Pharmaceutical composition for treating polycystic ovary syndrome with obesity combined with acne

Abstract

This invention discloses a pharmaceutical composition for treating obese polycystic ovary syndrome (PCOS) complicated with acne. The pharmaceutical composition comprises a traditional Chinese medicine herbal tea and metformin. The traditional Chinese medicine herbal tea comprises the following raw materials in parts by weight: Codonopsis pilosula 1-15 parts, Poria cocos 1-15 parts, Atractylodes macrocephala 1-15 parts, Loranthus parasiticus 1-15 parts, Dipsacus asper 1-15 parts, Lycium barbarum 1-15 parts, Ziziphus jujuba 1-15 parts, and Cuscuta chinensis 1-15 parts. Take the raw materials in parts by weight, combine them together in a container, soak them in water for about half an hour, bring to a boil over high heat, then simmer over low heat for 20-40 minutes to obtain 600-1000 ml of liquid. The combination of the traditional Chinese medicine herbal tea and metformin in the treatment of obese PCOS complicated with acne produces a synergistic effect, improving the pathological state of the ovaries, skin, and other tissues by regulating the phosphatidylinositol 3-kinase and protein kinase B pathways by reducing insulin-like growth factor 1 levels.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and more specifically, to a pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne. Background Technology

[0002] Polycystic ovary syndrome (PCOS) combined with acne is a common but difficult-to-treat dermatological condition characterized by a long course, severe symptoms, and frequent relapses. Studies indicate that up to 95% of PCOS patients develop acne at some point in their lives. The combination of acne and obesity with PCOS negatively impacts patients' self-image, increasing the risk of anxiety and depression, and severely affecting their mental and physical health and quality of life. While short-acting combined oral contraceptives are the first-line treatment for hyperandrogenemia and related acne in adolescents and women of reproductive age with PCOS, their potential side effects, such as weight gain, increased insulin resistance, and lipid metabolism disorders, limit their long-term and widespread use.

[0003] Prior art 1 (Publication No.: CN119113043A, Application Date: 2024.08.09) discloses a traditional Chinese medicine composition for treating adolescent insulin-resistant polycystic ovary syndrome with acne, its preparation method, and its application. This traditional Chinese medicine composition comprises the following components by weight: Astragalus membranaceus 3-10 parts, Gypsum fibrosum 5-20 parts, Platycodon grandiflorus 3-20 parts, Citrus medica 3-10 parts, Bupleurum chinense (processed with vinegar) 3-10 parts, Lycopus lucidus 5-20 parts, Morus alba root bark 6-12 parts, and Lophatherum gracile 6-10 parts. This formula focuses on the lungs, based on the theories of liver and kidney homology, metal-water mutual generation, and the lungs governing the skin and hair, and is used to treat adolescent insulin-resistant polycystic ovary syndrome with acne. This differs from the inventive concept of this invention.

[0004] Prior art 2 (Publication No.: CN105853659A, Application Date: 2016.06.15) discloses a traditional Chinese medicine composition for polycystic ovary syndrome, comprising, by weight, the following raw materials: 20-30 parts amethyst, 10-15 parts processed epimedium, 10-20 parts atractylodes, 10-20 parts acorus, 10-15 parts immature bitter orange, 6-12 parts pinellia, 5-10 parts arisaema cum bile, 10-20 parts deer antler powder, 10-20 parts trichosanthes, 10-20 parts leonurus japonicus, 10-20 parts cuscuta, 10-20 parts processed cyperus rotundus, 10-20 parts salvia miltiorrhiza, and 5-10 parts processed licorice. This prior art differs from the inventive concept of this invention.

[0005] Prior art 3 (Publication No.: CN106334060A, Application Date: 2017.01.18) discloses a pharmaceutical composition for treating obesity-related polyovarian syndrome. Its raw material composition is: 4-8 parts of ginger-processed Pinellia ternata, 25-35 parts of Epimedium, 8-12 parts of Atractylodes lancea, 16-24 parts of Poria cocos, 10-14 parts of Citrus reticulata peel, 25-35 parts of Dipsacus asper, 8-12 parts of Cyperus rotundus, 16-24 parts of Salvia miltiorrhiza, 8-12 parts of Achyranthes bidentata, 8-12 parts of Plantago asiatica, 4-8 parts of Cinnamomum cassia, and 4-8 parts of prepared Glycyrrhiza uralensis. The preparation method is as follows: Mix ginger-processed Pinellia ternata, Epimedium, Atractylodes lancea, Poria cocos, Citrus reticulata peel, Dipsacus asper, Cyperus rotundus, Salvia miltiorrhiza, Achyranthes bidentata, Plantago asiatica, Cinnamomum cassia, and prepared Glycyrrhiza uralensis, add water and decoct, filter, and combine the filtrates to obtain the final product. However, this composition differs from the present invention in its herbal formula and does not contain metformin, which is inconsistent with the inventive concept of the present invention.

[0006] Existing technology 4 (Wei Zhihui et al., Clinical observation on the treatment of acne and hyperinsulinemia in patients with polycystic ovary syndrome by Qingjie Yangming Decoction combined with metformin, Chinese Journal of Traditional Chinese Medicine, 2023, 41, 11, 66-69) discloses the following composition of Qingjie Yangming Decoction: Anemarrhena asphodeloides 10g, Gypsum fibrosum 15g, Dioscorea opposita 15g, Scutellaria baicalensis 15g, Lonicera japonica 20g, Forsythia suspensa 20g, Chrysanthemum indicum 15g, Taraxacum mongolicum 30g, Semiaquilegia adoxoides 15g, Magnolia biondii 15g, Cassia tora 15g. The herbs are decocted in water, and 180ml is used each time, three times daily. The control group received Diane-35 and metformin treatment, while the observation group received Qingjie Yangming Decoction in addition to the treatment given to the control group. The treatment cycle for both groups was three menstrual cycles. The efficacy of treatment was compared between the two groups, including body mass index (BMI), fasting blood glucose (FBG), total postprandial insulin, hormone levels, ovarian volume, and number of follicles before and after treatment. Results showed that the total effective rate of treatment in the observation group was higher than that in the control group (P<0.05). After treatment, BMI and FBG in both groups were lower than before treatment (P<0.05); the BMI and FBG in the observation group were lower than those in the control group after treatment (P<0.05). Acne lesion scores in both groups were lower than before treatment (P<0.05); the acne lesion score in the observation group was lower than that in the control group after treatment (P<0.05). Traditional Chinese medicine theory holds that PCOS mainly stems from congenital deficiency, which is the internal factor causing the disease. Excessive consumption of rich, fatty, and spicy foods can damage the spleen and stomach, leading to impaired spleen and stomach function, dryness, and fluid depletion. Emotional imbalance, liver stagnation transforming into fire, consumes stomach yin, resulting in stomach yin deficiency. Therefore, the treatment principle should be to nourish yin and moisten dryness, clear heat and purge fire, and detoxify. In Qingjie Yangming Decoction, Anemarrhena asphodeloides nourishes yin and moistens dryness, clears heat and purges fire; Gypsum fibrosum clears heat and purges fire, relieves irritability and thirst, and astringes and promotes tissue regeneration; Dioscorea opposita tonifies the spleen and stomach, generates fluids, tonifies the kidneys, and astringes essence; Scutellaria baicalensis purges fire and detoxifies, clears heat and dries dampness, stops bleeding, and calms the fetus; Lonicera japonica and Forsythia suspensa clear heat and detoxify, disperse wind-heat, reduce swelling and dissipate nodules; Chrysanthemum indicum reduces swelling and detoxifies, clears the liver and improves eyesight, and dispels wind and heat; Taraxacum mongolicum and Semiaquilegia adoxoides reduce swelling and dissipate nodules, and clear heat and detoxify; Magnolia biondii dispels wind and cold; and Cassia tora clears the liver and improves eyesight. However, the herbal formula in this invention differs from that in the present invention.

[0007] Existing technology 5 (Chen Wenyue et al., Meta-analysis of traditional Chinese medicine combined with metformin in the treatment of polycystic ovary syndrome with insulin resistance, Journal of Traditional Chinese Medicine, 2017, 23, 18, 102-108) shows that, compared with the control group, traditional Chinese medicine combined with metformin in the treatment of PCOS-IR better reduced serum luteinization, testosterone, luteinizing hormone to follicle-stimulating hormone ratio, fasting insulin, insulin resistance index, and body mass index, while there was no statistically significant difference in reducing follicle-stimulating hormone and fasting blood glucose. Conclusion: The clinical efficacy of traditional Chinese medicine combined with metformin in the treatment of PCOS-IR is higher than that of metformin alone, which can reduce the incidence of adverse reactions during treatment, improve ovulation rate and pregnancy rate, and provide guidance for clinical combined drug treatment. Xia Guicheng believes that the etiology of PCOS lies in kidney yin deficiency and insufficient water, which over time affects yang, and yang deficiency leads to phlegm and dampness stagnation. Treatment is divided into stages: in adolescence, the focus is on regulating menstruation, and in the reproductive age, the focus is on assisting conception. Data shows that frequently used traditional Chinese medicine formulas include: Cuscuta chinensis and Epimedium, which warm and tonify kidney yang; Cornus officinalis and Lycium barbarum, which nourish kidney essence; and Rehmannia glutinosa, Angelica sinensis, Ligusticum chuanxiong, Paeonia lactiflora, Salvia miltiorrhiza, and Prunus persica, which invigorate blood circulation, remove blood stasis, regulate menstruation, and replenish blood. However, the traditional Chinese medicine formulas used in these formulas differ from those in this invention.

