Traditional Chinese medicine composition for treating polycystic ovarian syndrome hyperluteinizing proteinemia and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating polycystic ovarian syndrome hyperluteinizing proteinemia and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following raw material medicines: 10 to 15 parts of radix paeoniae alba, 10 to 30 parts of raw oyster shell, 10 to 20 parts of concha haliotidis, 3 to 15 parts of fried jujube kernel, 3 to 15 parts of herba artemisiae scopariae, 10 to 30 parts of ruddle, 3 to 15 parts of radix salviae miltiorrhizae, 3 to 15 parts of spica prunellae, 3 to 12 parts of semen cuscutae, 3 to 12 parts of fructus ligustri lucidi and 3 to 10 parts of rhizoma seu radix notopterygii. The invention further discloses a preparation method of the traditional Chinese medicine composition and application of the traditional Chinese medicine composition in preparation of a medicine for treating polycystic ovarian syndrome hyperluteinizing proteinemia. The traditional Chinese medicine composition disclosed by the invention has the effects of reducing serum LH and androgen levels and promoting menstruation.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and more specifically, to a traditional Chinese medicine composition for treating polycystic ovary syndrome hyperluteinizing syndrome and its application. Background Art

[0002] Polycystic Ovary Syndrome (PCOS) is a common reproductive endocrine disorder in women of childbearing age, affecting 4%-20% of women of childbearing age worldwide. It is characterized by rare or no ovulation, clinical or biochemical hyperandrogenism, and polycystic ovaries. Although high luteinizing hormone (LH) blood is not a diagnostic criterion for PCOS, it is one of the common pathological changes of the disease. Its continued presence can aggravate hyperandrogenism and inhibit the development of follicles and ovulation.

[0003] Currently, there is no effective treatment for hyperluteinizing syndrome in polycystic ovary syndrome, and it is mainly treated indirectly by reducing androgens.

[0004] Therefore, for patients with PCOS and hyperluteinizing hormone, a Chinese medicine preparation is needed to reduce serum luteinizing hormone and androgen levels and promote menstruation. Summary of the invention

[0005] In view of the above technical problems, one object of the present invention is to provide a new Chinese medicine composition, which can effectively treat hyperluteinizing syndrome caused by polycystic ovary syndrome.

[0006] Another object of the present invention is to provide a method for preparing the above-mentioned Chinese medicine composition.

[0007] Another object of the present invention is to provide a Chinese medicine preparation comprising the above-mentioned Chinese medicine composition and the use of the above-mentioned Chinese medicine composition and its pharmaceutical preparation in the preparation of a drug for treating hyperluteinizing syndrome in polycystic ovary syndrome.

[0008] In order to achieve the above object, the present invention adopts the following technical solutions:

[0009] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating hyperluteinizing syndrome in polycystic ovary syndrome. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-15 parts of white peony root, 10-30 parts of raw oyster, 10-20 parts of semen cassiae, 3-15 parts of stir-fried jujube seeds, 3-15 parts of capillaris, 10-30 parts of magnetite, 3-15 parts of salvia miltiorrhiza, 3-15 parts of selfheal, 3-12 parts of dodder seed, 3-12 parts of glossy privet fruit, and 3-10 parts of notopterygium wilfordii.

[0010] The selection of the above medicinal materials is the result of the inventor's exploration and summary based on the theory of traditional Chinese medicine after many years of clinical experience, and has been analyzed, studied and verified. The prescription of the traditional Chinese medicine composition is concise and has good efficacy in reducing serum high luteinizing hormone and androgen levels and promoting menstruation.

[0011] In the prescription of the present invention, white peony root and raw oyster are both monarch drugs, nourishing blood and softening liver, nourishing yin and suppressing yang. Semen Cassiae, stir-fried jujube seeds, and daiheshi are assistant drugs, which enhance the effects of the monarch drugs in nourishing blood and softening liver, nourishing yin and suppressing yang. Artemisia capillaris clears away dampness and heat in the liver meridian, and is an adjuvant drug. Salvia miltiorrhiza and Prunella vulgaris promote blood circulation and disperse stagnation, and are adjuvant drugs. Cuscuta chinensis and Ligustrum lucidum replenish kidney qi, and are adjuvant drugs. Notopterygium wilfordii dispels wind and dampness, and is an adjuvant drug.

