A traditional Chinese medicine compound for treating insulin resistance of polycystic ovary syndrome

Abstract

The application provides a traditional Chinese medicine compound for treating polycystic ovary syndrome insulin resistance, and relates to the technical field of traditional Chinese medicine preparation. In the traditional Chinese medicine compound, gentiana scabra, and sophora flavescens are used as monarch drugs, scrophularia ningpoensis, sophora flavescens, smilax glabra, and radix rehmanniae are used as ministerial drugs, and then, humulus scandens, plantago, angelica sinensis, taraxacum, lycopus virginicus, luffa, chihkiu, and curcuma zedoary are used as auxiliary drugs. The whole prescription is used for clearing heat and drying dampness, purging fire and nourishing yin, and promoting dampness and dredging collaterals, and is suitable for treating polycystic ovary syndrome insulin resistance of the liver meridian damp-heat type.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine manufacturing technology, specifically to a traditional Chinese medicine compound for treating insulin resistance in polycystic ovary syndrome. Background Technology

[0002] Polycystic ovary syndrome (PCOS) is an endocrine and metabolic disorder that affects women's physical and mental health. Its global incidence rate is 5% to 18%, and the rate continues to rise. PCOS not only causes female infertility but is also closely related to metabolic abnormalities such as obesity, insulin resistance (IR), type 2 diabetes, and cardiovascular disease. IR refers to a state of decreased insulin sensitivity and / or decreased insulin responsiveness, and is considered one of the core components of the pathogenesis of PCOS. Studies show that approximately 50% to 70% of PCOS patients have IR. PCOS-IR patients often present clinically with ovulation disorders, irregular menstruation, low fertility, hyperandrogenemia, and metabolic dysfunction. Currently, PCOS treatment is mainly symptomatic and requires long-term health management. PCOS treatment based on improving IR includes lifestyle interventions, insulin sensitizers, and metabolic supplements. Lifestyle interventions are an important part of the treatment strategy, but patient adherence is often poor. While short-acting contraceptives and insulin sensitizers can improve the clinical symptoms of PCOS-IR to some extent, long-term use has many adverse reactions, and symptoms are prone to relapse after discontinuation. Traditional Chinese medicine believes that PCOS... This condition falls under the categories of "delayed menstruation," "amenorrhea," and "infertility," and its pathogenesis is closely related to dysfunction of the liver, spleen, and kidneys, as well as pathological products such as blood stasis, dampness, and phlegm. Multiple studies have found that traditional Chinese medicine methods have ideal effects in treating PCOS-IR and reducing adverse reactions. Based on the etiology, pathogenesis, and clinical manifestations of PCOS-IR, this invention innovatively provides a traditional Chinese medicine compound for the treatment of PCOS-IR, hoping to offer new ideas and solutions for the clinical diagnosis and treatment of PCOS-IR. Summary of the Invention

[0003] (a) Technical problems to be solved

[0004] To address the shortcomings of existing technologies, this invention provides a traditional Chinese medicine compound for treating insulin resistance in polycystic ovary syndrome.

[0005] (II) Technical Solution

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] This invention provides a traditional Chinese medicine compound for treating insulin resistance in polycystic ovary syndrome. The compound consists of the following herbs by weight: Scutellaria baicalensis 5-20g, Gardenia jasminoides 5-25g, Tetrapanax papyriferus 5-20g, Bupleurum chinense (processed with vinegar) 5-25g, Curcuma longa 5-25g, Angelica sinensis 5-25g, Rehmannia glutinosa 5-25g, Vaccaria segetalis 20-40g, Liquidambar formosana 10-30g, Luffa cylindrica 20-40g, Smilax glabra 20-40g, Plantago asiatica 20-40g, Gentiana scabra 5-25g, and Sophora flavescens 20-40g.

[0008] Preferably, the traditional Chinese medicine compound is composed of the following medicinal materials by weight: Scutellaria baicalensis 5-15g, Gardenia jasminoides 10-20g, Tetrapanax papyriferus 5-15g, Bupleurum chinense (processed with vinegar) 10-20g, Curcuma longa 10-20g, Angelica sinensis 10-20g, Rehmannia glutinosa 10-20g, Vaccaria segetalis 25-35g, Liquidambar formosana 15-25g, Luffa cylindrica 25-35g, Smilax glabra 25-35g, Plantago asiatica 25-35g, Gentiana scabra 10-20g, and Sophora flavescens 25-35g.

