CN113855754A - Traditional Chinese medicine composition for removing blood stasis and stopping bleeding as well as preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for removing blood stasis and stopping bleeding as well as preparation method and application thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for removing blood stasis and stopping bleeding and a preparation method and application thereof, and particularly discloses a traditional Chinese medicine composition which comprises the following components, by weight, 1-10 parts of pseudo-ginseng, 1-10 parts of fried cattail pollen, 5-15 parts of bran-fried bighead atractylodes rhizome, 5-15 parts of Chinese yam, 1-10 parts of vinegar trogopterus dung, 5-15 parts of calcined oyster shell, 1-10 parts of rhizoma cimicifugae, 10-20 parts of spina date seed and 1-10 parts of tree peony bark. The traditional Chinese medicine extract is extracted by the following method: extracting with water or extracting Notoginseng radix and parched pollen Typhae with ethanol, extracting the rest seven materials with water, and mixing the extract powders. The traditional Chinese medicine composition has the function of treating menorrhagia.
Description
Technical Field
The invention belongs to the field of traditional Chinese medicine extracts, and particularly provides a traditional Chinese medicine composition for removing blood stasis and stopping bleeding, and a preparation method and application thereof.
Background
Menorrhagia, also known as "menorrhagia", refers to the condition of irregular menstruation, i.e., irregular menstruation, with more regular and more pronounced increase of menstruation and basically normal cycle. It is generally considered that the menstrual blood amount is preferably 30-50ml, and that more than 80ml is menorrhagia. The disease belongs to the category of gynecological blood diseases, is a common and frequently-occurring disease of gynecology, and is equivalent to ovulation dysfunctional uterine bleeding in western medicine. According to the published national statistical office of the people's republic of China, the total population of the whole country reaches 12.9988 billion at the end of 2004, wherein 6.3012 billion women, 3.08 billion women with childbearing age (15-44 years) and 2.51 billion women with age above 45 are in the same year. More than 30% of women in the childbearing age of more than 5 hundred million in China and in climacteric period have gynecological blood diseases, and about 1.6 hundred million women in the whole country have gynecological blood diseases. According to the national economic and social development statistical bulletin of 2008 national general population 13.3474 hundred million and women 6.4822 hundred million released by the national statistical office on 26.2.2.2009, the national general population is predicted to be nearly 14 hundred million in 2015. Estimated to be approximately 7 billion in women, and estimated to be no less than 2 billion in hemopathic patients (plus the excessive bleeding resulting from improper contraceptive measures or unsafe contraception in women of childbearing age). Due to its high incidence, it seriously affects women's physical and mental health, daily work and life. Therefore, the treatment is very important and urgent.
Clinically, western medicine mostly adopts hormone and operation treatment, has wide adaptation symptoms, simple method and thorough hemostasis, but the applied medicine sometimes has side effects in aspects of neuroendocrine, cardiovascular system, bone metabolism, secondary sexual characteristics and the like, and also has the defects of long curative effect, slow effect and easy relapse; operative removal of the uterus results in structural and functional changes in the reproductive organs, which can cause permanent psychological damage to the patient and the family members.
From the perspective of traditional Chinese medicine, the main pathogenesis of menorrhagia is insecurity of thoroughfare and conception vessels and menstrual blood loss restriction. The common causes include qi deficiency, blood heat and blood stasis【1】. Weakness of the body, loss of appetite, or overstrain or chronic disease, damage of spleen qi, leading to insufficiency of middle-jiao, insecurity of thoroughfare and conception vessels, and loss of blood control, resulting in profuse menstruation. Long-term treatment can cause deficiency of both qi and blood, and deficiency of both heart and spleen, or spleen damage and kidney, resulting in deficiency of both spleen and kidney; the excessive yang of the body, or the transformation of liver depression into fire, or overeating of pungent and dry blood-moving products, or exogenous pathogenic heat, heat disturbing Chong and ren meridians, which urge recklessly blood flow, thus increasing the amount of menstruation; the medicine is mostly depressed, and blood stasis is caused by qi stagnation; or after the menstrual period, the patient feels exogenous pathogenic factors or is prohibited from sexual intercourse, and blood stasis is stopped inside. Blood stasis obstructing the thoroughfare and conception vessels can not lead to meridian obstruction, resulting in excessive menstruation volume. The above threeThe syndrome types can occur independently and often accompanied by deficiency-excess complicated syndrome types, such as qi deficiency and blood stasis.
The treatment of the disease is divided into a bleeding stage and a non-bleeding stage: the treatment in the bleeding stage is performed on the symptoms in case of emergency, and the bleeding is stopped firstly; the non-bleeding period is treated by adjusting the menstrual cycle to normal. It is indicated for qi deficiency and blood stasis syndrome during menorrhagia and hemorrhage stage. In the formula, pseudo-ginseng and fried cattail pollen are good medicines for stopping bleeding without retaining blood stasis, and are monarch medicines aiming at main pathogenesis; the bighead atractylodes rhizome and the Chinese yam have the effects of tonifying spleen and qi, helping the source of biochemistry, tonifying qi and taking blood, are designed for concurrent symptoms and are ministerial drugs; stir-baked Lingzhi helps monarch drugs to promote blood circulation, remove blood stasis and relieve pain, calcined oyster shell astringes and stops bleeding, cimicifuga foetida lifts and lifts sinking, controls blood and strengthens root, Ziren tonifies blood and calms heart and tranquilizes mind, and moutan cortex excels in blood system to clear heat, cool blood and stop bleeding, which are used as assistant drugs. The medicines are combined to play the roles of promoting blood circulation to remove blood stasis, tonifying qi and spleen, stopping bleeding and consolidating the constitution.
As for menorrhagia, it is recorded that the menstruation is too much in the formula of meridian-warming decoction from jin Kui Yao, Furen miscellaneous diseases and pulse treatment. The medical books from Han and then to jin Yuan are generally called "irregular menstruation" because there is little first sight and the menstruation cycle is preceded and followed by a few first sight. The "excessive menstruation" is proposed in "Su Bing Qi Yi Bao Ming Ji & Fu ren Tai Lun of pregnancy of women" among the Jinbai Liu Hehe, the pathogenesis of the disease is based on the excess heat of yang preponderance, the therapeutic method focuses on clearing heat and cooling blood, and nourishing blood and regulating menstruation are assisted. For excess menstruation of women, except for excess syndrome, one or two of radix Scutellariae and rhizoma Atractylodis Macrocephalae are added in the four herbs. Yuan Dynasty, the Danxi Xin Fa (Danxi Heart method) women classified the etiology and pathogenesis of this disease into blood heat, excessive phlegm and blood deficiency, and also had the corresponding treatment drugs in parallel, and the test case for treating women's deficiency of qi and blood intake and menorrhagia. The Ming Dynasty, dao Zhi Zhuan, woman, Tiaojing Men, considered that "excessive menstruation refers to deficient heat, which means that qi deficiency fails to control blood". The Qing Dynasty "Yi Zong jin Jian, gynecologic heart and law key formula, Tiaojing Men" distinguishes the deficiency, excess, cold, heat and cloud according to the color, quality, qi, taste of the menstrual blood and the characteristics of the leucorrhea: the foul and foul smell of the meridians and collaterals are also due to damp-heat decay. For the clear and fishy smell, it is also due to dampness, stasis and cold deficiency. The clear Dynasty 'Fu Qing Master Ladies & Tiaojing' considers that the disease is caused by blood deficiency without meridian tropism. The "heat blood coagulation" and "blood leaving and accumulating" proposed in "Yuchi & Yu Mei" of gynecology cause excessive menstruation, which is characterized by mass of menstruation and abdominal pain. It is considered that the constitution is different, the pathogenesis of excessive water is different, the fat people are mostly deficient cold, and the lean people are mostly vigorous in fire. The therapeutic method is warming meridians to induce astringency, and nourishing yin to clear heat.
