Traditional Chinese medicine composition for treating puberty insulin resistance type polycystic ovarian syndrome with acne as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating adolescent insulin resistance type polycystic ovarian syndrome with acne as well as a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following raw materials: 3-10 parts of scutellaria baicalensis, 5-20 parts of gypsum, 3-20 parts of platycodon grandiflorum, 3-10 parts of citron, 3-10 parts of vinegar-processed radix bupleuri, 5-20g of herba lycopi, 6-12 parts of white mulberry root-bark and 6-10 parts of lophatherum gracile. The traditional Chinese medicine composition provided by the invention has the effects of improving adolescent insulin resistance type polycystic ovarian syndrome acne and menstrual disorder, reducing body weight and the like by clearing away lung heat, soothing the liver, regulating qi, reducing phlegm and clearing damp, is reliable in effect and good in safety, and can be used for preparing related medical products for improving adolescent insulin resistance type polycystic ovarian syndrome acne.

Description

Technical Field

[0001] The invention belongs to the technical field of Chinese medicine compositions, and particularly relates to a Chinese medicine composition for treating adolescent insulin resistance polycystic ovary syndrome with acne, and a preparation method and application thereof. Background Art

[0002] Polycystic ovary syndrome (PCOS) is a reproductive endocrine disorder syndrome with chronic reproductive disorders and abnormal glucose and lipid metabolism that potentially occurs before puberty. Its pathogenesis covers multiple aspects, including insulin resistance (IR), chronic low-grade inflammation, androgen excess and obesity. Clinical manifestations include abnormal menstruation, ovulation disorders, obesity, and a series of skin symptoms such as acne, acanthosis nigricans, hair loss, and hirsutism. Paying attention to adolescent PCOS and intervening before entering the childbearing age may increase the natural pregnancy rate. Insulin resistance (IR) is the core link in the onset of PCOS, and improving IR is the key to breaking the vicious cycle of PCOS pathological chain. Acne is a chronic inflammatory disease of the hair follicles and sebaceous glands, which is prone to occur before and after puberty and can occur with PCOS. Studies have shown that the incidence of acne in PCOS patients is as high as 95%, which seriously affects the physical and mental health and quality of life of adolescent PCOS patients. Therefore, reconstructing the menstrual cycle and eliminating acne are two major problems that need to be solved in the clinic of adolescent insulin-resistant PCOS.

[0003] Currently, the U.S. Food and Drug Administration has not approved any drug for the treatment of PCOS, which may make PCOS one of the most common orphan diseases in adolescents. Western medicine treatment mainly focuses on symptomatic treatment or segmental treatment goals such as adjusting the menstrual cycle, reducing androgen levels, and improving insulin resistance. It has problems such as narrow scope of application and many adverse reactions. Clinical observations have found that adolescent PCOS is often accompanied by abnormal liver function, which adds limitations to Western medicine drug treatment. Therefore, it is urgent to explore and develop new treatment strategies.

[0004] Traditional Chinese medicine believes that the occurrence of PCOS is closely related to the kidney, liver, and spleen, and there are few discussions on treating PCOS from the lung. Adolescent women gradually replenish their kidney qi, their internal organs are delicate, and their yin and yang are balanced. It is not appropriate to use a large amount of tonic Chinese medicine. The medicine should be light and mild, and it is advocated that medicine and food have the same origin. The Yellow Emperor's Classic of Internal Medicine records the cause of acne: "Cold and thin are chapped, and depression is acne", pointing out that the occurrence of acne is closely related to the body's depression. The lung governs the skin and fur, and the lung meridian runs through the face, so acne is mostly caused by the stagnation of the lung meridian. Based on this, treating adolescent insulin-resistant PCOS with acne from the lung may become an effective treatment strategy. However, there is currently no research on precisely targeted Chinese medicine compositions. Therefore, it is urgent to develop a safe, effective, moderately flavored, and easy-to-prepare Chinese medicine composition for the treatment of adolescent insulin-resistant PCOS with acne. At present, there are certain Chinese medicine compositions for treating PCOS with acne, such as Chinese patent document CN: 202410120119.6, which discloses a Chinese medicine composition for treating polycystic ovary syndrome acne. Animal experiments have shown that this Chinese medicine composition can reduce the androgen level of model rats, and is expected to be used to treat PCOS patients with acne, so that acne can be cured quickly without leaving pigmentation and scars. However, the effect of further clinical trials is still unclear. Preliminary clinical studies of the present invention show that it has significant efficacy in adjusting the menstrual cycle, improving sex hormone levels, eliminating acne and reducing weight, and has good safety, which is worthy of further clinical promotion. Summary of the invention

