CN114886986A - A Chinese medicinal composition for treating menoxenia, amenorrhea and infertility - Google Patents
A Chinese medicinal composition for treating menoxenia, amenorrhea and infertility Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for treating irregular menstruation, amenorrhea and infertility. The traditional Chinese medicine composition comprises 10-14 parts by weight of prepared rehmannia root, 10-14 parts by weight of angelica, 10-14 parts by weight of white peony root, 7-11 parts by weight of ligusticum wallichii, 16-20 parts by weight of semen cuscutae, 12-18 parts by weight of medlar, 7-11 parts by weight of raspberry, 7-11 parts by weight of prepared schisandra chinensis, 4-8 parts by weight of salt plantain seed, 12-18 parts by weight of medicinal cyathula root, 10-14 parts by weight of vinegar-processed rhizoma cyperi, 10-14 parts by weight of bran-fried fructus aurantii, 10-14 parts by weight of codonopsis pilosula, 10-14 parts by weight of roasted herba epimedii, 10-14 parts by weight of salt rhizoma anemarrhenae and 12-18 parts by weight of motherwort, and can be conveniently prepared into various dosage forms with a pharmaceutical carrier, such as decoction, tablets, capsules, granules and the like, is convenient to take clinically and is more suitable for further industrialized mass production.
Description
Technical Field
The invention relates to an important composition, in particular to a traditional Chinese medicine composition for treating irregular menstruation, amenorrhea and infertility.
Background
Women have menstrual blood as the basis, and women doctors make great contribution to treating women diseases such as irregular menstruation and the like in all generations. Each doctor has various characteristics on menstruation regulating and medication, has a style of academic self-formation, and follows the treatment of the liver, spleen and kidney based on syndrome differentiation, and particularly, women who are Cheng-Zi-Ming, Fu-Qing-Zi, Ye-Tian and other doctors follow the way. The latter doctors find the treatment law and the medication law of the former generations in a dispute from the first and the second medical works, such as "the whole of the women's Liang Fang (the great prescriptions of the good prescriptions), the" Fuqing Master and the "clinical evidence guideline medical records", etc.
Menoxenia is a common gynecological disease characterized by abnormal changes in the cycle, period, menstrual volume, color and texture of menstruation and accompanying symptoms before and after menstruation. Irregular menstruation can be caused by a plurality of reasons, such as endocrine dyscrasia or menstrual diseases caused by certain diseases, and also can be caused by bad habits, such as irregular work and rest time, greedy coolness, overwork, excessive diet, addiction to cigarettes and alcohol, abnormal mood, high stress and the like.
In recent years, the irregular menstruation of women shows a trend of younger age, the incidence rate is increased year by year, the long-term, common and unavoidable gynecological diseases seriously affect the health and the life quality of women in China, and gradually tend to amenorrhea along with the progress of the disease, so that infertility is caused.
For irregular menstruation, the western medicine aims at clinical treatment of a certain symptom, the expected effect is often not achieved, a proper treatment method cannot be found, and the defects of long period, high treatment cost, easy relapse, unobvious curative effect and the like exist. In traditional Chinese medicine, the abnormal menstruation is related to kidney function, spleen, liver, qi and blood, thoroughfare vessel, conception vessel and uterus. The treatment principle mainly starts from tonifying kidney, supporting spleen, soothing liver and regulating qi and blood, and the traditional Chinese medicine for treating menstrual disorder is generally accepted by people at present and has better clinical effect. Traditional Chinese medicine researches on overall conditioning, but the conditioning process is slow, most of the existing prescriptions are used for symptomatic treatment of different people, the treatment period is long, the disease is easy to relapse, and the curative effect is not obvious.
The technology disclosed for irregular menstruation and infertility is more, such as:
chinese patent CN111558019B has effects of benefiting qi, nourishing blood, regulating menstruation and relieving pain, and its preparation method and application. The traditional Chinese medicine composition comprises 8-20 parts of wolfberry fruit, 10-23 parts of mulberry fruit, 1-15 parts of arillus longan, 1-20 parts of Chinese date, 5-18 parts of kudzu root, 5-20 parts of sophora flower bud, 5-18 parts of allium macrostemon, 1-15 parts of dried orange peel, 1-10 parts of fructus amomi, 1-10 parts of folium artemisiae argyi, 1-10 parts of angelica and 1-10 parts of ginseng. The Chinese medicinal composition has effects of benefiting qi, nourishing blood, regulating menstruation and relieving pain. It is mainly used for menoxenia due to deficiency of qi and blood.
Chinese patent CN110882313B A medicine for treating menoxenia, acute and chronic pelvic inflammatory disease and cervicitis and its application, the Chinese medicinal composition: herba Patriniae, Saviae Miltiorrhizae radix, radix Paeoniae Rubra, semen Persicae, Carthami flos, herba Lycopi, folium Pyrrosiae, Olibanum, and Myrrha. The type of irregular menstruation mainly refers to irregular menstruation caused by damp-heat stasis.
Chinese patent CN110742933B discloses a hematogenesis drug pill, a preparation method and an application thereof, wherein the hematogenesis drug pill comprises donkey-hide gelatin, angelica, red dates, astragalus, peony, ligusticum wallichii, achyranthes, lotus leaf extract, sea powder extract, mulberry, liquorice and honey, and is mainly used for treating qi-blood deficiency caused by irregular menstruation.
Disclosure of Invention
Aiming at the defects that the existing western medicines have negative effects and cannot radically cure, the invention provides a traditional Chinese medicine composition for treating irregular menstruation, amenorrhea and infertility, in particular to a traditional Chinese medicine composition for treating kidney deficiency type irregular menstruation by combining the compatibility theory of traditional Chinese medicines. The traditional Chinese medicine composition provided by the invention has a remarkable curative effect in treating irregular menstruation, amenorrhea and infertility, and provides another treatment scheme for clinical patients.