From the viewpoint of etiology, modern researches have generally considered that the disease is mainly related to congenital deficiency, acquired malnutrition, emotional impairment, overwork, six excesses and secondary factors such as damage of birth control measures. Teaching of three teaching[2]It is considered that the root cause of the excessive menstruation is kidney qi impairment and insecurity of thoroughfare and conception vessels. Yi Xiao Yun[3]Clinically, menorrhagia is rarely seen in the types of qi deficiency, blood heat and kidney deficiency, and also has the symptoms of internal stasis, and excessive menstruation if blood fails to enter meridians due to obstruction of thoroughfare and conception vessels; qi and yang deficiency, blood circulation failure, blood circulation retardation, and blood stasis. Teaching of Ouyang[4]It is considered that the pathogenesis of menorrhagia is the loss of qi and blood due to kidney deficiency, and the stasis of Chong and ren meridians caused by deficiency, and the deficiency and stasis can generate heat, move blood and consume blood, and the menstrual blood is decocted by heat to cause blood stasis. Lijunming[5]It is considered that the function of liver in smoothing flow of qi and blood directly affects the circulation of qi and blood, the menstruation depends mainly on the function of liver in smoothing flow of qi and storing blood, and the etiology, pathogenesis, syndrome differentiation and treatment of menorrhagia should be centered on the liver.
The differentiation of menorrhagia focuses on the color and quality of the meridians, and the differentiation of cold, heat, deficiency and excess is combined with the pulse syndrome. Li Wen[6]According to the clinical manifestations of menorrhagia, the types of menorrhagia are differentiated and classified into blood-heat type, liver-kidney yin deficiency type and qi-blood deficiency type. Modified Danzhi Xiaoyao san combined Shengmai san for blood heat type, modified Erzhi Wan combined Liuwei Dihuang Wan for liver and kidney yin deficiency type, and modified Bazhen Tang for qi and blood deficiency type. Korean English substitute[7]This disease is classified into type 4, blood-heat type, yin-deficiency and blood-heat type, liver-qi stagnation type and qi-deficiency type. The blood heat type is Qinlian Siwu Tang, the yin deficiency and blood heat type is Shuangdi Tang, the liver depression and qi stagnation type is Dan Zhi Xiao Yao san, and the qi deficiency type is Gui Pi Tang plus. Song Zhuo Ming[8]The disease is classified into type 2, blood deficiency and blood stasis, and blood deficiency and qi deficiency. Modified Siwu Tang for blood deficiency and blood stasis, or Dang Shen for qi deficiency and blood deficiency15g of ginseng and 30g of radix astragali preparata. For blood deficiency with heat, 15g of radix rehmanniae and 10g of peony are added.
Chen Hongmei[9]Collecting data of 102 outpatients with menorrhagia since 1986 to 1996, wherein 30 cases of spleen qi deficiency type are modified by Anchong decoction; for 42 cases with syndrome of blood stasis and heat accumulation, the decoction of Sandi is used for cutting; for 18 cases of yin deficiency and blood heat type, add Erzhi pills; 12 cases of kidney yang deficiency type are treated with kidney-tonifying and root-securing decoction, and the treatment effect is satisfactory through syndrome differentiation. The charging device is connected with[10]The decoction for treating menorrhagia is prepared by using the decoction for strengthening the menstrual flow for 46 cases, 41 cases are cured, 2 cases with obvious effect and 3 cases with no effect, and the total effective rate is 93.50 percent. Zhang Huashan mountain[11]The stasis-removing and meridian-clearing decoction is matched with Yunnan white drug powder to treat the menorrhagia caused by blood stasis, 45 cases are observed, 35 cases are cured, 9 cases are improved, 1 case is ineffective, and the total effective rate is 97.78%.
For some patients who want traditional Chinese medicine treatment but have difficulty in taking traditional Chinese medicine decoction orally, the Chinese patent medicine is undoubtedly the best choice. Especially, some innovative traditional Chinese medicines with definite curative effect come out in recent years, which brings convenience to the treatment of the disease. Wangfang et al[12]The therapeutic medicine, radix Lamiophlomidis Rotatae Capsule, is used for treating hypermenorrhea 108 cases by comparing with the control medicine, Yunnan Baiyao Capsule. The test group orally took the lamiophlomis rotata capsule 3 times a day, 3 capsules each time. The control group orally took Yunnan Baiyao Capsule 4 times a day, 2 capsules each time. 7 days are 1 course of treatment. The results show that the total effective rate of the experimental group is 80.00 percent, the total effective rate of the control group is 82.86 percent, and the lamiophlomis rotata capsule and the Yunnan Baiyao capsule are further verified to have similar clinical curative effect and safety to the menorrhagia. Tang Hao Zhi and so on[13]100 cases of patients with advanced menstruation and menorrhagia are treated by the uterus-preserving hemostasis granules (calcined oyster shell, white paeony root, rehmannia root, Chinese arborvitae charcoal, cherokee rose fruit, hairyvein agrimonia herb and bud, Chinese toon bark, indigowoad leaf, pseudo-ginseng and Chinese thorowax root), a control group adopts western medicine hemostasis treatment, the total effective rate and the total effective rate of the treatment group are respectively 84% and 93%, the total effective rate and the total effective rate of the control group are respectively 30% and 53%, and significant differences exist among groups. Yangfei[13]83 patients with menorrhagia are treated with GONGXUENING Capsule (rhizoma paridis extract), 80 cases are treated with glycine in control group, and after 3 months of menstruation, 60 cases and 18 cases are effective respectively, the total effective rate is 94%, 45 cases and 19 cases are effective respectively in control groupThe efficiency is 80%, and the comparison among groups has significant difference.
The traditional Chinese medicine accumulates abundant treatment experiences on the disease in long-term clinical practice, has the characteristics of definite curative effect and small side effect, and shows the unique advantages and wide prospects of the traditional Chinese medicine for treating the disease. However, the new traditional Chinese medicine is rarely used clinically at present, so that aiming at the current treatment situation and problems of the current disease, a subject group is based on the experience formula of the famous and old traditional Chinese medicine, the traditional Chinese medicine syndrome differentiation and the modern medicine syndrome differentiation are combined, and the hypermenorrhea treatment medicine with definite curative effect, less side effect, convenient taking and economic price is developed, so that the social requirement is met, and better economic benefit and social benefit are brought.
Disclosure of Invention
In order to solve the problems, the invention provides a traditional Chinese medicine composition and a preparation method and application thereof.