[0005] Technical problem to be solved: In view of the above technical problem, the present invention provides a traditional Chinese medicine composition for treating adolescent insulin-resistant polycystic ovary syndrome with acne and its application.

[0006] Technical solution: A traditional Chinese medicine composition for treating adolescent insulin-resistant polycystic ovary syndrome with acne, characterized in that the traditional Chinese medicine composition comprises the following components by weight: 3-10 parts of Scutellaria baicalensis, 5-20 parts of Gypsum Fibrosum, 3-20 parts of Platycodon grandiflorum, 3-10 parts of Citron, 3-10 parts of Bupleurum chinense, 5-20g of Zedoariae rhizome, 6-12 parts of Morus alba bark, and 6-10 parts of Lophatherum gracile.

[0007] Preferably, the Chinese medicine composition consists of 6g of Scutellaria baicalensis, 15g of Gypsum Fibrosum, 6g of Platycodon grandiflorum, 10g of Citron, 9g of Bupleurum chinense, 10g of Zedoariae rhizome, 10g of Morus alba bark, and 10g of Lophatherum gracile.

[0008] Application of the above-mentioned Chinese medicine composition in the preparation of a product for treating adolescent insulin-resistant polycystic ovary syndrome with acne.

[0009] The preparation method of the above product is as follows: after the medicinal materials are combined, water is added and decocted twice, the first time water is added in an amount of 12 times the weight of the medicinal materials, and the decocting is carried out for 2 hours, and the second time water is added in an amount of 10 times the weight of the medicinal materials, and the decocting is carried out for 2 hours. The decoctions are combined, and reduced pressure is concentrated at 0.07MPa and 60-70°C to a relative density of 1.15 at 65°C, 95% (v / v) ethanol is added to make the alcohol content reach 75% (v / v), stirred, and allowed to stand for 24 hours. The filtrate is reduced pressure to recover the ethanol and concentrate to obtain the effective ingredients, and then processed into the required dosage form as needed.

[0010] The above dosage forms include tablets, capsules, granules and oral solutions.

[0011] Preferably, when processing into the desired dosage form, western medicine ingredients are added without any conflict in efficacy between the ingredients.

[0012] A pharmaceutical preparation comprising the above-mentioned Chinese medicine composition as an active ingredient and at least one pharmaceutically acceptable carrier, excipient or diluent, the dosage form of the pharmaceutical preparation being suitable for oral administration, transdermal administration or any other suitable administration method, regardless of whether the preparation is used alone or in combination with other drugs or preparations.

[0013] Beneficial effects: The Chinese medicine composition provided by the present invention is obtained by screening through ancient Chinese medical books and clinical experience of Chinese medicine. PCOS belongs to the categories of "late menstruation", "amenorrhea" and "infertility" in traditional Chinese medicine. Traditional Chinese medicine believes that the liver, spleen and kidney are dysfunctional, the three meridians of Chong, Ren and Du are unfavorable, the water gasification and circulation are disordered, and the phlegm and lipid membrane block the uterus, hindering the growth of eggs, ovulation and menstruation, leading to the occurrence of PCOS. This prescription starts from the lungs, based on the theory of liver and kidney homology, the mutual generation of gold and water and the lung governing the skin and fur, and is used to treat adolescent insulin resistance polycystic ovary syndrome with acne. Scutellaria baicalensis is bitter and cold, clearing lung and detoxifying, while Gypsum gypsum is sweet and cold, clearing heat and purging fire, promoting body fluid and quenching thirst, and at the same time protecting yin fluid, which can avoid the adverse effects of excessive dryness of drugs; Platycodon grandiflorum can clear lung and resolve phlegm, help drugs ascend, clear lung and relieve heat, and relieve phlegm and dampness; Morus alba and Lophatherum gracile can clear heat and cool blood, detoxify and reduce swelling, so as to help eliminate acne; Vinegar Bupleurum, Zedoariae, Citron can regulate liver qi, eliminate stagnant heat, and at the same time dredge qi mechanism and promote the discharge of dampness in the body. The whole prescription is composed of 8 Chinese medicines, all of which are medicine and food products, simple, small and safe, and play the role of clearing lung heat, soothing liver and regulating qi, and resolving phlegm and removing dampness. Clinical studies have found that the combination can effectively improve acne, reduce patient weight, free testosterone and luteinizing hormone (LH) / follicle stimulating hormone (FSH) ratio, with good safety, and is worthy of promotion and application. DETAILED DESCRIPTION

