Four, the specific embodiment
Below in conjunction with concrete condition and embodiment the present invention is elaborated.
Cyclomastopathy belongs to the category of traditional Chinese medical science nodules of the breast, and its morbidity is many because of feelings will internal injury, and depression of liver-QI loses in catharsis, qi depression to blood stasis and lump formation due to accumulation of pathogens; Or worry impairing spleen, spleen fortune mistake department, give birth in expectorant is turbid, the turbid blood stasis of expectorant is tied mutually, hinder in newborn network and form nodules of the breast, therefore the present invention is with promoting flow of QI and blood, collateral dredging, the method prescription therapeutic of eliminating stagnation, so Chinese medicinal capsule of the present invention is to constitute in being incapsulated by medicated powder, its Chinese medicine powder adopts in weight percent: Rhizoma Cyperi 18-21%, Radix Salviae Miltiorrhizae 18-21%, Radix Bupleuri 11-14%, Radix Paeoniae Alba 11-14%, Fructus Trichosanthis 18-21% and Fructus Liquidambaris 14-17% make, and the production method that realizes above-mentioned Chinese medicinal capsule is by the component requirement, with Rhizoma Cyperi, Radix Bupleuri, the Radix Paeoniae Alba, Fructus Trichosanthis and Fructus Liquidambaris add water be drug weight 8-10 doubly, soaked 1 hour, be fried boiling the back with (promptly being undertaken by frying in shallow oil the Chinese medicine requirement) at a simmer 1.5-2 hour, pour out medicinal liquid, add 6-8 times again to the water of drug weight, fried in shallow oil again 1.5-2 hour, merge medicinal liquid twice, when boiling medicine, collect volatile oil with the volatile oil catcher, standby, after twice medicinal liquid merges, carry out evaporation and concentration, it is the thick extractum of 1.2-2.0 that medicinal liquid is condensed into to relative density, standby; The volatile oil beta-cyclodextrin inclusion compound of collecting during the decocting medicine, behind 55-65 ℃ of following vacuum drying, standby; By the requirement of compatibility component, it is 90% ethanol that Radix Salviae Miltiorrhizae is added mass concentration, and its addition is 6-7 a times of Radix Salviae Miltiorrhizae weight, reflux 2 times, each 1-1.5 hour, merge ethanol extract twice, reclaim ethanol, get relative density and be the thick tanshinol extraction cream of 1.2-2.0, standby; Radix Salviae Miltiorrhizae after the alcohol extraction adds the 6-8 water doubly of its weight again, fry in shallow oil 2 times, each 1.5-2 hour, merge the water liquid salvia twice, the water that is condensed into relative density and is 1.2-2.0 is carried thick extractum, merges above-mentioned three thick extractum, and sloughing moisture at 80 ℃ of following vacuum dryings (is that moisture content is at 2-3%, as follows), pulverize with Benexate Hydrochloride and to incapsulate promptly.It is 16-22% that medicine always extracts recovery rate.
Embodiment 1
Chinese medicinal capsule of the present invention is that medicated powder is incapsulated interior formation, and its medicated powder is by in weight percent: Rhizoma Cyperi 19.48%, Radix Salviae Miltiorrhizae 19.48%, Radix Bupleuri 12.99%, the Radix Paeoniae Alba 12.99%, Fructus Trichosanthis 19.48% and Fructus Liquidambaris 15.58% are made.
The production method that realizes is, by the said ratio requirement Rhizoma Cyperi, Radix Bupleuri, the Radix Paeoniae Alba, Fructus Trichosanthis, Fructus Liquidambaris being added water is 10 times of drug weight, soaks 1 hour, fried in shallow oil 2 hours, add 6 times in water again, fried in shallow oil 1.5 hours, boil medicine and collect volatile oil with the volatile oil catcher simultaneously, standby, merge medicinal liquid, medicinal liquid is condensed into the thick extractum that relative density is 1.2-2.0, above-mentioned volatile oil beta-cyclodextrin inclusion compound, 60 ℃ of following vacuum dryings, standby; Radix Salviae Miltiorrhizae adding mass concentration is 90% ethanol, and addition is the weight of 6 times of Radix Salviae Miltiorrhizaes, reflux 2 times, and each l hour, merge ethanol liquid, reclaim ethanol, get relative density and be the thick extractum of alcohol extraction of 1.2-2.0, standby; Radix Salviae Miltiorrhizae adds decocting 2 times again, adds the water of 6 times of amounts at every turn, and each 1.5 hours, merge medicinal liquid, be condensed into the water that every milliliter of herb liquid includes primary Chinese medicine 1.2-2.0 gram and carry thick extractum.Above-mentioned three thick extractum merge, and behind 80 ℃ of following vacuum dryings, are 100 order fine powders with the pulverizing of Benexate Hydrochloride mixing, and are encapsulated, powder charge powder 0.4 gram in each capsule.
