Traditional Chinese medicine composition for improving premature ovarian failure and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and discloses a traditional Chinese medicine composition for improving premature ovarian failure, the traditional Chinese medicine composition is formed by combining an oral medicine and an external application patch, and the oral medicine is prepared from the following medicinal materials: adenophora stricta, radix ophiopogonis, angelica sinensis, medlar, Chinese yam, radix rehmanniae recen, dogwood, glossy privet fruit, eclipta, ligusticum wallichii, radix paeoniae alba, semen cuscutae, schisandra chinensis, raspberry and mulberry. The external application patch is prepared from the following traditional Chinese medicinal materials: adenophora stricta, radix ophiopogonis, angelica sinensis, fructus lycii, Chinese yam, radix rehmanniae recen, dogwood, glossy privet fruit, eclipta, ligusticum wallichii, radix paeoniae alba, semen cuscutae, schisandra chinensis, raspberry, mulberry, herba epimedii, salvia miltiorrhiza, red ginseng, borneol and fructus evodiae. The traditional Chinese medicine composition disclosed by the invention is scientific and reasonable in compatibility, has the effects of exuberant kidney essence, sufficient liver blood, nourishing Chong and Ren channels and full blood sea, can nourish liver yin by nourishing kidney yin, regulate and treat symptoms such as premature ovarian failure, amenorrhea, hypomenorrhea, deficiency of liver-yin and kidney-yin, hectic fever and sweating, insomnia, dysphoria and irritability and improve ovarian functions, and is remarkable in clinical effect.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for improving premature ovarian failure and its preparation method. Background Technology

[0002] Premature ovarian failure (POF) is a gynecological endocrine disorder characterized by amenorrhea in women before the age of 40, elevated gonadotropin levels (FSH > 40 U / L), decreased estrogen levels, and varying degrees of perimenopausal symptoms. In recent years, due to social development, life stress, and environmental pollution, the onset of POF is trending towards younger ages, and the incidence rate continues to rise. It typically occurs before the age of 40, with some patients even experiencing symptoms around the age of 30.

[0003] The causes of premature ovarian failure are complex and diverse, including genetic factors, iatrogenic factors, immune factors, environmental factors, infectious factors, and psychological factors. Regarding genetic factors, chromosomal abnormalities and defects or mutations in specific genes can impair ovarian function. Among iatrogenic factors, a history of pelvic surgery and chemotherapy / radiotherapy can suppress ovarian function. Immune factors cause the immune system to attack normal ovarian tissue or cells. Environmental factors such as air pollution and chemicals can adversely affect ovarian function. Among infectious factors, certain viral infections can damage reproductive function. Psychological factors may affect the hypothalamus-pituitary-ovarian axis, leading to endocrine and metabolic disorders.

[0004] Modern medicine primarily treats premature ovarian failure with hormone replacement therapy and ovulation induction, which are quite effective, but suffer from high relapse rates after discontinuation. While ovulation induction can help some patients achieve their fertility goals, its success rate is relatively low, and it carries risks of complications such as multiple pregnancies and ovarian hyperstimulation syndrome. In view of the shortcomings of the existing technologies, this invention provides a traditional Chinese medicine composition and its preparation method for improving premature ovarian failure. This composition is used to treat premature ovarian failure, amenorrhea, oligomenorrhea, liver and kidney yin deficiency, hot flashes, sweating, insomnia, irritability, and other symptoms, improving ovarian function with significant clinical effects. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine composition for improving premature ovarian failure and its preparation method. The traditional Chinese medicine composition of this invention is scientifically and rationally formulated, possessing the effects of invigorating kidney essence, replenishing liver blood, nourishing the Chong and Ren meridians, and filling the blood sea. Furthermore, by nourishing kidney yin to nourish liver yin and restraining liver yang, it treats premature ovarian failure, amenorrhea, oligomenorrhea, liver and kidney yin deficiency, hot flashes and sweating, insomnia, irritability, and other symptoms, thereby improving ovarian function with significant clinical effects.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows: A traditional Chinese medicine composition for improving premature ovarian failure, comprising an oral medication and a topical application, wherein the oral medication is composed of the following traditional Chinese medicinal materials: Adenophora stricta, Ophiopogon japonicus, Angelica sinensis, Lycium barbarum, Dioscorea opposita, Rehmannia glutinosa, Cornus officinalis, Ligustrum lucidum, Eclipta prostrata, Ligusticum chuanxiong, Paeonia lactiflora, Cuscuta chinensis, Schisandra chinensis, Rubus idaeus, and Morus alba; The external application patch is composed of the following Chinese medicinal materials: Adenophora stricta, Ophiopogon japonicus, Angelica sinensis, Lycium barbarum, Dioscorea opposita, Rehmannia glutinosa, Cornus officinalis, Ligustrum lucidum, Eclipta prostrata, Ligusticum chuanxiong, Paeonia lactiflora, Cuscuta chinensis, Schisandra chinensis, Rubus idaeus, Morus alba, Epimedium brevicornu, Salvia miltiorrhiza, Panax ginseng, Borneol, and Evodia rutaecarpa.

[0007] Preferably, the oral medication is made from the following raw materials in parts by weight: 15-30 parts of Adenophora stricta, 15-30 parts of Ophiopogon japonicus, 15-30 parts of Angelica sinensis, 15-30 parts of Lycium barbarum, 15-30 parts of Dioscorea opposita, 15-30 parts of Rehmannia glutinosa, 15-30 parts of Cornus officinalis, 10-20 parts of Ligustrum lucidum, 10-20 parts of Eclipta prostrata, 15-30 parts of Ligusticum chuanxiong, 15-30 parts of Paeonia lactiflora, 10-20 parts of Cuscuta chinensis, 10-20 parts of Schisandra chinensis, 10-20 parts of Rubus idaeus, and 15-30 parts of Morus alba.