[0008] Existing technology 6 (a compilation of the experience of Professors Cai Shimin and Li Kunyin in treating infertility caused by polycystic ovary syndrome, doctoral dissertation of Guangzhou University of Chinese Medicine) discloses several prescriptions:

[0009] For Kidney Yang Deficiency Syndrome: The first 10 commonly used herbs are Aconitum carmichaelii, Cinnamomum cassia, Rehmannia glutinosa, Cornus officinalis, Dioscorea opposita, Paeonia suffruticosa, Alisma plantago-aquatica, Poria cocos, Citrus reticulata, and Bambusa textilis. Cluster analysis revealed two core formulas: Rehmannia glutinosa, Aconitum carmichaelii, Alisma plantago-aquatica, Cinnamomum cassia, Paeonia suffruticosa, Bambusa textilis, Dioscorea opposita, Cornus officinalis, Citrus reticulata, Poria cocos, Os draconis, and Dendrobium nobile, which are similar to modified versions of the Jin Gui Shen Qi Wan formula. The formulas also include Nelumbo nucifera, Pogostemon cablin, Atractylodes macrocephala, Psoralea corylifolia, Bletilla striata, Glycyrrhiza uralensis, Rehmannia glutinosa (processed), Dolichos lablab, and Eupatorium fortunei, with the key points being warming the spleen, tonifying Qi, and resolving dampness. After association rule calculation, multiple herbs shared a 98% support and 100% confidence level, including Aconitum carmichaelii, Rehmannia glutinosa, Alisma plantago-aquatica, Paeonia suffruticosa, and Cinnamomum cassia, indicating that these herbs all appeared in the prescription simultaneously, suggesting a strong correlation between them.

[0010] For kidney yin and yang deficiency syndrome: the first 10 commonly used herbs are licorice, poria, mulberry mistletoe, prepared rehmannia root, yam, epimedium, cornus officinalis, arborvitae seed, and bamboo shavings. Cluster analysis revealed the core formula as licorice, poria, mulberry mistletoe, yam, tangerine peel, prepared rehmannia root, epimedium, cornus officinalis, and arborvitae seed, which is similar to the modified Yougui Decoction. Association rules demonstrate a strong correlation between licorice, yam, mulberry mistletoe, poria, prepared rehmannia root, epimedium, and tangerine peel.

[0011] For spleen deficiency syndrome: the first 10 commonly used herbs are Codonopsis pilosula, Poria cocos, Glycyrrhiza uralensis, Atractylodes macrocephala, Citrus reticulata peel, Dolichos lablab, Astragalus membranaceus, Nelumbo nucifera seed, Bupleurum chinense, and Buzha leaf. Cluster analysis yielded two core formulas: Magnolia officinalis, Bambusa textilis, Dipsacus asper, Platycladus orientalis seed, Epimedium brevicornu, Os draconis, and Taxillus chinensis, which are combinations of kidney-tonifying and calming herbs; Dolichos lablab, Nelumbo nucifera seed, Atractylodes macrocephala, Citrus reticulata peel, Poria cocos, and Buzha leaf, a formula based on the Ginseng and Atractylodes Macrocephala Powder. Association rules show that Dolichos lablab, Glycyrrhiza uralensis, Buzha leaf, and Poria cocos have the highest association.

[0012] The top 10 commonly used herbs for spleen deficiency and qi sinking syndrome are yam, licorice, dipsacus, atractylodes macrocephala, codonopsis, dragon bone, cattail pollen, notoginseng, motherwort, and rubia cordifolia. Cluster analysis revealed two core formulas: prepared rehmannia root, bamboo shavings, tangerine peel, poria cocos, *Bletilla striata* leaf, mulberry mistletoe, *Polygonum multiflorum* stem, albizia bark, cornus officinalis, and arborvitae seed. This formula tonifies the kidneys and replenishes essence, nourishing kidney water. It is combined with heart-nourishing and calming herbs to prevent internal heat and disturbance of the mind. Furthermore, it is combined with spleen-strengthening and dampness-removing herbs to prevent the yin-nourishing and cloying nature of kidney-tonifying herbs from hindering the spleen and stomach. The formulas containing cattail pollen, notoginseng, motherwort, codonopsis, atractylodes macrocephala, rubia cordifolia, dipsacus, dragon bone, oyster shell, and cuttlebone are similar to a modified version of the Gu Chong Tang formula. Association rules showed that yam, cattail pollen, dipsacus, and notoginseng had the strongest associations.

[0013] For spleen and kidney yang deficiency syndrome: the first 10 commonly used herbs are Cuscuta chinensis, Atractylodes macrocephala, Glycyrrhiza uralensis, Taxillus chinensis, Dipsacus asper, Rubus idaeus, Codonopsis pilosula, Polygonum multiflorum, Poria cocos, and Citrus reticulata. Cluster analysis revealed the core formula as Taxillus chinensis, Atractylodes macrocephala, Glycyrrhiza uralensis, Dipsacus asper, Cuscuta chinensis, Rubus idaeus, Codonopsis pilosula, and Citrus reticulata, similar to a modified version of Sijunzi Wan combined with Shoutai Wan. Association rules indicate a strong correlation among Rehmannia glutinosa, Dipsacus asper, Atractylodes macrocephala, Rubus idaeus, and Glycyrrhiza uralensis.

[0014] For phlegm-dampness excess syndrome: the first 10 commonly used herbs are Pinellia ternata, Citrus reticulata peel, Citrus aurantium, Poria cocos, Glycyrrhiza uralensis, Bambusa textilis, Platycladus orientalis seed, Astragalus membranaceus, Albizia julibrissin bark, and Polygonum multiflorum. Cluster analysis revealed the core formula as Poria cocos, Bambusa textilis, Glycyrrhiza uralensis, Pinellia ternata, and Citrus aurantium, similar to the modified Wendan Decoction. Association rules all showed strong correlations among the five herbs: Poria cocos, Bambusa textilis, Glycyrrhiza uralensis, Citrus aurantium, and Pinellia ternata.

[0015] For Liver Qi Stagnation Transforming into Fire Syndrome: The first 10 commonly used herbs are Poria cocos, malt, tangerine peel, Fritillaria thunbergii, turmeric, chicken gizzard lining, bupleurum, saposhnikovia divaricata, Lindera strychnifolia, and astragalus membranaceus. Cluster analysis revealed the core formula as turmeric, chicken gizzard lining, malt, Fritillaria thunbergii, saposhnikovia divaricata, and bupleurum, closely resembling the self-formulated multi-cystic formula. Association rule calculations indicate the strongest association among chicken gizzard lining, turmeric, Fritillaria thunbergii, and malt.

[0016] Qi stagnation and blood stasis syndrome: The first 10 herbs are Rehmannia glutinosa, Ligusticum chuanxiong, Angelica sinensis, Paeonia lactiflora, Leonurus japonicus, Lindera aggregata, Glycyrrhiza uralensis, Platycladus orientalis seed, Curcuma aromatica, and Spatholobus suberectus. Two core prescriptions obtained by cluster analysis: Prunus persica, Carthamus tinctorius, Taxillus chinensis, Dolichos lablab, Citrus reticulata, Albizia julibrissin, and Polygonum multiflorum Thunb, which are composed of herbs for activating blood circulation and dredging meridians, invigorating the spleen and tonifying the kidney, and tranquilizing the mind; Angelica sinensis, Lindera aggregata, Paeonia lactiflora, Leonurus japonicus, Spatholobus suberectus, Curcuma aromatica, Ligusticum chuanxiong, Rehmannia glutinosa, and the prescription is similar to the modified Huoxue Decoction. From the fourth-order association rules, the combinations of Rehmannia glutinosa, Spatholobus suberectus, Lindera aggregata, and Curcuma aromatica, Platycladus orientalis seed, Paeonia lactiflora, Lindera aggregata, and Glycyrrhiza uralensis, and Paeonia lactiflora, Spatholobus suberectus, Curcuma aromatica, and Lindera aggregata have the strongest relevance in the prescription.

[0017] All the above traditional Chinese medicine prescriptions provided in the prior art 6 are different from the present invention.

[0018] The prior art 7 (Combined Disease and Syndrome Diagnosis and Treatment Guidelines for Polycystic Ovary Syndrome, Chinese Journal of General Practice, 2025, 23, 5, 726 - 736) discloses multiple prescriptions for combined disease and syndrome treatment:

[0019] Kidney yin deficiency syndrome: 24 g of Rehmannia glutinosa, 12 g of Dioscorea opposita, 12 g of Cornus officinalis, 12 g of Cuscuta chinensis, 12 g of Lycium barbarum, 9 g of Cyathula officinalis, 12 g of Cornu corvi colla, and 12 g of Plastrum testudinis.

[0020] Kidney yang syndrome: 24 g of Rehmannia glutinosa, 12 g of Dioscorea opposita, 12 g of Cornus officinalis, 12 g of Cuscuta chinensis, 6 g of Aconitum carmichaeli, 6 g of Cinnamomum cassia, 9 g of Angelica sinensis, 12 g of Cornu corvi colla, 12 g of Psoralea corylifolia, and 12 g of Epimedium brevicornu.

[0021] Spleen deficiency and phlegm dampness syndrome: 9 g of Atractylodes lancea, 10 g of Cyperus rotundus, 6 g of Citrus reticulata, 9 g of Arisaema cum bile, 10 g of Aurantii Fructus Immaturus, 9 g of Pinellia ternata, 10 g of Ligusticum chuanxiong, 10 g of Poria cocos, and 15 g of Medicago sativa.

[0022] Qi stagnation and blood stasis syndrome: 6 g of Trogopterus dung, 9 g of Angelica sinensis, 6 g of Ligusticum chuanxiong, 9 g of Prunus persica, 6 g of Paeonia suffruticosa, 6 g of Paeonia lactiflora, 6 g of Lindera aggregata, 3 g of Corydalis yanhusuo, 9 g of Glycyrrhiza uralensis, 6 g of Cyperus rotundus, 9 g of Carthamus tinctorius, and 6 g of Aurantii Fructus Immaturus. Compared with the simple use of metformin to treat obese PCOS patients, the modified Cangfu Dandao Decoction (Atractylodes lancea, Cyperus rotundus, Aurantii Fructus Immaturus, Citrus reticulata, Pinellia ternata, Poria cocos, Glycyrrhiza uralensis, Zingiber officinale, Arisaema cum bile) combined with metformin has better therapeutic effects in terms of improving the total effective rate, ovulation rate, and reducing BMI, insulin resistance index, follicle-stimulating hormone, luteinizing hormone, testosterone, and estradiol levels.