Embodiment 2
Chinese medicinal capsule of the present invention is to be made of capsule and interior medicated powder thereof, its medicated powder is by Rhizoma Cyperi 15 grams, Radix Salviae Miltiorrhizae 15 grams, Radix Bupleuri 10 grams, the Radix Paeoniae Alba 10 grams, Fructus Trichosanthis 15 grams restrain with Fructus Liquidambaris 12, its specific implementation method is with Rhizoma Cyperi 15 grams, Radix Bupleuri 10 grams, the Radix Paeoniae Alba 10 grams, Fructus Trichosanthis 15 grams and Fructus Liquidambaris 12 gram mixing and water addings 620 grams (being 620ml), soaked 1 hour, fried in shallow oil 1.5 hours, pour out medicinal liquid, add water 496 grams (being 496ml) again, fried in shallow oil 1.5 hours, merge medicinal liquid twice, when boiling medicine, collect volatile oil with the volatile oil catcher, standby, after twice medicinal liquid merged, being condensed into relative density was the thick extractum of 1.2-2.0; The volatile oil beta-cyclodextrin inclusion compound of collecting during the decocting medicine, standby behind 60 ℃ of following vacuum dryings; With Radix Salviae Miltiorrhizae 15 gram, add mass concentration and be 90% alcohol reflux 2 times, add ethanol 90 grams at every turn, refluxed 1 hour, merge ethanol extract twice, reclaim ethanol, get relative density and be the thick extractum of alcohol extraction of 1.2-2.0, standby; Again Radix Salviae Miltiorrhizae is added decocting 2 times, add water 90 grams (being 90ml) at every turn, all fried in shallow oil 1.5 hours, merge decocting liquid twice, the water that is concentrated into relative density and is 1.2-2.0 is carried thick extractum, the thick extractum of Rhizoma Cyperi, Radix Bupleuri, the Radix Paeoniae Alba, Fructus Trichosanthis and Fructus Liquidambaris, the thick extractum of Radix Salviae Miltiorrhizae alcohol extraction and water is carried thick extractum merge, and is ground into 100 purpose fine powders with Benexate Hydrochloride behind 80 ℃ of following vacuum dryings, incapsulate and get final product, general every intragranular is 0.4 gram medicated powder.With drug ratio, can make the Chinese medicinal capsule of any amount with production method of the present invention.
The present invention aims at the treatment cyclomastopathy, and Rhizoma Cyperi " being the Directorate-General DG of disorder of QI " in the side is blood medicine in the gas, energy depressed liver-energy dispersing and QI regulating, removing obstruction in the collateral to relieve pain; The Radix Salviae Miltiorrhizae blood circulation and promoting silt stimulates the menstrual flow, and the two delegation one lives, promoting flow of QI and blood, and it is smooth that QI and blood is transferred, and then pain disappears to tie and looses, so be monarch drug altogether.Liver storing blood, main catharsis, " body cloudy and with sun ", so transfer its sun with the Radix Bupleuri dispersing the stagnated live-QI to relieve the stagnation of QI, Radix Paeoniae Alba suppressing the hyperactive liver its body that softens that nourishes blood makes its catharsis normal, QI and blood and suitable and be minister.The Fructus Trichosanthis removing heat-phlegm, relieving stuffiness of the chest by dispersing aggregation of pathogens, the expectorant stasis of blood is gathered dissipated and newborn network from logical, be assistant.Fructus Liquidambaris has the sharp key of siphunculus, walks and the merit of not keeping, can promoting blood circulation to remove obstruction in the collateral, can draw the current passages through which vital energy circulates of all medicines again, and reach in sick institute, for making.Complete main compatibility is specially smart, plays promoting flow of QI and blood altogether, the effect of eleminating phlegm and freeing channels.
Practice is also as this, and through clinical proof, Chinese medicine of the present invention has all been obtained satisfied effect, and its clinical observation on the therapeutic effect data is as follows:
(1) selects the case standard
A plurality of tough tuberositys of circular matter that vary in size take place in the one-sided or both sides of all female breast, and often with distending pain of the breast, and through more so preceding, the age, the women in 20-60 year was the selection treatment target, and emphasis is 20-50 year women.
(2) diagnostic criteria
1, mammary gland tumor is arranged clinically, be scattered in whole breast, also can be confined to an one of breast.
2, lump obscure boundary with the skin adhesion, pushes away movably, and lump is the growth and decline with the susceptible to anger of feelings will whenever, all the time can diabrosis.
3, there is obvious distending pain in breast portion, increases the weight of before the menstruation of being everlasting, and alleviates after the menstruation.
4, get rid of the physiological distending pain of the breast, as through the fore udder distending pain, adolescence mastalgia and only mastalgia is arranged and do not have the mastalgia of lump.
5, utilize modern detection methods such as molybdenum target X line, dry plate, B ultrasonic, thermal image figure as auxiliary diagnosis.And get rid of breast carcinoma, mammary gland fibroma etc. and other mastopathy.