[0009] Preferably, the traditional Chinese medicine compound is composed of the following Chinese medicinal materials by weight: Scutellaria baicalensis 9g, Gardenia jasminoides 15g, Tetrapanax papyriferus 9g, Bupleurum chinense (processed with vinegar) 15g, Curcuma longa 15g, Angelica sinensis 15g, Rehmannia glutinosa 12g, Vaccaria segetalis 30g, Liquidambar formosana 20g, Luffa cylindrica 30g, Smilax glabra 30g, Plantago asiatica 30g, Gentiana scabra 15g, and Sophora flavescens 30g.

[0010] The traditional Chinese medicine compound provided by this invention is used to prepare a drug for treating insulin resistance in polycystic ovary syndrome. The drug is made from the above-mentioned weight of traditional Chinese medicinal materials as raw materials, supplemented with pharmaceutically acceptable excipients, and prepared into any one of oral liquid, granules, powder, tablets, capsules, pills, and decoctions.

[0011] All Chinese medicinal materials used in the compound Chinese medicine formula of this invention are processed in accordance with the requirements of the Chinese Pharmacopoeia or traditional Chinese medicine techniques.

[0012] In this traditional Chinese medicine compound formula, Gentiana scabra, being extremely bitter and cold, clears and drains excess heat in the liver and gallbladder, clearing heat and drying dampness, serving as the principal herb for clearing heat and promoting diuresis in the liver and gallbladder; Sophora flavescens, being bitter, cold, and descending, clears heat and dries dampness, promotes diuresis and detoxifies, specifically clearing damp-heat in the lower burner. These two herbs together serve as the principal herbs, working synergistically to clear damp-heat, drain liver fire, and detoxify. Scutellaria baicalensis clears heat and dries dampness, drains fire and detoxifies; Gardenia jasminoides clears and drains fire evil in the triple burner, cools the blood and promotes diuresis, guiding heat downwards; Smilax glabra, being sweet, bland, and neutral, detoxifies and eliminates dampness, specifically clearing damp-heat in the lower burner. These three herbs together assist the principal herbs in enhancing the overall formula's effects of clearing heat, draining fire, promoting diuresis, and detoxifying. Since most of the principal and assistant herbs in the formula are bitter, cold, and drying, they can easily deplete yin fluids. Combined with Rehmannia glutinosa, which clears heat, cools the blood, nourishes yin, and generates fluids, the entire formula clears heat without harming yin, and eliminates pathogens without harming the body's vital energy. These four herbs together serve as assistant herbs. Tetrapanax papyriferus and Plantago asiatica clear heat and dampness, promote urination and relieve strangury, guiding damp-heat out through urination; Vinegar-processed Bupleurum chinense and Curcuma longa soothe the liver and relieve depression, regulate qi and relieve pain, guiding the medicine to the liver and gallbladder meridians; Angelica sinensis invigorates blood and nourishes blood, promoting blood circulation without harming it; Vaccaria segetalis, Liquidambar formosana, and Luffa cylindrica unblock the meridians, promote urination and dissipate stagnation; The combined effects of these herbs assist the principal and assistant herbs in clearing heat and removing dampness, while simultaneously regulating qi and blood, soothing the liver and relieving depression, and unblocking the meridians and regulating menstruation, achieving the balance of qi, blood, dampness, and meridians, all acting as adjuvant herbs. The entire formula simultaneously clears heat and dries dampness, purges fire and nourishes yin, and promotes diuresis and unblocks the meridians, making it suitable for the treatment of polycystic ovary syndrome with insulin resistance due to damp-heat in the liver meridian.

[0013] The therapeutic effects of the traditional Chinese medicine compound of this invention on polycystic ovary syndrome complicated with insulin resistance are reflected in the following aspects:

[0014] 1. The traditional Chinese medicine compound of this invention can significantly reduce the levels of LH, FSH, T, TG, TC, FBG, FINS and HOMA-IR in rats with polycystic ovary syndrome and insulin resistance. By improving sex hormones and regulating glucose and lipid metabolism, it improves insulin resistance and achieves the treatment of polycystic ovary syndrome with insulin resistance.