One aspect of the invention provides a traditional Chinese medicine composition which comprises, by weight, 1-10 parts of pseudo-ginseng, 1-10 parts of fried cattail pollen, 5-15 parts of bran-fried bighead atractylodes rhizome, 5-15 parts of Chinese yam, 1-10 parts of vinegar trogopterus dung, 5-15 parts of calcined oyster shell, 1-10 parts of cimicifugae foetidae, 10-20 parts of spina date seed and 1-10 parts of tree peony bark.
In some technical schemes of the invention, by weight, 4-6 parts of pseudo-ginseng, 6-8 parts of fried cattail pollen, 8-12 parts of bran-fried bighead atractylodes rhizome, 8-12 parts of Chinese yam, 6-8 parts of vinegar trogopterus dung, 8-12 parts of calcined oyster shell, 3-5 parts of cimicifuga foetida, 12-16 parts of spina date seed and 6-8 parts of moutan bark.
In some technical schemes of the invention, by weight, 5 parts of pseudo-ginseng, 7 parts of fried cattail pollen, 10 parts of bran-fried bighead atractylodes rhizome, 10 parts of Chinese yam, 7 parts of vinegar trogopterus dung, 10 parts of calcined oyster shell, 4 parts of cimicifuga foetida, 14 parts of spina date seed and 7 parts of moutan bark.
One aspect of the invention provides a traditional Chinese medicine extract which is prepared from the following components, by weight, 1-10 parts of pseudo-ginseng, 1-10 parts of fried cattail pollen, 5-15 parts of bran-fried bighead atractylodes rhizome, 5-15 parts of Chinese yam, 1-10 parts of vinegar trogopterus dung, 5-15 parts of calcined oyster shell, 1-10 parts of cimicifugae foetidae, 10-20 parts of spina date seed and 1-10 parts of tree peony bark.
In some technical schemes of the invention, by weight, 4-6 parts of pseudo-ginseng, 6-8 parts of fried cattail pollen, 8-12 parts of bran-fried bighead atractylodes rhizome, 8-12 parts of Chinese yam, 6-8 parts of vinegar trogopterus dung, 8-12 parts of calcined oyster shell, 3-5 parts of cimicifuga foetida, 12-16 parts of spina date seed and 6-8 parts of moutan bark.
In some technical schemes of the invention, by weight, 5 parts of pseudo-ginseng, 7 parts of fried cattail pollen, 10 parts of bran-fried bighead atractylodes rhizome, 10 parts of Chinese yam, 7 parts of vinegar trogopterus dung, 10 parts of calcined oyster shell, 4 parts of cimicifuga foetida, 14 parts of spina date seed and 7 parts of moutan bark.
In some technical schemes of the invention, the traditional Chinese medicine extract is extracted by the following method:
extracting with water or extracting Notoginseng radix and parched pollen Typhae with ethanol, extracting the rest seven materials with water, and mixing the extract powders.
In some technical schemes of the invention, the traditional Chinese medicine extract is extracted by the following method:
1) weighing Notoginseng radix, pollen Typhae preparata, Atractylodis rhizoma parched with bran, rhizoma Dioscoreae, vinegar Oletum Trogopterori, Concha Ostreae preparata, cimicifugae rhizoma, semen Ziziphi Spinosae, and cortex moutan;
2) decocting Concha Ostreae in water for half an hour, decocting with other eight Chinese medicinal materials in water twice, each time with 12 times of water for 2 hr, and mixing decoctions;
or
2) Extracting Notoginseng radix and parched pollen Typhae with ethanol, adding 10 times of 60% ethanol, reflux extracting for 3 times, each time for 2 hr, decocting the rest seven materials with water twice, each time with 12 times of water for 2 hr, and mixing the extract powders.
One aspect of the invention provides a traditional Chinese medicine composition which comprises 1-10 parts of pseudo-ginseng, 1-10 parts of fried cattail pollen, 5-15 parts of bran-fried bighead atractylodes rhizome, 5-15 parts of Chinese yam, 1-10 parts of vinegar trogopterus dung, 5-15 parts of calcined oyster shell, 1-10 parts of cimicifuga foetida, 10-20 parts of spina date seed and 1-10 parts of moutan bark.
Another aspect of the present invention provides a method for preparing the above-mentioned herbal extract, which comprises the following steps:
extracting with water or extracting Notoginseng radix and parched pollen Typhae with ethanol, extracting the rest seven materials with water, and mixing the extract powders.
In some technical schemes of the invention, the preparation method of the Chinese medicine extract comprises the following steps:
1) weighing Notoginseng radix, pollen Typhae preparata, Atractylodis rhizoma parched with bran, rhizoma Dioscoreae, vinegar Oletum Trogopterori, Concha Ostreae preparata, cimicifugae rhizoma, semen Ziziphi Spinosae, and cortex moutan;
2) decocting Concha Ostreae in water for half an hour, decocting with other eight Chinese medicinal materials in water twice, each time with 12 times of water for 2 hr, and mixing decoctions;
or
2) Extracting Notoginseng radix and parched pollen Typhae with ethanol, adding 10 times of 60% ethanol, reflux extracting for 3 times, each time for 2 hr, decocting the rest seven materials with water twice, each time with 12 times of water for 2 hr, and mixing the extract powders.
One aspect of the invention provides a traditional Chinese medicine composition which comprises 1-10 parts of pseudo-ginseng, 1-10 parts of fried cattail pollen, 5-15 parts of bran-fried bighead atractylodes rhizome, 5-15 parts of Chinese yam, 1-10 parts of vinegar trogopterus dung, 5-15 parts of calcined oyster shell, 1-10 parts of cimicifuga foetida, 10-20 parts of spina date seed and 1-10 parts of moutan bark.
In another aspect of the present invention, a medicament is provided, which comprises the above-mentioned Chinese medicinal composition or Chinese medicinal extract.
In the technical scheme of the invention, the dosage form of the medicament is an oral dosage form, preferably granules, oral liquid, tablets, syrup and paste.
In the technical scheme of the invention, the medicine contains pharmaceutically acceptable auxiliary materials.
In the technical scheme of the invention, the dosage form of the medicine is granules, dextrin is used as an excipient, the mass ratio of the traditional Chinese medicine extract to the dextrin is 1: 1-1: 2, and preferably 1:1, wherein the traditional Chinese medicine extract is calculated by dry mass.
The invention also provides a preparation method of the medicine, the preparation of the medicine is granules, dextrin is used as an excipient, the mass ratio of the traditional Chinese medicine extract to the dextrin is 1: 1-1: 2, and 70-90% of ethanol is used as a wetting agent for preparation.
In the technical scheme of the invention, the mass ratio of the traditional Chinese medicine extract to the dextrin is 1: 1.
In the technical scheme of the invention, the granules are prepared by a wet granulation method.
In the technical scheme of the invention, the wetting agent is 90% ethanol.
The invention further provides application of the traditional Chinese medicine composition, the traditional Chinese medicine extract or the medicine, and the application is application in preparing medicines for promoting blood coagulation.
In another aspect, the invention provides an application of the traditional Chinese medicine composition, the traditional Chinese medicine extract or the medicine, and the application is an application in preparing a medicine for treating blood coagulation disorder.