[0023] All the above traditional Chinese medicine prescriptions provided in the prior art 7 are different from the present invention. Summary of the Invention

[0024] In view of this, the present invention provides a pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne.

[0025] The present invention provides a pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne, comprising a traditional Chinese medicine tea and metformin, wherein the traditional Chinese medicine tea comprises the following raw materials in parts by weight: Codonopsis pilosula 1-15 parts, Poria cocos 1-15 parts, Atractylodes macrocephala 1-15 parts, Loranthus parasiticus 1-15 parts, Dipsacus asper 1-15 parts, Lycium barbarum 1-15 parts, Jujube 1-15 parts, Cuscuta chinensis 1-15 parts;

[0026] The method for preparing the herbal tea substitute is as follows:

[0027] Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis;

[0028] Combine the above-mentioned raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 20-40 minutes to obtain 600-1000ml of liquid.

[0029] Optionally, the herbal tea substitute includes the following raw materials in parts by weight: Codonopsis pilosula 5-10 parts, Poria cocos 5-10 parts, Atractylodes macrocephala 5-10 parts, Taxillus chinensis 5-10 parts, Dipsacus asper 5-10 parts, Lycium barbarum 5-10 parts, Jujube 5-10 parts, Cuscuta chinensis 5-10 parts.

[0030] Optionally, the herbal tea substitute includes the following raw materials in parts by weight: 5 parts Codonopsis pilosula, 5 parts Poria cocos, 5 parts Atractylodes macrocephala, 5 parts Taxillus chinensis, 5 parts Dipsacus asper, 5 parts Lycium barbarum, 5 parts Jujube, and 5 parts Cuscuta chinensis.

[0031] Optionally, the dosage of metformin is 1 mg / kg to 2000 mg / kg.

[0032] Optionally, the dosage of metformin is 100 mg / kg to 1000 mg / kg.

[0033] Optionally, the dosage of metformin is 200 mg / kg to 500 mg / kg.

[0034] Optionally, the dosage of metformin is 270 mg / kg.

[0035] Optionally, in the composition, the weight ratio of the herbal tea to metformin is (5-50):(1-5).

[0036] Optionally, in the composition, the weight ratio of the herbal tea to metformin is (8-20):1.

[0037] Optionally, in the composition, the weight ratio of the herbal tea to metformin is 520-27.

[0038] Codonopsis pilosula, the dried root of Codonopsis pilosula, Codonopsis lanceolata, or Codonopsis chuanxiong, is a plant in the Campanulaceae family. It has the effects of strengthening the spleen and lungs, nourishing blood and promoting body fluids. It is mainly used to treat symptoms such as spleen and lung qi deficiency, poor appetite and fatigue, cough and wheezing, qi and blood deficiency, sallow complexion, palpitations and shortness of breath, thirst due to fluid depletion, and internal heat and thirst.

[0039] Poria cocos is sweet and bland in taste, neutral in nature, and enters the heart, lung, spleen, and kidney meridians. It promotes diuresis and eliminates dampness, strengthens the spleen and harmonizes the middle jiao, and calms the mind and soothes the nerves.

[0040] Atractylodes macrocephala has a bitter and sweet taste, is warm in nature, and enters the spleen and stomach meridians. It invigorates the spleen and replenishes qi, dries dampness and promotes diuresis, stops sweating, and calms the fetus.

[0041] Parasite, short for mulberry mistletoe, tastes bitter and sweet, is neutral in nature, and enters the liver and kidney meridians. It has the effects of dispelling wind and dampness, tonifying the liver and kidneys, strengthening muscles and bones, and calming the fetus.

[0042] Dipsacus asper, also known as Dipsacus asper, is slightly warm in nature and has a bitter and pungent taste. It enters the liver and kidney meridians and has the effects of tonifying the liver and kidneys, strengthening tendons and bones, stopping metrorrhagia and bleeding, and healing fractures.

[0043] Goji berries have the effects of nourishing the liver and kidneys, benefiting essence and improving eyesight. They are sweet in taste, neutral in nature, and enter the liver and kidney meridians.

[0044] Jujubes can invigorate the spleen and replenish qi, promote digestion and absorption, and enhance physical strength and immunity; they also nourish blood and calm the mind, replenish iron, and regulate sleep.

[0045] Cuscuta seed is sweet and warm in nature, and enters the kidney, liver and spleen meridians. It has the effects of nourishing the liver and kidneys, consolidating essence and reducing urination, calming the fetus, improving eyesight and stopping diarrhea.

[0046] Compared with the prior art, the pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne provided by the present invention achieves at least the following beneficial effects:

[0047] The herbal tea of ​​this invention contains Loranthus parasiticus, Dipsacus asper, and Lycium barbarum to nourish the liver and kidneys and replenish essence and blood; Codonopsis pilosula, Poria cocos, and Atractylodes macrocephala to invigorate qi, strengthen the spleen, and resolve dampness; and Jujube to replenish qi and blood, strengthen the spleen, and benefit the stomach. In clinical studies, the tea also improves palatability and increases patient compliance when taken orally. Combining the herbal tea with metformin to treat obese PCOS with acne produces a synergistic effect. By reducing insulin-like growth factor 1 (IGF-1) levels, it regulates the phosphatidylinositol 3-kinase (PI3K) and protein kinase B (AKT) pathways, thereby improving the pathological state of tissues such as the ovaries and skin.

[0048] Of course, any product implementing this invention does not necessarily need to achieve all of the technical effects described above at the same time.

[0049] Other features and advantages of the invention will become clear from the following detailed description of exemplary embodiments of the invention with reference to the accompanying drawings. Attached Figure Description

[0050] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments of the invention and, together with their description, serve to explain the principles of the invention.

[0051] Figure 1 Changes in rat body weight during the modeling period;

[0052] Figure 2 The estrous cycle changes in rats (×200);

[0053] Figure 3 Changes in the appearance of rat auricular skin;

[0054] Figure 4 HE staining of rat auricular tissue (×400);

[0055] Figure 5 HE staining of rat ovarian tissue (×50);

[0056] Figure 6 Changes in the estrous cycle of rats after intervention and treatment;

[0057] Figure 7 Changes in serum sex hormone levels in rats after intervention treatment;

[0058] Figure 8 Changes in serum INS and IGF-1 levels in rats after intervention treatment;

[0059] Figure 9 Changes in the appearance of rat auricular skin after intervention treatment;

[0060] Figure 10 HE staining changes in rat auricle tissue after intervention (×400).

[0061] Figure 11 Masson staining results of rat auricle tissue after intervention treatment (×400).

[0062] Figure 12 HE staining changes in rat ovarian tissue after intervention (×50);

[0063] Figure 13 Masson staining results for rat ovarian tissue (×50);

[0064] Figure 14 The expression of IGF-1, IGF-1R, PI3K, and Akt proteins in the auricular tissue of rats in each group was determined.

[0065] Figure 15 The expression of IGF-1, IGF-1R, PI3K, and Akt proteins in the ovarian tissues of rats in each group was determined. Detailed Implementation

[0066] Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be noted that, unless otherwise specifically stated, the relative arrangement, numerical expressions, and values ​​of the components and steps set forth in these embodiments do not limit the scope of the invention.

[0067] The following description of at least one exemplary embodiment is merely illustrative and is in no way intended to limit the invention or its application or use.

[0068] Techniques, methods, and equipment known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and equipment should be considered part of the specification.

[0069] In all the examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values.

[0070] It should be noted that similar labels and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be discussed further in subsequent figures.

[0071] Example 1

[0072] The pharmaceutical composition of this embodiment for treating obese polycystic ovary syndrome complicated with acne includes a traditional Chinese medicine tea and metformin, with 1000ml of the traditional Chinese medicine tea and 500mg of metformin.

[0073] The herbal tea substitute contains the following raw materials in parts by weight: Codonopsis pilosula 15 parts, Poria cocos 15 parts, Atractylodes macrocephala 15 parts, Taxillus chinensis 15 parts, Dipsacus asper 15 parts, Lycium barbarum 15 parts, Jujube 15 parts, Cuscuta chinensis 15 parts.

[0074] The preparation method for traditional Chinese medicine tea substitutes is as follows:

[0075] Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis;

[0076] Combine the above-mentioned raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 40 minutes to obtain 1000ml of liquid.

[0077] Example 2

[0078] The pharmaceutical composition of this embodiment for treating obese polycystic ovary syndrome complicated with acne includes a traditional Chinese medicine tea and metformin, with 800ml of the traditional Chinese medicine tea and 500mg of metformin.

[0079] The herbal tea substitute contains the following raw materials in parts by weight: Codonopsis pilosula 10 parts, Poria cocos 10 parts, Atractylodes macrocephala 10 parts, Taxillus chinensis 10 parts, Dipsacus asper 10 parts, Lycium barbarum 10 parts, Jujube 10 parts, Cuscuta chinensis 10 parts.

[0080] The preparation method for traditional Chinese medicine tea substitutes is as follows:

[0081] Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis;

[0082] Combine the above raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 30 minutes to obtain 800ml of liquid.

[0083] Example 3

[0084] The pharmaceutical composition of this embodiment for treating obese polycystic ovary syndrome complicated with acne includes a traditional Chinese medicine tea and metformin, with 600ml of the traditional Chinese medicine tea and 500mg of metformin.

[0085] The herbal tea substitute contains the following raw materials in parts by weight: Codonopsis pilosula 5 parts, Poria cocos 5 parts, Atractylodes macrocephala 5 parts, Taxillus chinensis 5 parts, Dipsacus asper 5 parts, Lycium barbarum 5 parts, Jujube 5 parts, Cuscuta chinensis 5 parts.

[0086] The preparation method for traditional Chinese medicine tea substitutes is as follows:

[0087] Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis;

[0088] Combine the above raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 30 minutes to obtain 600ml of liquid.

[0089] Example 4

[0090] The pharmaceutical composition of this embodiment for treating obese polycystic ovary syndrome complicated with acne includes a traditional Chinese medicine tea and metformin, with 600ml of the traditional Chinese medicine tea and 500mg of metformin.

