CN104474226A - Traditional Chinese medicine composition for treatment of endometrial hyperplasia and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treatment of endometrial hyperplasia and preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the field of traditional Chinese medicine (TCM), relates to a traditional Chinese medicine composition and a preparation method thereof, and specifically relates to a traditional Chinese medicine composition for the treatment of endometrial hyperplasia and a preparation method thereof. For overcoming the defects that existing chemotherapeutic drugs for endometrial hyperplasia are large in hepatotoxicity and poor in curative effect, the invention provides a traditional Chinese medicine composition for the treatment or prevention of endometrial hyperplasia, and the traditional Chinese medicine composition comprises the following components: 10-50 parts of herba leonuri, 10-20 parts of fructus ligustri lucidi, 5-20 parts of epimedium, 5-15 parts of cassia twig, 5-10 parts of radix achyranthis bidentatae, 5-15 parts of lotus leaves, 5-15 parts of honeysuckle, 1-10 parts of codonopsis pilosula, 5-15 parts of rhizoma anemarrhenae, 9-15 parts of caulis spatholobi, 9-15 parts of radix rehmanniae, 5-15 parts of folium artemisiae argyi, 1.5-9 parts of malaytea scurfpea fruits, 5.5-15 parts of semen cuscutae, 6-9 parts of fructus rosae laevigatae, and 10-15 parts of radix glycyrrhizae. The traditional Chinese medicine composition has a good treatment effect on the treatment or prevention of endometrial hyperplasia; and the traditional Chinese medicine composition has low drug side effects, and has significant clinical promotion value.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of Chinese medicine composition for the treatment of endometrial hyperplasia and preparation method thereof.
Background technology
Endometrial hyperplasia has certain cAMP content, therefore is listed in precancerous lesion.But according to long-term observation, large absolutely number endometrial hyperplasia is a kind of reversibility pathological changes, or keeps a kind of persistence benign state.Only minority case may develop into cancer after longer interval.3 types are divided into: 1. simple hyperplasia: the endometrium physiological reaction caused by the estrogen long-time stimulus without progesterone antagonism according to gland structure morphologic change with or without glandular epithelium atypia.Interstitial and body of gland hypertrophy and Non-gland body is crowded simultaneously, epithelioglandular form is without atypia.2. compound hypertrophy: diseased region body of gland is crowded, and interstitial obviously reduces, without epithelioglandular atypia.3. atypical hyperplasia: glandular epithelium has atypia, belongs to endometrial intraepithelial tumor, by the degree of pathological changes, be divided into light, in, weigh three degree.Endometrial hyperplasia is frequently-occurring disease, difficult disease in Gynecology, and its pathological characteristic is Ectopic Endometrium cyclic hemorrhage, companion's surrounding annulus hamartoplasia and adhesion, forms hyacinthine solid tuberosity and enclosed mass in lesion region.This causes huge body and mind misery and financial burden to patient, therefore, actively prevents and treats endometrial hyperplasia, has important society and economic implications.
For the treatment of atypical hyperplasia of endometrium, first to clarify a diagnosis, investigate thoroughly reason, if with polycystic ovary, functional tumors of ovary, other endocrine dysfunctions, should row immunotherapy targeted autoantibody.At once starting symptomatic treatment to being diagnosed as atypical hyperplasia of endometrium person simultaneously, adopting Drug therapy or operative treatment.But relapse rate is up to 38%-51% after operative treatment, and medical expenses are expensive, especially for requiring that the women's federation of giving birth to brings huge challenge.There is no the special effectively little desirable medicine of side effect clinically so far.The Western medicine of current application is mainly hormone medicine as GnRHa class, danazol, nemestran, tamoxifen, mifepristone etc., though energy temporary relief of symptoms, but can not effect a radical cure, and relapse rate is high after drug withdrawal, and the practical problem that hormone medicine side effect large (such as affecting the generation etc. of the liver function of patient and platelet, hemoglobin), expense are high, the acceptance of patient is not high.The medicine for the treatment of by Chinese herbs has Blood-Activating-and-Stasis-Removing Chinese patent medicine, the kidney invigorating blood stasis dispelling side Chinese patent medicine, gossypol etc. at present, but effect is not fairly obvious mostly.