[0012] Exemplarily, in parts by weight, the Chinese medicine composition for treating hyperluteinizing syndrome in polycystic ovary syndrome includes the following raw drugs: 15 parts of white peony root, 30 parts of raw oyster, 20 parts of semen cassiae, 15 parts of stir-fried jujube seeds, 15 parts of capillaris, 30 parts of magnetite, 15 parts of salvia miltiorrhiza, 15 parts of selfheal, 12 parts of dodder seed, 12 parts of glossy privet fruit, and 10 parts of notopterygium wilfordii.

[0013] Exemplarily, in parts by weight, the Chinese medicine composition for treating hyperluteinizing syndrome in polycystic ovary syndrome includes the following raw drugs: 12 parts of white peony root, 20 parts of raw oyster, 15 parts of semen cassiae, 12 parts of stir-fried jujube seeds, 12 parts of capillaris, 20 parts of magnetite, 12 parts of salvia miltiorrhiza, 12 parts of selfheal, 10 parts of dodder seed, 10 parts of glossy privet fruit, and 9 parts of notopterygium wilfordii.

[0014] Exemplarily, in parts by weight, the Chinese medicine composition for treating hyperluteinizing syndrome in polycystic ovary syndrome includes the following raw drugs: 10 parts of white peony root, 15 parts of raw oyster, 12 parts of semen cassiae, 10 parts of stir-fried jujube seeds, 10 parts of capillaris, 15 parts of magnetite, 10 parts of salvia miltiorrhiza, 9 parts of selfheal, 9 parts of dodder seed, 9 parts of glossy privet fruit, and 6 parts of notopterygium wilfordii.

[0015] The basic formula of each raw material medicine of the above-mentioned traditional Chinese medicine composition of the present invention can be adjusted according to clinical symptoms on the basis of the above-mentioned traditional Chinese medicine composition in a specific embodiment of the present invention to achieve the purpose of treating polycystic ovary syndrome and improving other clinical symptoms of patients, further enhance the adaptability of the composition of the present invention, and improve the therapeutic effect.

[0016] In a second aspect, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition for treating hyperluteinizingemia in polycystic ovary syndrome, the preparation method comprising the following steps: taking white peony root, raw oyster, semen cassiae, stir-fried jujube seeds, capillaris, magnetite, salvia miltiorrhiza, selfheal, dodder seed, glossy privet fruit, and notopterygium wilfordii according to the formula, decocting twice with water, combining the decoctions, filtering, and obtaining the composition.

[0017] Furthermore, in order to facilitate storage, the above preparation method may also include the step of concentrating the filtrate into a clear paste.

[0018] Furthermore, in the above preparation method, the amount of water added is 10-15 times the total mass of the raw material; the decoction time is 1-1.5 hours; and the clear paste has a relative density of 1.30-1.35 measured at 60°C.

[0019] In a third aspect, the present invention provides a traditional Chinese medicine preparation for treating hyperluteinizing syndrome in polycystic ovary syndrome, wherein the traditional Chinese medicine preparation comprises the above-mentioned traditional Chinese medicine composition as an active ingredient.

[0020] According to actual needs, the Chinese medicine preparation may also include pharmaceutically acceptable excipients, such as binders, disintegrants, lubricants, fillers, suspending agents, etc. According to conventional preparation processes, various preparations such as decoctions, granules, pills, capsules, tablets, powders, oral liquids, etc. are prepared.

[0021] The present invention also provides the use of the above-mentioned Chinese medicine composition or Chinese medicine preparation in preparing a medicine for treating hyperluteinizing syndrome caused by polycystic ovary syndrome.

[0022] In addition, unless otherwise specified, the raw materials of the Chinese medicine composition of the present invention can be obtained commercially, and any range recorded in the present invention, including the end values ​​and any numerical value between the end values, and any sub-range of the Chinese medicine composition composed of the end values ​​or any numerical value between the end values, can achieve the purpose of treating hyperluteinizing syndrome in polycystic ovary syndrome.