[0091] The herbal tea substitute contains the following raw materials in parts by weight: Codonopsis pilosula 9 parts, Poria cocos 8 parts, Atractylodes macrocephala 7 parts, Taxillus chinensis 9 parts, Dipsacus asper 6 parts, Lycium barbarum 7 parts, Jujube 8 parts, Cuscuta chinensis 9 parts;

[0092] The preparation method for traditional Chinese medicine tea substitutes is as follows:

[0093] Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis;

[0094] Combine the above-mentioned raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 38 minutes to obtain 600ml of liquid.

[0095] Example 5

[0096] The pharmaceutical composition of this embodiment for treating obese polycystic ovary syndrome complicated with acne includes a traditional Chinese medicine tea and metformin, with 700ml of the traditional Chinese medicine tea and 500mg of metformin.

[0097] The herbal tea substitute contains the following raw materials in parts by weight: Codonopsis pilosula 7 parts, Poria cocos 6 parts, Atractylodes macrocephala 9 parts, Taxillus chinensis 7 parts, Dipsacus asper 5 parts, Lycium barbarum 8 parts, Jujube 7 parts, Cuscuta chinensis 6 parts;

[0098] The preparation method for traditional Chinese medicine tea substitutes is as follows:

[0099] Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis;

[0100] Combine the above-mentioned raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 36 minutes to obtain 700ml of liquid.

[0101] Example 6

[0102] The pharmaceutical composition of this embodiment for treating obese polycystic ovary syndrome complicated with acne includes a traditional Chinese medicine tea and metformin, with 900ml of the traditional Chinese medicine tea and 500mg of metformin.

[0103] The herbal tea substitute contains the following raw materials in parts by weight: Codonopsis pilosula 6 parts, Poria cocos 9 parts, Atractylodes macrocephala 5 parts, Taxillus chinensis 8 parts, Dipsacus asper 7 parts, Lycium barbarum 5 parts, Jujube 6 parts, Cuscuta chinensis 7 parts;

[0104] The preparation method for traditional Chinese medicine tea substitutes is as follows:

[0105] Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis;

[0106] Combine the above-mentioned raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 34 minutes to obtain 900ml of liquid.

[0107] Example 7

[0108] The pharmaceutical composition of this embodiment for treating obese polycystic ovary syndrome complicated with acne includes a traditional Chinese medicine tea and metformin, with 1000ml of the traditional Chinese medicine tea and 500mg of metformin;

[0109] The herbal tea substitute contains the following raw materials in parts by weight: Codonopsis pilosula 12 parts, Poria cocos 5 parts, Atractylodes macrocephala 11 parts, Taxillus chinensis 7 parts, Dipsacus asper 6 parts, Lycium barbarum 5 parts, Jujube 8 parts, Cuscuta chinensis 14 parts.

[0110] The preparation method for traditional Chinese medicine tea substitutes is as follows:

[0111] Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis;

[0112] Combine the above-mentioned raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 30 minutes to obtain 1000ml of liquid.

[0113] Example 8

[0114] The pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne in this embodiment includes a traditional Chinese medicine tea and metformin, with 800ml of the traditional Chinese medicine tea and 1000mg of metformin;

[0115] The herbal tea substitute contains the following raw materials in parts by weight: Codonopsis pilosula 5 parts, Poria cocos 6 parts, Atractylodes macrocephala 13 parts, Taxillus chinensis 7 parts, Dipsacus asper 14 parts, Lycium barbarum 8 parts, Jujube 12 parts, Cuscuta chinensis 5 parts;

[0116] The preparation method for traditional Chinese medicine tea substitutes is as follows:

[0117] Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis;

[0118] Combine the above raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 25 minutes to obtain 800ml of liquid.

[0119] Example 9

[0120] The pharmaceutical composition of this embodiment for treating obese polycystic ovary syndrome complicated with acne includes a traditional Chinese medicine tea and metformin, with 700ml of the traditional Chinese medicine tea and 500mg of metformin;

[0121] The herbal tea substitute contains the following raw materials in parts by weight: Codonopsis pilosula 12 parts, Poria cocos 8 parts, Atractylodes macrocephala 5 parts, Taxillus chinensis 7 parts, Dipsacus asper 13 parts, Lycium barbarum 5 parts, Jujube 10 parts, Cuscuta chinensis 11 parts.

[0122] The preparation method for traditional Chinese medicine tea substitutes is as follows:

[0123] Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis;

[0124] Combine the above-mentioned raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 25 minutes to obtain 700ml of liquid.

[0125] Example 10

[0126] The pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne in this embodiment includes a traditional Chinese medicine tea and metformin, with 600ml of the traditional Chinese medicine tea and 1000mg of metformin;

[0127] The herbal tea substitute contains the following raw materials in parts by weight: Codonopsis pilosula 7 parts, Poria cocos 12 parts, Atractylodes macrocephala 5 parts, Taxillus chinensis 13 parts, Dipsacus asper 8 parts, Lycium barbarum 11 parts, Jujube 10 parts, Cuscuta chinensis 12 parts;

[0128] The preparation method for traditional Chinese medicine tea substitutes is as follows:

[0129] Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis;

[0130] Combine the above raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 20 minutes to obtain 600ml of liquid.

[0131] Example 11

[0132] The pharmaceutical composition of this embodiment for treating obese polycystic ovary syndrome complicated with acne includes a traditional Chinese medicine tea and metformin, with 700ml of the traditional Chinese medicine tea and 500mg of metformin;

[0133] The herbal tea substitute contains the following raw materials in parts by weight: Codonopsis pilosula 10 parts, Poria cocos 10 parts, Atractylodes macrocephala 12 parts, Loranthus parasiticus 13 parts, Dipsacus asper 5 parts, Lycium barbarum 7 parts, Jujube 13 parts, Cuscuta chinensis 14 parts.

[0134] The preparation method for traditional Chinese medicine tea substitutes is as follows:

[0135] Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis;

[0136] Combine the above-mentioned raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 27 minutes to obtain 700ml of liquid.

[0137] Example 12

[0138] The pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne in this embodiment includes a traditional Chinese medicine tea and metformin, with 800ml of the traditional Chinese medicine tea and 1000mg of metformin;

[0139] The herbal tea substitute contains the following raw materials in parts by weight: Codonopsis pilosula 15 parts, Poria cocos 15 parts, Atractylodes macrocephala 7 parts, Taxillus chinensis 15 parts, Dipsacus asper 5 parts, Lycium barbarum 11 parts, Jujube 7 parts, Cuscuta chinensis 13 parts.

[0140] The preparation method for traditional Chinese medicine tea substitutes is as follows:

[0141] Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis;

[0142] Combine the above raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 20 minutes to obtain 800ml of liquid.

[0143] Example 13

[0144] The pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne in this embodiment includes a traditional Chinese medicine tea and metformin, with 600ml of the traditional Chinese medicine tea and 500mg of metformin;

[0145] The herbal tea substitute contains the following raw materials in parts by weight: Codonopsis pilosula 5 parts, Poria cocos 8 parts, Atractylodes macrocephala 13 parts, Taxillus chinensis 5 parts, Dipsacus asper 8 parts, Lycium barbarum 12 parts, Jujube 13 parts, Cuscuta chinensis 9 parts;

[0146] The preparation method for traditional Chinese medicine tea substitutes is as follows:

[0147] Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis;

[0148] Combine the above raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 34 minutes to obtain 600ml of liquid.

[0149] Example 14

[0150] The pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne in this embodiment includes a traditional Chinese medicine tea and metformin, with 600ml of the traditional Chinese medicine tea and 500mg of metformin;

[0151] The herbal tea substitute contains the following raw materials in parts by weight: Codonopsis pilosula 1 part, Poria cocos 1 part, Atractylodes macrocephala 1 part, Taxillus chinensis 1 part, Dipsacus asper 1 part, Lycium barbarum 1 part, Jujube 1 part, Cuscuta chinensis 1 part;

[0152] The preparation method for traditional Chinese medicine tea substitutes is as follows:

[0153] Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis;

[0154] Combine the above raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 23 minutes to obtain 600ml of liquid.

[0155] Example 15

[0156] The pharmaceutical composition of this embodiment for treating obese polycystic ovary syndrome complicated with acne includes a traditional Chinese medicine tea and metformin, with 900ml of the traditional Chinese medicine tea and 500mg of metformin;

[0157] The herbal tea substitute contains the following raw materials in parts by weight: Codonopsis pilosula 8 parts, Poria cocos 12 parts, Atractylodes macrocephala 11 parts, Taxillus chinensis 6 parts, Dipsacus asper 13 parts, Lycium barbarum 14 parts, Jujube 14 parts, Cuscuta chinensis 14 parts;

[0158] The preparation method for traditional Chinese medicine tea substitutes is as follows:

[0159] Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis;

[0160] Combine the above raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 32 minutes to obtain 900ml of liquid.

[0161] Example 16

[0162] The pharmaceutical composition of this embodiment for treating obese polycystic ovary syndrome complicated with acne includes a traditional Chinese medicine tea and metformin, with 700ml of the traditional Chinese medicine tea and 500mg of metformin;

[0163] The herbal tea substitute contains the following raw materials in parts by weight: Codonopsis pilosula 6 parts, Poria cocos 6 parts, Atractylodes macrocephala 6 parts, Taxillus chinensis 8 parts, Dipsacus asper 12 parts, Lycium barbarum 13 parts, Jujube 14 parts, Cuscuta chinensis 13 parts.

[0164] The preparation method for traditional Chinese medicine tea substitutes is as follows:

[0165] Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis;

[0166] Combine the above raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 30 minutes to obtain 700ml of liquid.

[0167] The technical effects of this invention will be explained below in conjunction with clinical studies.