Motherland's medical science is of long standing and well established, and it has abundant theoretical basis and abundant clinical practice in treatment endometrial hyperplasia.The traditional Chinese medical science thinks that the basic reason causing endometrial hyperplasia infertile is that blood stasis blocks vessels of the uterus, collaterals of the uterus, and two essences can not be in conjunction with, so that infertile; Kidney storing essence, main reproduction, kidney yang deficiency, warm born of the same parents are unable, and blood stasis due to renal deficiency also causes infertile; Menstruation disorder is then water, and with the passing of time wetting is polymerized to expectorant, and expectorant stasis gathers vessels of the uterus, collaterals of the uterus, also causes infertile.Treatment or with cycling therapy, as Xia Guicheng, Si Tuyi treat endometrial hyperplasia infertile experience; Or Bushen Huayu, as Ou Yanghuiqing treats the infertile experience of endometrial hyperplasia etc.Method has the method such as oral medicinal herb, herbal enema, though achieve certain clinical effectiveness.But subject range is little mostly, and be not suitable for the complicated origin cause of formation of endometrial hyperplasia infertility, the course for the treatment of is long, take effect slow, patient is difficult to adhere to.Therefore, find a kind for the treatment of by Chinese herbs medicine for endometrial hyperplasia newly and there is important clinical meaning.
Make a general survey of the research direction of world's new drug, the eighties mainly researched and developed single chemicals and preparation thereof in the past, and start after the eighties to develop biotechnology and natural medicinal plants, drug research direction is tending towards multiformity.In conjunction with modern Chinese medicine theory of development, from improving curative effect of medication, reducing the angle of side effect, through carrying out to Chinese medicine ingredients the preparation that screening is extracted and/or compatibility is obtained, its side effect is little, and safety is high, has the advantage that chemical synthetic drug can not be compared.
Summary of the invention
Large in order to overcome existing endometrial hyperplasia hormonal therapy agent toxic and side effects, therapeutic effect is difficult to continue, and the prior art deficiency that operative treatment acceptance is not high, the invention provides a kind of Chinese medicine composition for the treatment of endometrial hyperplasia, this Chinese medicine composition determined curative effect, side effect is little, it obtains primarily of following raw material: Herba Leonuri 10-50 part, Fructus Ligustri Lucidi 10-20 part, Herba Epimedii 5-20 part, Ramulus Cinnamomi 5-15 part, Radix Achyranthis Bidentatae 5-10 part, Folium Nelumbinis 5-15 part, Flos Lonicerae 5-15 part, Radix Codonopsis 1-10 part, Rhizoma Anemarrhenae 5-15 part, Caulis Spatholobi 9-15 part, Radix Rehmanniae 9-15 part, Folium Artemisiae Argyi 5-15 part, Fructus Psoraleae 1.5-9 part, Semen Cuscutae 5.5-15 part, Fructus Rosae Laevigatae 6-9 part, Radix Glycyrrhizae 10-15 part.
Chinese medicine composition of the present invention on Chinese medicinal components is selected with promoting blood circulation to restore menstrual flow, loose Yu Xiao wei, removing blood stasis for main standard, have after Chinese medicine composition combination of the present invention and support kidney QI invigorating, analgesia and activating blood circulation to dissipate blood stasis effect significantly.The parts by weight of the present invention to above-mentioned all taste Chinese medicine carry out preferably, preferred condition be after drug matching uses medicine to the enhancing of endometrial hyperplasia therapeutic effect.As a preferred embodiment of the present invention, Chinese medicine composition of the present invention obtains primarily of the raw material of following weight portion: Herba Leonuri 30 parts, Fructus Ligustri Lucidi 15 parts, Herba Epimedii 15 parts, Ramulus Cinnamomi 10 parts, Radix Achyranthis Bidentatae 8 parts, 10 parts, Folium Nelumbinis, Flos Lonicerae 10 parts, Radix Codonopsis 6 parts, the Rhizoma Anemarrhenae 10 parts, Caulis Spatholobi 12 parts, 12 parts, the Radix Rehmanniae, Folium Artemisiae Argyi 10 parts, Fructus Psoraleae 5.5 parts, Semen Cuscutae 10 parts, Fructus Rosae Laevigatae 8 parts, 12 parts, Radix Glycyrrhizae.
