A traditional Chinese medicine composition for treating polycystic ovary syndrome and its application

Abstract

The present invention discloses a Chinese medicine composition for treating hyperluteinizing hormone (LH) in polycystic ovary syndrome (PCOS) and its application. The Chinese medicine composition comprises the following raw materials: 10-15 parts of white peony root, 10-30 parts of raw oyster, 10-20 parts of stone cassia seed, 3-15 parts of stir-fried jujube seeds, 3-15 parts of artemisia capillaris, 10-30 parts of daizheshi, 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. The present invention also discloses a preparation method of the above-mentioned Chinese medicine composition and its application in preparing a drug for treating hyperluteinizing hormone (LH) in polycystic ovary syndrome. The Chinese medicine composition of the present invention has the effect 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 particularly to a traditional Chinese medicine composition for treating polycystic ovary syndrome (PCOS) with hyperluteinizing hormone (HLH) 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 worldwide. It is characterized by oligo- or anovulation, clinical or biochemical hyperandrogenism, and polycystic ovaries. While elevated luteinizing hormone (LH) levels are not a diagnostic criterion for PCOS, they are a common pathological finding. Persistent hyperandrogenism can exacerbate hyperandrogenism and inhibit follicular development and ovulation.

[0003] Currently, there is no effective treatment for hyperluteinizing hormone in polycystic ovary syndrome, and the main treatment is indirect treatment by reducing androgens.

[0004] Therefore, for patients with polycystic ovary syndrome and hyperluteinizing hormone, a traditional Chinese medicine preparation that can reduce serum luteinizing hormone and androgen levels and promote menstruation needs to be developed. 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 polycystic ovary syndrome with hyperluteinizing hormone.

[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 traditional Chinese medicine preparation comprising the above-mentioned traditional Chinese medicine composition and the use of the above-mentioned traditional Chinese medicine composition and its pharmaceutical preparation in the preparation of a drug for treating polycystic ovary syndrome with hyperluteinizing hormone.

[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 hormone deficiency 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 stone cassia seed, 3-15 parts of stir-fried jujube seeds, 3-15 parts of artemisia 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 years of clinical experience and exploration by the inventors based on Traditional Chinese Medicine theory, and has been analyzed, researched, and verified. The Chinese medicine composition has a simple prescription and is effective in reducing serum luteinizing hormone and androgen levels and promoting menstruation.

[0011] In this prescription, white peony root and raw oyster are both monarch herbs, nourishing blood and softening the liver, nourishing yin and suppressing yang. Semen Cassiae, stir-fried jujube seeds, and daiheshi are assistant herbs, enhancing the monarch herbs' efficacy in nourishing blood and softening the liver, nourishing yin and suppressing yang. Artemisia capillaris clears damp-heat in the liver meridian and serves as an adjuvant. Salvia miltiorrhiza and Prunella vulgaris promote blood circulation and resolve stagnation, serving as adjuvants. Cuscuta seed and Ligustrum lucidum fruit tonify kidney qi and serve as adjuvants. Notopterygium wilfordii dispels wind and dampness and serves as an adjuvant.

[0012] Illustratively, in parts by weight, the traditional Chinese medicine composition for treating hyperluteinizingemia in polycystic ovary syndrome includes the following raw medicines: 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] Illustratively, in parts by weight, the traditional Chinese medicine composition for treating hyperluteinizingemia in polycystic ovary syndrome includes the following raw medicines: 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] Illustratively, in parts by weight, the traditional Chinese medicine composition for treating polycystic ovary syndrome with hyperluteinizing hormone includes the following raw medicines: 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 hyperluteinizing hormoneemia in polycystic ovary syndrome, the preparation method comprising the following steps: taking white peony root, raw oyster, stone cassia, fried jujube seed, capillaries, magnetite, salvia miltiorrhiza, selfheal, dodder seed, glossy privet fruit, and notopterygium wilfordii according to the formula, adding water and decocting twice, combining the decoctions, and filtering to obtain the composition.

[0017] Furthermore, in order to facilitate storage, the above preparation method may further 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 polycystic ovary syndrome with hyperluteinizing hormone, 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 further 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. can be prepared.