[0168] This clinical study was led by Liu Rui (Attending Physician, Traditional Chinese Medicine Center, Beijing Luhe Hospital, Capital Medical University). The research team also included Li Min (Attending Physician, Traditional Chinese Medicine Center, Beijing Luhe Hospital, Capital Medical University), Yu Ke (Chief Physician, Department of Endocrinology, Beijing Luhe Hospital, Capital Medical University), Wang Pei (Attending Physician, Traditional Chinese Medicine Center, Beijing Luhe Hospital, Capital Medical University), Wang Zheng (Attending Physician, Traditional Chinese Medicine Center, Beijing Luhe Hospital, Capital Medical University), and Yu Man (Resident Physician, Traditional Chinese Medicine Center, Beijing Luhe Hospital, Capital Medical University). The study period was from November 1, 2021 to October 30, 2022, a total of 12 weeks.

[0169] Based on previous literature reviews, this study estimated the sample size using the superiority test sample size calculation formula for ovulation rates in two groups. The formula is as follows:

[0170] ;

[0171] in , (power=0.9) The ovulation rate in the treatment group. The ovulation rate is for the control group. , Calculations yielded the following results. Considering the possibility of participants being uncooperative, dropping out midway, or lost to follow-up, the number of participants was increased by 20%. To determine the shedding rate, the sample size was increased. ,therefore Final sample size The number of cases is 41, meaning that 41 patients need to be included in each group, and a total of 82 patients need to be included in both groups.

[0172] Patients who visited the Department of Traditional Chinese Medicine Gynecology and the Endocrinology and Weight Loss Clinic at Luhe Hospital between November 1, 2021 and October 30, 2022 were recruited and screened. The recruitment link is: https: / / mp.weixin.qq.com / s / 6- VDPp5sa5C80tJjNc-bbg This study recruited 82 patients who met the diagnostic criteria for overweight and obese PCOS (Kidney Deficiency and Phlegm-Dampness Syndrome) and visited the TCM Gynecology and Endocrinology Weight Loss Clinic between November 1, 2021 and October 30, 2022. Patients were randomly assigned to a treatment group and a control group. Eligibility criteria included: meeting the diagnostic criteria for PCOS; meeting the evaluation criteria for overweight and obesity; being aged 18-40 years; meeting the TCM diagnostic criteria for Kidney Deficiency and Phlegm-Dampness Syndrome; providing informed consent; voluntarily participating in the study; and being available for follow-up observation.

[0173] The treatment group received a combination of traditional Chinese and Western medicine behavioral intervention, oral metformin, and oral Chinese herbal tea, while the control group received only oral metformin. The treatment period was 12 weeks.

[0174] The intervention medication is:

[0175] (1) Metformin Hydrochloride Tablets: Both the treatment group and the control group were required to take metformin hydrochloride tablets orally. Product specifications: 500mg*60 tablets, production batch number: National Drug Approval Number H20193269, manufacturer: Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. Metformin hydrochloride tablets were administered using a gradual dose-increasing method. The initial dose was 500mg twice a day, and the dose was gradually increased to 1000mg twice a day within 2 weeks according to the patient's own adaptation.

[0176] (2) The treatment group needs to take the following herbal tea: 5g each of Loranthus parasiticus, Dipsacus asper, Cuscuta chinensis, Lycium barbarum, Jujube, Codonopsis pilosula, Poria cocos and Atractylodes macrocephala. Manufacturer: Beijing Renwei Chinese Medicine Pieces Co., Ltd. One dose per day, boiled for 30 minutes and drunk as tea (at least 600ml per day).

[0177] A total of 61 patients (74.39%) completed the experiment, including 30 in the treatment group (4 of whom were pregnant) and 31 in the control group (2 of whom were pregnant).

[0178] The study observed changes in basal body temperature biphasic rate, acne and hair scores, BMI (body mass index), clinical symptom scores, seven hormones, fasting insulin and insulin resistance index, and blood lipids before and after treatment. Patients also completed the Self-Rating Depression Scale (SDS), Self-Rating Anxiety Scale (SAS) scores, Health-Promoting Lifestyle Scale (HPLP), and PCOS Patient Quality of Life Scale. A family member also completed the HPLP, and patients were followed up for one year.

[0179] 61 patients (74.39%) completed the trial, including 30 in the treatment group (4 of whom were pregnant) and 31 in the control group (2 of whom were pregnant).

[0180] It should be noted that all of the above embodiments have undergone clinical studies. Here, we will only take the herbal tea beverage in Embodiment 3 as an example with the minimum values ​​of each component for detailed explanation.

[0181] Changes in indicators after intervention:

[0182] 1.1 Changes in BMI.

[0183] As shown in Table 1, there was no statistically significant difference in body mass index (BMI) between the two groups before treatment (based on analysis of variance) (P>0.05). After treatment, BMI decreased in both groups, with the difference in BMI reduction being significantly greater in the treatment group than in the control group, and the difference was statistically significant (P<0.05).

[0184] Table 1. Changes in BMI before and after intervention.

[0185]

[0186] Note: P<0.05, P<0.01, compared with the control group.

[0187] 1.2 Comparison of basal body temperature biphasic rate.

[0188] As shown in Table 2, the treatment group underwent 90 cycles of treatment, with 67 instances of biphasic basal body temperature (BBT) occurrences, resulting in a BBT biphasic rate of 72.04%. The control group underwent 93 cycles of treatment, with 42 instances of biphasic basal body temperature (BBT) occurrences, resulting in a BBT biphasic rate of 45.16%. The ovulation rate in the treatment group was significantly higher than that in the control group (P<0.01).

[0189] Table 2 Comparison of basal body temperature biphasic rate after intervention treatment

[0190]

[0191] 1.3 Correlation between BMI and the number of biphasic basal body temperature cycles.

[0192] Referring to Table 3, the post-intervention BMI difference and the number of biphasic basal body temperature cycles showed a Pearson correlation coefficient of r = 0.532, P = 0.000 < 0.001, indicating a positive linear correlation between the post-intervention BMI difference and the number of biphasic basal body temperature cycles. The post-intervention BMI decrease percentage (post-intervention BMI difference / pre-treatment BMI) and the number of biphasic basal body temperature cycles showed a Pearson correlation coefficient of r = 0.575, P = 0.000 < 0.001, indicating a positive linear correlation between the percentage BMI decrease and the number of biphasic basal body temperature cycles. Overall, 15 patients in both the treatment and control groups experienced a weight loss of more than 10% after treatment, and all of them were able to resume 2-3 regular menstrual cycles. 38 patients in both groups experienced a weight loss of more than 5% after treatment, of whom 89.47% were able to resume 2-3 regular menstrual cycles. The treatment group showed significantly better results than the control group, and the difference was statistically significant (P < 0.01).

[0193] Table 3. Biphasic relationship between BMI, weight loss, and basal body temperature

[0194]

[0195] 1.4 Physical signs of Kaohsiung.

[0196] As shown in Table 4, there were no statistically significant differences in Plewig and Kligman acne scores and Ferriman-Gallwey hair scores between the two groups before treatment (based on ANOVA) (P>0.05). There were no significant changes in hair scores between the two groups after treatment (P>0.05). Acne scores decreased in both groups after treatment, with the difference in acne score reduction being significantly greater in the treatment group than in the control group, and the difference was statistically significant (P<0.01).

[0197] Table 4 Changes in acne and hair scores before and after intervention

[0198]

[0199] Note: P<0.05, P<0.01, compared with the control group.

[0200] 1.5 Correlation between BMI and acne.

[0201] The post-intervention BMI difference and the difference in Plewig and Kligman acne scores showed a Pearson correlation coefficient of r = 0.332, P = 0.011 < 0.05, indicating a positive linear correlation between the post-intervention BMI difference and the Plewig and Kligman acne score difference. The post-intervention BMI decrease percentage (post-intervention BMI difference / pre-treatment BMI) and the Plewig and Kligman acne score difference showed a Pearson correlation coefficient of r = 0.368, P = 0.004 < 0.05, indicating a positive linear correlation between the percentage decrease in BMI and the frequency of the biphasic basal body temperature.

[0202] 1.6 Sex hormones.

[0203] As shown in Table 5, there were no statistically significant differences in T, LH, and LH / FSH between the two groups before treatment (based on ANOVA) (P>0.05). After treatment, T decreased in both groups, with the difference in T reduction being greater in the treatment group than in the control group, and the difference was statistically significant (P<0.05). After treatment, LH decreased in the treatment group compared to before treatment, while no significant decrease was observed in the control group, but the difference in LH reduction between the two groups before and after treatment was not statistically significant (P>0.05). LH / FSH decreased in both groups after treatment, but the difference in LH / FSH reduction between the two groups before and after treatment was not statistically significant (P>0.05).

[0204] Table 5 Changes in female hormones before and after intervention

[0205]

[0206] Note: P<0.05, P<0.01, compared with the control group.

[0207] 1.7 Glucose and lipid metabolism.

[0208] As shown in Table 6, there were no statistically significant differences in fasting insulin, insulin resistance index, triglycerides, and cholesterol between the two groups before treatment (based on ANOVA) (P>0.05). After treatment, fasting insulin, insulin resistance index, triglycerides, and cholesterol decreased in the treatment group, while triglycerides decreased in the control group compared to before treatment. The differences in the decreases in fasting insulin, insulin resistance index, and cholesterol were significantly greater in the treatment group than in the control group, and these differences were statistically significant (P<0.05). There was no significant difference in triglycerides between the two groups after treatment (P>0.05).

[0209] Table 6 Changes in glucose and lipid metabolism indicators before and after intervention

[0210]

[0211] Note: P<0.05, P<0.01, compared with the control group.

[0212] 1.8 Overall therapeutic effect.

[0213] As shown in Table 7, the cure rate in the treatment group was 16.67%, the significant efficacy rate was 20.00%, the effective rate was 50.00%, the ineffective rate was 13.33%, and the total effective rate was 86.67%. In the control group, the cure rate was 6.45%, the significant efficacy rate was 6.45%, the effective rate was 32.36%, the ineffective rate was 54.84%, and the total effective rate was 45.16%. The total effective rate in the treatment group was significantly higher than that in the control group (P<0.05).

[0214] Table 7 Comparison of overall therapeutic effects after intervention

[0215]

[0216] Note: P<0.05, P<0.01, compared with the control group.

[0217] 1.9 Scale scoring.

