CN103405624B - TCM composition for treatment of seborrheic alopecia and alopecia areata and preparation method of TCM composition - Google Patents

TCM composition for treatment of seborrheic alopecia and alopecia areata and preparation method of TCM composition Download PDF

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CN103405624B
CN103405624B CN201310347047.0A CN201310347047A CN103405624B CN 103405624 B CN103405624 B CN 103405624B CN 201310347047 A CN201310347047 A CN 201310347047A CN 103405624 B CN103405624 B CN 103405624B
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赵步长
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Yangling Buchang Pharmaceutical Co ltd
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SHAANXI BUCHANG HIGH-TECH PHARMACEUTICAL Co Ltd
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Abstract

The invention relates to a TCM composition for treatment of seborrheic alopecia and alopecia areata and a preparation method of the TCM composition. The TCM composition comprises the following raw materials in parts by weight: 282-424 parts of radix polygonum multiflorum preparata, 253-332 parts of herba ecliptae, 229-343 parts of cacumen biotae, 117-175 parts of prepared rehmannia root, 106-158 parts of dried rehmannia root, 51-77 parts of dogwood, 46-69 parts of Chinese yam , 42-62 parts of ginseng, 37-55 parts of radix codonopsitis, 28-42 parts of Indian buead, 17-25 parts of tree peony bark, 26-38 parts of alisma, 19-28 parts of rhizoma anemarrhenae, 14-22 parts of cortex lycii radicis and 13-19 parts of radices stellariae dichotomae. The TCM composition is TCM oral liquid prepared by the steps of extracting and purifying the raw materials according to a certain technique and adding pharmaceutically acceptable auxiliary materials. According to the invention, the TCM oral liquid has the characteristics of simple and feasible preparation technology, safety, effectiveness, obvious pharmacological effect and remarkable clinical effect.

Description

A kind ofly treat Chinese medicine composition of seborrheic alopecia and alopecia areata and preparation method thereof
Technical field
The present invention relates to and a kind ofly treat Chinese medicine composition of seborrheic alopecia and alopecia areata and preparation method thereof, belong to pharmaceutical preparations technology field.
Background technology
The seborrheic alopecia traditional Chinese medical science is called " seborrhea ichthyosis ", and doctor trained in Western medicine is also known as male pattern alopecia, and androgenic alopecia, the alopecia that dispersivity alopecia is neck after adolescence, make slow progress in temporo, top, men and women's both sexes all can occur, but more common with male patient.Also being clinical commonly encountered diseases, the frequently-occurring disease of department of dermatologry, is also one of refractory disease.Modern medicine thinks that the generation of primary disease is too much relevant with gonadal hormone dysequilibrium, smegma more.This patient often goes out more with seborrhea capitis clinically, and the dandruff is many, the symptoms such as hair is withered, pruritus.Because primary disease hinders appearance, affect attractive in appearance, often bring very large stress and mental burden to patient, therefore the treatment of primary disease is also seemed particularly important.But, at present for seborrheic alopecia and alopecia areata disease, also do not have more effective Therapeutic Method.Current clinical drug therapy mainly androgen receptor blockade agent (as spironolactone, cyproterone acetate etc.) and 5-alpha reductase inhibitor (as finasteride, progestogen etc.).Though these medicines have certain hair regrowth, erious adverse reaction, relapse rate is high, the course for the treatment of is long, effect is still undesirable.But Chinese medicine is delaying there is more definite curative effect in primary disease development.
Analyze the pathogeny of seborrheic alopecia from Chinese medicine, mainly contain four broad aspect of heat in blood wind-dryness, damp-heat in the spleen and stomach, deficiency of the liver and kindey, stagnation of QI-blood type, its disease is in hair follicle, scalp, and pathological changes is at hair, and sick position is at internal organs, dirty in close relations with liver,spleen,kidney three.Due to the body of heat in blood usually, feel ailment said due to cold or exposure again, be converted into dry for a long time, and then hematozemia impairment of YIN, cloudy blood can not on reach top, mountain peak, and flourish hair of supporting, Rhizoma Imperatae dries up, therefore sends out Jiao and come off.Or because The spleen has the function to transport and transform nutrients, be the foundation of acquired constitution, if deficiency-weakness of spleen-QI, or surfeit delicious food, pungent, drinks, so that transporting and transforming function of the spleen and stomach is not normal, water wets cohesion heat-transformation, causes damp and hot upper steaming to be pushed up to mountain peak, corrode root of hair, white slurry, root of hair is gradually corroded and causes scalp sticky and come off or innate deficiency, excessive thinking, impairment caused by overstrain Liver and kidney and cause cloudy blood day by day virtual loss, hair loses to moisten and supports and cause and come off.Or do not control because of prolonged illness, hair network is obstructed, and stagnation of QI-blood is in hair network, so that scalp is hardening, poor growth and coming off.Therefore according to differentiation of tcm, reasonable formula, and with invigorating the spleen to clear away damp pathogen, heat clearing and blood cooling, liver and kidney tonifying, promoting blood circulation to remove obstruction in the collateral, hair care, the medicine of hair growth promoting is main.Easy to use, have no side effect, reach chronic disease and treat for a long time, stablize therapeutic scheme to reach curative effect.