In order to achieve the purpose, the invention adopts the following technical scheme:
the first purpose of the invention is to provide a traditional Chinese medicine composition for treating irregular menstruation, amenorrhea and infertility, which comprises the following raw materials:
10-14 parts of prepared rehmannia root, 10-14 parts of Chinese angelica, 10-14 parts of white peony root, 7-11 parts of ligusticum wallichii, 16-20 parts of semen cuscutae, 12-18 parts of wolfberry fruit, 7-11 parts of raspberry, 7-11 parts of prepared schisandra chinensis, 4-8 parts of salted plantain seed (wrapping and decocting), 12-18 parts of medicinal cyathula root, 10-14 parts of vinegar rhizoma cyperi, 10-14 parts of bran-fried fructus aurantii, 10-14 parts of codonopsis pilosula, 10-14 parts of roasted herba epimedii, 10-14 parts of salted rhizoma anemarrhenae and 12-18 parts of leonurus.
Further, the preferred formula of the traditional Chinese medicine composition for treating irregular menstruation, amenorrhea and infertility is as follows:
12 parts of prepared rehmannia root, 12 parts of Chinese angelica, 12 parts of white peony root, 9 parts of ligusticum wallichii, 18 parts of semen cuscutae, 15 parts of wolfberry fruit, 9 parts of raspberry, 9 parts of prepared schisandra chinensis, 6 parts of salted plantain seed (wrapping and decocting), 15 parts of medicinal cyathula root, 12 parts of vinegar-processed rhizoma cyperi, 12 parts of bran-fried fructus aurantii, 12 parts of codonopsis pilosula, 12 parts of roasted herba epimedii, 12 parts of salted rhizoma anemarrhenae and 15 parts of motherwort.
The Chinese medicaments in the invention have the following properties and flavors:
prepared rehmannia root: it enters liver and kidney meridians, and is sweet in nature and flavor and slightly warm in nature.
The functions are mainly used for nourishing yin, enriching blood, replenishing vital essence and replenishing marrow. Can be used for treating deficiency of liver-yin and kidney-yin, soreness of waist and knees, hectic fever, night sweat, nocturnal emission, internal heat, diabetes, blood deficiency, sallow complexion, cardiopalmus, severe palpitation, menoxenia, metrorrhagia, metrostaxis, hemorrhage, giddiness, tinnitus, and early white beard and hair.
Chinese angelica: it enters liver, heart and spleen meridians, and is sweet, pungent and warm in nature and flavor.
The functions of the medicine are mainly replenishing blood and activating blood, regulating menstruation and relieving pain, and relaxing bowel. Can be used for treating blood deficiency, sallow complexion, giddiness, palpitation, menoxenia, amenorrhea, dysmenorrhea, asthenia cold, abdominal pain, constipation due to intestinal dryness, rheumatic arthralgia, traumatic injury, superficial infection, pyocutaneous disease. The wine angelica sinensis can activate blood and promote menstruation. Can be used for treating amenorrhea, dysmenorrhea, rheumatalgia, and traumatic injury.
White peony root: meridian tropism enters liver and spleen meridians, and is bitter, sour and slightly cold in nature.
The functions are mainly used for calming the liver, relieving pain, nourishing blood, regulating menstruation, astringing yin and arresting sweating. Can be used for treating headache, vertigo, hypochondriac pain, abdominal pain, limb spasm and pain, blood deficiency, sallow complexion, menoxenia, spontaneous perspiration, and night sweat.
Ligusticum wallichii: it enters liver, gallbladder and pericardium meridians, and is pungent and warm in nature.
The functions are mainly used for activating blood and promoting qi circulation, and dispelling wind and relieving pain. Can be used for treating menoxenia, amenorrhea, dysmenorrhea, abdominal pain, pricking pain in chest and hypochondrium, traumatic injury, swelling and pain, headache, and rheumatalgia.
Dodder seed: it enters liver, kidney and spleen meridians, and is sweet in flavor and warm in nature.
The functions are mainly used for nourishing liver and kidney, securing essence and reducing urination, preventing miscarriage, improving eyesight and stopping diarrhea. Can be used for treating sexual impotence, spermatorrhea, enuresis, frequent micturition, soreness of waist and knees, blurred vision, tinnitus, fetal leakage due to kidney deficiency, threatened abortion, and spleen and kidney deficiency; externally treat vitiligo.
Wolfberry fruit: it enters liver and kidney meridians, and is sweet and neutral in nature and flavor.
The functions are mainly used for nourishing liver and kidney, replenishing vital essence and improving eyesight. Can be used for treating asthenia, soreness of waist and knees, vertigo, tinnitus, internal heat, diabetes, blood deficiency, sallow complexion, and blurred vision.
Raspberry: it enters kidney and bladder meridians, sweet, sour and warm in nature and taste.
The functions are mainly for tonifying the kidney, securing essence and reducing urination. Can be used for treating enuresis due to kidney deficiency, frequent micturition, sexual impotence, premature ejaculation, spermatorrhea, and spermatorrhea.
Preparing the schisandra chinensis: it enters lung, heart and kidney meridians, and is sour, sweet and warm in nature and taste.
The functions are mainly used for astringing and inducing astringency, tonifying qi and promoting the production of body fluid, tonifying the kidney and calming the heart. Can be used for treating chronic cough, asthma, nocturnal emission, enuresis, frequent micturition, chronic diarrhea, spontaneous perspiration, night sweat, thirst due to body fluid consumption, short breath, weak pulse, internal heat, diabetes, palpitation, and insomnia.
Salted plantain seed: it enters liver, kidney, lung and small intestine meridians, and is sweet in nature and taste and slightly cold.
The functions are mainly used for clearing heat and promoting urination, excreting dampness and treating stranguria, improving eyesight and eliminating phlegm. Can be used for treating edema, heat stranguria, pain, summer-heat dampness, diarrhea, conjunctival congestion, swelling and pain, and cough due to phlegm-heat.
Radix cyathulae: it enters liver and kidney meridians, and is sweet in flavor, slightly bitter and neutral.