[0015] 2. The traditional Chinese medicine compound of this invention can effectively regulate the sex hormone levels, blood glucose and lipid levels in patients with PCOS complicated by insulin resistance due to damp-heat in the liver meridian, improve insulin sensitivity and clinical symptoms, and has significant efficacy and high safety in patients with PCOS complicated by insulin resistance. This traditional Chinese medicine compound can be further promoted and applied clinically as a drug for treating polycystic ovary syndrome complicated by insulin resistance. Detailed Implementation

[0016] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0017] Example 1

[0018] A traditional Chinese medicine compound for treating insulin resistance in polycystic ovary syndrome, the compound consisting of the following Chinese medicinal materials by weight: Scutellaria baicalensis 5g, Gardenia jasminoides 5g, Tetrapanax papyriferus 5g, Bupleurum chinense (processed with vinegar) 5g, Curcuma longa 5g, Angelica sinensis 5g, Rehmannia glutinosa 5g, Vaccaria segetalis 20g, Liquidambar formosana 10g, Luffa cylindrica 20g, Smilax glabra 20g, Plantago asiatica 20g, Gentiana scabra 5g, Sophora flavescens 20g.

[0019] The traditional Chinese medicine compound provided by this invention is used to prepare a drug for treating insulin resistance in polycystic ovary syndrome. The drug is made from the above-mentioned weight of traditional Chinese medicinal materials as raw materials, supplemented with pharmaceutically acceptable excipients, and prepared into any one of oral liquid, granules, powder, tablets, capsules, pills, and decoctions.

[0020] All Chinese medicinal materials used in the compound herbal formula of this invention are processed in accordance with the provisions of the Chinese Pharmacopoeia.

[0021] Example 2

[0022] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound for treating insulin resistance in polycystic ovary syndrome is composed of the following Chinese medicinal materials by weight: Scutellaria baicalensis 20g, Gardenia jasminoides 25g, Tetrapanax papyriferus 20g, Bupleurum chinense (processed with vinegar) 25g, Curcuma longa 25g, Angelica sinensis 25g, Rehmannia glutinosa 25g, Vaccaria segetalis 40g, Liquidambar formosana 30g, Luffa cylindrica 40g, Smilax glabra 40g, Plantago asiatica 40g, Gentiana scabra 25g, and Sophora flavescens 40g.

[0023] Example 3

[0024] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound for treating insulin resistance in polycystic ovary syndrome is composed of the following Chinese medicinal materials by weight: Scutellaria baicalensis 16g, Gardenia jasminoides 22g, Tetrapanax papyriferus 18g, Bupleurum chinense (processed with vinegar) 21g, Curcuma longa 22g, Angelica sinensis 24g, Rehmannia glutinosa 22g, Vaccaria segetalis 36g, Liquidambar formosana 28g, Luffa cylindrica 36g, Smilax glabra 38g, Plantago asiatica 36g, Gentiana scabra 22g, and Sophora flavescens 38g.

[0025] Example 4

[0026] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound for treating insulin resistance in polycystic ovary syndrome is composed of the following Chinese medicinal materials by weight: Scutellaria baicalensis 5g, Gardenia jasminoides 10g, Tetrapanax papyriferus 5g, Bupleurum chinense (processed with vinegar) 10g, Curcuma longa 10g, Angelica sinensis 10g, Rehmannia glutinosa 10g, Vaccaria segetalis 25g, Liquidambar formosana 15g, Luffa cylindrica 25g, Smilax glabra 25g, Plantago asiatica 25g, Gentiana scabra 10g, and Sophora flavescens 25g.

[0027] Example 5

[0028] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound for treating insulin resistance in polycystic ovary syndrome is composed of the following Chinese medicinal materials by weight: Scutellaria baicalensis 15g, Gardenia jasminoides 20g, Tetrapanax papyriferus 15g, Bupleurum chinense (processed with vinegar) 20g, Curcuma longa 20g, Angelica sinensis 20g, Rehmannia glutinosa 20g, Vaccaria segetalis 35g, Liquidambar formosana 25g, Luffa cylindrica 35g, Smilax glabra 35g, Plantago asiatica 35g, Gentiana scabra 20g, and Sophora flavescens 35g.

[0029] Example 6

[0030] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound for treating insulin resistance in polycystic ovary syndrome is composed of the following Chinese medicinal materials by weight: Scutellaria baicalensis 7g, Gardenia jasminoides 12g, Tetrapanax papyriferus 7g, Bupleurum chinense (processed with vinegar) 12g, Curcuma longa 12g, Angelica sinensis 12g, Rehmannia glutinosa 10g, Vaccaria segetalis 26g, Liquidambar formosana 18g, Luffa cylindrica 28g, Smilax glabra 26g, Plantago asiatica 28g, Gentiana scabra 12g, and Sophora flavescens 26g.