[0014] The above contents of the present invention are further described in detail below in the form of embodiments, but this should not be understood as the scope of the above subject matter of the present invention being limited to the following examples, and all technologies realized based on the above contents of the present invention belong to the scope of the present invention.

[0015] Example 1

[0016] A method for preparing a traditional Chinese medicine composition for treating adolescent insulin resistance polycystic ovary syndrome with acne, comprising the following steps:

[0017] Take 6g of Scutellaria baicalensis, 15g of Gypsum Fibrosum, 6g of Platycodon grandiflorum, 10g of Citron, 9g of Vinegar Bupleurum, 10g of Zedoariae, 10g of Morus alba, and 10g of Lophatherum gracile, add water and boil twice, add water 8 times the weight of the medicinal materials for the first time, boil for 1h, add water 6 times the weight of the medicinal materials for the second time, boil for 1h, combine the decoctions, concentrate under reduced pressure at 0.07MPa and 60-70°C to a relative density of 1.10 at 65°C, add 95% (v / v) ethanol to make the alcohol content reach 85% (v / v), stir, let stand for 24 hours, and recover ethanol from the filtrate under reduced pressure. The filtrate is concentrated under reduced pressure at 0.07 MPa and 65°C to a relative density of 1.30 at 65°C, and spray-dried (under the conditions of inlet air temperature of 120°C, outlet air temperature of 100°C, material temperature of 90°C, atomization pressure of 0.4 MPa, and spray speed of 10 mL / s), starch is added, mixed evenly, moistened with an appropriate amount of 80% (v / v) ethanol, made into a soft material, sieved through a 30-mesh sieve for granulation, dried at 70-80°C, sieved through a 60-mesh sieve for granulation, tabletted, sugar-coated, packaged, packaged, and sent for inspection to obtain tablets.

[0018] Example 2

[0019] A method for preparing a traditional Chinese medicine composition for treating adolescent insulin resistance polycystic ovary syndrome with acne, comprising the following steps:

[0020] Take 6g of Scutellaria baicalensis, 15g of Gypsum, 6g of Platycodon grandiflorum, 10g of Citron, 9g of Bupleurum chinense, 10g of Zedoariae rhizome, 10g of Morus alba bark, and 10g of Lophatherum gracile, add water and boil twice. The first time, add water 10 times the weight of the medicinal materials and boil for 1.5h. The second time, add water 8 times the weight of the medicinal materials and boil for 1.5h. Combine the decoctions, concentrate under reduced pressure at 0.07MPa and 60-70℃ to a relative density of 1.15 at 65℃, and add 95% (v / v) ethanol to make the alcohol-containing The amount reaches 75% (v / v), stirred, and allowed to stand for 24 hours. The filtrate is decompressed to recover ethanol and concentrated. The filtrate is decompressed and concentrated under 0.07 MPa and 65°C conditions to a relative density of 1.25 at 65°C, spray dried (the conditions are inlet air temperature of 100°C, outlet air temperature of 80°C, material temperature of 80°C, atomization pressure of 0.2 MPa, and spray speed of 5 mL / s.), dextrin is added, dry granulated, passed through a 60-mesh sieve, and filled into No. 1 capsules to obtain capsules.