[0023] The beneficial effects of the present invention are as follows:

[0024] The Chinese medicine composition of the present invention can effectively reduce the serum LH and androgen levels of patients with polycystic ovary syndrome, promote menstruation, and has no adverse reactions, thereby realizing the target treatment of hyperluteinizing hormone syndrome in polycystic ovary syndrome by traditional Chinese medicine, and filling the gap in therapeutic drugs for hyperluteinizing hormone syndrome in polycystic ovary syndrome. DETAILED DESCRIPTION

[0025] In order to explain the present invention more clearly, the present invention is further described below in conjunction with preferred embodiments. It should be understood by those skilled in the art that the following specific description is illustrative rather than restrictive, and should not be used to limit the scope of protection of the present invention.

[0026] Example 1 A Chinese medicine composition for treating polycystic ovary syndrome with hyperluteinizing hormone

[0027] Raw material formula: white peony root 15g, raw oyster 30g, stone cassia twig 20g, fried jujube seed 15g, capillaris 15g, magnetite 30g, salvia miltiorrhiza 15g, selfheal 15g, dodder seed 12g, Ligustrum lucidum fruit 12g, and Notopterygium wilfordii 10g.

[0028] Take the above eleven raw materials, add 10 times the water and boil twice, boil for 1.5 hours and 1 hour respectively, combine the decoctions, filter, and concentrate the filtrate to an appropriate amount (clear paste with a relative density of 1.30-1.35 (60°C)).

[0029] Example 2 A drug (granules) for treating hyperluteinizing syndrome in polycystic ovary syndrome

[0030] Raw material formula: white peony root 12g, raw oyster 20g, stone cassia twig 15g, fried jujube seed 12g, capillaris 12g, magnetite 20g, salvia miltiorrhiza 12g, selfheal 12g, dodder seed 10g, Ligustrum lucidum fruit 10g, and Notopterygium wilfordii 9g.

[0031] Take the above eleven raw materials, add 10 times the water and decoct twice, decoct for 1.5 hours and 1 hour respectively, combine the decoctions, filter, concentrate the filtrate to an appropriate amount (clear paste with a relative density of 1.30-1.35 (60°C)), dry under reduced pressure, crush through an 80-mesh sieve, add an appropriate amount of dextrin, mix well, granulate, and dry to obtain.

[0032] Example 3 A medicine (decoction) for treating hyperluteinizing syndrome in polycystic ovary syndrome

[0033] Raw material formula: white peony root 10g, raw oyster 15g, stone cassia twig 12g, fried jujube seed 10g, capillaris 10g, magnetite 15g, salvia miltiorrhiza 10g, selfheal 9g, dodder seed 9g, glossy privet fruit 9g, and notopterygium wilfordii 6g.

[0034] Take the above eleven raw materials, add 10 times the water and boil twice, boil for 1.5 hours and 1 hour respectively, combine the decoctions, filter and you have it.

[0035] Example 4 Experimental study on the efficacy of the Chinese medicine composition of the present invention in treating polycystic ovary syndrome with hyperluteinizing hormone

[0036] 1 Materials and methods

[0037] 1.1 General Information

[0038] A retrospective analysis was performed on 29 patients with PCOS and hyperluteinemia who were treated in the gynecology clinic of Guang'anmen Hospital, China Academy of Chinese Medical Sciences from January 2022 to June 2024. The patients were aged 30.38±0.70 years. Before treatment, the median serum LH was 17.09mIU / ml, the menstrual cycle score was 3.48±0.30 points, and the median serum testosterone was 0.7ng / ml.

[0039] 1.2 Case selection criteria

[0040] 1.2.1 PCOS diagnostic criteria

[0041] Refer to the PCOS diagnostic criteria developed by the European Society of Human Reproduction and Embryology (ESHRE) and the American Society for Reproductive Medicine (ASRM) in May 2003 and recommended for use by the Chinese Medical Association's Obstetrics and Gynecology Branch.

[0042] 1.2.2 Case inclusion criteria

[0043] (1) Meet the diagnostic criteria for PCOS; (2) LH is above the normal range; (3) Age 18-35 years old;

[0044] 1.2.3 Case Exclusion Criteria

[0045] (1) Patients with other endocrine diseases such as diabetes, thyroid, adrenal glands, etc.; (2) Patients with serious diseases such as cardiovascular, liver, kidney and hematopoietic system and thrombotic diseases; (3) Patients with mental illness or cancer; (4) Patients who have taken hormones (except progesterone) and other drugs that affect reproductive endocrine in the past 3 months; (5) Patients with a history of severe allergy to traditional Chinese medicine; (6) Patients with less than 2 years of menstruation.