In another aspect, the invention provides an application of the traditional Chinese medicine composition, the traditional Chinese medicine extract or the medicine, and the application is an application in preparing a medicine for promoting platelet aggregation.
In another aspect, the invention provides an application of the traditional Chinese medicine composition, the traditional Chinese medicine extract or the medicine, and the application is an application in preparing a medicine for treating menorrhagia.
Preferably, the use for the preparation of a medicament for the treatment of menorrhagia due to ovulatory dysfunctional uterine bleeding.
More preferably, for the preparation of a medicament for hemostasis during menstrual bleeding.
In another aspect, the invention provides an application of the traditional Chinese medicine composition, the traditional Chinese medicine extract or the medicine, and the application is an application in preparing a medicine for reducing uterine smooth muscle contraction.
In another aspect, the invention provides a quality standard detection method for the traditional Chinese medicine composition, the traditional Chinese medicine extract or the medicine, which uses the ginsenoside Rg in the panax notoginseng1The content was measured as an index.
In some embodiments of the present invention, in the present invention, the components are as follows:
frying cattail pollen: is dried pollen of Typha angustifolia L, Typha orientalis or plants of the same genus. Adopts fried decoction pieces.
Stir-frying white atractylodes rhizome with bran: is dried rhizome of Atractylodes macrocephala Koidz of Compositae. Rhizoma Atractylodis Macrocephalae is stir-baked with bran.
Chinese yam: is dried rhizome of Dioscorea oppoa opposita Thunb. Adopts decoction pieces.
Vinegar trogopterus dung: dried feces of the Trogopterus Xanthipes Milne-Edwards, which is an animal of the family Trogopterus, or of the Pteromys volans L, which is an animal of the family Pteromys. Adopts vinegar trogopterus dung.
Calcining oysters: is the shell of Ostrea gigas thunberg, Ostrea talienhanensis cross or Ostrea rivularis gould of Ostrea gigas of Ostrea family Ostrea. Calcined oyster shells are adopted.
Cimicifugae foetidae: the product is dried rhizome of Cimicifuga dahurica Kom, Cimicifuga dahurica (Turcz.) Maxim, or Cimicifuga foetida L. Adopts decoction pieces.
Wild jujube seed: dried mature seeds of zizyphus jujube Z aliziphus jujuba mill. Adopts wild jujube seed decoction pieces.
Moutan bark: is dried root bark of Paeonia suffruticosa Andr. Adopts decoction pieces.
The prescription is an empirical prescription for clinical application, has years of clinical use experience, and adopts decoction. The preparation process is designed according to the medication characteristics of the variety clinically and the properties and the effects of each medicine in the prescription and the dosage form characteristics of the granules.
Monarch drug: notoginseng, fried cattail pollen. Notoginseng radix mainly contains saponins. Has effects in removing blood stasis, stopping bleeding, and relieving swelling and pain, and can be used for treating hemoptysis, hematemesis, hematochezia, metrorrhagia, traumatic hemorrhage, thoracico-abdominal pain, and traumatic injury with swelling and pain; pollen Typhae mainly contains flavonoids, has effects of stopping bleeding and removing blood stasis, and can be used for treating hemorrhage symptoms such as hematemesis and metrorrhagia, and the hemostasis effect can be enhanced after parching. Both of them are the essential herbs for removing blood stasis and stopping bleeding, and have the characteristics of removing blood stasis and promoting tissue regeneration, stopping bleeding without retaining blood stasis. The process adopts water boiling extraction.
Ministerial drugs: atractylodis rhizoma parched with bran, and rhizoma Dioscoreae. The Atractylodis rhizoma mainly contains atractylenolide, atractylone, etc., and has effects of invigorating spleen, invigorating qi, eliminating dampness, promoting diuresis, arresting sweating, and preventing miscarriage. The main component of Largehead Atractylodes rhizome parched with bran is atractylenolide, which can relieve dryness, and promote digestion and stomach function by entering into middle via bran. The rhizoma Dioscoreae mainly contains polysaccharide, and has effects of invigorating qi, invigorating spleen and nourishing stomach. Both the two medicines have the effects of tonifying qi and invigorating spleen, and modern researches show that both the two medicines can regulate the functions of gastrointestinal tracts and improve the immunity. Both of them contain polysaccharide with wide physiological activity, and the process adopts water boiling extraction.
The following are assisted and guided: vinegar trogopterus dung, calcined oyster shell, cimicifuga foetida, spina date seed and moutan bark are used as adjuvant and guiding drugs in the formula. The fried cattail pollen and the vinegar trogopterus dung are equivalently matched to form the famous gynecological prescription named Shixiao powder which is a medicine pair with the main functions of promoting blood circulation and removing blood stasis, and the vinegar trogopterus dung is used for assisting the fried cattail pollen to enhance the effects of promoting blood circulation and removing blood stasis; the oyster has the effects of tranquilizing mind, suppressing yang hyperactivity, nourishing yin, softening and resolving hard mass, and the calcined oyster is crisp and easy to crush, so that the effective components can be dissolved out easily, and the astringent effect is increased; cimicifugae rhizoma has effects of relieving exterior syndrome, promoting eruption, clearing away heat and toxic materials, and lifting yang qi; the spina date seed has the effects of nourishing heart and liver, calming heart and tranquilizing mind, and arresting sweating and promoting fluid production; cortex moutan has effects of clearing heat, cooling blood, promoting blood circulation and removing blood stasis. The five medicines are used together to assist the monarch and ministerial medicines to play the effects of removing blood stasis, stopping bleeding, tonifying qi and strengthening spleen. The process adopts water boiling extraction.
Square solution: . In the formula, pseudo-ginseng and fried cattail pollen are good medicines for stopping bleeding without retaining blood stasis, and are monarch medicines aiming at main pathogenesis; the white atractylodes rhizome fried with bran and the Chinese yam have the effects of tonifying spleen and qi, helping the source of biochemistry, and tonifying qi, can control blood, are designed for concurrent symptoms and are ministerial drugs; vinegar trogopterus dung helps monarch drugs to promote blood circulation, remove blood stasis and relieve pain, calcined oyster shell astringes and stops bleeding, cimicifuga foetida lifts and lifts sinking, takes up blood and consolidates foundation, jujube kernel nourishes blood, calms heart and calms nerves, cortex moutan is good at entering blood system to clear heat, cool blood and stop bleeding, and the two are used as assistant drugs. The medicines are combined to play the roles of promoting blood circulation to remove blood stasis, tonifying qi and spleen, stopping bleeding and consolidating the constitution.
Advantageous effects
The prescription of the invention is derived from clinical proved formulas of famous old Chinese medicine, and has reasonable prescription, precise and appropriate compatibility and reliable clinical curative effect. The Chinese medicinal decoction has obvious curative effect and no adverse reaction after being clinically used for many years.
The quality standard design is comprehensive, the reproducibility of main technical indexes is good, and the quality of the medicine can be effectively controlled.
The main pharmacodynamics proves that the product has the functions of reducing the uterine bleeding amount and shortening the bleeding time of the animals with the blood coagulation disorder.