Radix Polygoni Multiflori Preparata benefiting essence-blood, black beard and hair in we, Herba Ecliptae liver and kidney tonifying, Cacumen Platycladi heat clearing away is nourished blood, black hair three is monarch drug altogether, Radix Rehmanniae Preparata enriching yin and nourishing kidney, Radix Rehmanniae YIN nourishing and the production of body fluid promoting is ministerial drug, Rhizoma Dioscoreae, Radix Ginseng, Radix Codonopsis, invigorating the spleen and replenishing QI, Cortex Moutan, the Rhizoma Anemarrhenae, Cortex Lycii, Radix Stellariae, lets out deficiency-heat clearly, Fructus Corni liver and kidney tonifying, Rhizoma Alismatis dampness removing and to let out kidney turbid, Poria spleen invigorating eliminating dampness by diuresis, the taste that can alleviate Radix Rehmanniae Preparata is greasy, and the property of energy Fructus Corni (processed) and Radix Polygoni Multiflori Preparata warm-dryness syndrome, with being adjuvant drug.Full side share grows and oiliness, temperature and not dry, has benefit to have and rushes down, have nourishing the liver and kidney, replenishing YIN and removing heat, effect of benefiting QI and nourishing blood, the clinical deficiency of the liver and kindey that is used for the treatment of, deficiency of qi and blood, heat in blood wind-dryness and the seborrheic alopecia that causes and alopecia areata have significant curative effect.
Between this, patent of invention for this Chinese medicine composition application, its publication number is CN1343516A, publication date is on April 10th, 2002, the amounts of components that this patent of invention file is different from prescription, the aspects such as preparation technology are carried out open, protection, but in clinical practice application process, we find that the effect of the Chinese medicine composition be made up of above-mentioned preparation method is desirable not enough, and the application's patent is groped by great many of experiments, further optimized fabrication process, and have found better preparation technology's flow process and parameter, more remarkable by clinical trial proving effect, therefore, we are to improve for the purpose of preparation stability and bioavailability, and the creationary a kind of Chinese medicine composition for the treatment of seborrheic alopecia and alopecia areata succeeded in developing.
Summary of the invention
The object of the invention is to provide a kind of taking convenience, steady quality, Chinese medicine composition and the method for making thereof that quality controllable, curative effect treats seborrheic alopecia and alopecia areata reliably.
A kind of Chinese medicine composition for the treatment of seborrheic alopecia and alopecia areata of this Chinese medicine composition, is characterized in that it is made up of the raw material of following weight proportion: Radix Polygoni Multiflori Preparata 282 ~ 424 parts, Herba Ecliptae 253 ~ 332 parts, Cacumen Platycladi 229 ~ 343 parts, Radix Rehmanniae Preparata 117 ~ 175 parts, Radix Rehmanniae 106 ~ 158 parts, Fructus Corni 51 ~ 77 parts, Rhizoma Dioscoreae 46 ~ 69 parts, Radix Ginseng 42 ~ 62 parts, Radix Codonopsis 37 ~ 55 parts, 28 ~ 42 parts, Poria, Cortex Moutan 17 ~ 25 parts, Rhizoma Alismatis 26 ~ 38 parts, the Rhizoma Anemarrhenae 19 ~ 28 parts, Cortex Lycii 14 ~ 22 parts, Radix Stellariae 13 ~ 19 parts.
The concrete raw material prescription proportioning of this Chinese medicine composition is: Radix Polygoni Multiflori Preparata 353 parts, Herba Ecliptae 292 parts, Cacumen Platycladi 286 parts, Radix Rehmanniae Preparata 146 parts, Radix Rehmanniae 132 parts, Fructus Corni 64 parts, Rhizoma Dioscoreae 58 parts, Radix Ginseng 52 parts, Radix Codonopsis 46 parts, 35 parts, Poria, Cortex Moutan 21 parts, Rhizoma Alismatis 32 parts, the Rhizoma Anemarrhenae 24 parts, Cortex Lycii 18 parts, Radix Stellariae 16 parts.
The prescription proportioning of this Chinese medicine composition can be: Radix Polygoni Multiflori Preparata 424 parts, Herba Ecliptae 287 parts, Cacumen Platycladi 229 parts, Radix Rehmanniae Preparata 162 parts, Radix Rehmanniae 158 parts, Fructus Corni 51 parts, Rhizoma Dioscoreae 69 parts, Radix Ginseng 47 parts, Radix Codonopsis 37 parts, 42 parts, Poria, Cortex Moutan 19 parts, Rhizoma Alismatis 26 parts, the Rhizoma Anemarrhenae 22 parts, Cortex Lycii 17 parts, Radix Stellariae 13 parts.
The prescription proportioning of this Chinese medicine composition can also be: Radix Polygoni Multiflori Preparata 282 parts, Herba Ecliptae 332 parts, Cacumen Platycladi 301 parts, Radix Rehmanniae Preparata 175 parts, Radix Rehmanniae 126 parts, Fructus Corni 77 parts, Rhizoma Dioscoreae 46 parts, Radix Ginseng 42 parts, Radix Codonopsis 50 parts, 28 parts, Poria, Cortex Moutan 25 parts, Rhizoma Alismatis 38 parts, the Rhizoma Anemarrhenae 19 parts, Cortex Lycii 14 parts, Radix Stellariae 19 parts.
Its Chinese medicine composition proportioning can be again: Radix Polygoni Multiflori Preparata 327 parts, Herba Ecliptae 253 parts, Cacumen Platycladi 343 parts, Radix Rehmanniae Preparata 117 parts, Radix Rehmanniae 106 parts, Fructus Corni 61 parts, Rhizoma Dioscoreae 53 parts, Radix Ginseng 62 parts, Radix Codonopsis 55 parts, 33 parts, Poria, Cortex Moutan 17 parts, Rhizoma Alismatis 34 parts, the Rhizoma Anemarrhenae 28 parts, Cortex Lycii 22 parts, Radix Stellariae 17 parts.