The functions are mainly used for removing blood stasis, dredging channels, promoting joint movement, inducing diuresis and treating stranguria. Can be used for treating amenorrhea, abdominal mass, retention of exocytosis, arthralgia, flaccidity of feet, spasm of tendons, stranguria with hematuria and blood, and traumatic injury.
Vinegar processed nutgrass galingale rhizome: enter liver, spleen and triple energizer meridians, and are pungent, slightly bitter, slightly sweet and mild in nature and taste.
The functions are mainly used for promoting the circulation of qi, resolving depression, regulating menstruation and relieving pain. Can be used for treating stagnation of liver-qi, chest pain, hypochondrium pain, abdominal distention and pain, dyspepsia, chest and abdominal distention and fullness, cold hernia with abdominal pain, breast pain, menoxenia, amenorrhea, and dysmenorrhea.
Stir-frying fructus aurantii with bran: it enters spleen and stomach meridians, and is bitter, pungent, sour and warm in nature.
The functions are mainly used for regulating qi, relieving epigastric distention, activating stagnancy and relieving distension. Can be used for treating qi stagnation in chest and hypochondrium, fullness and pain, dyspepsia, and retention of phlegm and fluid; gastroptosis, proctoptosis, prolapse of the son-organs.
Codonopsis pilosula: the meridian entered spleen and lung meridians are sweet and neutral in nature and flavor.
The functions are mainly used for tonifying middle-jiao and Qi, strengthening spleen and benefiting lung. Can be used for treating spleen and lung deficiency, short breath, palpitation, anorexia, loose stool, asthma, cough, internal heat, and diabetes.
Roasting epimedium: it enters liver and kidney meridians, and is pungent, sweet and warm in nature.
The functions are mainly used for tonifying kidney yang, strengthening muscles and bones and dispelling wind-damp. Can be used for treating sexual impotence, spermatorrhea, tendons and bones flaccidity, rheumatalgia, numbness and contracture; climacteric hypertension.
Saline rhizoma anemarrhenae: it enters lung, stomach and kidney meridians and is bitter, sweet and cold in nature and taste.
The functions are mainly used for clearing heat and purging fire, promoting the production of body fluid and moistening dryness. Can be used for treating exogenous febrile disease, hyperpyrexia with polydipsia, lung heat with cough, hectic fever due to yin-deficiency, diabetes due to internal heat, and constipation due to intestinal dryness.
Motherwort: it enters liver and pericardium meridians, and is bitter, pungent and slightly cold in nature.
The functions are mainly used for promoting blood circulation, regulating menstruation, inducing diuresis and reducing edema. Can be used for treating menoxenia, dysmenorrhea, amenorrhea, lochiorrhea, edema, and oliguria; edema due to acute nephritis.
According to the nature, taste, meridian tropism and main function of the traditional Chinese medicinal materials, the compatibility mechanism of the traditional Chinese medicine composition is as follows: in the formula, semen Cuscutae and radix rehmanniae Preparata are used as monarch drug, and herba Epimedii, parched rhizoma anemarrhenae, radix Angelicae sinensis, radix Paeoniae alba, rhizoma Ligustici Chuanxiong, fructus Lycii, fructus Schisandrae chinensis, Rubi fructus, and semen plantaginis are used as ministerial drug; the monarch drug and the ministerial drugs are used in a matching way, so that the effects of nourishing blood and tonifying kidney are achieved, the epimedium herbs have the effects of tonifying kidney, warming yang and seeking yin from yang, and the effects of tonifying kidney and replenishing essence are enhanced; the stir-fried rhizoma anemarrhenae is used as a ministerial drug by purging fire and strengthening yin, and is matched with the epimedium herb to restrict the warm property of the epimedium herb, and the effect of seeking yin from yang of the epimedium herb without assisting deficiency heat is taken as a ministerial drug. The adjuvant drugs comprise rhizoma cyperi, fructus aurantii, codonopsis pilosula and leonurus, and have the effects of tonifying qi and strengthening spleen, tonifying qi and blood, tonifying qi and producing sperm, and the adjuvant drugs comprise rhizoma cyperi with vinegar, fried fructus aurantii and leonurus, and ligusticum wallichii for soothing liver, activating blood, promoting qi circulation and stimulating the menstrual flow, so that the aim of tonifying the middle-jiao and moving the middle-jiao is fulfilled. The guiding drug is radix cyathulae, which can strengthen the liver and kidney tonifying, blood circulation promoting and qi circulation promoting effects of the adjuvant drugs on the one hand and lead the other drugs to go downwards on the other hand. The medicines are combined, the mechanism is cut, the curative effect is exact, and the Chinese medicinal composition is suitable for further clinical popularization.
The second purpose of the invention is to provide a use of the composition, the traditional Chinese medicine composition is used for treating female reproductive organ development, especially uterine hypoplasia, hyposexuality and nocturia; dark eye sockets, dark facial patches, or dark lips; the Chinese medicinal composition has obvious curative effects on aspects of dark tongue, white fur, deep, thready and weak pulse and the like.
The invention also provides multiple uses of the composition, and the traditional Chinese medicine composition is suitable for infertility, amenorrhea, delayed menstruation, low menstrual flow, hypoovarian reserve function (DOR), Premature Ovarian Insufficiency (POI), Premature Ovarian Failure (POF) and the like.
Furthermore, the irregular menstruation of the invention comprises kidney deficiency type, blood heat type, liver depression transforming into heat type, qi deficiency type, blood cold type qi stagnation type and blood stasis type; especially, the traditional Chinese medicine composition aims at irregular menstruation caused by kidney deficiency, has the functions of tonifying kidney and replenishing essence, tonifying qi and nourishing blood, and is mainly suitable for delayed onset or amenorrhea after the menstrual cycle is prolonged, or infertility after long marriage, low menstruation volume and dark color; dizziness, tinnitus, soreness and weakness of the waist and knees, mental fatigue; a pale tongue with thin and white coating and a deep and thready pulse, especially on the two rules.