The toxicological test has comprehensive observation items, and the test result also proves that the product is safe to use and has no toxic or side effect, thereby providing a basis for the clinical safe application of the product.
Drawings
FIG. 1 shows the results of critical relative humidity measurements.
Detailed Description
In order to make the aforementioned objects, features and advantages of the present invention more comprehensible, specific embodiments thereof are described in detail below, but the present invention is not to be construed as being limited to the implementable range thereof.
Example 1 preparation of a full-formula aqueous extract of Chinese herbs
Firstly, 250g of pseudo-ginseng, 350g of fried cattail pollen, 500g of bran-fried largehead atractylodes rhizome, 500g of Chinese yam, 350g of vinegar trogopterus dung, 500g of calcined oyster shell, 200g of cimicifuga foetida, 700g of spina date seed and 350g of tree peony bark are weighed.
Decocting calcined oyster for half an hour, decocting the calcined oyster and other eight medicines (wherein pseudo-ginseng is crushed into coarse powder, and pollen typhae and trogopterus dung vinegar are wrapped and decocted) with water twice, 12 times and 2 hours each time, merging decoction, filtering, concentrating until the relative density is 1.1-1.2(60 ℃), drying, and pulverizing into fine powder to obtain the water-extracted traditional Chinese medicine extract of the whole formula. The cream yield is 16.2%, and each 1g of the cream corresponds to 6.17g of the raw medicinal material.
Example 2 preparation of partially alcoholic extracted Chinese medicinal extract
Taking 30 times of the medicinal materials in the prescription, 2.22kg in total, firstly carrying out alcohol extraction on the pseudo-ginseng and the fried cattail pollen, and the specific process comprises the following steps: adding 10 times of 60% ethanol, and extracting under reflux for 3 times, each for 2 hr. Mixing the two ethanol extractive solutions, recovering ethanol, concentrating to relative density of 1.1-1.2(60 deg.C), drying under reduced pressure below 60 deg.C, and pulverizing into fine powder. Adding 12 times of water into the rest 7 materials, decocting and extracting for 2 times, each time for 2 hr, filtering, concentrating the decoction to relative density of 1.1-1.2(60 deg.C), drying under reduced pressure below 60 deg.C, and pulverizing into fine powder. Mixing the fine powders to obtain 346.32g of extract powder, and extracting part of the Chinese medicinal extract with ethanol. The cream yield is 15.6%, and each 1g of the cream corresponds to 6.41g of the raw medicinal material.
EXAMPLE 3 preparation of Chinese medicinal granules
Adding a proper amount of dextrin into the traditional Chinese medicine extract obtained in the embodiment 1, uniformly mixing, granulating, drying and preparing into 1000 g.
Example 4 experiment of different extraction Processes on blood coagulation function of mice with blood coagulation dysfunction
The animals and drugs used in this example were as follows:
ICR mice, female, weight 19-21g, by Beijing Wittiulihua laboratory animal technology company. The whole formula of example 1 is water extract traditional Chinese medicine extract, and the partial alcohol extract traditional Chinese medicine extract of example 2 is partial alcohol extract traditional Chinese medicine extract.
The daily dosage of the experiment is 74g of the traditional Chinese medicine extract, calculated according to 60kg of body weight, namely 1.23g of the traditional Chinese medicine extract/kg, and the experimental dosages are respectively 5, 10 and 20 times of the human dosage, 24.6g of the traditional Chinese medicine extract/kg, 12.3g of the traditional Chinese medicine extract/kg and 6.15g of the traditional Chinese medicine extract/kg.
Menadiol acetate tablets: lake North America (group) Meisheng pharmaceutical industry Co. Batch number: 050507. the clinical daily dosage is 0.2 mg/kg. The experimental dosage is 10 times of the clinical dosage, namely 2 mg/kg.
Sodium chloride: analytically pure, Beijing chemical plant. Batch number: 20110114. warfarin: manufactured by Finland Orion Corporation; lot number 1421382.
Grouping: 132 mice are randomly divided into 9 groups, namely a control group, a model group and a menadione acetate group, and the groups of the water extract traditional Chinese medicine extract of the whole formula of the embodiment 1 are 24.6g/kg, 12.3g/kg and 6.15 g/kg; example 2 partial alcohol extracts Chinese medicinal extracts 24.6g/kg, 12.3g/kg, 6.15 g/kg. Of these, 12 were used as a control group and 15 were used as groups for the remaining groups.
Molding: except for the control group, the warfarin was administered by intragastric administration at an equivalent amount of drinking water (0.2mL/10g body weight), and warfarin was administered once a day at 2mg/kg daily for 4 times in each dose group.
Administration: the stomach of each group was drenched with the corresponding drug at day 4 of molding, 0.2mL/10g of body weight, and the control group and the model group were drenched with drinking water. The administration is 1 time daily for 5 days.
And (3) bleeding time measurement: in the experiment 1h after the last administration, the tail tip of each dose group of mice is cut off at the position 5mm away from the tail tip, the mice are immersed in physiological saline with the temperature of 37 ℃ and the depth of 2cm, the timing is started, the timing is stopped when the blood streak disappears, and the time is the bleeding time of the mice.
And (3) blood coagulation time determination: 1h after the last administration, one side of the eyeball of the mouse is picked up by curved forceps of ophthalmology, 3 drops of blood are respectively dripped at the two ends of the glass slide, and the radius of the blood drop is 5-10 mm. The control group was started from 1min, and was picked up once every 15s from the edge of the blood drop by a cleaning pin, and the remaining 4 groups were picked up once every 10s from 30s, and the presence or absence of the blood thread was observed. The time from the beginning of blood collection to the beginning of blood drawing to the end of blood drawing is the blood coagulation time of the mouse. Another drop of blood was given for final re-examination.
The statistical method comprises the following steps: statistical analysis of data was performed using SPSS 14.0, values were taken
The comparisons between groups were analyzed by ONEWAY-ANOVA, with the same variance being tested by LSD, and otherwise by Dunnett's T3.
Results
Effect on bleeding time in mice with blood coagulation disorders
The results are shown in Table 1. Compared with a control group, warfarin can remarkably prolong the bleeding time of mice (P <0.01), and the mouse model with the blood coagulation disorder is successfully replicated. The blood stasis removing and bleeding stopping granules can obviously shorten the bleeding time of mice with blood coagulation disorders in each process group and high dose, and the result has statistical significance (P < 0.01). However, the inhibitory effects of the two processes on the bleeding time of mice are not obviously different.
TABLE 1 Effect of different Chinese medicinal extracts on bleeding time of mice with blood coagulation dysfunction
Note: comparing with control group##P<0.01; comparison with model group**P<0.01
Not counting the unsuccessful molding in 15 cases
Effect on clotting time in clotting dysfunctional mice
The results are shown in Table 2. Compared with a control group, the warfarin can obviously prolong the coagulation time of the mice (P <0.01), and the mouse model with the coagulation disorder is successfully replicated. The blood stasis removing and bleeding stopping granules have high doses in various processes, the dose in the process 1 can obviously shorten the blood coagulation time of mice with blood coagulation disorders, and the result has statistical significance (P < 0.01). However, the inhibitory effects of the two processes on the bleeding time of mice are not obviously different.