Treat the Chinese medicine composition of seborrheic alopecia and alopecia areata described in technique scheme, finally can make granule, hard capsule, drop pill or tablet.
Granule: by gained Traditional Chinese drug mixture, with appropriate dextrin, sucrose, mixing, granulates, dry, makes granule.
Hard capsule: by gained Traditional Chinese drug mixture, adds suitable adjuvant, granulates, encapsulated, makes hard capsule.
Drop pill: by gained Traditional Chinese drug mixture, the substrate hot melt with suitable, stirs, and carries out dripping, make drop pill.
Tablet: by gained Traditional Chinese drug mixture, mixes with appropriate amount of starch, dextrin, granulates, is pressed into tablet.
Technical solution of the present invention is a kind of Chinese medicine composition being used for the treatment of seborrheic alopecia and alopecia areata, and it is prepared from by the following method:
(1) Radix Polygoni Multiflori Preparata, Rhizoma Dioscoreae, Poria powder are broken into coarse powder, then superfine powder is broken into the medicated powder being less than 100 μm, for subsequent use;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, ginseng crude drug, adding medical material weight ratio is 8 ~ 10 times amount 50% ~ 80% ethanol, reflux, extract, 1 ~ 3 time, each 1 ~ 3 h, filters, and merging filtrate also reclaims ethanol extremely without after alcohol taste, after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae medical material, add with medical material weight ratio is 8 ~ 11 times of water gagings, adopt vapor distillation 0.5 ~ 2h, collect volatile oil and with being for subsequent use after the beta-cyclodextrin inclusion compound of 4 ~ 7 times amount with volatile oil weight ratio, by the aqueous solution after distillation, filter, after filtrate reduced in volume drying, dry cream and medicinal residues for subsequent use;
(4) (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii medical material again, add the soak by water 1 ~ 3 time that medical material weight ratio is 8 ~ 12 times amount, each 0.5 ~ 2h, filter, merge to obtain filtrate, filtrate upper prop concentration is 0.1 ~ 0.2 g medical material/ml, cross AB-8 type macroporous resin, flow velocity be 2 ~ 4 times of column volumes/hour, after absorption, with distilled water eluting impurity, then use 40% ~ 60% ethanol elution, collect eluent, decompression recycling ethanol, after concentrate drying, is ground into dried cream powder, sieve for subsequent use;
(5) get the dried cream powder in medicated powder in above-mentioned (1) and (2), (3), (4), with obtained volatile oil clathrate compound in above-mentioned (3), after abundant mixing, obtain Traditional Chinese drug mixture, then to add on pharmaceutics conventional adjuvant and make various different oral formulations.
Technical solution of the present invention is a kind of Chinese medicine composition being used for the treatment of seborrheic alopecia and alopecia areata, and it is specifically prepared from by the following method:
(1), by Radix Polygoni Multiflori Preparata 353 parts, Rhizoma Dioscoreae 58 parts, 35 parts, Poria, be ground into coarse powder, then superfine powder is broken into the medicated powder being less than 100 μm, for subsequent use;
(2) get Herba Ecliptae 292 parts, Fructus Corni 64 parts, Radix Codonopsis 46 parts, the Rhizoma Anemarrhenae 24 parts, Rhizoma Alismatis 32 parts, Radix Ginseng 52 parts, adding medical material weight ratio is 9 times amount 70% ethanol, reflux, extract, 2 times, each 2h, filters, and merging filtrate also reclaims ethanol extremely without after alcohol taste, after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(3) get Cacumen Platycladi 286 parts, Cortex Moutan 21 parts, Radix Stellariae 16 parts, add with medical material weight ratio is 10 times of water gagings, adopt vapor distillation 1h, collect volatile oil and with being for subsequent use after the beta-cyclodextrin inclusion compound of 5 times amount with volatile oil weight ratio, by the aqueous solution after distillation, filter, after filtrate reduced in volume drying, dry cream and medicinal residues for subsequent use;
(4) (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata 146 parts, Radix Rehmanniae 132 parts, Cortex Lycii 18 parts again, add the soak by water 2 times that medical material weight ratio is 10 times amount, each 1h, filter, merge to obtain filtrate, filtrate upper prop concentration is 0.15g medical material/ml, cross AB-8 type macroporous resin, flow velocity be 3 times of column volumes/hour, after absorption, with distilled water eluting impurity, then use 50% ethanol elution, collect eluent, decompression recycling ethanol, after concentrate drying, is ground into dried cream powder, sieve for subsequent use;
(5) get volatile oil clathrate compound obtained in dried cream powder in medicated powder in above-mentioned (1) and (2), (3), (4) and above-mentioned (3), fully after mixing, obtain Traditional Chinese drug mixture, then add adjuvant conventional on pharmaceutics, make granule, to obtain final product.
The present invention is in the middle of practical study process; common oral preparation compared to the disclosure of the invention number of earlier application for CN1343516A protection; the main creation point of technical solution of the present invention is preparation and the purifying process aspect of medical material; bring significant technological progress thus, its main beneficial effect is as follows.