[0008] Preferably, the external dressing is made from the following raw materials in parts by weight: 15-30 parts of Adenophora stricta, 15-30 parts of Ophiopogon japonicus, 15-30 parts of Angelica sinensis, 15-30 parts of Lycium barbarum, 15-30 parts of Dioscorea opposita, 15-30 parts of Rehmannia glutinosa, 15-30 parts of Cornus officinalis, 10-20 parts of Ligustrum lucidum, 10-20 parts of Eclipta prostrata, 15-30 parts of Ligusticum chuanxiong, 15-30 parts of Paeonia lactiflora, 10-20 parts of Cuscuta chinensis, 10-20 parts of Schisandra chinensis, 10-20 parts of Rubus idaeus, 15-30 parts of Morus alba, 10-20 parts of Epimedium brevicornu, 15-30 parts of Salvia miltiorrhiza, 10-20 parts of Panax ginseng, 5-10 parts of Borneol, and 10-20 parts of Evodia rutaecarpa.

[0009] Preferably, the oral medication is prepared in the following mass ratio: Adenophora stricta: Ophiopogon japonicus: Angelica sinensis: Lycium barbarum: Dioscorea opposita: Rehmannia glutinosa: Cornus officinalis: Ligustrum lucidum: Eclipta prostrata: Ligusticum chuanxiong: Paeonia lactiflora: Cuscuta chinensis: Schisandra chinensis: Rubus idaeus: Morus alba 3:3:3:3:3:3:3:2:2:3:3:3:2:2:2:3.

[0010] Preferably, the preparation method of the oral medicine is as follows: weigh the Chinese medicinal materials according to the above components, wash them separately, put them in a container, add water and soak for 30-60 minutes, bring the decoction to a boil over high heat, then simmer over low heat for 30-60 minutes, then filter to remove the residue to obtain the first-stage processed decoction, then put the residue after the first decoction into a container, add water that is 6-8 times the total weight of the medicine, and decoct for another 20-40 minutes, then filter to remove the residue to obtain the second-stage processed decoction, and mix the first-stage processed decoction and the second-stage processed decoction to obtain the Chinese medicine composition.

[0011] Preferably, the preparation method of the external dressing is as follows: weigh the Chinese medicinal materials according to the above components, grind the weighed Chinese medicinal materials into powder, then add vinegar, then add honey and ginger juice to mix into a paste, and then evenly coat the above paste-like Chinese medicine composition onto a blank non-woven fabric patch to obtain the external dressing.

[0012] Preferably, the thickness of the ointment-like traditional Chinese medicine composition coating is about 1 cm.

[0013] The properties and effects of the traditional Chinese medicine used in this invention are as follows: Adenophora stricta: Sweet and slightly bitter in taste, slightly cold in nature. It enters the lung and stomach meridians. It nourishes and invigorates blood, regulates menstruation and relieves pain, and moistens the intestines to relieve constipation. It is used for blood deficiency, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic pain, traumatic injuries, carbuncles and sores, and constipation due to intestinal dryness.

[0014] Ophiopogon japonicus: Sweet, slightly bitter, slightly cold. It enters the heart, lung, and stomach meridians. It nourishes yin and generates fluids, moistens the lungs and clears the heart. It is used for dry cough due to lung dryness, consumptive cough due to yin deficiency, sore throat, thirst due to fluid depletion, internal heat and thirst, irritability and insomnia, and constipation due to intestinal dryness.

[0015] Angelica sinensis: A perennial herb belonging to the genus Angelica in the family Apiaceae. It nourishes blood, invigorates blood circulation, regulates menstruation and relieves pain, and moistens dryness and lubricates the intestines.

[0016] Goji berries: sweet in taste and neutral in nature. They enter the liver and kidney meridians. They can nourish the liver and kidneys, benefit essence and improve eyesight.

[0017] Yam: The rhizome of Dioscorea opposita, a perennial vine-like herbaceous plant belonging to the Dioscoreaceae family. It is sweet and neutral in nature. It enters the spleen, lung, and kidney meridians. It tonifies the qi of the spleen, lungs, and kidneys, and benefits the yin of the spleen, lungs, and kidneys.

[0018] Rehmannia glutinosa: Sweet, cold. Enters the heart, liver, and kidney meridians. Clears heat and cools the blood, nourishes yin and generates fluids. Used for heat entering the blood level, febrile rashes, hematemesis, epistaxis, yin deficiency due to febrile diseases, red tongue with thirst, constipation due to fluid depletion, yin deficiency with fever, steaming bone fever, and internal heat with thirst.

[0019] Cornus officinalis: Sour, astringent, slightly warm. It enters the liver and kidney meridians. It tonifies the liver and kidneys, and astringes and consolidates the body. It is used for dizziness and tinnitus, lower back and knee pain, impotence and seminal emission, enuresis and frequent urination, metrorrhagia and leukorrhea, profuse sweating and collapse, and internal heat and thirst.

[0020] Privet fruit: Sweet, bitter, and cool in nature. It enters the liver and kidney meridians. It nourishes the liver and kidneys, improves eyesight, and darkens hair. It is used for liver and kidney yin deficiency, dizziness and tinnitus, soreness and weakness of the lower back and knees, premature graying of hair, blurred vision, internal heat and thirst, and night sweats.

[0021] Eclipta prostrata: Sweet, sour, and cold in nature. It enters the kidney and liver meridians. It nourishes the liver and kidneys, cools the blood, and stops bleeding. It is used for liver and kidney yin deficiency, loose teeth, premature graying of hair, dizziness and tinnitus, soreness and weakness of the lower back and knees, yin deficiency and blood heat causing hematemesis, epistaxis, hematuria, bloody dysentery, metrorrhagia, and external bleeding.