[0021] Example 3

[0022] A method for preparing a traditional Chinese medicine composition for treating adolescent insulin resistance polycystic ovary syndrome with acne, comprising the following steps:

[0023] Take 6g of Scutellaria baicalensis, 15g of Gypsum, 6g of Platycodon grandiflorum, 10g of Citron, 9g of Vinegar Bupleurum, 10g of Zedoariae, 10g of Morus alba, and 10g of Lophatherum gracile, add water and boil twice. The first time, add water 12 times the weight of the medicinal materials and boil for 2h. The second time, add water 10 times the weight of the medicinal materials and boil for 2h. Combine the decoctions, concentrate under reduced pressure at 0.07MPa and 60-70℃ to a relative density of 1.15 at 65℃, add 95% (v / v) ethanol to make the alcohol content reach 75% (v / v), stir, let stand for 24 hours, and the filtrate is reduced to 100% (v / v). The ethanol is recovered under reduced pressure and concentrated, and the filtrate is concentrated under reduced pressure at 0.07 MPa and 65°C to a relative density of 1.25 at 65°C, and spray-dried (the conditions are that the inlet air temperature is 110°C, the outlet air temperature is 85°C, the material temperature is 85°C, the atomization pressure is 0.3 MPa, and the spray speed is 7.5 mL / s.), the above-mentioned β-cyclodextrin inclusion compound is added, crushed, and then an appropriate amount of lactose is added, and it is moistened with an appropriate amount of 80% (v / v) ethanol to make a soft material, granulated through a 14-mesh sieve, dried at 50-80°C, and granulated with a 60-mesh sieve to obtain granules.

[0024] Example 4

[0025] A method for preparing a traditional Chinese medicine composition for treating adolescent insulin resistance polycystic ovary syndrome with acne, comprising the following steps:

[0026] Combine 6 g of Scutellaria baicalensis, 15 g of Gypsum Fibrosum, 6 g of Platycodon grandiflorum, 10 g of Citron, 9 g of Bupleurum chinense, 10 g of Zedoariae rhizome, 10 g of Morus alba bark, and 10 g of Lophatherum gracile, add water and boil twice, add water 10 times the weight of the medicinal materials for the first time, boil for 1.5 h, add water 8 times the weight of the medicinal materials for the second time, boil for 1.5 h, combine the decoctions, concentrate under reduced pressure at 0.07 MPa and 60-70°C to a relative density of 1.15 at 65°C, add 95% (v / v) ethanol to make the alcohol content reach 75% (v / v), stir, let stand for 24 hours, recover ethanol from the filtrate under reduced pressure and concentrate, concentrate the filtrate under reduced pressure at 0.07 MPa and 65°C to a relative density of 1.25 at 65°C, add water and sucrose to prepare an oral solution.

[0027] Example 5

[0028] Clinical study on the use of the Chinese medicine composition of the present invention in treating adolescent insulin resistance polycystic ovary syndrome with acne

[0029] 1 Clinical Data

[0030] 1.1 Research methods and case sources

[0031] This study is a prospective multi-group controlled clinical study. According to the inclusion and exclusion criteria, patients diagnosed with PCOS-IR and acne in the outpatient clinic of Jiangsu Provincial Hospital of Traditional Chinese Medicine from October 2022 to December 2023 were collected. They were women aged 11 to 24 years old and met the phlegm-dampness-heat syndrome.

[0032] 1.2 Diagnostic criteria

[0033] 1.2.1 Western medicine diagnostic criteria

[0034] (1) PCOS diagnostic criteria

[0035] Patients aged 11-17 years old refer to the 2022 Diagnosis and Treatment Strategy for Polycystic Ovary Syndrome in Adolescence, and patients aged 18-24 years old refer to the 2022 JAMA Journal Diagnosis and Treatment of Polycystic Ovary Syndrome and the 2018 Chinese Diagnosis and Treatment Guidelines for Polycystic Ovary Syndrome to formulate the following standards:

[0036] 1) 11-17 years old: ① Oligomenorrhea lasting for at least 2 years after menarche or amenorrhea; ② Clinical manifestations of hyperandrogenism or hyperandrogenemia; ③ Ultrasound examination shows that the number of follicles with a diameter of 2-8 mm in at least one ovary is ≥12, and the interstitial echo is enhanced and the volume is enlarged (>10cm 3 ) (Transvaginal (for those with a history of sexual activity) or transrectal ultrasound examination.) The above 3 diagnostic criteria must be met, and other diseases that cause hyperandrogenism or ovulation disorders must be excluded, such as androgen-producing tumors, adrenal diseases such as adrenal cortical hyperplasia, ovarian theca cell hyperplasia, hereditary hirsutism and other endocrine diseases.

[0037] 2) 18-24 years old: ① Menstrual changes: oligomenorrhea or amenorrhea; ② Clinical manifestations of hyperandrogenism or hyperandrogenism; ③ Ultrasound examination shows that the number of follicles in at least one ovary is ≥12 or the volume of at least one ovary is enlarged (>10cm 3 ). Transvaginal (for those with a history of sexual life) or transrectal ultrasound examination. Must meet any of ①, ② and ③, and exclude other diseases that cause hyperandrogenism or ovulation disorders, such as androgen-producing tumors, adrenal diseases such as adrenal cortical hyperplasia, ovarian theca cell hyperplasia, hereditary hirsutism and other endocrine diseases.

[0038] (2) Diagnostic criteria for insulin resistance

[0039] HOMA-IR≥2.69. HOMA-IR=FINS(mIU / L)×FPG(mmol / L) / 22.5. Fasting insulin (FINS), fasting plasma glucose (FPG).

[0040] (3) Acne diagnostic criteria

[0041] It is common during adolescence and also seen in late adolescence. The lesions are mostly located in areas with well-developed sebaceous glands such as the face, chest and back, and are mostly symmetrically distributed. Common lesions include acne, papules, pustules, cysts, nodules, etc., and are sometimes accompanied by sebum overflow.

[0042] 1.2.2 TCM diagnostic criteria

[0043] ① Oligomenorrhea, scanty menstruation or amenorrhea, or menstrual disorders;

[0044] ② Strong body, thick hair, acne on face or back, acanthosis nigricans;

[0045] ③ Feeling irritable, feeling heavy-headed and heavy-bodied;

[0046] ④Dry mouth and constipation;

[0047] The tongue is red with yellow (greasy) coating, and the pulse is slippery and rapid.

[0048] If any one of ① and ②-④ is present at the same time, combined with tongue and pulse, it can be diagnosed as phlegm-dampness transforming into heat syndrome.

[0049] 1.3 Inclusion criteria

[0050] ①Meet both Western medicine and traditional Chinese medicine diagnostic standards;

[0051] ② Aged 11 to 24;

[0052] ③ No need to have children for the time being;

[0053] ④Informed consent and voluntary participation in the experiment.

[0054] Only those who meet all four of the above conditions can be included.

[0055] 1.4 Exclusion criteria

[0056] ① Oral use of hormones, insulin sensitizers and other endocrine regulation-related drugs in the past 3 months;

[0057] ② Those with allergic constitution or allergic to the ingredients of the medicine they need to take;

[0058] ③ Patients with serious cardiovascular, liver, kidney and other diseases and mental disorders.

[0059] Those who meet any of the above criteria will not be included.

[0060] 1.5 Elimination and termination criteria

[0061] ① Those who have not received treatment according to the prescribed regulations and whose efficacy cannot be judged;

[0062] ② Incomplete data affects the judgment of efficacy or safety;

[0063] ③ An unexpected event occurred during the treatment, making the experiment unable to continue;

[0064] ④ Patients are unwilling to cooperate with the treatment during the treatment process.

[0065] Those who meet any of the above conditions will be eliminated.

[0066] 2 Research Methods

[0067] 2.1 Study Groups

[0068] According to the inclusion and exclusion criteria, a total of 62 patients diagnosed with PCOS-IR with acne in the outpatient department of Jiangsu Provincial Hospital of Traditional Chinese Medicine from June 2022 to December 2023, who met the phlegm-dampness-heat syndrome, were collected. According to the patients' own wishes, they were divided into a treatment group and a control group, with 31 people in each group. The patients took the medicine according to the doctor's instructions.