Furthermore, dialectical treatment is carried out on kidney deficiency type menstrual diseases and infertility, a plurality of traditional Chinese medicines are combined, the medicines play a role in tonifying kidney and replenishing essence together, and the traditional Chinese medicine composition has an obvious synergistic effect and fully plays a compatible relationship of mutual reinforcement and mutual assistance.
In the research and development process, the inventor finds that the overall action effect of the traditional Chinese medicine composition is obviously reduced by reducing any one raw material component in the composition or replacing the raw material components of the traditional Chinese medicine composition by the raw material medicines with similar medicine properties; other raw material components are added on the basis of the traditional Chinese medicine composition, so that the overall effect of the traditional Chinese medicine composition is not obviously improved, and even the overall effect of the traditional Chinese medicine composition is reduced. Particularly, in the traditional Chinese medicine composition for treating kidney deficiency type irregular menstruation, all raw material components are organic whole, and the deficiency is not essential. It has also been demonstrated in the pharmacological experiments of the present invention that the pharmaceutical composition of the present invention is an integral whole.
The second purpose of the invention is to provide a pharmaceutical preparation for treating kidney deficiency type irregular menstruation, amenorrhea and infertility, which is prepared from the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials.
Further, the above Chinese medicinal composition for treating kidney deficiency type menoxenia, amenorrhea and infertility can be decocted in water to obtain decoction; can also be prepared into clinically acceptable dosage forms according to other methods.
Furthermore, the pharmaceutical preparation can be made into various pharmaceutical dosage forms, such as pills, capsules, tablets, powders, granules or oral liquids.
Further, the pharmaceutically acceptable auxiliary materials are conventional auxiliary materials in pharmaceutical preparations, such as: disintegrating agents, lubricants, binders, and the like.
In one embodiment of the present invention, the preparation method of the traditional Chinese medicine composition for treating kidney deficiency type irregular menstruation, amenorrhea and infertility comprises:
wrapping salted semen plantaginis with gauze, mixing with radix rehmanniae Preparata, radix Angelicae sinensis, radix Paeoniae alba, rhizoma Ligustici Chuanxiong, semen Cuscutae, fructus Lycii, Rubi fructus, fructus Schisandrae chinensis preparata, radix Cyathulae, Vinegar rhizoma Cyperi, bran-parched fructus Aurantii, radix Codonopsis, preparata herba Epimedii, salted rhizoma anemarrhenae, and herba Leonuri, decocting with water twice, filtering, and mixing filtrates. Adding 8-10 times of water for the first time, and decocting for 30-60 minutes; adding 6-8 times of water for the second time, and decocting for 20-40 minutes.
In another embodiment of the present invention, the preparation method of the granules comprises:
mixing the filtrates, concentrating the filtrate to relative density of 1.10-2.0 at 70 deg.C, drying the concentrated solution under reduced pressure, pulverizing, and sieving with 70 mesh sieve to obtain granule.
In another embodiment of the present invention, the capsule is prepared by the following steps:
adding appropriate amount of sorbitol and cyclodextrin into the granule, mixing with appropriate amount of binder, granulating, drying, and making into capsule.
In another embodiment of the present invention, a tablet is prepared by the method comprising:
adding appropriate amount of sorbitol and cyclodextrin into the granule, mixing, granulating with appropriate amount of binder, drying, and tabletting to obtain the final product.
The invention aims to explain that the traditional Chinese medicine has complex components, one medicinal material has water-soluble components and oil-soluble or alcohol-soluble components, and some active components are easy to inactivate in different solvents and other environments, so that the effective components of the traditional Chinese medicine can be extracted and separated to the maximum extent by selecting a proper extraction method and an extraction process, and the activity of the effective components is ensured, thereby ensuring the clinical effect of the product.
Experiments prove that the preparation method of water extraction can extract the effective components in the traditional Chinese medicine composition to the maximum extent and ensure the activity of the effective components and the control of harmful substances, thereby ensuring the clinical effect and the safety of the product.
Compared with the prior art, the traditional Chinese medicine composition for treating kidney deficiency type irregular menstruation, amenorrhea and infertility provided by the invention has the following advantages:
the traditional Chinese medicine composition or the pharmaceutical preparation has the functions of tonifying kidney, replenishing essence, benefiting qi and nourishing blood. Is mainly suitable for delayed menstruation, delayed menstruation or amenorrhea, or infertility, scanty menstruation and dark color; dizziness, tinnitus, soreness and weakness of the waist and knees, mental fatigue; a pale tongue with thin and white coating and a deep and thready pulse, especially on the two rules. Or uterine dysplasia, apathy, nocturia; dark eye sockets, dark facial patches, or dark lips; dark tongue with white coating, deep, thready and weak pulse. Is suitable for infertility, amenorrhea, delayed menstrual cycle, hypomenorrhea, DOR, POI, POF, etc.
The traditional Chinese medicine composition for treating kidney deficiency type irregular menstruation provided by the invention is scientific and reasonable in proportion by screening traditional Chinese medicine components according to the traditional Chinese medicine theory and the theory of treatment based on syndrome differentiation, and experimental results show that the traditional Chinese medicine composition provided by the invention has good effects of regulating amenorrhea, treating infertility and improving the life quality of patients.
The traditional Chinese medicine composition disclosed by the invention has the advantages that the selected medicinal materials are authentic, the compatibility is appropriate, the formula is refined, the functions complement each other, the purposes of tonifying kidney and replenishing essence, and tonifying qi and nourishing blood are achieved, and the medicines are used in a matching way, so that the composition can adjust the hypothalamus pituitary ovarian axis, improve the ovarian function, and has the effects of regulating menstruation, promoting ovulation, promoting conception and the like; the medicines are prepared with the assistance of the medicine property, and the administration is safe.