[0022] Chuanxiong (Ligusticum striatum): The rhizome of Chuanxiong, a perennial herbaceous plant belonging to the Apiaceae family. It is pungent and warm in nature. It enters the heart and liver meridians. It has the effects of promoting blood circulation, regulating qi, dispelling wind, and relieving pain.

[0023] White peony root: bitter, sour, slightly cold. It enters the liver and spleen meridians. It nourishes blood and regulates menstruation, astringes yin and stops sweating, softens the liver and relieves pain, and calms liver yang. It is used for blood deficiency and chlorosis, irregular menstruation, spontaneous sweating, night sweats, hypochondriac pain, abdominal pain, limb cramps, headache, and dizziness.

[0024] Cuscuta seed: pungent, sweet, and neutral in nature. It enters the liver, kidney, and spleen meridians. It tonifies the liver and kidneys, strengthens essence and reduces urination, calms the fetus, improves eyesight, and stops diarrhea.

[0025] Schisandra chinensis: Sour, sweet, and warm. It enters the lung, heart, and kidney meridians. It has astringent and consolidating properties, replenishes qi and generates fluids, tonifies the kidneys and calms the mind. It is used for chronic cough and wheezing, nocturnal emission and spermatorrhea, enuresis and frequent urination, chronic diarrhea, spontaneous sweating and night sweats, thirst due to fluid depletion, internal heat and thirst, palpitations and insomnia.

[0026] Raspberry: Sweet, sour, and warm in nature. It enters the liver, kidney, and bladder meridians. It benefits the kidneys, strengthens essence, reduces urination, nourishes the liver, and improves eyesight. It is used for seminal emission, frequent urination, impotence, premature ejaculation, and blurred vision.

[0027] Mulberry: Sweet and sour, cold in nature. It enters the heart, liver, and kidney meridians. It has the effects of nourishing yin and blood, promoting body fluid production and moistening dryness.

[0028] Epimedium: pungent, sweet, and warm. It enters the liver and kidney meridians. It tonifies kidney yang, strengthens tendons and bones, and dispels wind and dampness. It is used for kidney yang deficiency, impotence, seminal emission, weakness of tendons and bones, rheumatic pain, numbness, and contractures.

[0029] Salvia miltiorrhiza: Bitter, slightly cold. It enters the heart and liver meridians. It invigorates blood circulation and removes blood stasis, regulates menstruation and relieves pain, clears the heart and eliminates irritability, cools the blood and reduces swelling. It is used for chest pain, abdominal and hypochondriac pain, abdominal masses, painful arthralgia due to heat, insomnia due to irritability, irregular menstruation, dysmenorrhea, amenorrhea, and sores and swelling.

[0030] Red ginseng: Sweet, slightly bitter, and warm in nature. It enters the spleen, lung, heart, and kidney meridians. It greatly replenishes vital energy, restores the pulse and consolidates the body, and benefits qi and stops bleeding. It is used for weakness and impending collapse, cold limbs and weak pulse, qi failing to control blood, and metrorrhagia.

[0031] Borneol: Pungent, bitter, slightly cold. It enters the heart, spleen, and lung meridians. It opens the orifices and awakens the mind, clears heat and relieves pain. It is used for febrile delirium, convulsions, stroke with phlegm syncope, sudden syncope due to qi stagnation, coma due to sudden illness, chest pain, red eyes, mouth sores, sore throat, and ear discharge.

[0032] Evodia rutaecarpa: pungent, bitter, and hot; slightly toxic. It enters the liver, spleen, stomach, and kidney meridians. It dispels cold and relieves pain, relieves nausea and vomiting, and strengthens yang to stop diarrhea. It is used for Jueyin headache, cold hernia abdominal pain, cold-damp beriberi, menstrual cramps, abdominal distension and pain, vomiting and acid regurgitation, and early morning diarrhea.

[0033] Compared with the prior art, the beneficial effects of the present invention are as follows: (1) The present invention uses Adenophora stricta, Ophiopogon japonicus, Rehmannia glutinosa, Ligustrum lucidum, Eclipta prostrata, Lycium barbarum and Cornus officinalis to nourish yin and clear heat, tonify kidney yin deficiency, tonify kidney and replenish essence, and replenish essence and marrow; Angelica sinensis, Ligusticum chuanxiong and Paeonia lactiflora are used together to activate blood circulation, remove blood stasis and unblock collaterals, and are essential medicines for replenishing blood and regulating menstruation, activating blood circulation, removing blood stasis, regulating menstruation and relieving pain; Dioscorea opposita, Cuscuta chinensis, Schisandra chinensis, Rubus idaeus and Morus alba can tonify kidney and replenish essence, strengthen spleen and replenish qi, and astringe and stop diarrhea; Epimedium, Salvia miltiorrhiza, Panax ginseng, Borneol and Evodia rutaecarpa can replenish qi and activate blood, warm and tonify kidney essence, promote the coordination and balance of yin and yang, so that it can be replenished without stagnation, thereby regulating qi and activating blood, regulating Chong and Ren, and achieving the effect of nourishing yin and tonifying kidney, replenishing essence and filling marrow.