[0218] As shown in Table 8, there were no statistically significant differences between the two groups in the scores of the Self-Rating Depression Scale (SDS), Self-Rating Anxiety Scale (SAS), Health-Promoting Lifestyle Scale (HPLP), and PCOS Patient Quality of Life Scale before treatment (P>0.05, analyzed by ANOVA). After treatment, the differences in scores of the SDS, SAS, and PCOS Patient Quality of Life Scale were significantly lower in the two groups than in the control group (P<0.01), while the difference in HPLP scores was significantly higher in the two groups than in the control group (P<0.01). There were no statistically significant differences in the HPLP scores between the two groups before treatment (P>0.05), but the difference in HPLP scores between the two groups was significantly higher in the two groups after treatment than in the control group (P<0.05).

[0219] Table 8 Comparison of scale scores before and after intervention

[0220]

[0221] Note: P<0.05, P<0.01, compared with the control group.

[0222] 1.10 Correlation analysis of anxiety and depression scale scores with factors such as BMI, acne, and dietary habits.

[0223] Referring to Table 9, the correlation analysis between the Self-Rating Anxiety Scale score and BMI showed a Pearson correlation coefficient of r = 0.241 and P = 0.029 < 0.05, indicating a positive linear correlation between the Self-Rating Anxiety Scale score and BMI. Similarly, the correlation analysis between the Self-Rating Anxiety Scale score and acne score showed a Pearson correlation coefficient of r = 0.246 and P = 0.026 < 0.05, indicating a positive linear correlation. Finally, the correlation analysis between the Self-Rating Depression Scale score and dietary factors showed a Pearson correlation coefficient of r = 0.226 and P = 0.041 < 0.05, indicating a positive linear correlation between the Self-Rating Depression Scale score and the patient's habitual consumption of cold drinks.

[0224] Table 9. Correlation analysis between anxiety and depression scale scores and factors such as BMI, acne, and dietary habits.

[0225]

[0226] Note: P<0.05, P<0.01.

[0227] Therefore, it can be seen that:

[0228] Integrated traditional Chinese and Western medicine behavioral interventions for overweight and obese PCOS, compared to metformin alone, can effectively reduce patients' BMI, insulin resistance, cholesterol, and androgen levels, and improve clinical symptoms such as acne and menstrual cycles. Furthermore, the reduction in BMI is closely related to the restoration of regular menstrual cycles and the improvement of acne and anxiety.

[0229] After treatment, patients who lose more than 10% of their weight can resume 2-3 regular menstrual cycles; while for those who lose more than 5% of their weight, the combined Chinese and Western behavioral intervention treatment is significantly more effective than metformin treatment alone in restoring regular menstruation.

[0230] The combined Chinese and Western behavioral intervention for overweight and obese PCOS improved patients' scores on the health-promoting lifestyle scale and reduced their anxiety and depression scores, thereby significantly improving their quality of life scores.

[0231] Integrated traditional Chinese and Western medicine behavioral intervention can effectively reduce patients' weight and insulin levels, improve ovarian function and acne symptoms, verify the therapeutic effect of behavioral intervention on obese PCOS rats with acne, and preliminarily explore its mechanism of regulating the PI3K / AKT pathway through IGF-1. The following animal experiments will be used to study the specific pathological changes and therapeutic mechanisms in the ovaries and acne tissues.

[0232] Sixty SPF-grade SD rats were divided into six groups: Control group, Model group, Integrated Traditional Chinese and Western Medicine Behavioral Intervention group (ZXJH), Behavioral Intervention group (NZY), Integrated Traditional Chinese and Western Medicine Behavioral Intervention (Metformin-free) group (NMET), and Metformin group (MET). Except for the Control group, the other five groups established an obese rat model of PCOS combined with acne. Figure 7 , Figure 8 , Figure 14 , Figure 15 The letters on the horizontal axis represent the control group, the model group, the integrated traditional Chinese and Western medicine behavioral intervention group (ZXJH), the behavioral intervention group (NZY), the integrated traditional Chinese and Western medicine behavioral intervention (without metformin) group (NMET), and the metformin group (MET), respectively. These will not be elaborated further below.

[0233] In addition to normal feed, the treatment groups were further divided into two groups: the ZXJH group received a traditional Chinese medicine herbal tea and metformin via gavage, plus exercise intervention; the NZY group received metformin via gavage plus exercise intervention; the NMET group received a herbal tea via gavage plus exercise intervention; the MET group received metformin via gavage; and the Control and Model groups received 1.0 mL / (100g) of herbal tea. d) Gavage with physiological saline.

[0234] Drug intervention: The dosage for rats was calculated according to the human-animal drug dosage conversion method. The dosage of traditional Chinese medicine was 5g each of Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Loranthus parasiticus, Dipsacus asper, Lycium barbarum, Ziziphus jujuba, and Cuscuta chinensis, administered by gavage in two divided doses daily at a dose of 26ml / kg of rat body weight. In the metformin group, 270mg / kg was administered by gavage, dissolved in physiological saline to form a 27mg / ml suspension, and administered at a volume of 10ml / kg for 14 consecutive days, once daily.

[0235] Exercise intervention: Referring to Bedford’s animal exercise load standards, moderate-intensity aerobic exercise was selected and trained on a weightless animal experimental treadmill with a 0° incline. The initial speed of aerobic exercise was 15 m / min for 15 min, and the speed and time were increased by 1 m / min and 5 min each day thereafter, until the speed was 20 m / min and the time was 60 min. The intervention was carried out 6 days a week with 1 day of rest.

[0236] Dietary intervention: Normal feed was administered. The integrated traditional Chinese and Western medicine behavioral intervention group received herbal tea and metformin via gavage, combined with normal feed and exercise intervention; the behavioral intervention group received metformin via gavage, combined with normal feed and exercise intervention; the integrated traditional Chinese and Western medicine behavioral intervention (without metformin) group received herbal tea via gavage, combined with normal feed and exercise intervention; the metformin group received metformin via gavage; the blank control group and model group received 1.0 mL / (100g) d) Gavage with physiological saline. Continue gavage for 15 consecutive days.

[0237] The body weight and vaginal exfoliated cells of rats were monitored before and after intervention; sex hormone levels and serum insulin (INS) and insulin-like growth factor 1 (IGF-1) in rats were detected by ELISA; pathological changes in auricle and ovarian tissue were observed by HE staining and Masson staining; and the relative expression levels of IGF-1, insulin-like growth factor 1 receptor (IGF-1R), phosphatidylinositol 3-kinase (PI3K), and protein kinase B (Akt) were detected by Western blot.

[0238] Observation indicators:

[0239] 2.1 Weight measurement and observation of auricular acne phenotype.

[0240] Before daily administration, the body weight of rats in each group was measured using an electronic balance, and the morphological changes of auricular acne (including the number of papules, the degree of redness and swelling, and the formation of pustules) were recorded simultaneously.

[0241] 2.2 Vaginal exfoliated cell detection.

[0242] The morphological changes of exfoliated cells in the vagina of rats were observed for 15 consecutive days to determine the stage of the estrous cycle.

[0243] 2.3 HE staining of rat ovarian and auricular tissues.

[0244] Rat ovary and auricle tissues were paraffin-embedded and sectioned, stained with hematoxylin, dehydrated with graded alcohols, stained with eosin, dewaxed with xylene, dried, and observed and photographed under a light microscope.

[0245] 2.4 Masson staining of rat ovarian and auricular tissues.

[0246] Rat ovarian and auricular tissues were paraffin-embedded and sectioned, and then stained with potassium dichromate, Ponceau S, phosphomolybdic acid, and aniline blue in sequence. After dehydration with anhydrous ethanol, the sections were cleared, mounted, and the images were acquired and analyzed.

[0247] 2.5 Serum sex hormones and INS and IGF-1 levels in rats were detected by ELISA.

[0248] The levels of serum testosterone (T) and estradiol (E2) in rats of each group were detected by enzyme-linked immunosorbent assay (ELISA). The levels of insulin-like growth factor 1 (IGF-1), luteinizing hormone (LH), and follicle-stimulating hormone (FSH) in each group were detected by double-antibody sandwich ELISA. All procedures were performed in accordance with the manufacturer's instructions.

[0249] 2.6 The relative expression levels of IGF-1, IGF-1R, PI3K, and Akt proteins in lesions of ovarian tissue and rat ear tissue were detected by Westen blot.

[0250] Rat ovarian and auricular tissue samples were added to an appropriate amount of prepared protein lysis buffer, and proteins were extracted. The proteins were quantified using the BCA method. After electrophoresis, membrane transfer, and incubation with primary and secondary antibodies, the proteins were detected by enhanced chemiluminescence (ECL).

[0251] Experimental results:

[0252] Establishment of a rat model of obese polycystic ovary syndrome complicated with acne:

[0253] 3.1 Changes in rat body weight.

[0254] See Table 10. Figure 1 Before modeling, there was no statistically significant difference in weight between the Model group and the Control group (P>0.05). After modeling, the weight of the Model group was significantly greater than that of the Control group (P<0.01).

[0255] Table 10 Changes in rat body weight before and after modeling

[0256]

[0257] 3.2 Changes in the estrous cycle of rats.

[0258] See Figure 2 During proestrus, the majority of cells are epithelial, with a small number of keratinized epithelial cells visible (see A). During estrus, the mature epithelial cells slough off, revealing a large number of anucleate, polygonal, keratinized cells accumulating in a "fallen leaf" pattern (see B). During metestrus, all three cell types are visible (see C). During interestrus, vaginal smears under a microscope show a large number of leukocytes and a small number of epithelial cells (see D). Observation of rat vaginal smears showed that the Control group rats had regular ovulation and a complete estrous cycle of approximately 4-5 days. In contrast, the Model group rats remained in the interestrus phase, indicating that they lacked an estrous cycle and did not ovulate.

[0259] 3.3 Changes in the appearance of rat auricular skin.

[0260] See Figure 3 In the A Control group, the normal rats had soft, pale red auricles without skin thickening, sebaceous gland shedding, pustules, or papules. In the B Model group, the rats had significantly thickened capillaries in their ears, with visible papules and pustules, and localized thickening and hardening of the auricle tissue.