The traditional Chinese medicine composition provided by the invention is suitable for wide crowds. The traditional Chinese medicine composition can be used for women of all ages, especially for women with kidney deficiency type irregular menstruation, and is combined with an economical and effective treatment scheme specially designed for traditional Chinese medicine syndrome differentiation treatment, so that the traditional Chinese medicine composition is used for treating poor follicular development quality, can obviously improve symptoms, improves the hypomenorrhea, treats infertility and the like.
The extract of the traditional Chinese medicine composition provided by the invention can be conveniently prepared into various dosage forms with pharmaceutical carriers, such as decoction, tablets, capsules, granules and the like, is convenient to take clinically, and is more suitable for further industrialized mass production.
Drawings
FIG. 1: comparison of serum P in rats in each example group.
FIG. 2: rat serum E in each example group 2 Comparison of hormones.
FIG. 3: comparison of AMH in serum of mice in each example group.
FIG. 4: comparison of FSH in the serum of mice in each example group.
Detailed Description
In order to make the purpose and technical solution of the present invention more clear, the present invention is further described with reference to the following examples, but the scope of the present invention is not limited to these examples, and the examples are only used for explaining the present invention. It will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true scope of the invention.
Example 1: a Chinese medicinal composition comprises the following raw materials and dosage
The formula is as follows: 12g of prepared rehmannia root, 12g of Chinese angelica, 12g of white paeony root, 9g of szechuan lovage rhizome, 18g of south dodder seed, 15g of barbary wolfberry fruit, 9g of raspberry, 9g of prepared Chinese magnoliavine fruit, 6g of salt plantain seed (bag-fried), 15g of medicinal cyathula root, 12g of vinegar nutgrass galingale rhizome, 12g of bran-fried bitter orange, 12g of pilose asiabell root, 12g of roasted epimedium herb, 12g of salt anemarrhena asphodeloides bunge and 15g of motherwort herb.
The preparation method comprises the following steps:
wrapping semen plantaginis with gauze, mixing with radix rehmanniae Preparata, radix Angelicae sinensis, radix Paeoniae alba, rhizoma Ligustici Chuanxiong, semen Cuscutae, fructus Lycii, Rubi fructus, fructus Schisandrae chinensis preparata, radix Cyathulae, rhizoma Cyperi processed with vinegar, fructus Aurantii parched with bran, radix Codonopsis, herba Epimedii preparata, rhizoma anemarrhenae processed with salt, and herba Leonuri, decocting with water twice, filtering, and mixing filtrates. Adding 8-10 times of water for the first time, and decocting for 30-60 minutes; adding 6-8 times of water for the second time, and decocting for 20-40 minutes.
Example 2: a Chinese medicinal composition comprises the following raw materials and dosage
The formula is as follows: 10g of prepared rehmannia root, 14g of Chinese angelica, 10g of white paeony root, 11g of szechuan lovage rhizome, 16g of south dodder seed, 18g of barbary wolfberry fruit, 7g of raspberry, 11g of prepared Chinese magnoliavine fruit, 4g of salt plantain seed (bag-fried), 18g of medicinal cyathula root, 10g of vinegar nutgrass galingale rhizome, 14g of bran-fried bitter orange, 10g of pilose asiabell root, 14g of roasted epimedium herb, 10g of salt anemarrhena asphodeloides bunge and 18g of motherwort herb.
The preparation method is the same as example 1:
example 3: a Chinese medicinal composition comprises the following raw materials and dosage
The formula is as follows: 14g of prepared rehmannia root, 10g of Chinese angelica, 14g of white paeony root, 7g of szechuan lovage rhizome, 20g of south dodder seed, 12g of barbary wolfberry fruit, 11g of raspberry, 7g of prepared Chinese magnoliavine fruit, 8g of salt plantain seed (bag-fried), 12g of medicinal cyathula root, 14g of vinegar nutgrass galingale rhizome, 10g of bran-fried bitter orange, 14g of pilose asiabell root, 10g of roasted epimedium herb, 14g of salt anemarrhena asphodeloides bunge and 12g of motherwort herb.
The preparation method is the same as that of example 1:
example 4: a Chinese medicinal granule comprises the following raw materials and dosage
Concentrating the filtrate obtained in the step of decocting the raw materials in the embodiment 1 to a relative density of 1.10-2.0 at 70 ℃, drying the concentrated solution under reduced pressure, crushing, and sieving with a 70-mesh sieve to obtain granules.
Example 5: a capsule containing Chinese medicinal composition comprises the following raw materials and dosage
Taking the granules in the embodiment 4, adding a proper amount of sorbitol and cyclodextrin, uniformly mixing, mixing with a proper amount of adhesive, granulating, drying and encapsulating to obtain capsules, wherein the specification of each capsule is 0.25 g.
Example 6: a Chinese medicinal tablet comprises the following raw materials and dosage
And (3) adding a proper amount of sorbitol and cyclodextrin into the granules prepared in the embodiment 4, uniformly mixing, mixing with a proper amount of adhesive, granulating, drying, and tabletting to obtain tablets.
Comparative example 1: a Chinese medicinal composition comprises the following raw materials and dosage
12 parts of prepared rehmannia root, 12 parts of Chinese angelica, 12 parts of white peony root, 9 parts of ligusticum wallichii, 15 parts of medicinal cyathula root, 12 parts of vinegar-processed rhizoma cyperi, 12 parts of bran-fried fructus aurantii, 12 parts of codonopsis pilosula, 12 parts of roasted herba epimedii, 12 parts of salt rhizoma anemarrhenae and 15 parts of motherwort.
The preparation process is the same as in example 1.
Comparative example 2: a Chinese medicinal composition comprises the following raw materials and dosage
18 parts of semen cuscutae, 15 parts of fructus lycii, 9 parts of raspberry, 9 parts of prepared schisandra chinensis, 6 parts of salted plantain seed (bag-fried), 15 parts of radix cyathulae, 12 parts of vinegar-fried rhizoma cyperi, 12 parts of bran-fried fructus aurantii, 12 parts of codonopsis pilosula, 12 parts of roasted herba epimedii, 12 parts of salted rhizoma anemarrhenae and 15 parts of motherwort.