[0031] Example 7

[0032] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound for treating insulin resistance in polycystic ovary syndrome is composed of the following Chinese medicinal materials by weight: Scutellaria baicalensis 12g, Gardenia jasminoides 18g, Tetrapanax papyriferus 12g, Bupleurum chinense (processed with vinegar) 18g, Curcuma longa 18g, Angelica sinensis 18g, Rehmannia glutinosa 15g, Vaccaria segetalis 33g, Liquidambar formosana 22g, Luffa cylindrica 33g, Smilax glabra 32g, Plantago asiatica 32g, Gentiana scabra 18g, and Sophora flavescens 32g.

[0033] Example 8

[0034] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound for treating insulin resistance in polycystic ovary syndrome is composed of the following Chinese medicinal materials by weight: Scutellaria baicalensis 9g, Gardenia jasminoides 15g, Tetrapanax papyriferus 9g, Bupleurum chinense (processed with vinegar) 15g, Curcuma longa 15g, Angelica sinensis 15g, Rehmannia glutinosa 12g, Vaccaria segetalis 30g, Liquidambar formosana 20g, Luffa cylindrica 30g, Smilax glabra 30g, Plantago asiatica 30g, Gentiana scabra 15g, and Sophora flavescens 30g.

[0035] Experimental Example

[0036] Effects of the traditional Chinese medicine compound of this invention on a rat model of polycystic ovary syndrome with insulin resistance

[0037] 1. Materials and Methods

[0038] 1.1 Laboratory Animals

[0039] Fifty-four SPF-grade 6-8 week old female SD rats, weighing 180-220g, were selected. All rats were acclimatized for one week before the experiment.

[0040] 1.2 Experimental Drugs

[0041] Traditional Chinese Medicine Compound Decoction: Scutellaria baicalensis 9g, Gardenia jasminoides 15g, Tetrapanax papyriferus 9g, Bupleurum chinense (processed with vinegar) 15g, Curcuma longa 15g, Angelica sinensis 15g, Rehmannia glutinosa 12g, Vaccaria segetalis 30g, Liquidambar formosana 20g, Luffa cylindrica 30g, Smilax glabra 30g, Plantago asiatica 30g, Gentiana scabra 15g, Sophora flavescens 30g. Weigh each herb according to the above weights, wash them, and soak them in 8 times their weight of water for 20 minutes. Then bring to a boil over high heat, simmer over low heat for 40 minutes, filter, and take the filtrate. Add 6 times their weight of water to the dregs, bring to a boil over high heat, simmer over low heat for 30 minutes, filter, combine the two filtrates, and concentrate under reduced pressure to a drug concentration of 1g / mL (each milliliter contains 1g of raw herb). Refrigerate for later use and prepare as needed.

[0042] Positive control drug: Metformin hydrochloride tablets, 0.5g / tablet.

[0043] 1.3 Establishment of a PCOS-IR rat model

[0044] Fifty-four rats were acclimatized for 7 days, and 11 were randomly selected as the control group, while the remaining 43 were selected as the model group. Rats were weighed and their weight recorded on the same day and at the same time each week. The model group was fed a high-fat diet combined with letrozole (1 mg / kg) dissolved in 1% carboxymethyl cellulose solution via gavage, while the control group was fed a normal diet and gavage with 1% carboxymethyl cellulose solution (4 mL / kg) for 21 consecutive days. After modeling, all rats were fasted for 12 hours, and serum fasting blood glucose (FBG) was measured the following morning. FINS levels were measured using ELISA, and HOMA-IR was calculated. One rat from the control group and three rats from the model group were randomly selected. After anesthesia, both ovaries were removed for observation of their appearance and morphology. The ovaries were then fixed, sectioned, and stained with hematoxylin and eosin (HE) to observe morphological changes. If the ovaries of the model group showed polycystic changes, significant weight gain, and IR, the modeling was considered successful.

[0045] 1.4 Grouping and Processing

[0046] The remaining 40 rats after successful modeling were randomly divided into four groups: model group, positive control group, low-dose traditional Chinese medicine compound group, and high-dose traditional Chinese medicine compound group, with 10 rats in each group. The positive control group was given metformin hydrochloride tablets 0.25 g / kg by gavage. The low-dose and high-dose traditional Chinese medicine compound groups were given the traditional Chinese medicine compound of this invention at 13.31 g / kg and 26.65 g / kg (calculated based on the amount of raw herbs), respectively, by gavage. The model group and the blank group were given an equal volume of physiological saline by gavage. All groups were administered the drugs once daily for 4 consecutive weeks.