[0034] (2) The traditional Chinese medicine composition of the present invention is scientifically and rationally formulated, and has the effects of replenishing kidney essence, ensuring sufficient liver blood, nourishing the Chong and Ren meridians, and filling the blood sea. Furthermore, by nourishing kidney yin to nourish liver yin and restraining liver yang, it can treat premature ovarian failure, amenorrhea, oligomenorrhea, liver and kidney yin deficiency, hot flashes and sweating, insomnia, irritability and anger, etc., and improve ovarian function. The clinical effect is significant. Detailed Implementation

[0035] To enable those skilled in the art to better understand the present invention, the technical solutions in the embodiments of the present invention are clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0036] It should be noted that the terms "first," "second," etc., used in the specification and claims of this invention are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the invention described herein can be implemented in orders other than those described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0037] Example 1 A traditional Chinese medicine composition for improving premature ovarian failure, the oral medication being composed of the following traditional Chinese medicinal materials in parts by weight: 15 parts of Adenophora stricta, 15 parts of Ophiopogon japonicus, 15 parts of Angelica sinensis, 15 parts of Lycium barbarum, 15 parts of Dioscorea opposita, 15 parts of Rehmannia glutinosa, 15 parts of Cornus officinalis, 10 parts of Ligustrum lucidum, 10 parts of Eclipta prostrata, 15 parts of Ligusticum chuanxiong, 15 parts of Paeonia lactiflora, 10 parts of Cuscuta chinensis, 10 parts of Schisandra chinensis, 10 parts of Rubus idaeus, and 15 parts of Morus alba.

[0038] Weigh the Chinese medicinal materials according to the above components, wash them separately, put them in a container, add water and soak for 30 minutes. Bring the liquid to a boil over high heat, then reduce to a simmer and cook for 30 minutes. Filter to remove the residue to obtain the first-stage processed liquid. Put the residue from the first decoction into a container, add water (6 times the total weight of the medicine) and decoct for another 30 minutes. Filter to remove the residue again to obtain the second-stage processed liquid. Mix the first-stage processed liquid and the second-stage processed liquid to obtain the Chinese herbal composition.

[0039] The external application patch is composed of the following Chinese medicinal materials in parts by weight: 15 parts of Adenophora stricta, 15 parts of Ophiopogon japonicus, 15 parts of Angelica sinensis, 15 parts of Lycium barbarum, 15 parts of Dioscorea opposita, 15 parts of Rehmannia glutinosa, 15 parts of Cornus officinalis, 10 parts of Ligustrum lucidum, 10 parts of Eclipta prostrata, 15 parts of Ligusticum chuanxiong, 15 parts of Paeonia lactiflora, 10 parts of Cuscuta chinensis, 10 parts of Schisandra chinensis, 10 parts of Rubus idaeus, 15 parts of Morus alba, 10 parts of Epimedium brevicornu, 15 parts of Salvia miltiorrhiza, 10 parts of Panax ginseng, 5 parts of Borneol, and 10 parts of Evodia rutaecarpa.

[0040] Weigh the Chinese medicinal materials according to the above components, grind the weighed Chinese medicinal materials into powder, then add vinegar, honey and ginger juice to make a paste, and then evenly coat the above paste-like Chinese medicine composition onto a blank non-woven fabric patch to obtain the external application patch.

[0041] Example 2 A traditional Chinese medicine composition for improving premature ovarian failure, comprising the following parts by weight of Chinese medicinal materials: 21 parts of Adenophora stricta, 21 parts of Ophiopogon japonicus, 21 parts of Angelica sinensis, 21 parts of Lycium barbarum, 21 parts of Dioscorea opposita, 21 parts of Rehmannia glutinosa, 21 parts of Cornus officinalis, 14 parts of Ligustrum lucidum, 14 parts of Eclipta prostrata, 21 parts of Ligusticum chuanxiong, 21 parts of Paeonia lactiflora, 14 parts of Cuscuta chinensis, 14 parts of Schisandra chinensis, 14 parts of Rubus idaeus, and 21 parts of Morus alba.

[0042] Weigh the Chinese medicinal materials according to the above components, wash them separately, put them in a container, add water and soak for 45 minutes. Bring the liquid to a boil over high heat, then reduce to a simmer and cook for 45 minutes. Filter to remove the residue to obtain the first-stage processed liquid. Put the residue from the first decoction into a container, add water that is 7 times the total weight of the medicine, and decoct for another 35 minutes. Filter to remove the residue again to obtain the second-stage processed liquid. Mix the first-stage processed liquid and the second-stage processed liquid to obtain the Chinese herbal composition.

[0043] The external application patch is composed of the following Chinese medicinal materials in parts by weight: 21 parts of Adenophora stricta, 21 parts of Ophiopogon japonicus, 21 parts of Angelica sinensis, 21 parts of Lycium barbarum, 21 parts of Dioscorea opposita, 21 parts of Rehmannia glutinosa, 21 parts of Cornus officinalis, 14 parts of Ligustrum lucidum, 14 parts of Eclipta prostrata, 21 parts of Ligusticum chuanxiong, 21 parts of Paeonia lactiflora, 14 parts of Cuscuta chinensis, 14 parts of Schisandra chinensis, 14 parts of Rubus idaeus, 21 parts of Morus alba, 14 parts of Epimedium brevicornu, 21 parts of Salvia miltiorrhiza, 14 parts of Panax ginseng, 7 parts of Borneol, and 14 parts of Evodia rutaecarpa.

[0044] Weigh the Chinese medicinal materials according to the above components, grind the weighed Chinese medicinal materials into powder, then add vinegar, honey and ginger juice to make a paste, and then evenly coat the above paste-like Chinese medicine composition onto a blank non-woven fabric patch to obtain the external application patch.