The preparation process is the same as in example 1.
Comparative example 3: a Chinese medicinal composition comprises the following raw materials and dosage
8g of prepared rehmannia root, 14g of Chinese angelica, 10g of white paeony root, 11g of szechuan lovage rhizome, 22g of south dodder seed, 10g of barbary wolfberry fruit, 7g of raspberry, 11g of prepared Chinese magnoliavine fruit, 10g of salt plantain seed (bag-fried), 8g of medicinal cyathula root, 10g of vinegar nutgrass galingale rhizome, 14g of bran-fried bitter orange, 8g of pilose asiabell root, 18g of roasted epimedium herb, 8g of salt anemarrhena asphodeloides bunge and 20g of motherwort herb.
The preparation process is the same as in example 1.
Comparative example 4: a Chinese medicinal composition comprises the following raw materials and dosage
12g of prepared rehmannia root, 12g of Chinese angelica, 12g of white paeony root, 9g of szechuan lovage rhizome, 15g of barbary wolfberry fruit, 9g of raspberry, 9g of prepared Chinese magnoliavine fruit, 6g of salt plantain seed (bag-decocted), 15g of medicinal cyathula root, 12g of vinegar nutgrass galingale rhizome, 12g of bran-fried bitter orange, 12g of pilose asiabell root, 12g of salt common anemarrhena rhizome and 15g of motherwort herb.
The preparation process is the same as in example 1.
Comparative example 5: a Chinese medicinal composition comprises the following raw materials and dosage
12g of prepared rehmannia root, 12g of astragalus root, 12g of white peony root, 9g of ligusticum wallichii, 18g of semen cuscutae, 15g of medlar, 9g of raspberry, 9g of prepared schisandra chinensis, 6g of salt plantain seed (bag-fried), 15g of medicinal cyathula root, 12g of vinegar-processed rhizoma cyperi, 12g of bran-fried fructus aurantii, 12g of American ginseng, 12g of roasted herba epimedii, 12g of fructus forsythiae and 15g of leonurus.
The preparation process is the same as in example 1.
Verification examples
And (3) clinical trials:
the influence of the traditional Chinese medicine composition on the treatment effect of the kidney deficiency type delayed menstrual cycle
1. Study object
120 kidney deficiency type delayed menstrual period patients who come to hospital for treatment in 2018, 9, 2022 and 5 are selected, and the selected patients are randomly divided into a treatment group and a control group, wherein each group comprises 60 patients. The age, disease course and the like of the treatment group and the control group have no significant significance (P is more than 0.05), and the treatment group and the control group have comparability.
2. Diagnostic criteria
2.1 Chinese medicine diagnosis standard: the diagnosis standard is formulated according to the standard of curative effect of diagnosis of the disease symptoms of traditional Chinese medicine (national administration of traditional Chinese medicine), and is as follows:
(1) the menstrual cycle is more than 35 days and is more than 2 months continuously;
(2) the later period of the women of childbearing age should be identified with the later period of pregnancy, puberty and climacteric menstruation;
(3) gynecological examination, B-ultrasonography or pneumoperitoneum imaging to eliminate organic diseases of uterus and ovary.
2.2 Standard of traditional Chinese medicine syndrome differentiation
Reference is made to the guiding principle of clinical research of new Chinese medicines and the related content of the later menstrual period and the kidney deficiency type standard of Chinese medicine in the gynecology of traditional Chinese medicine (the publishing society of Chinese medicine, the second edition of the new century).
The main symptoms are: (1) delayed menstruation; (2) soreness of the waist and knees or heel pain.
The secondary symptoms are as follows: a. soft tibia, dizziness, tinnitus, alopecia, and dribbling after d.urination.
Tongue manifestation: pale with white coating. The pulse condition: deep pulse.
The major symptoms include 2 items and the minor symptoms include 1-2 items, and can be diagnosed by combining tongue pulse.
3. The treatment method comprises the following steps:
treatment groups: the decoction prepared in the embodiment 1 of the invention is orally taken twice a day, and 28 days are a treatment course.
Control group: the medicine is orally taken according to instructions, and 28 days is a treatment course
Continuously taking for 3 courses of treatment, observing the conditions before and after treatment, and performing statistical analysis.
4. The curative effect standard is as follows: formulated according to the standard of curative effect for diagnosis of traditional Chinese medicine symptoms (national administration of traditional Chinese medicine), the method comprises the following steps:
(1) and (3) curing: the menstrual cycle returns to normal and is maintained for more than 3 months.
(2) Improvement: the menstrual cycle returns to normal but cannot be maintained for more than 3 months.
(3) The disease is not cured: the menstrual cycle did not improve.
The total effective rate is (cure + improvement)/total case x 100%
5. The results of the treatment are shown in Table 1
After treatment, both groups were evaluated for efficacy. The total effective rate of the treatment group is 83.33 percent, and the control group is 86.67 percent. No significant difference was observed between the two groups (P > 0.05). No adverse reaction in the treatment process. The traditional Chinese medicine and the composition have better clinical effect on the later period of menstruation, and are safe without toxic or side effect.
TABLE 1 comparison of the efficacy of the two groups of patients
Secondly, the influence of the traditional Chinese medicine composition on the infertility treatment effect
1. Study object
124 infertility patients who come to hospital for treatment in 2018, 9, 2022, 5 were selected, and the selected patients were randomly divided into a treatment group and a control group, each of which comprises 62 patients. The age, disease course and the like of the treatment group and the control group have no significant significance (P is more than 0.05), and the treatment group and the control group have comparability.
2. Diagnostic criteria
2.1 traditional Chinese medicine diagnosis of infertility
According to the infertility diagnosis of the Chinese gynaecology and obstetrics science, the method comprises the following steps: the couple live together, the sexual life is normal, the reproduction function of the male is normal, the male does not have contraception for 1 year, and the female does not have infertility. The primary infertility is seen in the patients who have never been pregnant, and the secondary infertility is seen in the patients who have had a history of pregnancy.