[0047] 1.5 Observation Indicators

[0048] 1.5.1 Rat body weight recording

[0049] The body weight of rats in each group was measured and recorded before modeling, and at 7, 14, 21 and 28 days after modeling and administration of the drug.

[0050] 1.5.2 Detection of serum biochemical indicators, glucose metabolism indicators, and sex hormone indicators in rats

[0051] After administration, rats were fasted for 24 hours. Then, each group of rats was anesthetized with 3% sodium pentobarbital, and blood was collected from the abdominal aorta. The blood was centrifuged, and the serum was separated. Various biochemical indicators (LH, FSH, T, TG, TC) were detected using a fully automated biochemical analyzer. Fasting blood glucose levels were detected by a blood glucose meter, and insulin resistance index (HOMA-IR) was detected by an ELISA kit.

[0052] HOMA-IR = FBG × FINS / 22.5

[0053] 1.5.3 Evaluation of ovarian-related indicators and ovarian histopathology in rats

[0054] After drug administration, the mice were fasted for 24 hours before being harvested. The ovaries on both sides of the uterus were dissected and cleaned. The long axis (L) and short axis (S) of the ovaries were measured using calipers, and the maximum cross-sectional area and volume of the ovaries were calculated. The ovarian mass was weighed using a balance, and the ovarian index (average ovarian mass / rat body mass × 10) was calculated. -3 ), and record it.

[0055] The left ovary of a rat was harvested, adhering connective tissue was removed, and the tissue was fixed in 4% formaldehyde buffer. Then, it was dehydrated, embedded in paraffin, sectioned, stained with hematoxylin and eosin (HE), and photographed under a biological microscope to observe the pathological changes of the rat ovarian tissue.

[0056] 1.6 Statistical Analysis

[0057] Statistical analysis was performed using SPSS 26.0 software (SPSS IBM Inc., Chicago, IL, USA). Data are presented as mean ± standard deviation. Mean ± standard deviation (S) indicates the statistical significance of the results. One-way ANOVA was used. If there were significant differences between groups, the SNK method was used for pairwise post-hoc comparisons between groups. P < 0.05 was considered statistically significant.

[0058] 2 Results

[0059] 2.1 Changes in body weight of rats in each group

[0060] Before modeling, there was no statistically significant difference in body weight among the groups (P>0.05). After modeling, compared with the control group, the body weight of rats in each group increased significantly (P<0.05). After 28 days of drug administration, compared with before drug administration, the body weight of rats in each drug administration group decreased to varying degrees. Among them, the body weight of rats in the positive control group and the high-dose group was significantly lower than that of the model group (P<0.05). The results are shown in Table 1.

[0061] Table 1. Body weight (g) of rats in each group

[0062] Note: In peer data, compared with the blank group, # P<0.05; *P<0.05 compared with the model group.

[0063] 2.2 Serum biochemical indicators and glucose metabolism indicators of rats in each group

[0064] As shown in Tables 2 and 3, compared with the control group, the serum levels of LH, FSH, T, TG, and TC in the model group rats were significantly increased (P<0.05, P<0.01). Compared with the model group, the serum levels of LH, FSH, T, TG, and TC in each treatment group rats were significantly decreased (P<0.05, P<0.01), with the low-dose and high-dose groups showing significantly lower serum levels of LH, FSH, T, TG, and TC than the model group (P<0.05, P<0.01).

[0065] Table 2 Serum LH, FSH, and T levels in rats of each group

[0066]

[0067] Note: Compared with the blank group, # P<0.05, ## P<0.01; compared with the model group, *P<0.05, **P<0.01.

[0068] Table 3 Serum TG, TC, and other indicators in each group of rats

[0069]

[0070] Note: Compared with the blank group, # P<0.05; *P<0.05 compared with the model group.

[0071] As shown in Table 4, compared with the blank group, the serum FBG and FINS levels in the model group were significantly increased (P<0.01), and the HOMA-IR was significantly elevated (P<0.01). Compared with the model group, the serum FBG and FINS levels in each drug-treated group were significantly decreased (P<0.01), and the HOMA-IR was significantly reduced (P<0.01).

[0072] Table 4. Serum FBG, FINS levels and HOMA-IR in rats of each group

[0073]

[0074] Note: Compared with the blank group, # P<0.05, ## P<0.01; compared with the model group, *P<0.05, **P<0.01.