Preferably, Chinese medicine composition of the present invention also contains 7 parts, Poria further, the Radix Aucklandiae 5 parts, Radix Sanguisorbae 2 parts, Myrrha 8 parts.The use of above-mentioned four taste Chinese medicines can strengthen the therapeutic effect of Chinese medicine composition of the present invention to endometrial hyperplasia further.
The Chinese medicine composition being used for the treatment of endometrial hyperplasia provided by the present invention is to pathogenetic understanding of endometrial hyperplasia and Therapeutic Principle based on the traditional Chinese medical science, with reference to modern pharmacology achievement in research, from motherland's medicine treasure-house, filter out the natural plant of promoting blood circulation to restore menstrual flow, loose Yu Xiao wei, removing blood stasis, by theory of Chinese medical science prescription and modern pharmaceutical technology, skim the cream off milk, can be made into common formulations clinically, as it can be powder, water preparation, tablet or capsule.
Present invention also offers a kind of preparation method of Chinese medicine composition described above, it mainly comprises following step: get the above-mentioned Chinese crude drug of recipe quantity and be broken into coarse powder, the alcoholic solution that volumetric concentration is 40% ~ 95% is added according to 4 ~ 9 times of coarse powder gross weight, reflux, extract, three times, return time is 2 ~ 5h, filters, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying; Those skilled in the art can technically prepare conventional Chinese medicine pharmaceutical dosage form clinically, as tablet, capsule etc. in this preparation method.
The present invention also asks to protect the purposes of above-mentioned Chinese medicine composition in preparation treatment endometrial hyperplasia medicine.The embodiment of the present invention 19 have studied the therapeutic effect of Chinese medicine composition of the present invention to endometrial hyperplasia rat model, result shows, Chinese medicine composition of the present invention high, medium and low dosage group all significantly can reduce the whole blood viscosity under the high, medium and low shear rate of endometriosis model rat, its reduction amplitude not only has pole significant difference with model group, also has significant difference compared with positive control medicine danazol group.And the affect result of pharmaceutical composition on rat uterus Ectopic Endometrium body of gland shows, compared with model (blank) matched group, Chinese medicine composition of the present invention respectively organize all can to make with positive controls Ectopic Endometrium cyst wall and smooth muscle layer thinning, false body of gland reduces, superficial epithelium and Interstitial cell rareness.Wherein Chinese medicine high, medium and low group of Ectopic Endometrium cyst wall and smooth muscle layer obviously thinning, the obvious atrophy of false body of gland, superficial epithelium and interstitial cell hyperplasia obviously alleviate.Show thus, compound Chinese medicinal preparation of the present invention has effect of blood circulation promoting and blood stasis dispelling, the effect for the treatment of endometrial hyperplasia disease.
In a word, pharmaceutical composition of the present invention, in treatment endometrial hyperplasia, compared with prior art has following advantage:
1) compared with positive control drug danazol group, pharmaceutical composition Chinese medicine composition of the present invention is not only significantly being better than positive drug in activating blood circulation to dissipate blood stasis, and after treatment, false body of gland number is significantly less than positive drug, and the volume of false body of gland also significantly reduces.This shows to have significant synergism in present composition film hypertrophy disease treatment in uterus, significantly can not only improve the symptom of endometrial hyperplasia, can also delay the development of endometrial hyperplasia, reduce the generation of complication.
2) compared with the chemotherapeutic agent of Current therapeutic endometrial hyperplasia, Chinese medicine composition of the present invention is natural pure Chinese medicinal preparation, untoward reaction and side effect significantly reduce, and Chinese medicine composition effect of the present invention is comprehensive, medication effect is better, significantly improve the compliance of endometrial hyperplasia patient, and improve the quality of life of patient.
3) existing endometrial hyperplasia medicine in uterus film hypertrophy disease initial therapy effect still can, but all occur obvious drug resistance problem along with the prolongation for the treatment of time, the therapeutic effect of endometrial hyperplasia declines.Containing multi-medicament component in Chinese medicine composition of the present invention, action target spot is numerous, efficiently solves the Commpensation And Adaptation of endometrial hyperplasia medicine, and it does not decline because treatment time extends to the therapeutic effect of endometrial hyperplasia.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, the present invention is not limited only to following examples.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the change carried out the present invention, combination or replacement, be apparent for a person skilled in the art, and be included within the scope of the present invention.