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

[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 values ​​between the end values, and any sub-range of Chinese medicine compositions composed of the end values ​​or any numerical values ​​between the end values, can achieve the purpose of treating hyperluteinizingemia 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. It realizes the target treatment of polycystic ovary syndrome hyperluteinizing hormoneemia by traditional Chinese medicine and fills the gap in the treatment of polycystic ovary syndrome hyperluteinizing hormoneemia. DETAILED DESCRIPTION

[0025] In order to explain the present invention more clearly, the present invention is further described below in conjunction with preferred embodiments. Those skilled in the art should understand 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, artemisia capillaris 15g, magnetite 30g, salvia miltiorrhiza 15g, selfheal 15g, dodder seed 12g, privet fruit 12g, and angelica dahurica 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 (relative density of 1.30-1.35 (60°C) clear paste).

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

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

[0031] 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, concentrate the filtrate to an appropriate amount (relative density of 1.30-1.35 (60°C) clear paste), dry under reduced pressure, crush through an 80-mesh sieve, add an appropriate amount of dextrin, mix well, granulate, and dry to obtain the product.

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

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

[0034] Take the above eleven raw materials, add 10 times the amount of 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 therapeutic effect of the Chinese medicine composition of the present invention on 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 polycystic ovary syndrome and hyperluteinizing hormone (PLH) who visited the gynecology clinic of Guang'anmen Hospital, China Academy of Chinese Medical Sciences between January 2022 and June 2024. The patients were aged 30.38 ± 0.70 years. Before treatment, the median serum LH level was 17.09 mIU / ml, the menstrual cycle score was 3.48 ± 0.30, and the median serum testosterone level was 0.7 ng / 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 by the Obstetrics and Gynecology Branch of the Chinese Medical Association.

[0042] 1.2.2 Case inclusion criteria

[0043] (1) Meet the diagnostic criteria for PCOS; (2) LH level higher than the normal range; (3) Age 18-35 years;

[0044] 1.2.3 Case Exclusion Criteria

[0045] (1) Patients with other endocrine diseases such as diabetes, thyroid, and adrenal gland diseases; (2) Patients with serious cardiovascular, liver, kidney, and hematopoietic system diseases 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 function 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

[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 (a decoction made of 15g white peony root, 30g raw oyster, 20g stone cassia, 15g stir-fried jujube seed, artemisia capillaris, 30g magnetite, 15g salvia miltiorrhiza, 15g selfheal, dodder seed 12g, glossy privet fruit 12g, and notopterygium wilfordii). Take one dose a day, decocted in water, twice a day, morning and evening, for 12 consecutive 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] A database was established using SPSS 26.0 statistical software. Measurement data were expressed as mean ± standard deviation (±s) or mean (interquartile range). Paired t-tests were used to analyze the data. Nonparametric tests were used for nonnormally distributed 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, the serum LH level of POCS was significantly lower after treatment compared with that before treatment, and the difference was statistically significant (P < 0.01), indicating that the Chinese herbal composition of the present invention has the effect of lowering 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, the serum T level after treatment was significantly lower than that before treatment, and the difference was statistically significant (P < 0.01), indicating that the Chinese herbal 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, the menstrual cycle score was significantly reduced after treatment compared with that before treatment, and the difference was statistically significant (P < 0.01), indicating that the Chinese herbal 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 present 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 menstrual periods every 5-6 days and every 30-90 days since menarche at age 14. The flow is slightly heavy (changing six sanitary napkins daily), dark red, with numerous blood clots. During menstruation, she experiences a cold, heavy, and bloated lower abdomen, as well as low back pain. In 2020, she visited a local hospital and was diagnosed with polycystic ovary syndrome (PCOS). She has been taking Diane-35, dydrogesterone, and Usire. PMP: December 29, 2023 (Usire), LMP: March 10, 2024 (dydrogesterone). The flow is the same as before, with no blood clots.

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

[0078] [Marital and reproductive history] G1P1, history of sexual intercourse since last menstruation.

[0079]

Past medical history

[0080] [Auxiliary examination] On January 9, 2024, the complete biochemical test results were as follows: TG: 2.09↑; no obvious abnormalities were 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. 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), 72-day cycle, heavy flow (six sanitary napkin changes daily), no blood clots, lower back pain during menstruation. Presenting symptoms: impatience, irritability, hot palms, easy awakening, formed bowel movements, once daily. Dark tongue, thin white fur, wiry pulse. No history of sexual intercourse since 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): 6.03 mmol / L, glucose (1 hour after meal): 8.78 mmol / L, glucose (2 hours after meal): 7.34 mmol / L, pancreatic islet function (fasting): 55.05 pmol / L, pancreatic islet function (1 hour after meal): 499.52 pmol / L, pancreatic islet function (2 hours after meal): 219.63 pmol / L. Ultrasound examination on March 19, 2024: endometrial thickness 0.5 cm, polycystic ovaries bilaterally.