[0069] 2.2 Control method

[0070] Two control methods were used: self-control before and after and between-group control.

[0071] 2.3 Treatment options

[0072] 2.3.1 Medication selection

[0073] (1) Treatment group: composed of 6g of Scutellaria baicalensis, 15g of Gypsum Fibrosum, 6g of Platycodon grandiflorum, 10g of Citron, 9g of Bupleurum chinense, 10g of Zedoariae rhizome, 10g of Morus alba bark, and 10g of Lophatherum gracile. Take one dose per day, decoct in water, 250mL / time, and take warm half an hour after breakfast and dinner (stop taking during menstruation).

[0074] (2) Control group: Oral administration of metformin (North China Pharmaceutical Co., Ltd., 0.5 g per tablet) once in the morning and evening with meals, 1 tablet each time.

[0075] 2.3.2 Medication course and precautions

[0076] Every 4 weeks or 1 menstrual cycle is a course of treatment, and a total of 3 courses of treatment are continuous. From the date of starting medication, if menstruation does not come on its own for 12 consecutive weeks, dydrogesterone tablets are given for withdrawal bleeding. In addition to the study medication, other therapeutic drugs related to this study are prohibited. Inform patients to pay attention to healthy diet and daily life during medication, avoid spicy and cold food, and keep a regular work and rest schedule.

[0077] 2.3.3 Observation and recording nodes and indicators

[0078] (1) Symptom and sign indicators: Physical examination, acne score and TCM syndrome score of the patient were observed and recorded once before and after medication. Physical examination and adverse reactions of the patient were observed and recorded once after each course of medication.

[0079] (2) Laboratory test indicators: Check once before and after medication, including liver and kidney function, serum gonadal hormones, FINS, FPG and blood lipid indicators.

[0080] (3) Imaging examination: Gynecological B-ultrasound examination should be performed once before and after medication.

[0081] 3. Observation Project

[0082] 3.1 General Information

[0083] Basic information of the subject including name, age, contact information, clinic number, menarche time, and disease course.

[0084] 3.2 Safety indicators

[0085] Physical examination, adverse reaction monitoring, and liver and kidney function tests.

[0086] 3.3 Efficacy indicators

[0087] 3.3.1BMI

[0088] The height and weight of the patients were measured on the first visit day and the 12th week, and the body mass index (BMI) was calculated. BMI = weight (kg) / height (m) 2 .

[0089] 3.3.2 Serum gonadal hormone measurement

[0090] Venous blood was drawn on an empty stomach in the morning of the 2nd to 4th day of the natural menstrual cycle or withdrawal bleeding to measure serum SHBG (nmol / L), AMH (ng / mL), DHEAS (μg / dL), T (ng / dL), estradiol (Estradiol, E2) (ng / L), LH (mIU / mL), FSH (mIU / mL), progesterone (Progesterone, P) (ng / mL), PRL (ng / mL), and calculate the free androgen index (Free androgen index, FAI) and LH / FSH. The test was performed once before and after treatment.

[0091] FAI=T(nmol / L)×100 / SHBG(nmol / L)

[0092] 3.3.3 Determination of glucose metabolism related indicators

[0093] Venous blood was drawn on an empty stomach in the morning of the 2nd to 4th day of the natural menstrual cycle or withdrawal bleeding to measure serum FINS (mIU / L) and FPG (mmol / L) levels, and HOMA-IR was calculated. The blood was measured once before and after treatment.

[0094] 3.3.4 Blood lipid measurement

[0095] Venous blood was drawn on an empty stomach in the morning of the 2nd to 4th day of the natural menstrual cycle or withdrawal bleeding to measure serum total cholesterol (TC) (mmol / L), triglyceride (TG) (mmol / L), high-density lipoprotein cholesterol (HDL-C) (mmol / L), and low-density lipoprotein cholesterol (LDL-C) (mmol / L). The levels were measured once before and after treatment.