TABLE 2 Effect of Chinese medicinal extracts of different processes on clotting time of clotting dysfunction mice
Note: comparing with control group##P<0.01; comparison with model group**P<0.01
Not counting the unsuccessful molding in 15 cases
Conclusion
The traditional Chinese medicine extract has a promoting effect on the blood coagulation function of mice with blood coagulation dysfunction, and the traditional Chinese medicine extracts in different processes have little difference on the hemostasis function. For example, the whole formula water extraction process can be preferably adopted in consideration of the original extraction process (clinical application is decoction), the process operability and the economic effect of the prescription.
Example 5 experiment of different extraction Processes on blood coagulation function of mice with blood coagulation dysfunction
The animals and drugs used in this example were as follows:
ICR mice, female, weight 19-21g, by Beijing Wittiulihua laboratory animal technology company. Example 1 the full formula aqueous extract traditional Chinese medicine extract.
Menadiol acetate tablets: lake North America (group) Meisheng pharmaceutical industry Co. Batch number: 050507. the clinical daily dosage is 0.2 mg/kg. The experimental dosage is 10 times of the clinical dosage, namely 2 mg/kg.
Sodium chloride: analytically pure, Beijing chemical plant. Batch number: 20110114. warfarin: manufactured by Finland Orion Corporation; lot number 1421382.
Grouping: namely a control group, a model group, a menadiol acetate group, and groups of 17.22g/kg, 8.61g/kg and 4.31g/kg of the Chinese medicinal extract of the water extract of the whole formula in the embodiment 1; of these, 12 were used as a control group and 15 were used as groups for the remaining groups.
Molding: except for the control group, the warfarin was administered by intragastric administration at an equivalent amount of drinking water (0.2mL/10g body weight), and warfarin was administered once a day at 2mg/kg daily for 4 times in each dose group.
Administration: the stomach of each group was drenched with the corresponding drug at day 4 of molding, 0.2mL/10g of body weight, and the control group and the model group were drenched with drinking water. The administration is 1 time daily for 5 days.
Platelet aggregation rate and clotting factor assays: determination of maximum platelet aggregation rate induced by ADP, TT, PT and APTT time and plasma FIB content in rat with blood coagulation disorder by turbidimetry
The statistical method comprises the following steps: statistical analysis of data was performed using SPSS 14.0, values were taken
The comparisons between groups were analyzed by ONEWAY-ANOVA, with the same variance being tested by LSD, and otherwise by Dunnett's T3.
Platelet aggregation rate:
the traditional Chinese medicine extract of example 1, 4.31g crude drug/kg, can improve the maximal platelet aggregation rate induced by ADP (P <0.05) of rats with blood coagulation dysfunction.
Blood coagulation factors: the traditional Chinese medicine extracts of example 1, 4.31, 8.61 and 17.22g crude drugs/kg, can obviously shorten the TT time (P <0.01) and the PT time (P <0.01) of the rat with the blood coagulation dysfunction.
Example 6 Effect on uterine smooth muscle tone and blood flow
The experiment adopts normal rat and rabbit respectively, and observes the influence of the blood stasis removing and bleeding stopping granules on the uterine contraction activity and uterine blood flow of animals after 1 time of administration through duodenum.
Grouping: in the uterine contraction group, the administration dosage of the group to which the aqueous extract traditional Chinese medicine extract of the whole formula in the embodiment 1 is administered is 3.075g/kg, 6.15g/kg and 12.3 g/kg.
In the uterine smooth muscle tone group, the group administered with the aqueous extract of the Chinese medicinal material of the whole formula of example 1 was administered at doses of 4.31g/kg, 8.61g/kg and 17.22 g/kg.
The results show that the administration group compared to the control group:
(1) uterine contraction: example 1 administration of 4.31g/kg of the Chinese medicinal extract can reduce the rate of decrease in the uterine basal pressure of rats 30-60 min after administration, and administration of 17.22g of the crude drug/kg can reduce the uterine contraction activity within 90-150 min after administration. The effect of each dosage on the intrauterine pressure and the uterine contraction frequency has no significant difference.
(2) Uterine blood flow volume: example 1 the traditional Chinese medicine extract is administered at 12.3g/kg, the blood flow of uterus of rabbits (P <0.05, 0.01) can be obviously reduced at 15min, 30min and 45min after administration, and the blood flow of uterus tends to be reduced at 4.31 g/kg.
Example 7 Effect on blood stasis model rats
In the experiment, an acute blood stasis model is copied by adopting ice water swimming load adrenalin, the influence of the blood stasis removing and hemostasis granules on blood rheology indexes of a blood stasis rat is observed, and the effect of removing blood stasis is discussed.
Molding: the ice water swimming load adrenalin replicates the acute blood stasis model.
Administration: the preparation is administered by intragastric administration at dosage of 4.31g/kg, 8.61g/kg, and 17.22g/kg once daily for 7 days. The control group was given physiological saline.
The results show that the administration group compared to the model group: the dosages of the blood stasis removing and bleeding stopping granules have no obvious reduction effect on the low cutting rate, the medium cutting rate, the high cutting rate and the plasma viscosity of whole blood; each dose had a tendency to increase the erythrocyte deformability index, but the difference was not statistically significant.
The pharmacodynamic research results show that: the blood stasis removing and bleeding stopping particles have obvious effects of stopping bleeding and promoting coagulation, can reduce the bleeding amount of rats in a dysfunctional mouse model with dysfunctional blood caused by warfarin, can obviously shorten the blood coagulation time, and can obviously shorten the TT, PT and APTT time of rats in the dysfunctional blood caused by warfarin; the mechanism of its hemostatic and procoagulant action may be associated with the promotion of platelet aggregation, the promotion of blood coagulation factor activity and the reduction of uterine blood flow. The research results provide experimental basis for the preparation to be clinically used for functional uterine bleeding.
Example 8 selection of extraction Process
The method is expected to determine the process by using an ultraviolet-visible spectrophotometry and taking the content of the panax notoginseng saponins as an index, and test results show that the interference of a negative solution lacking panax notoginseng medicinal materials is serious, and the determination results cannot be used as a process screening basis. Therefore, HPLC method is selected to use ginsenoside Rg in Notoginseng radix1As an index, an orthogonal test is adopted to preferably extract process parameters.
1 ginsenoside Rg1Extraction and measurement of
1.1 extraction conditions
Selecting water addition amount, extraction time and extraction frequency as factors, and adopting ginsenoside Rg in Notoginseng radix1The content is used as an index to screen extraction process parameters.
Weighing 9 parts of each medicinal material in the prescription according to the proportion, and 74g of each part. According to the orthogonal experiment L9(34) The table was designed for testing. See table 3 for details.
TABLE 3 factor level table
1.2 ginsenoside Rg in Notoginseng radix1Content determination method
The determination is carried out by adopting a determination method under the item of pseudo-ginseng medicinal materials in the first part of Chinese pharmacopoeia 2010 edition.
1.3 orthogonal test results and analysis of variance
The results of the tests carried out according to the above experimental design are shown in tables 4 and 5.
Ginsenoside Rg in Notoginseng radix1The content is used as an index, and an orthogonal test is adopted to optimize extraction process parameters.