[0046] 1.3 Treatment methods

[0047] The basic formula is white peony root, raw oyster, stone cassia, stir-fried jujube seed, artemisia capillaris, magnetite, salvia miltiorrhiza, selfheal, dodder seed, glossy privet fruit, and notopterygium wilfordii (15g of white peony root, 30g of raw oyster, 20g of stone cassia, 15g of stir-fried jujube seed, 15g of artemisia capillaris, 30g of magnetite, 15g of salvia miltiorrhiza, 15g of selfheal, 12g of dodder seed, 12g of glossy privet fruit, and 10g of notopterygium wilfordii, made into a decoction), one dose a day, decocted in water, taken twice a day, morning and evening, for continuous treatment for 12 weeks.

[0048] 1.4 Observation indicators

[0049] (1) Serum LH level; (2) Serum testosterone (T) level; (3) Menstrual cycle score for evaluation.

[0050] 1.5 Statistical methods

[0051] SPSS26.0 statistical software was used to establish a database. The measurement data were expressed as mean ± standard deviation (±s) or mean (interquartile range). Paired t-test was used to process the data. Nonparametric test was used for non-normal distribution data. P < 0.05 was considered statistically significant.

[0052] 2 Results

[0053] 2.1 Comparison of serum LH before and after treatment

[0054] As shown in Table 1, compared with before treatment, the POCS serum LH level was significantly reduced after treatment, and the difference was statistically significant (P<0.01), indicating that the Chinese medicine composition of the present invention has the effect of reducing serum LH.

[0055] Table 1 Comparison of serum LH before and after treatment

[0056]

[0057] Note: **P<0.01.

[0058] 2.2 Comparison of serum T before and after treatment

[0059] As shown in Table 2, compared with before treatment, the serum T level after treatment was significantly reduced, and the difference was statistically significant (P < 0.01), indicating that the Chinese medicine composition of the present invention has the effect of reducing serum androgen.

[0060] Table 2 Comparison of serum T before and after treatment

[0061]

[0062] Note: **P<0.01.

[0063] 2.3 Comparison of menstrual cycle scores before and after treatment

[0064] As shown in Table 3, compared with before treatment, the menstrual cycle score after treatment was significantly reduced, and the difference was statistically significant (P < 0.01), indicating that the Chinese medicine composition of the present invention has the effect of reducing the menstrual cycle score and promoting menstruation.

[0065] Table 3 Comparison of menstrual cycle scores before and after treatment

[0066]

[0067]

[0068] Note: **P<0.01.

[0069] 3 Conclusion

[0070] The Chinese medicinal composition of the invention has the effects of lowering serum LH and androgen levels and promoting menstruation.

[0071] Example 5 Typical Cases

[0072] Typical Case 1

[0073] Liu, female, 35 years old

[0074] First visit: March 12, 2024

[0075]

Main complaint

[0076] [Current medical history] The patient has had menstruation for 5-6 days / 30-90 days since her menarche at the age of 14, with slightly more blood (6 sanitary napkins per day), dark red color, many blood clots, cold lower abdomen, heaviness and pain in the waist during menstruation. In 2020, she was diagnosed with polycystic ovary syndrome (PCOS) at a local hospital and took Diane-35, dydrogesterone, and Usire. PMP: December 29, 2023 (taking Usire), LMP: March 10, 2024 (taking dydrogesterone), the amount is the same as before, and there are no blood clots.

[0077] [Current symptoms] Impatience, hot palms, easy to wake up from sleep, formed stool, once a day. Pale red tongue, thin white fur, stringy pulse.

[0078] [Marital and reproductive history] G1P1, whether there is sexual history since the last menstrual period.

[0079]

Past medical history

[0080] [Auxiliary examination] Complete biochemical examination on January 9, 2024: TG: 2.09↑; no obvious abnormality was found in thyroid function.