[0096] 3.3.5 Acne assessment

[0097] The acne scores of the patients were recorded once before and after treatment. The scoring criteria are shown in Table 1.

[0098] 3.3.6 TCM syndrome score and comprehensive efficacy evaluation

[0099] The TCM syndrome scores of the patients were recorded once before and after treatment, and the total effective rate was calculated. The scoring criteria are shown in Table 2.

[0100] 3.4 Criteria for determining efficacy

[0101] Refer to the "Guidelines for Clinical Research of New Chinese Medicines" to formulate the criteria for determining the efficacy of TCM syndromes:

[0102] ① Clinical recovery: clinical signs and symptoms disappear or basically disappear, n≥95%;

[0103] ② Significantly effective: clinical signs and symptoms were significantly improved, 95%>n≥70%;

[0104] ③ Effective: clinical signs and symptoms improved, 70%>n≥30%;

[0105] ④ Ineffective: There is no significant improvement in clinical signs and symptoms, or they are even worse than before, n < 30%.

[0106] Clinical efficacy index (n) = (total score before treatment - total score after treatment) / total score before treatment × 100%.

[0107] Table 1 GAGS acne overall grading score table

[0108]

[0109] The score of each area = factor score × skin lesion score, and the GAGS score is the sum of the scores of each area.

[0110] Table 2 TCM syndrome scoring table

[0111]

[0112] 4 Research results

[0113] The composition can effectively improve acne, reduce the patient's body weight, free testosterone and luteinizing hormone (LH) / follicle stimulating hormone (FSH) ratio, and has good safety, as shown in Table 3-4.

[0114] The composition can effectively improve acne, reduce the patient's body weight, free testosterone and luteinizing hormone (LH) / follicle stimulating hormone (FSH) ratio, and has good safety.

[0115] 4.1 Comparison of acne before and after treatment

[0116] Intra-group comparison: The acne score results of the Chinese medicine group before and after treatment showed P < 0.01, and there were differences in the intra-group comparison, and the differences were statistically significant, indicating that the treatment group had a significant effect in improving acne; the acne score results of the control group before and after treatment showed P > 0.05, and the difference was not statistically significant, indicating that the control group had no obvious effect in improving acne.

[0117] Comparison between groups: The comparison of acne scores between the two groups after treatment showed P < 0.05, indicating that there were differences between the groups, and the treatment effect of the treatment group was better than that of the control group.

[0118] Table 3 Comparison of acne scores and TCM syndrome scores between the two groups before and after treatment

[0119]

[0120] Note: ΔΔ compared with that before treatment, P<0.01.

[0121] 4.2 Comparison of TCM syndrome scores before and after treatment

[0122] Intra-group comparison: After treatment, the TCM syndrome scores of the two groups were compared, P < 0.01, and there were significant differences in the intra-group comparisons, indicating that both groups could effectively improve TCM syndromes;

[0123] Comparison between groups: After treatment, the comparison of TCM syndrome score between the two groups showed P < 0.01, and there was a difference between the groups, indicating that the treatment group had better efficacy than the control group.

[0124] 4.3 Comparison of BMI before and after treatment

[0125] Intra-group comparison: After treatment, the BMI comparison between the two groups showed P < 0.01, and there was a significant statistical difference, indicating that both groups could effectively reduce BMI.

[0126] Inter-group comparison: The comparison of BMI between the two groups after treatment showed P>0.05, and no statistically significant difference was found, indicating that the effect of reducing BMI in the treatment group after treatment was not inferior to that in the control group.

[0127] 4.4 Comparison of FAI before and after treatment

[0128] Intra-group comparison: The FAI level of the treatment group after treatment was compared with that before treatment, which showed P < 0.01. There was a difference in the intra-group comparison, and the difference was statistically significant, indicating that the treatment group can effectively reduce the FAI level; the FAI level of the control group before and after treatment was compared with that before treatment, which showed P > 0.05. There was no statistically significant difference, indicating that the control group had no obvious effect in reducing FAI.