TABLE 4 Quadrature test and results
The extraction rate is dry extract ginsenoside Rg1Content/ginsenoside Rg in Notoginseng radix1Content 100
Ginsenoside Rg in pseudo-ginseng medicinal material1The contents are as follows: 2.84 percent.
TABLE 5 analysis of variance in complex extraction orthogonal test
Note: differences are significant when the value of Pr > F is less than 0.05, and differences are very significant when the value is less than 0.01.
As a result: uses ginsenoside Rg in pseudo-ginseng1The content is an investigation index, and the analysis of variance result shows that A (solvent dosage), B (extraction time) and C (extraction frequency) have no significant influence. According to the visual analysis of the orthogonal table, the optimal extraction process is as follows: a. the3B3C2I.e. 12 times the amount of water, 2 times each for 2 hours.
1.4 validation test
Precisely weighing 74g of prescription decoction pieces, and performing the preferred process A3B3C2(i.e., 12 times the amount of water, 2 extractions, 2 hours each) were performed for the validation test. The results are shown in Table 6 below.
TABLE 6 verification test
As a result: the process is stable and feasible.
And (4) conclusion: selection A3B3C2Is an extraction process. Namely: 12 times of water, 2 times for 2 hours each time.
2 ultraviolet determination of panax notoginseng saponins content
2.1 preparation of control solutions
Precisely weighing notoginsenoside R19.97mg of the control was put in a 10ml volumetric flask and the volume was determined with methanol. The concentration is 0.997mg/ml solution for standby.
2.2 preparation of sample solutions
2.2.1 preparation of Notoginseng radix medicinal solution 0.6g of Notoginseng radix powder (sieved with sieve IV), precisely weighing, precisely adding 50ml of methanol, weighing, standing overnight, keeping boiling in 80 deg.C water bath for 2 hr, cooling, weighing again, adding methanol to make up for the lost weight, shaking, filtering, and collecting the filtrate.
2.2.2 preparation of Quadrature No. 9 solution taking 1.00g of Quadrature No. 9 extract powder, precisely weighing, diluting methanol to a constant volume of 25ml in a measuring flask, carrying out ultrasonic treatment for 10min, filtering, and taking a subsequent filtrate to obtain the product.
2.2.3 preparation of the solution of Notoginsen triterpenes, 1.00g of extract powder of Notoginsen triterpenes is taken, precisely weighed, methanol is added to a constant volume of 25ml in a measuring flask, ultrasonic treatment is carried out for 10min, and filtration is carried out to obtain a subsequent filtrate.
2.3 ginsenoside Rg1Investigation of linear relationships
Collecting ginsenoside Rg with concentration of 0.997mg/ml prepared under item 2.11Precisely sucking 60 μ l, 80 μ l, 90 μ l, 100 μ l, 140 μ l, 150 μ l, 1800 μ l into 10ml penicillin bottles, placing in 80 deg.C water bath, volatilizing solvent, precisely adding newly prepared 5% vanillin glacial acetic acid solution 0.2ml and 0.8ml perchloric acid, and shaking. Heating the mixed solution in a constant temperature water bath at 60 deg.C for 15min, cooling in a cold water bath for 5min, measuring the absorption value at 548nm with the absorbance as ordinate and the reference substance concentration as abscissa, and obtaining a regression equation Y of 3.7904X-0.0025, R2＝0.9995。
2.4 determination of results
TABLE 7 Experimental results of UV-VIS spectrophotometry
Test results show that negative solutions of panax notoginseng-deficient medicinal materials are seriously interfered, and the measurement results can not be used as process screening bases. Therefore, HPLC method is selected to use ginsenoside Rg in Notoginseng radix1The content is used as an index, and an orthogonal test is adopted to optimize extraction process parameters.
In the experimental process, the ginsenoside Rg in the panax notoginseng is used1The content was measured as an index. In the experiment, attempts were made to correct ginsenoside Rg in Notoginseng radix1Ginsenoside Rb1And notoginsenoside R1The content determination of the three components is investigated, and although the optimization of the pretreatment method, the repeated search of factors such as mobile phase composition, gradient program, column temperature, flow rate and the like in chromatographic conditions are carried out, the negative interference and the separation degree can not meet the analysis requirements, and only the ginsenoside Rg in the panax notoginseng is adopted to ensure the accuracy of the method1The content was measured as an index.
Wherein, the content determination research of isorhamnetin-3-O-neohesperidin and typhaneoside in cattail pollen is carried out, and the result can not be established due to negative interference.
The difficulty of the product in measuring the content of the pseudo-ginseng is reflected through the search process of a large number of experimental conditions, and the important reason for causing the interference of the mixed peaks is found through further experimental search and is related to the composition complexity of the trogopterus dung, even related to the omnivorous nature of the trogopterus dung. In addition, the interference of saponin components in the spina date seeds on the notoginsenoside is also serious.
EXAMPLE 9 preparation of finished granules
In order to facilitate the taking of patients, granules are selected as finished product dosage forms, and the preparation of the granules is carried out, so as to ensure the uniformity, the fluidity and the taking dosage of the medicine in the prescription.
1) Selection of different dextrin dosage and different ethanol concentration
Mixing the dry extract powder with dextrin at different ratio, and using ethanol with different concentrations as wetting agent. The evaluation indexes are the granulation difficulty and the granulation condition. The results are shown in Table 8.
TABLE 8 granule formation Process optimization test results
As a result: when dextrin is used as an excipient, the dry extract powder and the dextrin are 1: 1-1: 2, 70-90% ethanol is used as a wetting agent, and granulation can be carried out, so that the auxiliary material dosage is reduced while the granule yield is ensured, and the ratio of the dry extract powder to the dextrin is 1: 1.
And (4) conclusion: adding dextrin into the dry extract powder in equal proportion, and performing wet granulation by using 90% ethanol as a wetting agent.
2) Examination of particle flowability
It is generally considered that when the angle of repose is less than 40 degrees, the fluidity is good; when the temperature is more than 40 degrees, the fluidity is poor and the powder has a loose feeling. The angle of repose of the samples was determined by the fixed cone groove method and the results are shown in Table 9.
TABLE 9 table for determining angle of repose of granules
As a result: the mean value of the angle of repose of the granules was 31.24 degrees.
And (4) conclusion: the flowability of the particles is good.
3) Determination of critical relative humidity
And (4) respectively taking the extract powder and the granules, and determining according to a literature method. And drawing a moisture absorption curve by taking the relative humidity as an abscissa and the weight gain percentage of the extract powder and the particles as an ordinate. The results are shown in FIG. 1.
As a result: the critical relative humidity of the powder is about 65%, the critical relative humidity of the granules is about 75%, and the hygroscopicity of the drug after granulation is improved.
And (4) conclusion: during the processes of crushing, mixing and granulating, the relative humidity is preferably controlled below 65%.