[0092]

deal with

[0093] White peony root 15g, raw oyster 30g, stone cassia twig 20g, stir-fried jujube seed 15g, artemisia capillaris 15g, magnetite 30g, salvia miltiorrhiza 15g, selfheal 15g, dodder seed 12g, privet fruit 12g, and angelica root 10g. 14-28 packets, decocted in water, one dose per day, divided into morning and evening doses.

[0094] Third visit date: April 30, 2024

[0095] After 28 days of use, LMP: April 14, 2024, a 34-day cycle, moderate flow (4-5 sanitary napkin changes daily), no blood clots, and lower back pain. Currently: poor sleep and frequent awakenings have improved, stools are sticky, and only once a day, tongue dark with a thin white coating, pulse stringy. No sexual history since 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 formula with 10g of stir-fried Chinese date seeds, and continue taking for 14 doses.

[0098] [Comment] The patient's menstrual cycle was delayed, and ultrasound revealed polycystic ovary-like changes. Combined with her history of PCOS, a diagnosis of PCOS was possible. Since her previous menstrual cycle was delayed, and she was menstruating at the time of the first visit, she was instructed to undergo an examination to determine the cause. The patient's serum luteinizing hormone (LH) was elevated. LH is secreted by the pituitary gland, which is regulated by the hypothalamus. The hypothalamus is a key anatomical structure connecting women's emotions and reproductive endocrine function. Traditional Chinese medicine believes that "the liver governs emotions" and "women are born with the liver." The patient was often impatient and irritable, and had a dark tongue and a stringy pulse. Therefore, the treatment was based on the liver. The white peony root in the prescription nourishes yin and softens the liver, preventing liver yin deficiency and preventing liver yang from rising. Raw oyster calms the liver and suppresses yang, allowing hyperactive liver yang to subside. It is often used with white peony to treat patients with impatience and irritability. Semen Cassiae and Hematite calm the liver and suppress yang, clearing the head. Ziziphus jujuba seed nourishes the liver and aids yin, restrains qi and calms the mind. Artemisia capillaris clears liver heat and soothes liver qi. For lumbago during menstruation, Ligustrum lucidum and Cuscuta australis were used to nourish the liver and kidneys. The patient had symptoms of heat in the palms of her hands, suggesting heat in the blood. Salvia miltiorrhiza and Prunella vulgaris were used to clear heat in the blood, and Notopterygium wilfordii slightly lifted the follicles to aid ovulation. At the third visit, the patient's hormone levels returned to normal and her sleep improved, so the dosage of stir-fried Ziziphus jujuba seed was reduced and continued to consolidate the therapeutic effect, helping the patient stabilize ovulation and menstruation.

[0099] Typical Case 2

[0100] Wang, female, 35 years old.

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

[0102]

Chief complaint

[0103] [Current medical history] Menarche at age 16, menstrual cycle 30 days to 1 year, menstrual period 5 to 10 days, moderate flow (up to 4-5 sanitary napkins changed per day), dark red color, a few blood clots, back pain, lower abdominal distension during menstruation, prefers warmth, last menstrual period was September 2023. Previously treated with 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, and hard-formed stools. The tip of the tongue is red with teeth marks on the edges, the tongue coating is thin and white, and the pulse is stringy and thin.

[0105] [Marital and reproductive history] G0P0. No sexual history in the past three 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): uterine 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 Medical Diagnosis] 1. PCOS?; 2. Hashimoto's thyroiditis; 3. Hyperlipidemia.

[0108]

Chinese Medicine Diagnosis

[0109]

Treatment method

[0110]

deal with

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

[0112] 2. Stop taking the medicine during menstruation / come back for follow-up visit if menstruation does not occur after 7 days of stopping the medicine.

[0113] 3. On the 2nd to 4th day of the next menstrual period, check the following 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, privet fruit 10g, and angelica root 9g; 21 packets, decocted in water and taken orally, 1 dose per day, warm in the morning and evening.