[0075] 2.3 Ovarian tissue indices and pathological changes in each group of rats

[0076] As shown in Table 5, compared with the control group, the model group rats showed significantly increased maximum ovarian cross-sectional area, ovarian volume, and ovarian index (P<0.05, P<0.01). Compared with the model group, the drug-treated groups showed significantly decreased maximum ovarian cross-sectional area, ovarian volume, and ovarian index (while the maximum ovarian cross-sectional area, ovarian volume, and ovarian index were all significantly increased).

[0077] Table 5. Ovarian tissue indices of rats in each group

[0078] Note: Compared with the blank group, # P<0.05, ## P<0.01; compared with the model group, *P<0.05, **P<0.01.

[0079] 3. Conclusion

[0080] Based on the above results, this experiment successfully established a rat model of polycystic ovary syndrome (PCOS) complicated with insulin resistance. The model rats exhibited typical symptoms including significant weight gain, a marked increase in the maximum cross-sectional area of ​​the ovary, ovarian volume, and ovarian index. After administration of the traditional Chinese medicine compound of this invention, all ovarian indicators in the model rats significantly decreased. Simultaneously, the traditional Chinese medicine compound of this invention significantly reduced the levels of LH, FSH, T, TG, TC, FBG, FINS, and HOMA-IR in the model rats, achieving the effects of improving sex hormones, regulating glucose and lipid metabolism, and improving insulin resistance. These experimental results provide theoretical support for the use of the traditional Chinese medicine compound of this invention in the treatment of PCOS complicated with insulin resistance.

[0081] Application examples

[0082] Clinical observation of the efficacy of the traditional Chinese medicine compound of this invention in polycystic ovary syndrome complicated with insulin resistance

[0083] 1. Materials and Methods

[0084] 1.1 General Information

[0085] Eighty-four patients with polycystic ovary syndrome and insulin resistance admitted to our hospital from January 2024 to December 2025 were selected and randomly divided into an observation group and a control group, with 42 patients in each group. There were no significant differences in general characteristics between the two groups (P>0.05), making them comparable. See Table 1.

[0086] Table 1 General information of the two groups of patients

[0087]

[0088] 1.2 Diagnostic criteria

[0089] Western medicine diagnostic criteria: (1) PCOS meets the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Polycystic Ovary Syndrome, with oligomenorrhea, amenorrhea, or irregular uterus, and also meets one of the following two criteria: ① clinical manifestations of hyperandrogenism or hyperandrogenemia; ② ultrasound findings of polycystic ovarian morphology (PCOM). And other diseases that may cause hyperandrogenism and ovulation abnormalities are excluded one by one; (2) Insulin resistance index (HOMA-IR) ≥ 2.0; abnormal insulin release curve after glucose load.

[0090] Traditional Chinese Medicine Diagnostic Criteria: Based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines," the diagnosis is damp-heat syndrome of the liver meridian, with the following symptoms: menstrual irregularities, heavy or prolonged bleeding, delayed menstruation, scanty menstruation, infertility after prolonged marriage, yellow and profuse vaginal discharge, thick hair, facial acne, premenstrual chest, rib, and breast distension and pain, and dry stools. The tongue is red with a yellow and greasy coating, and the pulse is wiry and rapid.

[0091] 1.3 Inclusion Criteria

[0092] Meets the diagnostic criteria; is 18 years of age or older; has normal cardiopulmonary, liver and kidney function; has no recent desire to conceive; and can actively cooperate with medication and complete various clinical indicator tests.

[0093] 1.4 Exclusion Criteria

[0094] Patients with other endocrine disorders; those who have taken hormones, lipid-lowering drugs, or hypoglycemic drugs within 3 months prior to treatment; those who are allergic to or have contraindications to the study drug; and those with serious primary diseases of the heart, liver, kidneys, or other organs, or mental illnesses.

[0095] 1.5 Treatment Methods

[0096] Both groups of patients received dietary and exercise guidance. Dietary guidance focused on modifying dietary structure and controlling intake, avoiding high-sugar and high-fat foods, and prohibiting fried foods and fast food. Exercise guidance required at least 30 minutes of aerobic exercise daily.

[0097] Control group: Administered metformin hydrochloride tablets, 0.5g each time, three times daily; ethinylestradiol / cyproterone acetate tablets, 2mg / tablet, starting from day 5 of menstruation, one tablet daily for 21 consecutive days, until day 5 of withdrawal bleeding, at which point a new 21-day treatment cycle begins. Treatment lasted for 3 cycles.