Claims (10)
1. A Chinese medicinal composition comprises (by weight parts) Notoginseng radix 1-10, pollen Typhae preparata 1-10, Atractylodis rhizoma 5-15, rhizoma Dioscoreae 5-15, Oletum Trogopterori preparata 1-10, Concha Ostreae preparata 5-15, cimicifugae rhizoma 1-10, semen Ziziphi Spinosae 10-20, and cortex moutan 1-10;
preferably, by weight, 4-6 parts of pseudo-ginseng, 6-8 parts of fried cattail pollen, 8-12 parts of bran-fried bighead atractylodes rhizome, 8-12 parts of Chinese yam, 6-8 parts of vinegar trogopterus dung, 8-12 parts of calcined oyster shell, 3-5 parts of cimicifuga foetida, 12-16 parts of spina date seed and 6-8 parts of tree peony bark;
more preferably, the traditional Chinese medicine composition comprises 5 parts of pseudo-ginseng, 7 parts of fried cattail pollen, 10 parts of bran-fried bighead atractylodes rhizome, 10 parts of Chinese yam, 7 parts of vinegar trogopterus dung, 10 parts of calcined oyster shell, 4 parts of cimicifuga foetida, 14 parts of spina date seed and 7 parts of moutan bark by weight.
2. A Chinese medicinal extract is prepared from (by weight parts) Notoginseng radix 1-10, pollen Typhae preparata 1-10, Atractylodis rhizoma 5-15, rhizoma Dioscoreae 5-15, Oletum Trogopterori 1-10, Concha Ostreae preparata 5-15, cimicifugae rhizoma 1-10, semen Ziziphi Spinosae 10-20, and cortex moutan 1-10;
preferably, by weight, 4-6 parts of pseudo-ginseng, 6-8 parts of fried cattail pollen, 8-12 parts of bran-fried bighead atractylodes rhizome, 8-12 parts of Chinese yam, 6-8 parts of vinegar trogopterus dung, 8-12 parts of calcined oyster shell, 3-5 parts of cimicifuga foetida, 12-16 parts of spina date seed and 6-8 parts of tree peony bark;
more preferably, the traditional Chinese medicine composition comprises 5 parts of pseudo-ginseng, 7 parts of fried cattail pollen, 10 parts of bran-fried bighead atractylodes rhizome, 10 parts of Chinese yam, 7 parts of vinegar trogopterus dung, 10 parts of calcined oyster shell, 4 parts of cimicifuga foetida, 14 parts of spina date seed and 7 parts of moutan bark by weight.
3. The herbal extract of claim 2, wherein the herbal extract is extracted by the following method:
extracting with water or extracting Notoginseng radix and parched pollen Typhae with ethanol, extracting the rest seven materials with water, and mixing the extract powders;
preferably, the traditional Chinese medicine extract is extracted by the following method:
1) weighing Notoginseng radix, pollen Typhae preparata, Atractylodis rhizoma parched with bran, rhizoma Dioscoreae, vinegar Oletum Trogopterori, Concha Ostreae preparata, cimicifugae rhizoma, semen Ziziphi Spinosae, and cortex moutan;
2) decocting Concha Ostreae in water for half an hour, decocting with other eight Chinese medicinal materials in water twice, each time with 12 times of water for 2 hr, and mixing decoctions;
or
2) Extracting Notoginseng radix and parched pollen Typhae with ethanol, adding 10 times of 60% ethanol, reflux extracting for 3 times, each time for 2 hr, decocting the rest seven materials with water twice, each time with 12 times of water for 2 hr, and mixing the extract powders.
4. The method for preparing the Chinese medicinal composition of claim 1 or the Chinese medicinal extract of claim 2, which comprises the following steps:
extracting with water or extracting Notoginseng radix and parched pollen Typhae with ethanol, extracting the rest seven materials with water, and mixing the extract powders;
preferably, the preparation method of the Chinese medicinal extract comprises the following steps:
1) weighing Notoginseng radix, pollen Typhae preparata, Atractylodis rhizoma parched with bran, rhizoma Dioscoreae, vinegar Oletum Trogopterori, Concha Ostreae preparata, cimicifugae rhizoma, semen Ziziphi Spinosae, and cortex moutan;
2) decocting Concha Ostreae in water for half an hour, decocting with other eight Chinese medicinal materials in water twice, each time with 12 times of water for 2 hr, and mixing decoctions;
or
2) Extracting Notoginseng radix and parched pollen Typhae with ethanol, adding 10 times of 60% ethanol, reflux extracting for 3 times, each time for 2 hr, decocting the rest seven materials with water twice, each time with 12 times of water for 2 hr, and mixing the extract powders.
5. A medicament comprising the herbal composition of claim 1 or herbal extract of claim 2;
preferably, the dosage form of the medicament is an oral dosage form, and more preferably granules, oral liquid, tablets, syrups and paste.
6. The medicine according to claim 5, wherein the dosage form of the medicine is granules, dextrin is used as an excipient, and the mass ratio of the traditional Chinese medicine extract to the dextrin is 1: 1-1: 2, preferably 1:1, wherein the traditional Chinese medicine extract is calculated by dry mass.
7. A preparation method of the medicine of claim 5 or 6, wherein the preparation of the medicine is granules, dextrin is used as an excipient, the mass ratio of the traditional Chinese medicine extract to the dextrin is 1: 1-1: 2, and 70-90% of ethanol is used as a wetting agent;
preferably, the mass ratio of the traditional Chinese medicine extract to the dextrin is 1: 1;
preferably, the granules are prepared by a wet granulation method;
preferably, the wetting agent is 90% ethanol.
8. The use of the traditional Chinese medicine composition according to claim 1, the traditional Chinese medicine extract according to claim 2 or 3, or the medicament according to claim 5 or 6, in the preparation of a medicament for promoting blood coagulation, or in the preparation of a medicament for treating blood coagulation disorders, or in the preparation of a medicament for promoting platelet aggregation, or in the preparation of a medicament for reducing uterine smooth muscle contraction.
9. Use of a traditional Chinese medicine composition according to claim 1, a traditional Chinese medicine extract according to claim 2 or 3, or a medicament according to claim 5 or 6, in the preparation of a medicament for treating menorrhagia;
preferably, for the manufacture of a medicament for the treatment of menorrhagia due to ovulatory dysfunctional uterine bleeding;
more preferably, for the preparation of a medicament for hemostasis during menstrual bleeding.
10. The method for detecting the quality standard of the Chinese medicinal composition according to claim 1, the Chinese medicinal extract according to claim 2 or 3 or the medicament according to claim 5 or 6, wherein the quality standard is ginsenoside in panax notoginsengRg1The content was measured as an index.
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| CN1116110A (en) * | 1994-08-04 | 1996-02-07 | 张成桂 | Benglouting (traditional Chinese prepared medicine for uterine bleeding) |
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| CN1116110A (en) * | 1994-08-04 | 1996-02-07 | 张成桂 | Benglouting (traditional Chinese prepared medicine for uterine bleeding) |
| CN104984224A (en) * | 2015-08-14 | 2015-10-21 | 侯瑞田 | Chinese medicinal formula for treating perimenopause endomentrium hyperplasis |
| CN107744580A (en) * | 2017-09-13 | 2018-03-02 | 谢世鹏 | Dysmenorrhoea Chinese medicine preparation and preparation method thereof |
| CN110384762A (en) * | 2019-07-25 | 2019-10-29 | 陈国生 | Orally taken for curing digestive system hemorrhage, traditional Chinese powder medicine of ulcer and preparation method thereof |
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