In order to the overall beneficial effect of technical solution of the present invention is more intuitively described, We conducted a series of pharmacy comparative experimental research, its particular content is as follows:
Overall beneficial effect in 1 technical solution of the present invention:
The technological merit of 1.1 prescription proportionings:
Medicament composing prescription proportioning of the present invention is the improvement applied at publication number CN1343516A on basis, unexpected effect is achieved in process of clinical application, this prescription proportioning is that we accidentally obtain in long-term clinical practice, the feature of its consumption proportion is monarch drug Radix Polygoni Multiflori in raising side, Herba Ecliptae, the proportionate share of Cacumen Platycladi medical material, strengthen the liver and kidney tonifying of medicine, black hair and heat clearing away are nourished blood effect, suitably reduce major part assistant simultaneously, make the proportionate share of medicine, can make efficacy of drugs high concentration in the treatment of primary symptom, more meet the clinical treatment purposes of medicine thus.Grope through large quantity research, the prescription proportioning of medicine achieves preferably effect on curative effect of medication.
The technological merit of 1.2 preparation technologies:
Superfine communication technique beneficial effect:
Modern study shows, Radix Polygoni Multiflori Preparata, Rhizoma Dioscoreae, in Poria medical material, effective ingredient is: stilbene glucoside, Anthraquinones, phospholipid, Chinese yam polysaccharide, Rhizoma Dioscoreae starch, Rhizoma Dioscoreae ethanol extract, the chemical compositions such as pachyman, Conventional solvents extracting method is adopted to obtain Chinese crude drug active component, need through infiltrating, swelling, infiltration and the stripping of diffusion ability, intracellular active component just can need enter in solvent through several even dozens of cell wall, and, and have quite a few directly with Chinese crude drug or coarse powder, intracellular active component is difficult to enter solvent through cell wall, by solvent extraction, cause extraction ratio not high, drug effect can not be played to greatest extent.
Chinese crude drug is after micronizing, there is significantly change in physicochemical property and microstructure, after cell wall breaking, in born of the same parents, active component can fully come out, and the burst size of active component can be improved, due to low temperature, closed and 100% pulverize the result of (without medicinal residues), remain whole active component of Chinese crude drug, a large amount of medical materials can be saved, quality and bioavailability can be improved again.
Get respectively Radix Polygoni Multiflori Preparata (282 ~ 424 g), Rhizoma Dioscoreae (46 ~ 69 g), (mixture of 28 ~ 42 g) 3 kinds of crude drugs, adopts superfine powder to be broken into the micropowders being less than 100 μm, carries out common flour and be broken into 120 order fine powders, obtain working sample Poria; Adopting Phenol sulfuric acid procedure, take glucose as reference substance, measures the content of total polysaccharides; Phosphomolybdic acid method is adopted to measure lecithin content; Adopt high-efficient liquid phase technique, with 2,3,5,4 ' – tetrahydroxystilbene-2-O-β-D-Glucose glycosides is reference substance, with acetonitrile: water=23:77 is mobile phase, and determined wavelength is 320nm, measures the stilbene glucoside content in medicated powder.
Table 1 mixes assay in medical material and compares
From experimental result, mixing medical material superfine powder compares with common fine powder, total polysaccharides in medicine, lecithin, stilbene glucoside content is all greatly improved, mixing medical material is after micronizing, effective ingredient stripping in medical material can be increased, modern pharmacological research shows, lecithin forms nervous tissue, particularly encephalomyelic main component, also be the important composition raw material of cell membrane simultaneously, and new life and the growth of cell can be promoted, these effective ingredient are all the material bases for the treatment of seborrheic alopecia, this also illustrates the superiority of superfine communication technique in technical solution of the present invention.
After above-mentioned pharmacy comparative experimental research, because core innovative point of the present invention is and on the preparation of medical material and purifying process, in selection process, we carry out a large amount of tests and grope, in order to the reasonable of technical solution of the present invention and feasibility are described, therefore select representative prescription proportioning as trial drug of the present invention, we are immediate correlation technique with the technical scheme of publication number CN1343516A, in conjunction with the research level of modern pharmacology, and by equity test, illustrate the pharmacodynamics curative effect of Drug therapy seborrheic alopecia of the present invention and alopecia areata fully.In order to simplify experimental implementation, save research expenditure, follow the experiment principle of parallel control, the Different therapeutical effect that each medicine group of forgoing is brought because of dosage form itself, thus the creativeness of the outstanding technical solution of the present invention of science more, so this can derive for those skilled in the art completely thus, and understand the beneficial effect of other parameter point technical scheme in the application, therefore the technology of the present invention content and pharmacodynamic results are certainly not limited thereto scope.
1. the preparation of trial drug:
A. the preparation of trial drug of the present invention: namely a. is by Radix Polygoni Multiflori Preparata 353g, Rhizoma Dioscoreae 58g, Poria 35g, is ground into coarse powder, then superfine powder is broken into the medicated powder being less than 100 μm, for subsequent use, b. Herba Ecliptae 292 g is got, Fructus Corni 64g, Radix Codonopsis 46g, Rhizoma Anemarrhenae 24g, Rhizoma Alismatis 32g, Radix Ginseng 52g, adding medical material weight ratio is 9 times amount 70% ethanol, reflux, extract, 2 times, each 2h, filter, merging filtrate also reclaims ethanol extremely without after alcohol taste, after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues c. for subsequent use gets Cacumen Platycladi 286g, Cortex Moutan 21g, Radix Stellariae 16g, add with medical material weight ratio is 9 times of water gagings, adopt vapor distillation 2h, collect volatile oil and with being for subsequent use after the beta-cyclodextrin inclusion compound of 4 times amount with volatile oil weight ratio, by the aqueous solution after distillation, filter, after filtrate reduced in volume drying, dry cream and medicinal residues for subsequent use, d. (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata 146g, Radix Rehmanniae 132g, Cortex Lycii 18g again, add the soak by water 1 time that medical material weight ratio is 12 times amount, each 2h, filter, merge to obtain filtrate, filtrate upper prop concentration is 0.15g medical material/ml, cross AB-8 type macroporous resin, flow velocity be 3 times of column volumes/hour, after absorption, with distilled water eluting impurity, then use 40% ethanol elution, collect eluent, decompression recycling ethanol, after concentrate drying, is ground into dried cream powder, sieve for subsequent use, get the medicated powder in above-mentioned a, the dried cream powder in b, c, d, with obtained volatile oil clathrate compound in above-mentioned c, fully after mixing, obtain Traditional Chinese drug mixture, before use, adding distil water is mixed with medicinal liquid, obtains product group in the middle of medicine of the present invention.
