis chinensis, and 6 parts Glycyrrhiza uralensis.

3. A traditional Chinese medicine preparation obtained from the traditional Chinese medicine composition for treating polycystic ovary syndrome according to claim 1 or 2.

4. The traditional Chinese medicine preparation according to claim 1, characterized in that, The dosage forms of the traditional Chinese medicine preparations include decoctions, pastes, mixtures, granules, powders, tablets, pills, or capsules.

5. The traditional Chinese medicine preparation according to claim 4, characterized in that, It also includes pharmaceutically acceptable excipients.

6. The method for preparing the traditional Chinese medicine preparation according to claim 4 or 5, characterized in that, When the dosage form of the traditional Chinese medicine preparation is a decoction, the following steps are included: soak the raw materials in 8-10 times their weight of water for 20-30 minutes, then heat to boiling, maintain a gentle boil for 0.5-1 hour, filter, repeat the decoction of the residue 1-2 times, combine the filtrates, and the medicine is obtained.

7. The use of the traditional Chinese medicine composition for treating polycystic ovary syndrome as described in claim 1 or 2 in the preparation of a drug for treating polycystic ovary syndrome.

8. The use of the traditional Chinese medicine preparation according to any one of claims 3-5 in the preparation of a drug for treating polycystic ovary syndrome.

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