[0116] Second visit: March 27, 2024, 21 doses of the above formula were taken. LMP: March 19 (P), 9 days clear, moderate volume (3 tablets per day), bright red color, rapid bleeding, abdominal distension during menstruation, mild diarrhea, fatigue. Current: Hair loss improved, impatience and anxiety improved, skin on hands and feet cracks easily, sleep is easy to wake, bowel movements are normal. Tongue pale with teeth marks, thin white fur, pulse stringy and weak on the left.

[0117] [Auxiliary examination] 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 taking 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 on the 2nd to 4th day of the next menstrual period.

[0123] Third visit: April 24, 2024. 14 doses of the above formula were taken. Menstruation began on April 23rd, with a 35-day cycle. The flow was heavier than before (10 tablets per day), dark red, without clots, and accompanied by lower back pain. Last month, BBT was biphasic. Current: Only one bowel movement per day, loose stools, with poor bowel movements and poor appetite. The tongue had tooth marks, a thin white coating, and a deep, 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 taking 14 doses of the above prescription to consolidate the therapeutic effect.

[0126] [Comment] The patient, a young woman, presented with a diagnosis of "20-year delayed menstruation." She hadn't had her period for 5 months, ruling out the possibility of pregnancy, which falls under the category of "late menstruation" in Traditional Chinese Medicine. Based on her clinical manifestations and pulse and tongue, she was diagnosed with a syndrome of liver yang hyperactivity. She was known for her impatience, irritability, and anxiety. The liver is associated with anger, which harms the liver. Failure of the liver to regulate qi flow can lead to poor qi circulation, which can transform into fire and trigger liver yang, leading to liver yang hyperactivity. "Women are born with the liver," and liver qi stagnation can lead to delayed menstruation. Qi stagnation and blood stasis can cause minor blood clots during menstruation. Failure of liver qi regulation can also lead to delayed menstruation and ovulation disorders. Her hormone levels suggest elevated LH and hyperandrogenism. The treatment focuses on calming the liver and suppressing yang. The prescription used is modified Zhengan Xifeng Decoction. White peony root nourishes blood and softens the liver, calming liver yang. Raw oysters suppress yang and replenish yin, providing a calming and tranquilizing effect. Together, these two herbs calm and descend liver yang, nourishing yin and blood. Stir-fried jujube seeds nourish blood and tonify the liver, astringing yin and tranquilizing the mind. Daizheshi and Shijueming are heavy and suppress rising yang. Artemisia capillaris clears dampness and heat. Ligustrum lucidum and Cuscuta chinensis nourish kidney yin and yang, replenishing the kidney and replenishing essence. The patient's tongue tip was red, so the prescription used Danshen to clear the heart and cool the blood, Prunella vulgaris to clear the liver and purge fire, and Notopterygium wilfordii to slightly lift and promote ovarian follicle discharge. A second visit revealed that the patient still had high LH levels, but the LH level was lower than before, and her impatience, irritability, and hair loss had improved. Therefore, the dosages of Shijueming, Daizheshi, Ligustrum lucidum, and Cuscuta chinensis were reduced, and the above prescription was continued to consolidate the therapeutic effect. At the third visit, the patient's menstruation had already started and her BBT was biphasic. A review of female hormones showed that the LH level had returned to normal, indicating that this prescription was effective.

[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 experienced intermittent missed periods after menarche at age 13, with periods lasting up to three to four months, occasionally with a normal, seven-day period. She was diagnosed with PCOS at a local hospital and treated with oral traditional Chinese medicine and progesterone, but relapsed after discontinuation of these medications. PMP: December 14, 2023, moderate volume, 3-4 sanitary napkin changes daily, bright red, no blood clots, occasional dysmenorrhea, and premenstrual breast tenderness. LMP: 3.16-3.22 (progesterone).

[0132] [Current symptoms] Hair loss, fatigue, dry mouth, anxiety, sadness, and crying, good appetite, light sleep and easy awakening, normal urination, 2-3 bowel movements daily, normal stool consistency. Tongue is thick, with a red tip, dark purple with cracks, white greasy coating, and a stringy pulse.