The preparation of product group in the middle of B.CN1343516A: be about to 1. Radix Polygoni Multiflori Preparata 208g, Radix Ginseng 28g are ground into fine powder, sterilizing respectively, continue to employ, 2. get respectively Rhizoma Dioscoreae 69g, Cacumen Platycladi 139g, Poria 56g, Cortex Moutan 49g, Cortex Lycii 42g 1/3 amount be ground into fine powder, sterilizing, continue to employ, 3. remaining Rhizoma Dioscoreae is got, Cacumen Platycladi, Poria, Cortex Moutan, Cortex Lycii, with Herba Ecliptae 104g, Radix Codonopsis 56g, Rhizoma Alismatis 42g, Radix Stellariae 35g, Rhizoma Anemarrhenae 62g, Fructus Corni 83g crude drug mixes, it is the water of 8 times amount that first time adds with crude drug weight ratio, soak 30min, decoct 1.5h, it is the water of 6 times amount that second time adds with crude drug weight ratio, decoct 1h, it is the water of 6 times amount that third time adds with crude drug weight ratio, decoct 1h, collecting decoction, filter, it is 1.35-1.45 that filtrate is concentrated into relative density in 55 DEG C, add above-mentioned 2. in whole Rhizoma Dioscoreae, Poria fine powder and 1. middle part Radix Polygoni Multiflori Preparata fine powder 177g altogether, mixing, be ground into fine powder in 70 DEG C of dryings, continue to employ, 4. Radix Rehmanniae Preparata 208g is got, Radix Rehmanniae 208g, it is the water of 8 times amount that first time adds with crude drug weight ratio, soak 30min, decoct 1.5h, it is the water of 6 times amount that second time adds with crude drug weight ratio, decoct 1h, it is the water of 6 times amount that third time adds with crude drug weight ratio, decoct 1h, collecting decoction, filter, it is 1.20 that filtrate is concentrated into relative density in 50 DEG C, when being chilled to 40 DEG C, adding ethanol makes alcohol content reach 80%, cold preservation leaves standstill 24h, filter and reclaim ethanol, it is 1.35-1.45 that filtrate is concentrated into relative density in 50 DEG C, add remaining Radix Polygoni Multiflori Preparata medicated powder 1., mixing, be ground into fine powder in 70 DEG C of dryings, continue to employ, 5. by the Radix Ginseng in 1., 2. in Cacumen Platycladi, Cortex Moutan, Cortex Lycii and 3., 4. in the medicated powder mixing of continuing to employ, and be ground into dried cream powder, before use, adding distil water is mixed with the concentration liquid be equal to product group in the middle of the invention described above, obtains product group in the middle of CN1343516A.
1.2 experimental animals: Wistar rat 40, weight (220 ± 20) kg, male and female half and half, are provided by The Fourth Military Medical University's Experimental Animal Center.
1.3 statistical procedures: experimental result with represent, adopt t inspection, measure the significance of group difference.
2 test methods and result:
Get rat 40, after adaptability feeds 1 week, be divided into product group in the middle of Normal group, seborrheic alopecia model group, CN1343516A at random, product group in the middle of medicine of the present invention, totally 4 groups, often organize 10.Front every the rat of experiment chooses the fur of back 7cm × 5cm area, with 3% picric acid solution stained yellow, to determine district of losing hair or feathers.Except Normal group, the testosterone propionate of subcutaneous injection 5mg/kg d dosage after all the other each treated animal necks, every day 1 time, continuous 60 days, causes seborrheic alopecia model, subcutaneous injection equal-volume normal saline after normal control treated animal neck.Administration while modeling, in the middle of medicine group of the present invention, product group and the middle product group of CN1343516A press 2.12g crude drug/kg dosage gavage, gavage normal saline Normal group and seborrheic alopecia model group, administration volume is identical with test administration group, and each group gavage equal every day 1 time, tests and within the 3rd week, play the raising of single cage, every day is by magnifier observed and recorded dyed hair dropping situations, successive administration, after 60 days, gets blood from posterior vena cava, detects testosterone (T), estradiol (E in each treated animal serum with putting the method for exempting from 2).Statistical procedures is carried out in result t inspection.
Table 2 is on the impact of rat unit area day dose,epilation, serum testosterone and estradiol
Note: compare with Normal group, * *p<0.001; Compare with product group in the middle of CN1343516A, △ △p<0.01, △ △ △p<0.001.