Part I Chinese medicinal composition preparation of the present invention, preparation and using method thereof
Embodiment 1-6 Chinese medicine composition composition powders
Table 1 Chinese medicine composition composition powders of the present invention prescription
Embodiment 1 preparation method: get each medical material in compositions, conveniently technique grinds to form powdery, cross 100 mesh sieves, little fire drying is for subsequent use, obtains powder.During use, directly take after mixing it with water with after water dissolution.Embodiment 2-6 preparation method is with embodiment 1.
Embodiment 7-12 Chinese medicine composition water preparation
Table 2 Chinese medicine composition water preparation of the present invention prescription
Embodiment 7 preparation method: get each medical material in prescription, conveniently decocting for Chinese herbal medicine technological operation, filtering medicinal residues and get final product.When this water preparation (or claiming decoction) is treated for endometrial hyperplasia, daily 2-3 time.Embodiment 8-12 preparation method and using method are with embodiment 7.
Embodiment 13-18 Chinese medicine composition tablet/capsule of the present invention
Table 3 Chinese medicine composition tablet of the present invention/capsule prescription
Embodiment 13 preparation technology: each traditional Chinese medicine powder getting recipe quantity is broken into coarse powder, adds according to 5 times of coarse powder gross weight the alcoholic solution that volumetric concentration is 80%, reflux, extract, three times, the each 3h of return time, filters, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying; By Chinese medical concrete drying, pulverize and make dried cream powder, add customary adjuvant components utilising prior art and be prepared into tablet or capsule.
Embodiment 14-18 preparation technology is with embodiment 13.
Part II Chinese medicine composition pharmacodynamic study of the present invention
Embodiment 19 compound Chinese medicinal preparation of the present invention is on the impact of rat endometrium model of hyperplasia
Get SPF level female sd inbred rats 60, body weight 200-250 gram, be divided into 6 groups at random, be i.e. group and Chinese medicine high group in normal group, model control group, positive controls, low group of Chinese medicine, Chinese medicine.Adaptability raises subcutaneous injection diethylstilbestrol 0.1ml/100g after a week, every day 1 time, continuously injection 3 days.4th day with 3% pentobarbital sodium intraperitoneal injection of anesthesia, 0.1ml/100g, open abdomen, cut left uterine and be about 2cm, row end-to-end anastomosis, the endometrial tissue slide calliper rule amount of stripping is cut into the inner membrance block of 3*3mm size, with not damaged No. 6 absorbable threads be sewn on respectively right side stomach wall, right side fallopian tube just in and near right ovary, close abdomen.Normal group only excises uterus, side, does not sew up endometrium.
After two weeks, second time opens abdomen, within the 3rd day, starts to give following medicine after modeling success:
Model group and normal group gavage give the normal saline of respective volume;
Positive controls: gavage gives 67mg/kg danazol (Jiangsu Lianhuan Pharmaceutical Co., Ltd.'s production);
Low group of Chinese medicine: gavage gives the Chinese medicine composition 2g crude drug amount/kg prepared by the embodiment of the present invention 1;
Group in Chinese medicine: gavage gives the Chinese medicine composition 4g crude drug amount/kg prepared by the embodiment of the present invention 1;
Chinese medicine high group: gavage gives the Chinese medicine composition 8g crude drug amount/kg prepared by the embodiment of the present invention 1;
Each treatment group is by 1 times/day of administration, and successive administration is drawn materials for three weeks.Animal fasting 16 hours before drawing materials, pentobarbital sodium is anaesthetized, abdominal aortic blood, surveys hemorheology index, the results are shown in Table 4.Get uterus and ectopic tissue 10% formaldehyde is fixed, paraffin embedding, section, HE dyes, and the endometrial tissue morphology of observation by light microscope, counts the number of false body of gland simultaneously, measures the transverse diameter of false body of gland and perpendicular footpath, compares, the results are shown in Table 5 between organizing.
Table 4 Chinese medicine composition of the present invention is on the impact of endometrial hyperplasia hemorheology of rat
Compare with normal group, * * P < 0.01; Compare with model group, #P < 0.05, ##P < 0.05;
Table 5 Chinese medicine composition of the present invention is on the impact of rat uterus Ectopic Endometrium body of gland
Compare with model group, #P < 0.05, ##P < 0.05.