2.2 Standard of traditional Chinese medicine syndrome differentiation
The diagnosis standard of kidney deficiency syndrome is drawn up according to the relevant section of infertility in TCM gynecology and the reference standard of differentiation of deficiency syndrome in TCM. (1) The main symptoms are: infertility. (2) The secondary symptoms are as follows: (1) soreness and weakness of waist and knees, (2) soreness and weakness of shin or heel pain, (3) dizziness and tinnitus, (4) alopecia or tooth shaking, (5) dribbling after urination, and (6) sexual hypofunction. (3) Tongue pulse: pale, swollen with white coating and deep and weak pulse. The main symptoms are necessary, the secondary symptoms are 3 or more, and the kidney deficiency type infertility can be diagnosed by referring to the tongue pulse.
3. The treatment method comprises the following steps:
the treatment group orally takes the decoction prepared in the embodiment 1 of the invention twice a day, and 28 days are a treatment course.
The control group was orally administered with Fenmolong according to the instructions, and 28 days was one treatment course.
After 3 consecutive courses of treatment, the treatment was observed in both groups and statistically analyzed.
4. The curative effect standard is as follows: according to the formulation, the method specifically comprises the following steps:
(1) and (3) curing: and (4) conception.
(2) The disease is not cured: is not pregnant.
5. Results
The results of the treatment are shown in Table 2
Proved by chi fang test, compared with a control group and a control group, the effective rate of the treatment group to the infertility treatment group is obviously improved, and no adverse reaction is generated in the treatment process. The traditional Chinese medicine and the composition have better clinical effect on infertility, and are safe without toxic and side effects.
TABLE 2 statistics of the treatment of two groups of patients
Thirdly, the influence of the traditional Chinese medicine composition on the curative effect of amenorrhea
1. Study object
120 patients with kidney deficiency type amenorrhea who come to hospital for diagnosis in 2018, 9, 2022 and 5 are selected, and the selected patients are randomly divided into a treatment group and a control group, wherein each group comprises 60 patients. The age, disease course and the like of the treatment group and the control group have no significant significance (P is more than 0.05), and the treatment group and the control group have comparability.
2. Diagnostic criteria
2.1 Chinese medicine diagnosis standard: the method is formulated according to the clinical research guiding principle of the secondary amenorrhea of new Chinese medicine treatment in the Chinese medicine gynecology (Chinese medicine publishing society, the second edition of the new century) and the clinical research guiding principle of the new Chinese medicine.
(1) In the later stage of menstruation, the amount of the menstruation gradually decreases to amenorrhea (the menopause time is more than 6 months);
(2) the menstruation is normal, sudden amenorrhea occurs, and the menstruation does not run for months (calculated according to the original menstrual cycle per se, the menopause time is more than 3 months of menstrual cycle);
(3) irregular menstruation, sudden amenorrhea and no menstruation for months (the menstruation stopping time is more than 6 months).
2.2 Standard of traditional Chinese medicine syndrome differentiation
Reference is made to the content related to amenorrhea and kidney deficiency type standard of traditional Chinese medicine in the guide principle of clinical research of new traditional Chinese medicine and the gynecology of traditional Chinese medicine (the publishing society of traditional Chinese medicine and New century, second edition of New century).
The main symptoms are: (1) the menstruation stopping time is longer than the original period of the user by 3 months or more than 6 months;
(2) soreness of the waist and knees or heel pain.
The secondary symptoms are as follows: a. soft tibia, dizziness, tinnitus, alopecia, and dribbling after d.urination.
Tongue manifestation: pale with white coating. The pulse condition: deep pulse.
The major symptoms include 2 items and the minor symptoms include 1-2 items, and can be diagnosed by combining tongue pulse.
3. The treatment method comprises the following steps:
treatment groups: the decoction prepared in the embodiment 1 of the invention is orally taken twice a day, and 28 days are a treatment course.
Control group: the medicine is orally taken according to instructions, and 28 days is a treatment course
Continuously taking for 3 courses of treatment, observing the conditions before and after treatment, and performing statistical analysis.
4. The curative effect standard is as follows: formulated according to the standard of curative effect for diagnosis of traditional Chinese medicine symptoms (national administration of traditional Chinese medicine), the method comprises the following steps:
(1) and (3) curing: the menstrual cycle returns to normal and is maintained for more than 3 months.
(2) Improvement: the menstrual cycle returns to normal but cannot be maintained for more than 3 months.
(3) The disease is not cured: the menstrual cycle did not improve.
5. The results of the treatment are shown in table 3.
After treatment, both groups were evaluated for efficacy. The total effective rate of the treatment group is lower than that of the control group, but has no statistical significance (P is more than 0.05). No adverse reaction in the treatment process. The traditional Chinese medicine and the composition have better clinical effect on amenorrhea, and are safe and have no toxic or side effect
TABLE 3 comparison of the efficacy of the two groups of patients
Typical cases
Case 1: old certain, woman, age 30. The main complaints are: the menstrual cycle is delayed by 1 year. The former menstrual cycle, once a month, delayed menstrual cycle of nearly one year, 2-3 months, scanty menstruation, pale or dark color, thin and thin texture, soreness and weakness of waist and knees, dizziness and tinnitus, pale tongue, thin and white fur, and deep and weak pulse. The diagnosis is as follows: in the later stage of menstruation, the amount of menstruation is small, and the pattern is kidney essence deficiency; therapeutic method: tonify kidney, replenish essence, tonify qi and nourish blood. After the traditional Chinese medicine composition (decoction) of the embodiment 1 of the invention is taken for 3 months, menstrual period and menstrual flow are basically normal, waist and knees are weak, and symptoms of dizziness and tinnitus basically disappear; after the consolidation is continued for 1 month, all symptoms disappear, and the menstrual cycle returns to normal and is cured. No recurrence was observed in 6 months of follow-up.