[0098] Treatment group: In addition to the treatment given to the control group, the treatment group was given the compound decoction of traditional Chinese medicine of this invention. The formula consists of: Scutellaria baicalensis 9g, Gardenia jasminoides 15g, Tetrapanax papyriferus 9g, Bupleurum chinense (processed with vinegar) 15g, Curcuma longa 15g, Angelica sinensis 15g, Rehmannia glutinosa 12g, Vaccaria segetalis 30g, Liquidambar formosana 20g, Luffa cylindrica 30g, Smilax glabra 30g, Plantago asiatica 30g, Gentiana scabra 15g, and Sophora flavescens 30g. The decoction was prepared according to conventional methods, and 400mL of the decoction was taken. 200mL was taken after breakfast and dinner each day, one dose per day, for three cycles of treatment.

[0099] 1.6 Observation Indicators

[0100] 1.6.1 Hormone and Glucose / Lipid Metabolism Indicators

[0101] Venous blood was collected before treatment and on the third day of the next menstrual cycle after treatment. The levels of FSH, LH, T hormones, as well as FINS, FBG, TG, and TC in both groups of patients were measured, and HOMA-IR was calculated.

[0102] 1.6.2 Traditional Chinese Medicine Symptom Scores

[0103] The TCM syndromes of the two groups of patients were scored before and after treatment.

[0104] Menstrual cycle: 21-35 days, 0 points; 36-45 days, 2 points; 46-89 days, 4 points; 90 days or more, 6 points;

[0105] Obesity: BMI ≤ 18.5 kg / m2, score 0; 18.5 kg / m2, score 0. 2 <BMI≤24 kg / m 2 2 points; 24 kg / m 2 <BMI≤28 kg / m 2 4 points; BMI ≥ 28 kg / m 2 6 points.

[0106] Secondary symptoms: thick hair, facial acne, premenstrual chest and breast tenderness, yellow and copious vaginal discharge, and constipation. Symptoms are scored as follows: none, mild, moderate, and severe, with scores of 0, 1, 2, and 3 respectively. The higher the total score, the more severe the symptoms.

[0107] 1.6.3 Clinical efficacy

[0108] The efficacy of the two groups of patients was evaluated according to the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine" after treatment.

[0109] Cure: Symptoms disappear, menstruation returns to normal, and relevant laboratory indicators return to normal;

[0110] Significant effect: menstrual cycle is significantly improved, other clinical symptoms are significantly improved, and related laboratory indicators are basically at normal levels;

[0111] Effective: Improved menstrual status, reduced other clinical symptoms, and some improvement in relevant laboratory indicators, but not reaching the target level;

[0112] Ineffective: No improvement or even worsening of clinical symptoms, menstrual status, or laboratory indicators.

[0113] Overall effective rate = cure rate + significant effect rate + effective rate.

[0114] 1.6.4 Incidence of adverse reactions

[0115] The incidence of adverse reactions such as dry mouth, gastrointestinal reactions, and rashes was statistically analyzed and compared between the two groups of patients.

[0116] 1.6.7 Statistical Analysis

[0117] Statistical analysis was performed using SPSS 26.0 (SPSS IBM Inc., Chicago, IL, USA). Quantitative data are expressed as mean ± standard deviation. Data are expressed as mean ± standard deviation (±s). One-way ANOVA was used. If there were significant differences between groups, the SNK method was used for pairwise post-hoc comparisons between groups. Count data are expressed as percentages and expressed using the χ² method. 2 The test was used to compare between groups. P < 0.05 was considered statistically significant.

[0118] 2 Results

[0119] 2.1 Comparison of sex hormone levels between the two groups of patients

[0120] Before treatment, there were no statistically significant differences in FSH, LH, and T levels between the two groups. Compared with before treatment, the levels of FSH, LH, and T in both groups decreased significantly after treatment (P<0.05); among them, the LH and T levels in the observation group were significantly lower than those in the control group after treatment (P<0.05). The results are shown in Table 6.

[0121] Table 6 Comparison of sex hormone levels between the two groups of patients

[0122]

[0123] Note: Within both groups, *P<0.05 compared to before treatment; after treatment, compared to the control group, # P<0.05.