[0081]

Western Medicine Diagnosis

[0082]

Chinese medicine diagnosis

[0083]

Treatment method

[0084]

deal with

[0085] 1. Check today: female hormones, blood sugar (fasting, 1 hour after meal, 2 hours after meal), insulin (fasting, 1 hour after meal, 2 hours after meal), blood routine, AMH, COR, ACTH;

[0086] 2. Check B-ultrasound (transvaginal) on the 5th to 7th day of menstruation;

[0087] 3. Measure basal body temperature.

[0088] Second consultation date: March 19, 2024

[0089] LMP: March 10, 2024 (taking dydrogesterone) cycle 72 days, heavy flow (6 sanitary napkins per day), no blood clots, low back pain during menstruation. Current symptoms: impatience and irritability, hot palms, easy to wake up when sleeping, formed stool, once a day. Dark tongue, thin white fur, stringy pulse. No sexual history since the last menstrual period.

[0090] [Auxiliary examination] Female hormones on March 13, 2024: E2: 22.87pg / ml, FSH: 4.7mIU / ml, PRL: 5.77ng / ml, T: 0.37ng / ml, LH: 14.6↑mIU / ml, P: 0.18ng / ml, A2: 9.31nmol / L, HEAS: 8.17umol / L, AMH: 11.65↑ng / ml, SHBG: 43.3nmol / L, ACTH: 13.17, COR: 5.65;

[0091] Glucose (fasting): 6.03mmol / L, glucose (1h after meal): 8.78mmol / L, glucose (2h after meal): 7.34mmol / L, islet function (fasting): 55.05Pmol / L, islet function (1h after meal): 499.52Pmol / L, islet function (2h after meal): 219.63Pmol / L. B-ultrasound on March 19, 2024: endometrial thickness 0.5cm, bilateral ovarian polycystic changes.

[0092]

deal with

[0093] White peony root 15g, raw oyster 30g, stone cassia twig 20g, stir-fried jujube seed 15g, wormwood 15g, magnetite 30g, salvia miltiorrhiza 15g, Prunella vulgaris 15g, dodder seed 12g, Ligustrum lucidum 12g, Notopterygium incisum 10g; 14-28 packs, decocted in water, one dose per day, divided into morning and evening

[0094] Third visit date: April 30, 2024

[0095] Take the above for 28 days, LMP: April 14, 2024, cycle 34 days, moderate volume (change 4-5 sanitary napkins per day), no blood clots, low back pain. At present: poor sleep and easy awakening improved, sticky stool, once a day, dark tongue, thin white fur, stringy pulse. No sexual history since the last menstrual period.

[0096] [Auxiliary examination] Female hormones were rechecked on April 17, 2024: E2: 31.57pg / ml, FSH: 5.5mIU / ml, PRL: 4.66ng / ml, T: 0.45ng / ml, LH: 6.1mIU / ml, P: 0.28ng / ml, A2: 8.3nmol / L, DHEAS: 9.42umol / L, SHBG: 36.2nmol / L.

[0097] [Treatment] Replace the above with 10g stir-fried Chinese date seeds, and continue taking 14 doses;

[0098]

Comments

[0099] Typical Case 2

[0100] Wang, female, 35 years old.

[0101] Date of first diagnosis: February 24, 2024.

[0102]

Main complaint

[0103] [Current medical history] Menarche at the age of 16, menstrual cycle 30 days to 1 year, menstrual period 5 to 10 days, moderate amount (up to 4-5 sanitary napkins per day), dark red color, a few blood clots, back pain, lower abdominal distension during menstruation, like warmth, last menstrual period was September 2023. She had taken Yasmin for 9 months (September 2022-June 2023).

[0104] [Present symptoms] Hair loss, impatience, anxiety, easy cracking of the skin on the hands and feet, easy waking from sleep, formed stools. Red tip of tongue, teeth marks on the edges, thin white fur, stringy and thin pulse.

[0105] [Marital and reproductive history] G0P0. No sexual history in the past 3 years.