(3) Therapeutic Method
Oral capsule of the present invention, each 2-5 grain, every medicated powder 0.4 gram, every day three times, one month is a course of treatment.
(4) criterion of therapeutical effect
Formulate with reference to " the inside and outside Gynecology ﹠ Pediatrics Dept. disease diagnosis of traditional Chinese medical science criterion of therapeutical effect (trying) " that Department of Medical Administration of State Administration of Traditional Chinese Medicine issues in October, 1988.
Cure: mastalgia and lump disappear.
Effectively: mastalgia alleviates, and lump dwindles.
Invalid: mastalgia does not alleviate, and lump does not dwindle.
(5) statistical procedures
According to selecting case standard and treatment standard, the present invention in clinical practice to 320 routine patients, the oldest person 60 years old, reckling 20 years old, 20-30 year person's 116 examples wherein, 31-40 year person's 125 examples, 41-50 year person's 66 examples, 51-60 year person's 13 examples, 34 years old mean age, warp is treated by the aforementioned therapies method, in 320 examples, healing person's 110 examples account for 34.37%; Responder's 001 example accounts for 62.81%; Total effective rate 97.18%.
(6) case for example
Thousand XX, woman, 30 years old, peasant, military people from county.Because of two newborn pain surplus prescriptions on individual diagnosis of seeking medical advice on March 12nd, 1998 half a year.Patient's bilateral mastalgia, and relevant with feelings will and menstrual cycle easily enrages, whenever increasing the weight of through preceding then pain, through after pain relief.Irregular before and after the menstruation, dysmenorrhea, purple coloured menses is black, and clot is arranged sometimes, and menstrual period, lumbar and back pain was drawn shoulder and oxter pain during mastalgia.Look into: two breasts can reach the granular tuberosity of diffuse type foxtail millet, the pain of pressing, and local lump is harder, does not have obvious adhesion with surrounding tissue, and is removable by it, the no enlargement of axillary lymph knot.B ultrasonic is examined and is cyclomastopathy.Give the capsule with the present invention, each 5, serve on medicine 2 months every day three times, lump disappears, and pain disappears, ultrasound diagnosis, two breasts are normal.
(7) zoopery situation
A, to the influence of rat mammary gland model of hyperplasia: capsule of the present invention is given continuous 30 days of rat with the dosage of 0.625g/kg, 1.25g/kg, 2.5g/kg, every day each 1 time, gavage, can obviously suppress the cyclomastopathy of rat due to the estradiol, and can regulate rat blood serum E2, LH, FSH level.
B, to the microcirculatory influence of mice auricular concha: capsule of the present invention gavaged for mice in continuous 5 days with the dosage of 0.625g/kg, 1.25g/kg, 2.5g/kg, every day each 1 time, can obviously improve the mice auricular concha microcirculation disturbance due to the epinephrine, expansion small artery, venule, increase open blood capillary netting index, improve blood flow.
C, analgesic activity: capsule of the present invention gavaged for mice in continuous 5 days with the dosage of 0.625g/kg, 1.25g/kg, 2.5g/kg, every day each 1 time, the threshold of pain that can obviously improve hot plate method induced mice pain; Obviously prolong antimony potassium tartrate pain caused incubation period, and reduce by 10 minutes mouse writhing number of times.
D, to the swollen influence that forms of rat granuloma: capsule of the present invention gavaged for rat in continuous 7 days with the dosage of 0.625g/kg, 1.25g/kg, 2.5g/kg, every day each 1 time, can obviously suppress the bullate formation of rat granuloma.
E, acute toxicity: this capsular maximum tolerated dose is 48g/kg/d, and during experiment, every Mus connects to 3 times every day, and each 16g does not have any untoward reaction, and this amount has been more than 280 times of clinical consumption, can think that clinical drug safety is nontoxic.
F, chronic toxicity: medicine is with 7.5g/kg in this capsule, 5g/kg, 2.5g/kg three dosage gavaged for rat in continuous 3 months, every day each 1 time, to the rat general activity, diet, feces, body weight does not have obvious harmful effect, to rat hemogram (erythrocyte, leukocyte, platelet, leukocyte differential count, hemoglobin), blood biochemical (glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT, total protein, albumin, cholesterol, blood glucose, the flesh liver, blood urea nitrogen) there is not obvious harmful effect, to rats'liver, the heart, spleen, lung, kidney device index has no adverse effects, to rats'liver, the heart, spleen, lung, kidney, stomach, intestinal, brain, the no obvious harmful effect of ovary organs and tissues such as (uterus) section.
(8) conclusion
By above-mentioned situation as can be known, Chinese medicinal capsule production method advanced person of the present invention, its medicine promoting flow of QI and blood, activating collaterals and eliminating stagnation, be effective to treat cyclomastopathy, effective percentage reaches more than 97%, has no side effect, be that other drug can't be compared, be that development prospect is wide, benefits the world to creative contribution of Chinese medicine and pharmacy.