[0045] Example 3 A traditional Chinese medicine composition for improving premature ovarian failure, comprising the following parts by weight of Chinese medicinal materials: 30 parts of Adenophora stricta, 30 parts of Ophiopogon japonicus, 30 parts of Angelica sinensis, 30 parts of Lycium barbarum, 30 parts of Dioscorea opposita, 30 parts of Rehmannia glutinosa, 30 parts of Cornus officinalis, 20 parts of Ligustrum lucidum, 20 parts of Eclipta prostrata, 30 parts of Ligusticum chuanxiong, 30 parts of Paeonia lactiflora, 20 parts of Cuscuta chinensis, 20 parts of Schisandra chinensis, 20 parts of Rubus idaeus, and 30 parts of Morus alba.

[0046] Weigh the Chinese medicinal materials according to the above components, wash them separately, put them in a container, add water and soak for 50 minutes. Bring the liquid to a boil over high heat, then reduce to a simmer and cook for 50 minutes. Filter to remove the residue to obtain the first-stage processed liquid. Put the residue from the first decoction into a container, add water equal to 8 times the total weight of the medicine, and decoct for another 40 minutes. Filter to remove the residue again to obtain the second-stage processed liquid. Mix the first-stage processed liquid and the second-stage processed liquid to obtain the Chinese herbal composition.

[0047] The external application patch is composed of the following Chinese medicinal materials in parts by weight: 30 parts of Adenophora stricta, 30 parts of Ophiopogon japonicus, 30 parts of Angelica sinensis, 30 parts of Lycium barbarum, 30 parts of Dioscorea opposita, 30 parts of Rehmannia glutinosa, 30 parts of Cornus officinalis, 20 parts of Ligustrum lucidum, 20 parts of Eclipta prostrata, 30 parts of Ligusticum chuanxiong, 30 parts of Paeonia lactiflora, 20 parts of Cuscuta chinensis, 20 parts of Schisandra chinensis, 20 parts of Rubus idaeus, 30 parts of Morus alba, 20 parts of Epimedium brevicornu, 30 parts of Salvia miltiorrhiza, 20 parts of Panax ginseng, 10 parts of Borneol, and 20 parts of Evodia rutaecarpa.

[0048] Weigh the Chinese medicinal materials according to the above components, grind the weighed Chinese medicinal materials into powder, then add vinegar, honey and ginger juice to make a paste, and then evenly coat the above paste-like Chinese medicine composition onto a blank non-woven fabric patch to obtain the external application patch.

[0049] Example 4 A traditional Chinese medicine composition for improving premature ovarian failure, comprising the following parts by weight of Chinese medicinal materials: 18 parts of Adenophora stricta, 18 parts of Ophiopogon japonicus, 18 parts of Angelica sinensis, 18 parts of Lycium barbarum, 18 parts of Dioscorea opposita, 18 parts of Rehmannia glutinosa, 18 parts of Cornus officinalis, 12 parts of Ligustrum lucidum, 12 parts of Eclipta prostrata, 18 parts of Ligusticum chuanxiong, 18 parts of Paeonia lactiflora, 12 parts of Cuscuta chinensis, 12 parts of Schisandra chinensis, 12 parts of Rubus idaeus, and 18 parts of Morus alba.

[0050] Weigh the Chinese medicinal materials according to the above components, wash them separately, put them in a container, add water and soak for 30 minutes. Bring the liquid to a boil over high heat, then reduce to a simmer and cook for 40 minutes. Filter to remove the residue to obtain the first-stage processed liquid. Put the residue from the first decoction into a container, add water that is 6 times the total weight of the medicine, and decoct for another 20 minutes. Filter to remove the residue again to obtain the second-stage processed liquid. Mix the first-stage processed liquid and the second-stage processed liquid to obtain the Chinese herbal composition.

[0051] The external application patch is composed of the following Chinese medicinal materials in parts by weight: 18 parts of Adenophora stricta, 18 parts of Ophiopogon japonicus, 18 parts of Angelica sinensis, 18 parts of Lycium barbarum, 18 parts of Dioscorea opposita, 18 parts of Rehmannia glutinosa, 18 parts of Cornus officinalis, 12 parts of Ligustrum lucidum, 12 parts of Eclipta prostrata, 18 parts of Ligusticum chuanxiong, 18 parts of Paeonia lactiflora, 12 parts of Cuscuta chinensis, 12 parts of Schisandra chinensis, 12 parts of Rubus idaeus, 18 parts of Morus alba, 12 parts of Epimedium brevicornu, 18 parts of Salvia miltiorrhiza, 12 parts of Panax ginseng, 6 parts of Borneol, and 12 parts of Evodia rutaecarpa.

[0052] Weigh the Chinese medicinal materials according to the above components, grind the weighed Chinese medicinal materials into powder, then add vinegar, honey and ginger juice to make a paste, and then evenly coat the above paste-like Chinese medicine composition onto a blank non-woven fabric patch to obtain the external application patch.

[0053] Example 5 A traditional Chinese medicine composition for improving premature ovarian failure, comprising the following parts by weight of Chinese medicinal materials: 24 parts of Adenophora stricta, 24 parts of Ophiopogon japonicus, 24 parts of Angelica sinensis, 24 parts of Lycium barbarum, 24 parts of Dioscorea opposita, 24 parts of Rehmannia glutinosa, 24 parts of Cornus officinalis, 16 parts of Ligustrum lucidum, 16 parts of Eclipta prostrata, 24 parts of Ligusticum chuanxiong, 24 parts of Paeonia lactiflora, 16 parts of Cuscuta chinensis, 16 parts of Schisandra chinensis, 16 parts of Rubus idaeus, and 24 parts of Morus alba.

[0054] Weigh the Chinese medicinal materials according to the above components, wash them separately, put them in a container, add water and soak for 40 minutes. Bring the liquid to a boil over high heat, then reduce to a simmer and cook for 40 minutes. Filter to remove the residue to obtain the first-stage processed liquid. Put the residue from the first decoction into a container, add water that is 7 times the total weight of the medicine, and decoct for another 30 minutes. Filter to remove the residue again to obtain the second-stage processed liquid. Mix the first-stage processed liquid and the second-stage processed liquid to obtain the Chinese herbal composition.