[0261] 3.4 HE staining of rat auricle tissue.

[0262] See Figure 4 In the Control group (A), the ear tissue showed a cartilage framework covered by skin on both the inner and outer surfaces. The epidermis and dermis of the skin were intact, and hair follicles and sebaceous glands were scattered in the dermis. The cartilage showed regularly arranged cells with no obvious pathological changes. In the Model group (BD), the skin tissue was uneven in thickness, with localized significant thickening. The epidermis showed mild thickening in small areas (brown arrows), and the epidermal cells were neatly arranged without obvious abnormalities. A small amount of fibroblast proliferation was observed in the dermis (black arrows), and numerous granulomas were formed (yellow arrows). Necrotic foci were also observed in some areas, containing numerous necrotic cell fragments (blue arrows). Inflammatory cell infiltration, mainly composed of lymphomonocytes and macrophages, was also observed (red arrows).

[0263] 3.5 HE staining of rat ovarian tissue.

[0264] See Figure 5In the control group, rats (A) showed follicles at different developmental stages within the ovarian tissue. The follicles were regular in shape, and their number and size were not significantly abnormal. The granulosa cells of the follicles were neatly and tightly arranged, and multiple corpora lutea were visible. No obvious fibrosis or abnormalities were observed in the stroma. In the model group, rats (B) showed numerous cystic follicles with irregular shapes and cavities of varying sizes. The granulosa layer of the follicles was thinned, and the granulosa cells were not neatly arranged (black arrows). There were few developing follicles and corpora lutea. Occasionally, the cavities within the corpora lutea were filled with fluid (yellow arrows). Mature follicles showed irregularly arranged granulosa cells, and the follicular cavity was filled with follicular fluid (blue arrows). Fibrous hyperplasia in the stroma was not obvious.

[0265] Model establishment was successful: 1) The weight gain of rats in the model group was greater than that in the control group, with a statistically significant difference. 2) Vaginal smears of rats after modeling showed predominantly white blood cells, indicating that they were in the interestrous phase and had lost their ovulation function. 3) The capillaries in the ears of rats in the model group were significantly thickened, with papules and pustules visible. The local tissue inside the auricle was thickened and hardened, and HE staining of the auricle tissue showed pathological changes consistent with acne. 4) HE staining of the ovarian tissue in the model group showed obvious polycystic changes, indicating that the model was successfully established.

[0266] 4. Results after intervention and treatment.

[0267] 4.1 Changes in rat body weight after intervention treatment.

[0268] After treatment, the body weight of rats in all groups was significantly lower than that in the Model group (P<0.01). The ZXJH group showed a significantly greater decrease in body weight than the other groups (P<0.05), as shown in Table 11. Furthermore, the NZY group showed a significantly greater decrease in body weight than the NMET and MET groups (P<0.01). There was no significant difference in body weight decrease between the NMET and MET groups (P>0.05).

[0269] Table 11 Changes in rat body weight after intervention

[0270]

[0271] Note: Compared with group ZXJH P<0.05, P<0.01.

[0272] 4.2 Changes in the estrous cycle of rats after intervention and treatment.

[0273] like Figure 6 As shown, the ZXJH group basically recovered regular estrous cycles, the NZY and NMET groups recovered two estrous cycles, and the MET group did not recover estrous cycles.

[0274] 4.3 Changes in serum sex hormone levels in rats after intervention.

[0275] See Table 12. Figure 7 , Figure 7 In the graph, (1) the vertical axis represents the concentration of serum estradiol (E2) (unit: pg / ml), and the horizontal axis represents the group; (2) the vertical axis represents the concentration of serum luteinizing hormone (LH) (unit: mIU / ml), and the horizontal axis represents the group; (3) the vertical axis represents the concentration of serum follicle-stimulating hormone (FSH) (unit: ng / ml), and the horizontal axis represents the group; and (4) the vertical axis represents the concentration of serum testosterone (T) (unit: ng / ml), and the horizontal axis represents the group. Compared with the control group, the T, LH, and E2 values ​​of rats in the Model group were significantly increased, while the FSH value was decreased, and the differences were statistically significant (P<0.01). Compared with the Model group, the T, LH, and E2 values ​​of rats in each treatment group were decreased, while the FSH value was increased, and the differences were statistically significant (P<0.05). The T value in the ZXJH group was lower than that in the other treatment groups, while the FSH value was higher, with statistically significant differences (P<0.05). After treatment, the LH value in the ZXJH group was lower than that in the NMET and MET groups, with statistically significant differences (P<0.05). There were no statistically significant differences in the decrease in T, LH, and E2 values, or the increase in FSH value among the NZY, NMET, and MET groups (P>0.05).

[0276] Table 12 Changes in serum sex hormone levels in rats after intervention treatment

[0277]

[0278] Note: Compared with group ZXJH P<0.05, P<0.01.

[0279] 4.4 Changes in serum INS and IGF-1 levels in rats after intervention.

[0280] See Table 13. Figure 8 , Figure 8In the figure, (1) the vertical axis represents the concentration of serum insulin (INS) (unit: pg / ml) and the horizontal axis represents the group; (2) the vertical axis represents the concentration of serum insulin-like growth factor-1 (IGF-1) (unit: ng / ml) and the horizontal axis represents the group. Compared with the control group, the INS and IGF-1 values ​​of rats in the Model group were significantly increased, and the difference was statistically significant (P<0.01). The INS and IGF-1 values ​​of rats in each treatment group were significantly decreased compared with those in the Model group, and the difference was statistically significant (P<0.01). The IGF-1 value of the ZXJH group was significantly lower than that of the other treatment groups, and the difference was statistically significant (P<0.01). The INS value of the ZXJH group was significantly lower than that of the NMET group and the MET group, and the difference was statistically significant (P<0.01), while the difference between the ZXJH group and the NZY group was not statistically significant (P>0.05). Moreover, the decrease in INS and IGF-1 values ​​in the NZY group was greater than that in the NMET group and the MET group, and the difference was statistically significant (P<0.05). There was no statistically significant difference in the reduction levels of INS and IGF-1 between the NMET and MET groups (P>0.05).

[0281] Table 13 Changes in serum INS and IGF-1 levels in rats after intervention treatment

[0282]

[0283] Note: Compared with group ZXJH P<0.05, P<0.01.

[0284] 4.5 Changes in the appearance of rat auricular skin after intervention treatment.

[0285] See Figure 9 The appearance of the auricular skin of rats in the Control and Model groups is shown in Figures A and B, as described above. Group C (ZXJH group) shows soft, pale red auricular skin with localized thickening of capillaries and small papules at the base of the ear. Group D (NZY group) shows significantly thickened capillaries at the base of the ear compared to Group C, with small papules and localized thickening and hardening of the auricular tissue. Group E (NMET group) shows significantly thickened capillaries at the base of the ear compared to Group C, with papules and pustules, and localized thickening and hardening of the auricular tissue. Group F (MET group) shows significantly thickened capillaries at the base of the ear compared to Group C, with papules and pustules, and localized thickening and hardening of the auricular tissue.

[0286] 4.6 Changes in HE staining of rat auricle tissue after intervention treatment.

[0287] See Figure 10Among them, A is the ZXJH group: the skin tissue in the ear is relatively uniform in thickness, the epidermal structure is clear, the epidermal cells are neatly arranged, and no obvious abnormalities are seen. No obvious fibroblast proliferation is seen in the dermis, and occasional granuloma formation is seen (yellow arrow). Scattered lymphomonocyte infiltration is visible (red arrow), and no other obvious abnormalities are seen. B is the NZY group: the skin tissue in the ear is uneven in thickness, the epidermal structure is clear, the epidermal cells are neatly arranged, and no obvious abnormalities are seen. More fibroblast proliferation is seen in the dermis (black arrow), a small number of granuloma formation is seen (yellow arrow), and a small number of inflammatory cells, mainly lymphomonocytes and macrophages, are seen (red arrow). C is the NMET group: the skin tissue in the ear is uneven in thickness, the epidermal structure is clear, the epidermal cells are neatly arranged, and no obvious abnormalities are seen. A small number of fibroblast proliferation is seen in the dermis (black arrow), a small number of granuloma formation is seen (yellow arrow), and a large number of inflammatory cells, mainly lymphomonocytes and macrophages, are seen (red arrow). D represents the MET group: the thickness of the skin tissue within the tissue is uneven, the epidermal structure is clear, the epidermal cells are arranged neatly, no obvious abnormalities are seen, a small amount of fibroblast proliferation is seen in the dermis (black arrow), a large number of granulomas are seen in the local area (yellow arrow), and a large number of inflammatory cells, mainly lymphomonocytes and macrophages, are seen infiltrating (red arrow).

[0288] 4.7 Changes in Masson staining of rat auricle tissue after intervention treatment.

[0289] See Figure 11 In the figure, AE represent the Masson staining results of rat auricle tissue from the Control group, Model group, ZXJH group, NZY group, NMET group, and MET group, respectively. The blue area represents the positive area (mainly collagen fibers). In the Model group, collagen fibers were disordered and curled. In the intervention groups ZXJH group and NZY group, the collagen fibers were smoother and more regular than those in the NMET group and MET group.

[0290] 4.8 Changes in HE staining of rat ovarian tissue after intervention.