[0106] [Auxiliary examination] Female hormones (2024.01.03): E2: 37.66pg / ml, FSH: 4.8mIU / ml, PRL: 9.39ng / ml, T: 0.76ng / ml↑, LH: 24.16mIU / ml↑, P: 0.16ng / ml, A2: 12.6nmol / L↑, DHEAS: 8.44umol / L; Thyroid function (2024-01-03): aTG: 164.5IU / ml ↑, aTPO>1300IU / ml↑; biochemistry: P: 1.48mmol / L↑, UA: 428umol / L↑, TG: 2.35mmol / L↑, HDL-C: 0.99mmol / L↓, VLDL: 1.07mmol / L↑; ultrasound (2023.6): uterus size is 4.8x3.9x2.4cm, endometrial thickness is 0.5cm, left ovary size is 2.6x1.7cm, right ovary size is 2.8x1.9cm.

[0107]

Western medicine diagnosis

[0108] [Chinese medicine diagnosis] Liver Yang hyperactivity syndrome in the late menstrual period.

[0109]

Treatment method

[0110]

deal with

[0111] 1. 2 boxes of progesterone capsules, oral, 200 mg, for 10 days, qn.

[0112] 2. Stop medication during menstruation / do not return for follow-up visit if menstruation does not occur after 7 days of stopping medication.

[0113] 3. On the 2nd-4th day of the next menstruation, check: female hormones, AMH, GLU (0, 1h, 2h), INS (0, 1h, 2h), COR, ACTH.

[0114] 4. Measure basal body temperature.

[0115] 5. White peony root 12g, raw oyster 20g, stone cassia twig 15g, stir-fried jujube seed 12g, artemisia capillaris 12g, magnetite 20g, salvia miltiorrhiza 12g, selfheal 12g, dodder seed 10g, Ligustrum lucidum 10g, and Notopterygium wilfordii 9g; 21 packs, decocted in water, 1 dose per day, taken warm in the morning and evening.

[0116] Second visit: March 27, 2024, took 21 sets of the above prescription. LMP: March 19 (P), 9 days clean, moderate amount (changed 3 tablets a day), bright red color, rapid bleeding, abdominal distension during menstruation, mild diarrhea, fatigue. At present: hair loss improved, impatience and anxiety improved, skin on hands and feet easily cracked, easy to wake up when sleeping, normal bowel movements. Tongue pale with tooth marks, thin white fur, stringy and thin pulse with left weak pulse.

[0117] [Auxiliary examination] Pancreatic islet function (2024.3.20): INS 0h: 128.6mU / L↑, INS1h: 1251.37mU / L, INS2h: 725.44mU / L; Female hormones (2024.3.20): E2: 37.96pg / ml, FSH: 5.1mIU / ml, PRL: 9.06ng / ml, T: 0.63ng / ml, LH: 15.3mIU / ml↑, P: 0.9ng / ml, A2: 8.44nmol / L; AMH 9.88ng / ml↑; ACTH: 17.42pmol / L; COR: 5.172ug / L.

[0118]

deal with

[0119] 1. Measure basal body temperature.

[0120] 2. Continue to take the above

[0121] 14 doses, decocted in water, 1 dose per day, taken warm in the morning and evening.

[0122] 3. Check female hormone levels again on the 2nd to 4th day of the next menstrual period.

[0123] Third visit: April 24, 2024, 14 sets of the above prescription were taken. Menstruation started on April 23, with a cycle of 35 days, with more volume than before (10 tablets per day), dark red, no blood clots, and back pain during menstruation. Last month, BBT was biphasic. Now: 1 bowel movement per day, loose stools, constipation, and poor appetite. Tooth marks on the sides of the tongue, thin white fur, and deep and stringy pulse.

[0124] [Auxiliary examination] Female hormones (2024.4.24): E2: 25.42pg / ml, FSH: 4.5mIU / ml, PRL: 8.48ng / ml, T: 0.41ng / ml, LH: 5.02mIU / ml, P: 0.14ng / ml, A2: 4.13nmol / L; DHEAS: 8.85umol / L, SHBG: 16.5nmol / L.

[0125] [Treatment] Continue to take 14 doses of the above prescription to consolidate the therapeutic effect.