Model group rats continuous subcutaneous injection testosterone propionate is after 3 weeks, back hair color is gloomy, tarnish, after 4 weeks, engender alopecia, remaining hair becomes very thin, matter is crisp, compare with Normal group, the unit plane day of year dose,epilation of seborrheic alopecia model group rats, serum testosterone T, serum estradiol has significant difference (P<0.001), and the rat alopecia model success of setting up is described.From experimental result, compare with product group in the middle of CN1343516A, in the middle of medicine of the present invention, product group improves seborrheic alopecia rat model unit plane day of year dose,epilation symptom obviously (P<0.001); Compare with product group in the middle of CN1343516A, in the middle of medicine of the present invention, product group reduction rat blood serum testosterone and increasing serum estradiol level have significant difference (P<0.01), this shows, in the middle of medicine of the present invention, product group can regulate androgen and estrogenic level in rat body, improves the alopecia phenomenon of seborrheic alopecia rat model.
In sum, in the middle of medicine of the present invention, product group and the middle product group of CN1343516A all can improve seborrheic alopecia model group rats depilation symptom, and reduce the effect such as rat blood serum testosterone and increasing serum estradiol level, these effects are pharmacological basis for the treatment of seborrheic alopecia and alopecia areata disease, wherein medicine of the present invention is evident in efficacy, as can be seen here, medicine of the present invention has outstanding beneficial effect with compared with correlation technique.
We also carry out sample and to keep sample stability test to this, temperature 25 ± 2 DEG C, under RH65% ± 5% condition, place after 12 months, experimental result finds, not there is significant change in the stilbene glucoside content in trial drug of the present invention and CN1343516A medicine, and the phenomenon of the moisture absorption does not occur Chinese medicine composition, and obvious moisture absorption phenomenon has appearred in CN1343516A medicine group.This point may with this technological invention scheme in adopt AB-8 type macroporous resin to remove protein, the purification of the impurity such as phlegmatic temperament is relevant, and this illustrates that the medicine made of technical solution of the present invention has the good feature of quality stability.
Detailed description of the invention
Below the specific embodiment of content of the present invention, for set forth in present specification want the technical scheme of technical solution problem, contributes to those skilled in the art and understand content of the present invention, but the realization of technical solution of the present invention is not limited to these embodiments.
The concrete proportioning of Chinese medicine composition of the present invention:
Prescription a. Radix Polygoni Multiflori Preparata 353g, Herba Ecliptae 292g, Cacumen Platycladi 286g, Radix Rehmanniae Preparata 146 g, Radix Rehmanniae 132g, Fructus Corni 64g, Rhizoma Dioscoreae 58g, Radix Ginseng 52g, Radix Codonopsis 46g, Poria 35 g, Cortex Moutan 21g, Rhizoma Alismatis 32g, Rhizoma Anemarrhenae 24g, Cortex Lycii 18g, Radix Stellariae 16g;
Prescription b. Radix Polygoni Multiflori Preparata 424g, Herba Ecliptae 287g, Cacumen Platycladi 229g, Radix Rehmanniae Preparata 162g, Radix Rehmanniae 158g, Fructus Corni 51g, Rhizoma Dioscoreae 69g, Radix Ginseng 47g, Radix Codonopsis 37g, Poria 42g, Cortex Moutan 19g, Rhizoma Alismatis 26g, Rhizoma Anemarrhenae 22g, Cortex Lycii 17g, Radix Stellariae 13g;
Prescription c. Radix Polygoni Multiflori Preparata 282g, Herba Ecliptae 332g, Cacumen Platycladi 301g, Radix Rehmanniae Preparata 175g, Radix Rehmanniae 126 g, Fructus Corni 77g, Rhizoma Dioscoreae 46g, Radix Ginseng 42g, Radix Codonopsis 50g, Poria 28g, Cortex Moutan 25g, Rhizoma Alismatis 38g, Rhizoma Anemarrhenae 19g, Cortex Lycii 14g, Radix Stellariae 19g;
Prescription d. Radix Polygoni Multiflori Preparata 327g, Herba Ecliptae 253g, Cacumen Platycladi 343g, Radix Rehmanniae Preparata 117g, Radix Rehmanniae 106 g, Fructus Corni 61g, Rhizoma Dioscoreae 53g, Radix Ginseng 62g, Radix Codonopsis 55g, Poria 33g, Cortex Moutan 17g, Rhizoma Alismatis 34g, Rhizoma Anemarrhenae 28g, Cortex Lycii 22g, Radix Stellariae 17g.
Embodiment 1
Get the prescription proportioning composition of above-mentioned a prescription, and by following preparation method operation:
(1) by Radix Polygoni Multiflori Preparata, Rhizoma Dioscoreae, Poria, be ground into coarse powder, then superfine powder is broken into the medicated powder being less than 100 μm, for subsequent use;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, Radix Ginseng, adding medical material weight ratio is 9 times amount 70% ethanol, reflux, extract, 2 times, each 2h, filter, merging filtrate also reclaims ethanol extremely without after alcohol taste, after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae, add with medical material weight ratio is 10 times of water gagings, adopt vapor distillation 1h, collect volatile oil and with being for subsequent use after the beta-cyclodextrin inclusion compound of 5 times amount with volatile oil weight ratio, by the aqueous solution after distillation, filter, after filtrate reduced in volume drying, dry cream and medicinal residues for subsequent use;
(4) (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii again, add the soak by water 2 times that medical material weight ratio is 10 times amount, each 1h, filter, merge to obtain filtrate, filtrate upper prop concentration is 0.15g medical material/ml, cross AB-8 type macroporous resin, flow velocity be 3 times of column volumes/hour, after absorption, with distilled water eluting impurity, then use 50% ethanol elution, collect eluent, decompression recycling ethanol, after concentrate drying, is ground into dried cream powder, sieve for subsequent use;
(5) get the dried cream powder in medicated powder in above-mentioned (1) and (2), (3), (4), with above-mentioned (3) in obtained volatile oil clathrate compound, fully after mixing, obtain Traditional Chinese drug mixture, add appropriate dextrin, sucrose, then mix, granulate, drying, makes 1000g granule.