[0291] See Figure 12In the control and model groups, HE staining of ovarian tissue was performed as shown in Figures A and B, respectively, as described above. After intervention, HE staining of ovarian tissue was performed. Figure C represents the ZXJH group. Within the field of view, follicles at different developmental stages were visible in the ovarian tissue. The follicles were regular in shape, with a thick granulosa layer and neatly arranged granulosa cells. Mature follicles were occasionally observed, with neatly arranged granulosa cells. The follicular cavity was filled with follicular fluid. Numerous corpora lutea were observed, but no obvious cystic follicles were seen. No significant fibrosis was observed in the stroma. Figure D represents the NZY group. Within the field of view, fewer follicles were visible in the ovarian tissue. The follicles were regular in shape, with relatively thick granulosa cells and relatively neatly arranged granulosa cells. Numerous corpora lutea were observed, but no obvious cystic follicles were seen. No significant fibrosis was observed in the stroma. Group E (NMET) shows occasional cystic follicles with thinned granulosa layers and irregularly arranged granulosa cells (black arrows). There are numerous developing follicles with thickened granulosa layers and neatly arranged granulosa cells. Mature follicles are occasionally observed with neatly arranged granulosa cells. The follicular cavity is filled with follicular fluid. Numerous corpora lutea are present, and no significant fibrosis is observed in the stroma. Group F (MET) shows few cystic follicles with irregular shapes, thinned granulosa layers, and irregularly arranged granulosa cells (black arrows). There are numerous developing follicles with thickened granulosa layers and neatly arranged granulosa cells. Mature follicles are occasionally observed with irregularly arranged granulosa cells. The follicular cavity is filled with follicular fluid (blue arrows). Numerous corpora lutea are present, and no significant fibrosis is observed in the stroma.

[0292] 4.9 Changes in Masson staining of rat ovarian tissue after intervention.

[0293] Masson staining of rat ovaries in all groups showed that tissue fibrosis was mainly present in the theca membrane, atrophied corpus luteum, and stroma. (See also...) Figure 13 Masson staining results of rat ovarian tissue from the Control, Model, ZXJH, NZY, NMET, and MET groups, respectively. The blue areas represent positive areas (mainly collagen fibers). In the Model group, thickening, wrinkling, and indentation of the zona pellucida were observed, indicating that both the primary and secondary follicles were in an early atresia state. Compared to the Control group, the ZXJH group showed no significant thickening, wrinkling, or indentation of the zona pellucida, and its morphology was superior to the NZY group. The NZY group was superior to both the NMET and MET groups.

[0294] 4.10 Effects of intervention on the expression of IGF-1, IGF-1R, PI3K, and Akt proteins in rat auricle tissue

[0295] Specific reference Figure 14 , Figure 14In (1), the ordinate represents the relative expression level of IGF-1 protein (with β-actin as the internal reference), and the abscissa represents the different groups. In (2), the ordinate represents the relative expression level of Akt protein (with AKT as the internal reference), and the abscissa represents the different groups. In (3), the ordinate represents the relative expression level of PI3K protein (with β-actin as the internal reference), and the abscissa represents the different groups. In (4), the ordinate represents the relative expression level of phosphorylated IGF-1R (p-IGF-1R) protein (with total IGF-1R as the internal reference), and the abscissa represents the different groups. Compared with the Control group, the expression of IGF-1 and IGF-1R proteins in the auricle tissue of rats in the Model group was significantly increased, and the difference was statistically significant (P < 0.01). The expression of PI3K and Akt proteins was significantly decreased, and the difference was statistically significant (P < 0.01). Compared with the Model group, the expression of IGF-1 and IGF-1R proteins in the auricle tissue of rats in all treatment groups was increased, and the differences were statistically significant (P < 0.05), while the relative expression of PI3K and Akt proteins was decreased, and the differences were statistically significant (P < 0.01). The difference in protein expression before and after treatment in the ZXJH group was greater than that in the NZY group, and the NZY group was greater than that in the NMET group and the MET group, and the differences were statistically significant (P < 0.01). There was no statistically significant difference in protein expression levels between the NMET group and the MET group (P > 0.05).

[0296] 4.11 Effects of intervention on the expression of IGF-1, IGF-1R, PI3K, and Akt proteins in rat ovarian tissue.

[0297] Reference Figure 15 , Figure 15In (1), the ordinate represents the relative expression level of IGF-1 protein (with β-actin as the internal reference), and the abscissa represents the different groups. In (2), the ordinate represents the relative expression level of Akt protein (with AKT as the internal reference), and the abscissa represents the different groups. In (3), the ordinate represents the relative expression level of PI3K protein (with β-actin as the internal reference), and the abscissa represents the different groups. In (4), the ordinate represents the relative expression level of phosphorylated IGF-1R (p-IGF-1R) protein (with total IGF-1R as the internal reference), and the abscissa represents the different groups. Compared with the Control group, the expression of IGF-1 and IGF-1R proteins in the ovarian tissue of rats in the Model group was significantly increased, and the difference was statistically significant (P < 0.01). The expression of PI3K and Akt proteins was significantly decreased, and the difference was statistically significant (P < 0.01). Compared with the Model group, the expression of IGF-1 and IGF-1R proteins in the ovarian tissue of rats in all treatment groups was significantly increased (P < 0.05), while the relative expression of PI3K and Akt proteins was significantly decreased (P < 0.01). The difference in protein expression before and after treatment in the ZXJH group was greater than that in the NZY group, and the NZY group was greater than that in the NMET and MET groups, with significant differences (P < 0.01). There was no significant difference in protein expression levels between the NMET and MET groups (P > 0.05).

[0298] After treatment, the body weight of rats in each group was significantly lower than that in the model group (P<0.01). The difference in body weight loss was greater in the ZXJH group than in the NZY group, which in turn was greater in the NMET and MET groups (P<0.05). The ZXJH group showed a near-complete recovery of regular estrous cycles, with a lower T value compared to the other treatment groups (P<0.05). The difference in IGF-1 reduction was greater in the ZXJH group than in the NZY group, which in turn was greater in the NMET and MET groups (P<0.01). HE staining of the auricle tissue of rats in the ZXJH group showed reduced inflammatory cells and fibrosis, while Masson staining revealed smooth and regular collagen fibers. HE staining of the ovarian tissue showed follicles at different developmental stages, with regular follicle morphology, a thick granulosa layer, and neatly arranged granulosa cells; mature follicles were occasionally observed. Masson staining showed no significant thickening, wrinkling, or depression of the zona pellucida. Compared to the model group, the expression of IGF-1 and IGF-1R proteins was decreased in the auricle and ovarian tissue of rats in all treatment groups (P<0.05), while the expression of PI3K and Akt proteins was significantly increased (P<0.01).

[0299] The combined traditional Chinese and Western medicine behavioral intervention can significantly reduce the levels of T and IGF-1 in rats, restore the estrous cycle in rats and improve auricular acne. Its mechanism of action may be to regulate the PI3K / AKT pathway by reducing IGF-1 levels to improve the pathological state of tissues such as ovaries and skin.

[0300] This provides a composition for treating obese PCOS complicated with acne, comprising a traditional Chinese medicine herbal tea and metformin. Administration of this composition to an obese PCOS rat model with acne, combined with exercise intervention, significantly reduced T and IGF-1 levels, restored estrous cycles, and improved auricular acne. Its mechanism of action may involve regulating the PI3K / AKT pathway by reducing IGF-1 levels to improve the pathological state of tissues such as the ovary and skin. The treatment effect in this group was significantly better than that of the traditional Chinese medicine herbal tea, the MET group, or the exercise intervention group alone, indicating that the combination of the traditional Chinese medicine herbal tea and MET will produce a synergistic effect in treating obese PCOS complicated with acne.

[0301] While specific embodiments of the invention have been described in detail by way of examples, those skilled in the art should understand that the examples are for illustrative purposes only and not intended to limit the scope of the invention. Those skilled in the art should understand that modifications can be made to the above embodiments without departing from the scope and spirit of the invention. The scope of the invention is defined by the appended claims.

Claims

1. A pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne, characterized in that, The products include traditional Chinese medicine tea substitutes and metformin. The traditional Chinese medicine tea substitutes include the following raw materials in parts by weight: Codonopsis pilosula 1-15 parts, Poria cocos 1-15 parts, Atractylodes macrocephala 1-15 parts, Taxillus chinensis 1-15 parts, Dipsacus asper 1-15 parts, Lycium barbarum 1-15 parts, Jujube 1-15 parts, and Cuscuta chinensis 1-15 parts. The method for preparing the herbal tea substitute is as follows: Take the following raw materials by weight: Codonopsis pilosula, Poria cocos, Atractylodes macrocephala, Taxillus chinensis, Dipsacus asper, Lycium barbarum, Jujube, and Cuscuta chinensis; Combine the above-mentioned raw materials and place them in a container. Soak them in water for about half an hour, bring to a boil over high heat, then reduce to low heat and simmer for another 20-40 minutes to obtain 600-1000ml of liquid.

2. The pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne according to claim 1, characterized in that, The herbal tea substitute includes the following raw materials in parts by weight: Codonopsis pilosula 5-10 parts, Poria cocos 5-10 parts, Atractylodes macrocephala 5-10 parts, Taxillus chinensis 5-10 parts, Dipsacus asper 5-10 parts, Lycium barbarum 5-10 parts, Jujube 5-10 parts, Cuscuta chinensis 5-10 parts.

3. The pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne according to claim 2, characterized in that, The herbal tea substitute includes the following raw materials in parts by weight: Codonopsis pilosula 5 parts, Poria cocos 5 parts, Atractylodes macrocephala 5 parts, Taxillus chinensis 5 parts, Dipsacus asper 5 parts, Lycium barbarum 5 parts, Jujube 5 parts, Cuscuta chinensis 5 parts.

4. The pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne according to claim 1, characterized in that, The dosage of metformin is 1 mg / kg to 2000 mg / kg.

5. The pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne according to claim 4, characterized in that, The dosage of metformin is 100 mg / kg to 1000 mg / kg.

6. The pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne according to claim 5, characterized in that, The dosage of metformin is 200 mg / kg to 500 mg / kg.

7. The pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne according to claim 6, characterized in that, The dosage of metformin is 270 mg / kg.

8. The pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne according to claim 1, characterized in that, In the composition, the weight ratio of the herbal tea to metformin is (5-50):(1-5).

9. The pharmaceutical composition for treating obese polycystic ovary syndrome complicated with acne according to claim 8, characterized in that, In the composition, the weight ratio of the herbal tea substitute to metformin is (8-20):

1.

10. The pharmaceutical composition according to claim 8 for treating obese polycystic ovary syndrome complicated with acne, characterized in that, In the composition, the weight ratio of the herbal tea to metformin is 520-27.

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