[0126]

Comments

[0127] Typical Case 3

[0128] Zhang Lin, female, 26 years old

[0129] First visit: March 29, 2024

[0130]

Main complaint

[0131] [Current medical history] The patient had intermittent missed menstruation after her menarche at the age of 13, with the longest period lasting 3 or 4 months, and occasionally normal, with a menstrual period of 7 days. She was diagnosed with PCOS at a local hospital and was treated with oral Chinese medicine or progesterone. The menstrual period relapsed after stopping the medication. PMP: 2023.12.14 Medium volume, 3-4 sanitary napkins per day, bright red color, no blood clots, occasional dysmenorrhea, premenstrual breast pain, LMP: 3.16-3.22 (progesterone).

[0132] [Current symptoms] Hair loss, fatigue, dry mouth, easy to be anxious, sad and crying, good appetite, shallow sleep and easy to wake up, normal urination, 2-3 bowel movements per day, normal stool quality. The tongue is fat, the tip of the tongue is red, the tongue is dark purple, there are cracks on it, the tongue coating is white and greasy, and the pulse is stringy.

[0133] [Marriage and reproductive history] G0P0, denied sexual life in the past month

[0134] [Auxiliary examination] 2024.3.3 Gynecological B-ultrasound: uterus 40x40x35mm, endometrium 7.9mm, cervix without echo 4x3mm, left ovarian cyst 7x7mm, right ovarian cyst 8x6mm; 2024.3.4 Female hormones: LH 20.9mIU / ml↑, FSH 7.2mIU / ml, PRL 15.220pg / ml, P 0.33pg / ml, T 0.68pg / ml, E2 38.25pg / ml.

[0135]

deal with

[0136] 1. Measure basal body temperature

[0137] 2. White peony root 10g, raw oyster 15g, stone cassia seed 12g, stir-fried jujube seed 10g, artemisia capillaris 10g, magnetite 15g, salvia miltiorrhiza 10g, selfheal 9g, dodder seed 9g, Ligustrum lucidum 9g, and Notopterygium wilfordii 6g; 14-28 packets, decocted in water and taken orally, one dose per day, divided into morning and evening.

[0138] Second visit: June 5, 2024

[0139] LMP: 6.4PMP: 3.16Cycle 79 days, no increase in flow, bright red color, blood clots, tolerable premenstrual abdominal pain, breast swelling

[0140] At present: Hair loss improved, fatigue, good appetite, bowel movement once a day, formed. Denied sexual history since last menstruation. Tongue fat, few tooth marks, thin white fur, tip petechiae, stringy pulse.

[0141] [Auxiliary examination] 2024-6-5 Female hormones: E2 33.34pg / ml, FSH 4.9mIU / ml, PRL 24.47ng / ml, T 0.42pg / ml, LH 4.63mIU / ml, P 1.26pg / ml, A2 5.01nmol / L, DHEAS 7umol / L, AMH11.92ng / ml↑, SHBG 30.3nmol / L. Glucose (fasting): 5.03mmol / L, glucose (1h after meal): 5mmol / L, glucose (2h after meal): 5.02mmol / L, pancreatic islet function (fasting): 63.93Pmol / L, pancreatic islet function (1h after meal): 295.29Pmol / L, pancreatic islet function (2h after meal): 219.46Pmol / L. There were no obvious abnormalities in COR, ACTH, biochemistry, blood R, and thyroid function.

[0142] [Comment] The patient had delayed her menstruation for more than 10 years and was already old, so we asked her to undergo a check-up to identify the cause of the disease: a female hormone test revealed elevated serum luteinizing hormone (LH) in the patient. LH is secreted by the pituitary gland and regulated by the hypothalamus, which is an important anatomical structure that connects female emotions and reproductive endocrine system. The patient was usually anxious and easy to cry, and had a dark tongue and a stringy pulse. Traditional Chinese medicine believes that "the liver governs emotions" and anxiety belongs to "liver qi discomfort". Considering the liver as the treatment, the white peony root in the prescription nourishes yin and softens the liver, so that the liver yin is not deficient and the liver yang is not hyperactive; raw oyster calms the liver and suppresses yang, so that the hyperactive liver yang can be suppressed, and it is often used with white peony root to treat patients with liver qi stagnation; Daizheshi and Shijueming calm the liver and suppress yang, clear the head; Ziziphus jujuba seed nourishes the liver and helps yin, restrains qi and calms the mind; Artemisia capillaris clears liver heat and soothes liver qi; Ligustrum lucidum and Cuscuta chinensis nourish the liver and kidney; Salvia miltiorrhiza and Prunella vulgaris clear liver fire, activate blood circulation and disperse knots; Notopterygium wilfordii raises yang qi to help follicles discharge. The second visit showed that the patient's hair loss was relieved, so the dosage of Ligustrum lucidum and Cuscuta chinensis was reduced, and the above prescription was continued for consolidation. The female hormone level was basically restored to normal after reexamination, indicating that the drug and the evidence were in harmony and the efficacy was clear.