Result shows, Chinese medicine composition of the present invention high, medium and low dosage group all significantly can reduce the whole blood viscosity under the high, medium and low shear rate of endometriosis model rat, its reduction amplitude not only has pole significant difference with model group, also has significant difference compared with positive control medicine danazol group.And the affect result of pharmaceutical composition on rat uterus Ectopic Endometrium body of gland shows, compared with model (blank) matched group, Chinese medicine composition of the present invention respectively organize all can to make with positive controls Ectopic Endometrium cyst wall and smooth muscle layer thinning, false body of gland reduces, superficial epithelium and Interstitial cell rareness.Wherein Chinese medicine high, medium and low group of Ectopic Endometrium cyst wall and smooth muscle layer obviously thinning, the obvious atrophy of false body of gland, superficial epithelium and interstitial cell hyperplasia obviously alleviate.Show thus, compound Chinese medicinal preparation of the present invention has blood circulation promoting and blood stasis dispelling, suppresses ectopic endometrium hypertrophy, the effect for the treatment of endometrial hyperplasia disease.
Claims (7)
1. treat a Chinese medicine composition for endometrial hyperplasia, it is characterized in that it obtains primarily of the raw material of following weight portion:
Herba Leonuri 10-50 part, Fructus Ligustri Lucidi 10-20 part, Herba Epimedii 5-20 part, Ramulus Cinnamomi 5-15 part, Radix Achyranthis Bidentatae 5-10 part, Folium Nelumbinis 5-15 part, Flos Lonicerae 5-15 part, Radix Codonopsis 1-10 part, Rhizoma Anemarrhenae 5-15 part, Caulis Spatholobi 9-15 part, Radix Rehmanniae 9-15 part, Folium Artemisiae Argyi 5-15 part, Fructus Psoraleae 1.5-9 part, Semen Cuscutae 5.5-15 part, Fructus Rosae Laevigatae 6-9 part, Radix Glycyrrhizae 10-15 part.
2. Chinese medicine composition as claimed in claim 2, is characterized in that it also containing, for example the raw material of lower weight portion: 7 parts, Poria, the Radix Aucklandiae 5 parts, Radix Sanguisorbae 2 parts, Myrrha 8 parts.
3. Chinese medicine composition as claimed in claim 1, is characterized in that it obtains primarily of the raw material of following weight portion:
Herba Leonuri 30 parts, Fructus Ligustri Lucidi 15 parts, Herba Epimedii 15 parts, Ramulus Cinnamomi 10 parts, Radix Achyranthis Bidentatae 8 parts, 10 parts, Folium Nelumbinis, Flos Lonicerae 10 parts, Radix Codonopsis 6 parts, the Rhizoma Anemarrhenae 10 parts, Caulis Spatholobi 12 parts, 12 parts, the Radix Rehmanniae, Folium Artemisiae Argyi 10 parts, Fructus Psoraleae 5.5 parts, Semen Cuscutae 10 parts, Fructus Rosae Laevigatae 8 parts, 12 parts, Radix Glycyrrhizae.
4. Chinese medicine composition as claimed in claim 2, is characterized in that it also containing, for example the raw material of lower weight portion: 7 parts, Poria, the Radix Aucklandiae 5 parts, Radix Sanguisorbae 2 parts, Myrrha 8 parts.
5. the Chinese medicine composition as described in as arbitrary in claim 1-4, is characterized in that it is powder, water preparation, tablet or capsule.
6. prepare the method for Chinese medicine composition as claimed in claim 5 for one kind, it is characterized in that it comprises the following steps:: get the above-mentioned Chinese crude drug of recipe quantity and be broken into coarse powder, the alcoholic solution that volumetric concentration is 40% ~ 95% is added according to 4 ~ 9 times of coarse powder gross weight, reflux, extract, three times, return time is 2 ~ 5h, filters, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying.
7. the Chinese medicine composition as described in as arbitrary in claim 1-4 is purposes in preparation treatment endometrial hyperplasia medicine.
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| CN105311576A (en) * | 2015-11-27 | 2016-02-10 | 程凤菊 | Traditional Chinese medicine for treating simple endometrial hyperplasia and preparation method thereof |
| CN105327011A (en) * | 2015-11-19 | 2016-02-17 | 包莉丽 | Traditional Chinese medicine for treating endometrial hyperplasia |
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