[0133] [Marital history] G0P0, denied sexual activity for the past month

[0134] [Auxiliary examination] Gynecological B-ultrasound on March 3, 2024: uterus 40x40x35mm, endometrium 7.9mm, cervix 4x3mm without echo, left ovarian cyst 7x7mm, right ovarian cyst 8x6mm; Female hormones on March 4, 2024: 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, Prunella vulgaris 9g, Cuscuta australis 9g, Ligustrum lucidum 9g, Notopterygium wilfordii 6g; 14-28 packets, decocted in water and taken orally, one dose per day, divided into morning and evening doses.

[0138] Second visit: June 5, 2024

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

[0140] At present: Hair loss has improved, fatigue has improved, appetite is good, bowel movements are once daily, and they are formed. She denies any sexual history since her last menstrual period. Tongue is plump, with few tooth marks, thin white fur, petechiae at the tip, and pulse is stringy.

[0141] [Auxiliary examination] Female hormones on June 5, 2024: E2 33.34 pg / ml, FSH 4.9 mIU / ml, PRL 24.47 ng / ml, T 0.42 pg / ml, LH 4.63 mIU / ml, P 1.26 pg / ml, A2 5.01 nmol / L, DHEAS 7 μmol / L, AMH 11.92 ng / ml↑, SHBG 30.3 nmol / L. Glucose (fasting): 5.03 mmol / L, glucose (1 hour after meal): 5 mmol / L, glucose (2 hours after meal): 5.02 mmol / L, pancreatic islet function (fasting): 63.93 pmol / L, pancreatic islet function (1 hour after meal): 295.29 pmol / L, pancreatic islet function (2 hours after meal): 219.46 pmol / 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 she was asked to undergo examination to identify the cause of the disease: a female hormone test showed that the patient's serum luteinizing hormone (LH) was elevated. LH is secreted by the pituitary gland and regulated by the hypothalamus, which is an important anatomical structure connecting female emotions and reproductive endocrine system. The patient was anxious and prone to crying, and also had a dark tongue and a wiry pulse. Traditional Chinese medicine believes that "the liver governs emotions," and anxiety is a manifestation of "liver qi disharmony." Therefore, treatment should be focused on the liver. The white peony root in the formula nourishes yin and softens the liver, ensuring that liver yin is maintained and liver yang is not hyperactive. Raw oyster calms the liver and suppresses yang, allowing hyperactive liver yang to subside. It is often used with white peony root to treat patients with liver qi stagnation. Hematite and Cassiae chinensis calm the liver and suppress yang, clearing the head and eyes. Ziziphus jujuba seed nourishes the liver and yin, astringes qi and calms the mind. Artemisia capillaris clears liver heat and soothes liver qi. Ligustrum lucidum and Cuscuta chinensis nourish the liver and kidneys. Salvia miltiorrhiza and Prunella vulgaris clear liver fire, activate blood circulation and resolve stagnation. Notopterygium wilfordii raises yang to aid ovarian follicle discharge. On the second visit, the patient's hair loss had resolved, so the dosage of Ligustrum lucidum and Cuscuta chinensis was reduced, and the above formula was continued for consolidation. A follow-up examination showed that female hormone levels had essentially returned to normal, demonstrating a well-matched medication and clear efficacy.

[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 scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating polycystic ovary syndrome with hyperluteinizing hormone, characterized in that: The traditional Chinese medicine composition is prepared from 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 stone cassia seed, 3-15 parts of fried jujube seeds, 3-15 parts of artemisia 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 privet fruit, and 3-10 parts of notopterygium wilfordii.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of white peony root, 30 parts of raw oyster, 20 parts of stone cassia seed, 15 parts of stir-fried jujube seeds, 15 parts of artemisia 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 The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 12 parts of white peony root, 20 parts of raw oyster, 15 parts of stone cassia seed, 12 parts of stir-fried jujube seeds, 12 parts of artemisia 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 The Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 parts of white peony root, 15 parts of raw oyster, 12 parts of stone cassia seed, 10 parts of fried jujube seeds, 10 parts of artemisia 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 polycystic ovary syndrome with hyperluteinizing hormone 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, stone cassia seed, fried jujube seed, capillaries, 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 further comprises 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 uses the Chinese medicine composition according to any one of claims 1 to 4 as an active ingredient.

9. The Chinese medicine preparation according to claim 8, characterized in that The traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients.

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

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

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