Case 2:
dou somebody, woman, 18 years old. The main complaints are: no contraception and no pregnancy for 1+ year. Pingsu menstruation takes 40-50 days, accompanied by dizziness, tinnitus, soreness of the waist and legs, mental fatigue, pale tongue with thin and white coating, and deep and thready pulse. B-mode ultrasonic prompt: bilateral ovarian polycystic alterations. The diagnosis is as follows: infertility, delayed menstrual cycle. The syndrome belongs to kidney essence deficiency. Therapeutic method: tonify kidney, replenish essence, tonify qi and nourish blood. After the decoction prepared in the embodiment 1 of the invention is used for 3 months, the patient is successfully pregnant, and the traditional Chinese medicine is used for continuing fetus protection after pregnancy.
Case 3:
often, a woman is 30 years old. Complaining of the amenorrhea for 3 months. Pinsu menstruation, once a month. Since the end of the last menstruation, it has stopped for 3 months, and often the heel is painful and the shin is limp. The patients were found to have belching, nausea, white fur and wiry pulse by examination. Amenorrhea was diagnosed. The syndrome belongs to kidney essence deficiency. Therapeutic methods: tonify kidney, replenish essence, tonify qi and nourish blood. By adopting the traditional Chinese medicine of the embodiment 1 of the invention, 14 doses are taken continuously, the menstruation comes, the menstruation is continued to be taken for 3 months, and the menstruation returns to normal. After 3 months, no recurrence was observed.
II, animal experiments:
according to the regulation of luteal phase insufficiency model rat ovarian endoplasmic reticulum stress by the prescription of tonifying kidney and assisting pregnancy of Schlolu et al, the decoction prepared in the examples 1-3 of the present invention and the comparative examples 1-5 are studied to detect the serum P and E of rats 2 Hormone levels, the results show that the decoctions prepared in examples 1-3 can improve the egg of model ratThe nest function. The results are shown in FIGS. 1 and 2.
According to the research on the improvement effect and mechanism of the decanyuan decoction formula granules on the ovarian reserve function reduction model mice, such as Wangyoujiao and the like. The decoction prepared in examples 1-3 of the present invention was studied to detect the levels of AMH and FSH in the serum of mice. The results are shown in FIGS. 3 and 4.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and decorations can be made without departing from the principle of the invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (10)
1. The traditional Chinese medicine composition is characterized by being prepared from the following raw material medicines in parts by weight:
10-14 parts of prepared rehmannia root, 10-14 parts of Chinese angelica, 10-14 parts of white peony root, 7-11 parts of ligusticum wallichii, 16-20 parts of semen cuscutae, 12-18 parts of wolfberry fruit, 7-11 parts of raspberry, 7-11 parts of prepared schisandra chinensis, 4-8 parts of salted plantain seed, 12-18 parts of medicinal cyathula root, 10-14 parts of vinegar rhizoma cyperi, 10-14 parts of bran-fried fructus aurantii, 10-14 parts of codonopsis pilosula, 10-14 parts of roasted herba epimedii, 10-14 parts of salted rhizoma anemarrhenae and 12-18 parts of motherwort.
2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight:
12 parts of prepared rehmannia root, 12 parts of Chinese angelica, 12 parts of white peony root, 9 parts of ligusticum wallichii, 18 parts of semen cuscutae, 15 parts of wolfberry fruit, 9 parts of raspberry, 9 parts of prepared schisandra chinensis, 6 parts of salted plantain seed, 15 parts of medicinal cyathula root, 12 parts of vinegar-processed rhizoma cyperi, 12 parts of bran-fried fructus aurantii, 12 parts of codonopsis pilosula, 12 parts of roasted herba epimedii, 12 parts of salted rhizoma anemarrhenae and 15 parts of leonurus.
3. The traditional Chinese medicine composition as claimed in claims 1-2, wherein the salted plantain seed is wrapped and decocted, specifically by wrapping the salted plantain seed with gauze.
4. A pharmaceutical preparation prepared from the traditional Chinese medicine composition of claim 1 or 2 and/or pharmaceutically acceptable auxiliary materials.
5. The pharmaceutical preparation according to claim 4, wherein the pharmaceutical dosage form is a clinically acceptable dosage form such as decoction, pill, capsule, powder, granule or oral liquid.
6. The pharmaceutical preparation of claim 5, wherein said decoction comprises the steps of:
1) wrapping semen plantaginis with gauze;
2) mixing semen plantaginis, prepared rehmannia root, Chinese angelica, white paeony root, Szechuan lovage rhizome, south dodder seed, medlar, raspberry, prepared Chinese magnoliavine fruit, medicinal cyathula root, vinegar-fried rhizoma cyperi, bran-fried bitter orange, codonopsis pilosula, roasted epimedium herb, salted rhizoma anemarrhenae and motherwort, adding water for decocting twice, adding 8-10 times of water for the first time, decocting for 30-60 minutes, and filtering; adding 6-8 times of water for the second time, decocting for 20-40 min, filtering, and mixing filtrates.
7. Use of the traditional Chinese medicine combination of claim 1 or 2 in the preparation of a medicament for preventing and treating amenorrhea.
8. Use of the combination of Chinese herbs according to claim 1 or 2 for the preparation of a medicament for the prevention or treatment of infertility.
9. Use of the combination of Chinese traditional medicine according to claim 1 or 2 for preparing the medicine for preventing and treating menoxenia.
10. The use of claim 9, wherein the irregular menstruation includes any one of kidney deficiency type, blood heat type, liver depression type transforming into heat type, qi deficiency type, blood cold type qi stagnation type, and blood stasis type.
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| CN101496862A (en) * | 2009-03-19 | 2009-08-05 | 王新民 | Chinese medicinal composition for treating infertility and preparation method thereof |
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| Title |
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| 李瑞娟等: "刘金星教授补肾养精汤治疗早发性卵巢功能不全的经验", 光明中医, vol. 33, no. 23, pages 3481 * |
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