Embodiment 2
Get the weight proportion medical material described in above-mentioned prescription b, prepare according to the preparation method of " embodiment 1 ", to obtain final product.
Embodiment 3
Get the weight proportion medical material described in above-mentioned prescription c, prepare according to the preparation method of " embodiment 1 ", to obtain final product.
Embodiment 4
Get the weight proportion medical material described in above-mentioned prescription d, prepare according to the preparation method of " embodiment 1 ", to obtain final product.
Embodiment 5
Get the prescription proportioning composition of above-mentioned a prescription, and by following preparation method operation:
(1) by Radix Polygoni Multiflori Preparata, Rhizoma Dioscoreae, Poria, be ground into coarse powder, then superfine powder is broken into the medicated powder being less than 100 μm, for subsequent use;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, Radix Ginseng, adding medical material weight ratio is 9 times amount 50% ethanol, reflux, extract, 1 time, each 3h, filter, merging filtrate also reclaims ethanol extremely without after alcohol taste, after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae, add with medical material weight ratio is 11 times of water gagings, adopt vapor distillation 0.5h, collect volatile oil and with being for subsequent use after the beta-cyclodextrin inclusion compound of 6 times amount with volatile oil weight ratio, by the aqueous solution after distillation, filter, after filtrate reduced in volume drying, dry cream and medicinal residues for subsequent use;
(4) (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii again, add the soak by water 3 times that medical material weight ratio is 8 times amount, each 0.5h, filter, merge to obtain filtrate, filtrate upper prop concentration is 0.10g medical material/ml, cross AB-8 type macroporous resin, flow velocity be 2 times of column volumes/hour, after absorption, with distilled water eluting impurity, then use 50% ethanol elution, collect eluent, decompression recycling ethanol, after concentrate drying, is ground into dried cream powder, sieve for subsequent use;
(5) get the dried cream powder in medicated powder in above-mentioned (1) and (2), (3), (4), with above-mentioned (3) in obtained volatile oil clathrate compound, fully after mixing, obtain Traditional Chinese drug mixture, add appropriate dextrin, granulate, encapsulated, make 1000 hard capsules.
Embodiment 6
Get the weight proportion medical material described in above-mentioned prescription b, prepare according to the preparation method of " embodiment 5 ", to obtain final product.
Embodiment 7
Get the weight proportion medical material described in above-mentioned prescription c, prepare according to the preparation method of " embodiment 5 ", to obtain final product.
Embodiment 8
Get the weight proportion medical material described in above-mentioned prescription d, prepare according to the preparation method of " embodiment 5 ", to obtain final product.
Embodiment 9
Get the prescription proportioning composition of above-mentioned a prescription, and by following preparation method operation:
(1) by Radix Polygoni Multiflori Preparata, Rhizoma Dioscoreae, Poria, be ground into coarse powder, then superfine powder is broken into the medicated powder being less than 100 μm, for subsequent use;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, Radix Ginseng, adding medical material weight ratio is 8 times amount 80% ethanol, reflux, extract, 3 times, each 1h, filter, merging filtrate also reclaims ethanol extremely without after alcohol taste, after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae, add with medical material weight ratio is 8 times of water gagings, adopt vapor distillation 1.5h, collect volatile oil and with being for subsequent use after the beta-cyclodextrin inclusion compound of 7 times amount with volatile oil weight ratio, by the aqueous solution after distillation, filter, after filtrate reduced in volume drying, dry cream and medicinal residues for subsequent use;
(4) (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii again, add the soak by water 2 times that medical material weight ratio is 9 times amount, each 1h, filter, merge to obtain filtrate, filtrate upper prop concentration is 0.2g medical material/ml, cross AB-8 type macroporous resin, flow velocity be 4 times of column volumes/hour, after absorption, with distilled water eluting impurity, then use 60% ethanol elution, collect eluent, decompression recycling ethanol, after concentrate drying, is ground into dried cream powder, sieve for subsequent use;
(5) get the dried cream powder in medicated powder in above-mentioned (1) and (2), (3), (4), with above-mentioned (3) in obtained volatile oil clathrate compound, fully after mixing, obtain Traditional Chinese drug mixture, with suitable substrate hot melt, stir, and carry out dripping, make 1000 drop pill.
Embodiment 10
Get the weight proportion medical material described in above-mentioned prescription b, prepare according to the preparation method of " embodiment 9 ", to obtain final product.
Embodiment 11
Get the weight proportion medical material described in above-mentioned prescription c, prepare according to the preparation method of " embodiment 9 ", to obtain final product.
Embodiment 12
Get the weight proportion medical material described in above-mentioned prescription d, prepare according to the preparation method of " embodiment 9 ", to obtain final product.