[0055] The external application patch is composed of the following Chinese medicinal materials in parts by weight: 24 parts of Adenophora stricta, 24 parts of Ophiopogon japonicus, 24 parts of Angelica sinensis, 24 parts of Lycium barbarum, 24 parts of Dioscorea opposita, 24 parts of Rehmannia glutinosa, 24 parts of Cornus officinalis, 16 parts of Ligustrum lucidum, 16 parts of Eclipta prostrata, 24 parts of Ligusticum chuanxiong, 24 parts of Paeonia lactiflora, 16 parts of Cuscuta chinensis, 16 parts of Schisandra chinensis, 16 parts of Rubus idaeus, 24 parts of Morus alba, 16 parts of Epimedium brevicornu, 24 parts of Salvia miltiorrhiza, 16 parts of Panax ginseng, 8 parts of Borneol, and 16 parts of Evodia rutaecarpa.

[0056] Weigh the Chinese medicinal materials according to the above components, grind the weighed Chinese medicinal materials into powder, then add vinegar, honey and ginger juice to make a paste, and then evenly coat the above paste-like Chinese medicine composition onto a blank non-woven fabric patch to obtain the external application patch.

[0057] Clinical Cases Case source: Ninety patients with premature ovarian failure who visited Hubei Provincial Maternal and Child Health Hospital between October 2022 and October 2024 were selected for observation and treatment.

[0058] Diagnostic criteria: The Western medicine diagnosis refers to the content of "premature ovarian failure" in "Chinese Obstetrics and Gynecology" and "Clinical Manifestations and Diagnostic Criteria for Premature Ovarian Failure", and the proposed criteria are as follows: (1) Age 18-40 years old; (2) Previously regular menstruation, but now experiencing oligomenorrhea or amenorrhea for 4 months or more; accompanied by perimenopausal symptoms, such as hot flashes, night sweats, etc.; (3) At least two or more baseline serum sex hormone levels showed FSH > 40 IU / L and estradiol (E2) < 73.22 pmol / L (1 pg / mL = 3.67 pmol / L) (different menstrual cycles). The TCM diagnosis refers to "Guiding Principles for Clinical Application of New Chinese Medicines" and "Traditional Chinese Medicine Gynecology". The main symptoms are: amenorrhea and lumbosacral pain. The secondary symptoms are: irritability, fatigue in the limbs, decreased libido, chest tightness and insomnia, breast tenderness, hot flashes and night sweats, vaginal dryness; the tongue and pulse are not scored. A diagnosis can be made based on the presence of both primary symptoms and any three secondary symptoms, combined with the tongue coating and pulse examination.

[0059] Inclusion criteria: (1) Meets the above-mentioned diagnostic criteria of both traditional Chinese and Western medicine; (2) Has not taken any hormone drugs or other drugs that affect reproductive endocrine function in the past 3 months; (3) The patient voluntarily participates in this research project, agrees to the treatment plan of this project, can strictly follow the doctor's orders to take medication, accepts regular follow-up visits, and completes clinical observation; (4) Signs an informed consent form.

[0060] Exclusion criteria: (1) Those with serious primary diseases of the heart, brain, liver, kidneys and hematopoietic system or mental illness; (2) Those with other endocrine diseases; (3) Those whose menstrual cessation is caused by damage or developmental abnormalities of the uterus or ovaries, chromosomal problems, etc.; (4) Those who are allergic to the drugs in the project; (5) Those who have fertility needs during the project research period; (6) Those who do not take the drugs as required or whose examination data is incomplete, which affects the judgment of efficacy; (7) Those who voluntarily request to withdraw from the project research.

[0061] Treatment methods: Control group: Estradiol valerate tablets 1 mg were administered orally once daily for 21 days starting on the 5th day after menstruation. Progesterone capsules 100 mg were added twice daily after 16 days of estradiol valerate administration.

[0062] Treatment group: The oral medication and external application patch from Example 1 were used in combination. The oral medication was taken with water, one dose per day, divided into two doses taken warm, half an hour after breakfast and dinner. At the same time, the external application patch was fixed to the Yongquan acupoint with adhesive tape for 4-6 hours, once a day. Patients were advised to rest, relax, regulate their emotions, strengthen their diet, and pay attention to the balance between work and rest.

[0063] Therapeutic effect evaluation: Observation indicators and methods (1) Compare the TCM syndrome scores before and after treatment in the two groups. Referring to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial Implementation)", the two main symptoms were scored as 0, 2, 4, and 6 points, and the seven secondary symptoms were scored as 0, 1, 2, and 3 points. The higher the score, the more severe the TCM symptoms. (2) Compare the hormone levels before and after treatment in the two groups. Serum was collected as above, and the serum FSH, luteinizing hormone (LH), and E2 levels were detected using a fully automated chemiluminescence immunoassay analyzer.

[0064] Therapeutic criteria: The efficacy index = (TCM syndrome score before treatment - TCM syndrome score after treatment) / TCM syndrome score before treatment × 100%. (1) Cured: The proportion of TCM syndrome score reduction ≥ 95%, menstruation is regular during the research period, symptoms such as soreness of the waist and knees, irritability, and depression are improved or disappear, and serum hormone levels return to normal. (2) Significantly effective: 70% ≤ proportion of TCM syndrome score reduction < 95%; menstruation occurs at least once during the research period, soreness of the waist and knees, mental tension and depression; symptoms such as irritability are relieved compared with before, and FSH < 40 IU / L. (3) Effective: 30% ≤ proportion of TCM syndrome score reduction < 70%. Menstruation occurs once during the research period, menstrual flow is light, clinical symptoms and signs are relieved compared with before, FSH > 40 IU / L but decreases by more than 15% compared with before treatment. (4) Ineffective: The percentage of TCM syndrome score decreases by <30%, or menstruation has not started, or clinical symptoms have not improved significantly, and FSH >40 IU / L but has decreased by less than 15% compared to before treatment. Total effective rate = (number of cured cases + number of cases with significant effect + number of effective cases) / total number of cases × 100%.