[0143] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not limitations on the implementation methods of the present invention. For ordinary technicians in the relevant field, other different forms of changes or modifications can be made based on the above description. It is impossible to list all the implementation methods here. All obvious changes or modifications derived from the technical solution of the present invention are still within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating polycystic ovary syndrome hyperluteinizing syndrome, characterized in that: In parts by weight, the Chinese medicine composition includes the following raw materials: 10-15 parts of white peony root, 10-30 parts of raw oyster, 10-20 parts of semen cassiae, 3-15 parts of stir-fried jujube seeds, 3-15 parts of capillaris, 10-30 parts of magnetite, 3-15 parts of salvia miltiorrhiza, 3-15 parts of selfheal, 3-12 parts of dodder seed, 3-12 parts of glossy privet fruit, and 3-10 parts of notopterygium wilfordii.

2. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the Chinese medicine composition includes the following raw materials: 15 parts of white peony root, 30 parts of raw oyster, 20 parts of semen cassiae, 15 parts of stir-fried jujube seeds, 15 parts of capillaris, 30 parts of magnetite, 15 parts of salvia miltiorrhiza, 15 parts of selfheal, 12 parts of dodder seed, 12 parts of glossy privet fruit, and 10 parts of notopterygium wilfordii.

3. The Chinese medicine composition according to claim 1, characterized in that In parts by weight, the Chinese medicine composition includes the following raw materials: 12 parts of white peony root, 20 parts of raw oyster, 15 parts of semen cassiae, 12 parts of stir-fried jujube seeds, 12 parts of capillaris, 20 parts of magnetite, 12 parts of salvia miltiorrhiza, 12 parts of selfheal, 10 parts of dodder seed, 10 parts of glossy privet fruit, and 9 parts of notopterygium wilfordii.

4. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the Chinese medicine composition includes the following raw materials: 10 parts of white peony root, 15 parts of raw oyster, 12 parts of semen cassiae, 10 parts of stir-fried jujube seeds, 10 parts of capillaris, 15 parts of magnetite, 10 parts of salvia miltiorrhiza, 9 parts of selfheal, 9 parts of dodder seed, 9 parts of glossy privet fruit, and 6 parts of notopterygium wilfordii.

5. The method for preparing the Chinese medicine composition for treating hyperluteinizing syndrome in polycystic ovary syndrome according to any one of claims 1 to 4, characterized in that: The preparation method comprises the following steps: taking white peony root, raw oyster, cassia bark, stir-fried jujube seed, capillaris, magnetite, salvia miltiorrhiza, selfheal, dodder seed, glossy privet fruit and notopterygium wilfordii according to the formula, adding water and boiling twice, combining the decoctions and filtering to obtain the product.

6. The preparation method according to claim 5, characterized in that: The preparation method also includes the step of concentrating the filtrate into a clear paste.

7. The preparation method according to claim 6, characterized in that: The amount of water added is 10-15 times the total weight of the API; The decoction time is 1-1.5 hours; The clear paste has a relative density of 1.30-1.35 measured at 60°C.

8. A Chinese medicine preparation for treating polycystic ovary syndrome with hyperluteinizing hormone, characterized in that: The Chinese medicine preparation comprises the Chinese medicine composition according to any one of claims 1 to 4 as an active ingredient; Preferably, the traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients.

9. The Chinese medicine preparation according to claim 8, characterized in that: The dosage form of the Chinese medicine preparation is decoction, granules, pills, capsules, tablets, powders or oral liquid.

10. Use of the Chinese medicine composition according to any one of claims 1 to 4 or the Chinese medicine preparation according to any one of claims 8 to 9 in the preparation of a drug for treating hyperluteinizing syndrome in polycystic ovary syndrome.

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