[0129] Comparison between groups: The comparison of FAI levels between the two groups after treatment showed P < 0.05. There were differences between the groups, and the differences were statistically significant, indicating that the treatment group was more effective in reducing FAI levels than the control group.

[0130] 4.5 Comparison of HOMA-IR before and after treatment

[0131] Intra-group comparison: After treatment, the HOMA-IR of the two groups was compared with that before treatment, which showed P < 0.01. There were differences in the intra-group comparison, and the differences were statistically significant, indicating that both groups can effectively reduce the HOMA-IR index and improve the insulin resistance state.

[0132] Comparison between groups: The comparison of HOMA-IR levels between the two groups after treatment showed P < 0.05. There was a difference between the groups, and the difference was statistically significant, indicating that the control group had a more obvious effect in improving insulin resistance than the treatment group.

[0133] 4.6 Comparison of LH / FSH before and after treatment

[0134] Intra-group comparison: Comparison of the LH / FSH ratio between the two groups before and after treatment showed P < 0.01. There were differences within the groups, and the differences were statistically significant, indicating that both groups can effectively regulate sex hormone levels and reduce LH / FSH levels.

[0135] Inter-group comparison: After treatment, the comparison of LH / FSH between the two groups showed P>0.05, and no statistically significant difference was found, indicating that the effect of reducing BMI in the treatment group after treatment was not inferior to that in the control group.

[0136] Table 4 Comparison of efficacy indicators between the two groups before and after treatment

[0137]

[0138] Note: ΔΔ compared with that before treatment, P<0.01.

[0139] 4.7 Security Analysis

[0140] No obvious abnormalities were found in the patient's physical examination and liver and kidney function tests before, during and after treatment, and no serious adverse events occurred during the medication.

[0141] The above is a schematic description of the present invention and its implementation methods, which is not restrictive. Therefore, if a person skilled in the art is inspired by it and does not deviate from the purpose of the present invention, structural methods and embodiments similar to the technical solution without creative design should all fall within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating adolescent insulin resistance polycystic ovary syndrome with acne, It is characterized in that The traditional Chinese medicine composition comprises the following components by weight: 3-10 parts of scutellaria baicalensis, 5-20 parts of gypsum, 3-20 parts of platycodon grandiflorum, 3-10 parts of citron, 3-10 parts of vinegar bupleurum, 5-20g of zedoaria, 6-12 parts of mulberry bark and 6-10 parts of lophatherum gracile.

2. The Chinese medicine composition according to claim 1, It is characterized in that The traditional Chinese medicine composition consists of 6g of scutellaria baicalensis, 15g of gypsum, 6g of platycodon grandiflorum, 10g of citron, 9g of bupleurum chinense, 10g of zedoaria officinalis, 10g of mulberry bark and 10g of lophatherum gracile.

3. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of a product for treating adolescent insulin-resistant polycystic ovary syndrome with acne.

4. The use according to claim 3, It is characterized in that The preparation method comprises the following steps: after combining the medicinal materials, adding water and decocting twice, the first time adding water is 12 times the weight of the medicinal materials and decocting for 2 hours, the second time adding water is 10 times the weight of the medicinal materials and decocting for 2 hours, combining the decoctions, concentrating under reduced pressure at 0.07MPa and 60-70°C to a relative density of 1.15 at 65°C, adding 95% (v / v) ethanol to make the alcohol content reach 75% (v / v), stirring, standing for 24 hours, decompressing the filtrate to recover the ethanol and concentrate to obtain the effective ingredients, and then processing into the required dosage form as needed.

5. The use according to claim 3, It is characterized in that The dosage forms include tablets, capsules, granules and oral liquids.

6. The use according to claim 3, It is characterized in that When processing into the required dosage form, western medicine ingredients are added without any conflict of efficacy between the ingredients.

7. A pharmaceutical preparation, It is characterized in that The pharmaceutical preparation comprises the Chinese medicine composition according to claim 1 or 2 as an active ingredient, and at least one pharmaceutically acceptable carrier, excipient or diluent, the dosage form of the pharmaceutical preparation is suitable for oral administration, skin administration or any other suitable administration method, and no matter the preparation is used alone or in combination with other drugs or preparations.

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