[0065] Statistical methods: Statistical analysis was performed using SPSS 21.0 statistical software. Quantitative data were expressed as mean and standard deviation. x (ˉ±s) indicates that paired t-tests were used for within-group comparisons and independent samples t-tests were used for between-group comparisons; P<0.05 was considered statistically significant.

[0066] Treatment results: During the two trials, data was missing for one case in the control group and two cases withdrew midway; data was missing for one case in the treatment group and two cases withdrew midway; a total of 84 cases were completed, including 42 cases in the treatment group and 42 cases in the control group.

[0067] Table 1 Comparison of age and disease duration between the two groups of patients Of the 42 cases in the treatment group, 4 were cured, 20 showed significant improvement, 13 showed improvement, and 5 showed no improvement, with a total effective rate of 88.09%.

[0068] In the control group of 42 cases, 0 cases were cured, 15 cases showed significant improvement, 16 cases showed improvement, and 11 cases showed no improvement, with a total effective rate of 69.04%.

[0069] Analysis showed that the difference in efficacy between the two groups was statistically significant (P < 0.05), with the treatment group being superior to the control group. See Table 2. Table 2 Comparison of therapeutic effects between the two groups.

[0070] Table 3 Comparison of TCM syndrome scores before and after treatment in the two groups In Table 3, the scores of each TCM syndrome and the total score in both groups decreased after treatment compared with those before treatment (P<0.05), and the decrease was more significant in the treatment group than in the control group (P<0.05), showing a statistically significant difference.

[0071] Table 4 Comparison of hormone levels before and after treatment.

[0072] After treatment, the levels of FSH and LH in both groups were lower than before treatment (P<0.05), while the level of E2 was higher than before treatment (P<0.05). After treatment, the serum levels of FSH and LH in the treatment group were lower than those in the control group (P<0.05), while the level of E2 was higher than that in the control group (P<0.05).

[0073] The above table illustrates that the herbal composition of this invention has significant therapeutic effects, superior to the use of estradiol valerate tablets alone or the addition of progesterone capsules. Conclusion: The herbal composition of this invention has a good therapeutic effect in improving premature ovarian failure. No adverse reactions were observed during the observation.

[0074] Typical case: Patient Li XX, female, 31 years old, first visit on May 23, 2023. Chief complaint: Normal sexual activity, infertility for 3 years without contraception, amenorrhea for over a year, treated at multiple hospitals, menstruation returned after artificial cycle therapy, doctors advised premature ovarian failure, desired to conceive, hence this consultation. Symptoms: Amenorrhea for over a year, last menstrual period May 4, 2023, scanty flow (after progesterone treatment), previous menstrual period April 2, 2022, scanty flow; occasional mild lower abdominal pain, accompanied by backache, vaginal dryness, dizziness, irritability, hot flashes, night sweats, chest tightness, insomnia, normal appetite; tongue pale red, slightly greasy yellow coating, pulse deep and thready. Gynecological examination: Vulva development fair, pubic hair sparse, vagina patent, cervix smooth, uterus anteverted, small, mobile, no abnormalities palpable in the bilateral adnexa. Male semen analysis normal. Western medicine diagnosis: Premature ovarian failure; primary infertility; uterine hypoplasia. Traditional Chinese medicine diagnosis: Amenorrhea; infertility. Syndrome differentiation: Deficiency of both spleen and kidney, deficiency of qi and blood, and malnourishment of the Chong and Ren meridians; The herbal composition in Example 1 of this invention is used, one dose per day, divided into two administrations, taken warm half an hour after breakfast and dinner. At the same time, the external application is fixed to the Yongquan acupoint with adhesive tape once a day. The patient is advised to pay attention to rest, relax, regulate emotions, strengthen dietary conditioning, and pay attention to the balance between work and rest.

[0075] Second consultation on June 24, 2023: The patient reported that premenstrual breast tenderness had improved, menstrual flow was slightly increased, the color was dark red, and the blood clots were significantly smaller. She also reported lower back pain and weakness, and fewer hot flashes and night sweats. She experienced irritability and anxiety, but her appetite and sleep were good. Her tongue was red with a thin coating, and her pulse was thready and slippery. The patient continued to use the herbal composition from Example 1 of this invention, one dose per day, divided into two administrations, taken warm half an hour after breakfast and dinner. Simultaneously, the external application patch was fixed to the Yongquan acupoint with adhesive tape, once a day.

[0076] Third consultation on July 20, 2023: The patient's menstruation resumed, with moderate flow, lasting for 7 days and ceasing completely, without dizziness or lower back pain. The herbal composition of Example 1 of this invention was used, one dose per day, divided into two administrations, taken warm half an hour after breakfast and dinner. For the next two months, the patient continued to take the herbal composition of Example 1 of this invention, while simultaneously applying an external poultice to the Yongquan acupoint with adhesive tape once daily.

[0077] Follow-up visit on September 25, 2023: The patient reported significant improvement in irritability, lower back pain, pale red tongue with thin white coating, slippery pulse, and normal sex hormone levels. The patient was advised to have regular follow-up visits.