[0124] 2.2 Comparison of glucose and lipid metabolism levels between the two groups of patients

[0125] Before treatment, there were no statistically significant differences in FINS, FBG, TG, TC, and HOMA-IR levels between the two groups. Compared with pre-treatment levels, FINS, FBG, TG, TC, and HOMA-IR levels in both groups decreased significantly after treatment (P<0.05); among them, the levels of FINS, FBG, TG, TC, and HOMA-IR in the observation group were significantly lower than those in the control group after treatment (P<0.05). The results are shown in Table 7.

[0126] Table 7 Comparison of glucose and lipid metabolism levels between the two groups of patients

[0127] Note: Within both groups, *P<0.05 compared to before treatment; after treatment, compared to the control group, # P<0.05.

[0128] 2.3 Comparison of TCM syndrome scores between the two groups of patients

[0129] Before treatment, there was no statistically significant difference in TCM syndrome scores between the two groups. Compared with before treatment, the TCM syndrome scores of both groups decreased significantly after treatment (P<0.05); among them, the TCM syndrome score of the observation group was significantly lower than that of the control group after treatment (P<0.05). The results are shown in Table 8.

[0130] Table 8 Comparison of TCM syndrome scores between the two groups of patients

[0131]

[0132] 2.4 Comparison of clinical efficacy between the two groups

[0133] The total effective rate of treatment in the observation group was 95.24%, while that in the control group was 80.95%. The total effective rate of treatment in the observation group was significantly higher than that in the control group, and the difference was statistically significant (P<0.05).

[0134] Table 9 Comparison of clinical efficacy between the two groups [n (%)]

[0135] 3. Conclusion

[0136] The traditional Chinese medicine compound of this invention has significant therapeutic effects on patients with PCOS complicated with insulin resistance due to damp-heat in the liver meridian. It can effectively regulate sex hormone levels, improve insulin sensitivity, regulate blood glucose and lipid metabolism, and improve patients' clinical symptoms. It is safe and effective for patients. The traditional Chinese medicine compound of this invention can be further promoted and applied in clinical practice as a drug for the treatment of polycystic ovary syndrome complicated with insulin resistance.

[0137] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine compound for treating insulin resistance in polycystic ovary syndrome, characterized in that, The herbal compound is composed of the following herbs by weight: Scutellaria baicalensis 5-20g, Gardenia jasminoides 5-25g, Tetrapanax papyriferus 5-20g, Bupleurum chinense (processed with vinegar) 5-25g, Curcuma longa 5-25g, Angelica sinensis 5-25g, Rehmannia glutinosa 5-25g, Vaccaria segetalis 20-40g, Liquidambar formosana 10-30g, Luffa cylindrica 20-40g, Smilax glabra 20-40g, Plantago asiatica 20-40g, Gentiana scabra 5-25g, and Sophora flavescens 20-40g.

2. A traditional Chinese medicine compound for treating insulin resistance in polycystic ovary syndrome as described in claim 1, wherein the traditional Chinese medicine compound is composed of the following medicinal materials by weight: Scutellaria baicalensis 5-15g, Gardenia jasminoides 10-20g, Tetrapanax papyriferus 5-15g, Bupleurum chinense (processed with vinegar) 10-20g, Curcuma longa 10-20g, Angelica sinensis 10-20g, Rehmannia glutinosa 10-20g, Vaccaria segetalis 25-35g, Liquidambar formosana 15-25g, Luffa cylindrica 25-35g, Smilax glabra 25-35g, Plantago asiatica 25-35g, Gentiana scabra 10-20g, Sophora flavescens 25-35g.

3. A traditional Chinese medicine compound for treating insulin resistance in polycystic ovary syndrome as described in claim 1, wherein the traditional Chinese medicine compound is composed of the following medicinal materials by weight: Scutellaria baicalensis 9g, Gardenia jasminoides 15g, Tetrapanax papyriferus 9g, Bupleurum chinense (processed with vinegar) 15g, Curcuma longa 15g, Angelica sinensis 15g, Rehmannia glutinosa 12g, Vaccaria segetalis 30g, Liquidambar formosana 20g, Luffa cylindrica 30g, Smilax glabra 30g, Plantago asiatica 30g, Gentiana scabra 15g, Sophora flavescens 30g.

4. The use of the traditional Chinese medicine compound according to any one of claims 1 to 3 in the preparation of a medicament for treating insulin resistance in polycystic ovary syndrome, characterized in that, The drug is made from the above-mentioned weight of Chinese medicinal materials as raw materials, supplemented with pharmaceutically acceptable excipients, and prepared into any one of the following: oral liquid, granules, powder, tablets, capsules, pills, and decoction.

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