[0078] Therefore, it can be seen that the traditional Chinese medicine composition of the present invention is scientifically and rationally formulated, and has the effects of replenishing kidney essence, ensuring sufficient liver blood, nourishing the Chong and Ren meridians, and filling the blood sea. Furthermore, by nourishing kidney yin to nourish liver yin and restraining liver yang, it can treat premature ovarian failure, amenorrhea, oligomenorrhea, liver and kidney yin deficiency, hot flashes and sweating, insomnia, irritability and anger, and other symptoms, thereby improving ovarian function and achieving significant clinical effects.

[0079] The above description is merely a preferred embodiment of the present invention, and the scope of protection of the present invention is not limited thereto. Any simple changes or equivalent substitutions of the technical solutions that can be obviously obtained by those skilled in the art within the scope of the technology disclosed in the present invention shall fall within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for improving premature ovarian failure, characterized in that, The traditional Chinese medicine composition consists of an oral medication and a topical application. The oral medication is composed of the following traditional Chinese medicinal materials: Adenophora stricta, Ophiopogon japonicus, Angelica sinensis, Lycium barbarum, Dioscorea opposita, Rehmannia glutinosa, Cornus officinalis, Ligustrum lucidum, Eclipta prostrata, Ligusticum chuanxiong, Paeonia lactiflora, Cuscuta chinensis, Schisandra chinensis, Rubus idaeus, and Morus alba. The external application patch is composed of the following Chinese medicinal materials: Adenophora stricta, Ophiopogon japonicus, Angelica sinensis, Lycium barbarum, Dioscorea opposita, Rehmannia glutinosa, Cornus officinalis, Ligustrum lucidum, Eclipta prostrata, Ligusticum chuanxiong, Paeonia lactiflora, Cuscuta chinensis, Schisandra chinensis, Rubus idaeus, Morus alba, Epimedium brevicornu, Salvia miltiorrhiza, Panax ginseng, Borneol, and Evodia rutaecarpa.

2. The traditional Chinese medicine composition for improving premature ovarian failure according to claim 1, characterized in that, The oral medication is made from the following raw materials in parts by weight: 15-30 parts of Adenophora stricta, 15-30 parts of Ophiopogon japonicus, 15-30 parts of Angelica sinensis, 15-30 parts of Lycium barbarum, 15-30 parts of Dioscorea opposita, 15-30 parts of Rehmannia glutinosa, 15-30 parts of Cornus officinalis, 10-20 parts of Ligustrum lucidum, 10-20 parts of Eclipta prostrata, 15-30 parts of Ligusticum chuanxiong, 15-30 parts of Paeonia lactiflora, 10-20 parts of Cuscuta chinensis, 10-20 parts of Schisandra chinensis, 10-20 parts of Rubus idaeus, and 15-30 parts of Morus alba.

3. The traditional Chinese medicine composition for improving premature ovarian failure according to claim 1, characterized in that, The external application patch is made from the following raw materials in parts by weight: 15-30 parts of Adenophora stricta, 15-30 parts of Ophiopogon japonicus, 15-30 parts of Angelica sinensis, 15-30 parts of Lycium barbarum, 15-30 parts of Dioscorea opposita, 15-30 parts of Rehmannia glutinosa, 15-30 parts of Cornus officinalis, 10-20 parts of Ligustrum lucidum, 10-20 parts of Eclipta prostrata, 15-30 parts of Ligusticum chuanxiong, 15-30 parts of Paeonia lactiflora, 10-20 parts of Cuscuta chinensis, 10-20 parts of Schisandra chinensis, 10-20 parts of Rubus idaeus, 15-30 parts of Morus alba, 10-20 parts of Epimedium brevicornu, 15-30 parts of Salvia miltiorrhiza, 10-20 parts of Panax ginseng, 5-10 parts of Borneol, and 10-20 parts of Evodia rutaecarpa.

4. The traditional Chinese medicine composition for improving premature ovarian failure according to claim 1, characterized in that, The oral medication, by mass ratio, contains: *Adenophora stricta*: The ratio of Ophiopogon japonicus, Angelica sinensis, Lycium barbarum, Dioscorea opposita, Rehmannia glutinosa, Cornus officinalis, Ligustrum lucidum, Eclipta prostrata, Ligusticum chuanxiong, Paeonia lactiflora, Cuscuta chinensis, Schisandra chinensis, Rubus idaeus, and Morus alba is 3:3:3:3:3:3:3:2:2:3:3:2:2:2:

3.

5. The traditional Chinese medicine composition for improving premature ovarian failure according to claim 1, characterized in that, The preparation method of the oral medicine is as follows: Weigh the Chinese medicinal materials according to the above components, wash them separately, put them in a container, add water and soak for 30-60 minutes, bring the liquid to a boil over high heat, then simmer over low heat for 30-60 minutes, then filter to remove the residue to obtain the first-stage processed liquid. Then put the residue after the first decoction into a container, add water that is 6-8 times the weight of the total amount of medicine, and decoct for another 20-40 minutes. After filtering to remove the residue, the second-stage processed liquid is obtained. Mix the first-stage processed liquid and the second-stage processed liquid to obtain the Chinese medicine composition.

6. The traditional Chinese medicine composition for improving premature ovarian failure according to claim 1, characterized in that, The preparation method of the external dressing is as follows: weigh the Chinese medicinal materials according to the above components, grind the weighed Chinese medicinal materials into powder, then add vinegar, then add honey and ginger juice to make a paste, and then evenly coat the above paste-like Chinese medicine composition onto a blank non-woven fabric patch to obtain the external dressing.

7. The traditional Chinese medicine composition for improving premature ovarian failure according to claim 6, characterized in that, The thickness of the ointment-like traditional Chinese medicine composition coating is approximately 1 cm.

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