Embodiment 13
Get the prescription proportioning composition of above-mentioned a prescription, and by following preparation method operation:
(1) by Radix Polygoni Multiflori Preparata, Rhizoma Dioscoreae, Poria, be ground into coarse powder, then superfine powder is broken into the medicated powder being less than 100 μm, for subsequent use;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, Radix Ginseng, adding medical material weight ratio is 10 times amount 60% ethanol, reflux, extract, 2 times, each 1h, filter, merging filtrate also reclaims ethanol extremely without after alcohol taste, after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae, add with medical material weight ratio is 9 times of water gagings, adopt vapor distillation 2h, collect volatile oil and with being for subsequent use after the beta-cyclodextrin inclusion compound of 4 times amount with volatile oil weight ratio, by the aqueous solution after distillation, filter, after filtrate reduced in volume drying, dry cream and medicinal residues for subsequent use;
(4) (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii again, add the soak by water 1 time that medical material weight ratio is 12 times amount, each 2h, filter, merge to obtain filtrate, filtrate upper prop concentration is 0.15g medical material/ml, cross AB-8 type macroporous resin, flow velocity be 3 times of column volumes/hour, after absorption, with distilled water eluting impurity, then use 40% ethanol elution, collect eluent, decompression recycling ethanol, after concentrate drying, is ground into dried cream powder, sieve for subsequent use;
(5) get the dried cream powder in medicated powder in above-mentioned (1) and (2), (3), (4), with above-mentioned (3) in obtained volatile oil clathrate compound, fully after mixing, obtain Traditional Chinese drug mixture, add appropriate amylum pregelatinisatum, granulate, tabletted, 1000 tablets made by coating.
Embodiment 14
Get the weight proportion medical material described in above-mentioned prescription b, prepare according to the preparation method of " embodiment 13 ", to obtain final product.
Embodiment 15
Get the weight proportion medical material described in above-mentioned prescription c, prepare according to the preparation method of " embodiment 13 ", to obtain final product.
Embodiment 16
Get the weight proportion medical material described in above-mentioned prescription d, prepare according to the preparation method of " embodiment 13 ", to obtain final product.
Because pharmacy test research cost cost is comparatively large, we are parallel, science choose following technical scheme: test 1 group choose embodiment 1 with a prescription proportioning, test 2 groups choose embodiment 6 with b prescription proportioning, test 3 groups choose embodiment 11 with c prescription proportioning, test 4 groups and choose embodiment 16 with d prescription proportioning; The clinical effectiveness of the present invention's test, can represent the prescription proportioning in technical solution of the present invention, this also it will be appreciated by those skilled in the art that.Now concrete outcome is reported as follows.
Clinical observation and curative effect
1. physical data:
1.1 seborrheic alopecia
Collect in June, 2009 ~ 2011 routine in the tested case 185 of Dermatology Outpatient Department for year July, wherein male 96 example, women 89 example; Age is 32 ~ 61 years old, year mean age (43.54 ± 1.14); The course of disease 10 months ~ 2.7 years, average course of disease (2.13 ± 1.02) year; Diagnostic criteria: 1. oils and fats is many, dandruff is many, scalp pruritus, and with continuous alopecia 3 months, alopecia every day quantity more than 50; 2. forehead hairline raises; 3. alopecia in continuous 3 months is every day more than 100, and hair is tapered.All 2 of meeting in above-mentioned 3, are namely diagnosed as seborrheic alopecia.Exclusion standard is endocrine alopecia 1., as hypothyroidism or hyperfunction, parathyroid gland or primary pituitary hypofunction, hypogonadism, diabetes etc.; 2. alopecia medicamentosa, symptomatic alopecia, women's puerperal alopecia; 3. suckling or pregnancy women; 4. treat in first 1 month and used glucocorticoid or immunosuppressant, in 1 week, took the patients such as the medicine of Chinese medicine or inhibition hormone.Patient is divided at random test 1 group, 2 groups, 3 groups, 4 groups, CN1343516A medicine group, matched group (YANGXUE SHENGFA JIAONANG); Each group is in physical data such as sex, age, the courses of disease, and through statistical analysis process, the indifference opposite sex, has comparability (P > 0.05).
1.2 alopecia areata
Choose the patient of 173 examples from Dermatology Outpatient Department, all meet alopecia areata diagnostic criteria.Wherein, man 93 example, female 80 example, 35 ~ 59 years old age, the course of disease all in 0.6 ~ 1.8 year, average course of disease (1.36 ± 0.56) year; Skin lesion 1 ~ 5 place, alopecia area 0.5cm × 1.0cm ~ 5.0cm × 7.0cm.Get rid of alopecia syphilitica, androgenetic alopecia etc.Without hypertension, diabetes aldosterone disease, hypokalemia, hepatic and kidney function obstacle, anemia of pregnant woman, age of sucking patient.Patient is divided into test 1 group, 2 groups, 3 groups, 4 groups, CN1343516A medicine group, matched group (Sanguis Draxonis sheet); Each group is in physical data such as sex, age, the courses of disease, and no significant difference, has comparability (P > 0.05).
2. Therapeutic Method
2.1 seborrheic alopecia
The patient of seborrheic alopecia, treatment group oral test 1 group, 2 groups, 3 groups, 4 groups, CN1343516A medicine group medicine, each serving with 4 dosage units, every day 3 times; Matched group simultaneously oral YANGXUE SHENGFA JIAONANG, 4 tablets/time, every day 3 times, 6 groups was all the l course for the treatment of with 3 months, and treat and judge curative effect 2 courses for the treatment of, observe its clinical efficacy, treatments period diet, based on light, avoids high heat or fried food.Adhere to scalp massage.
2.2 alopecia areata
Patients with alopecia areata, treatment group oral test 1 group, 2 groups, 3 groups, 4 groups, CN1343516A medicine group medicine, each serving with 4 dosage units, every day 3 times; The oral Sanguis Draxonis sheet of matched group 4 pieces/times, every day 3 times, 6 groups was all the l course for the treatment of with 3 months, treated and judged curative effect 2 courses for the treatment of, observe its clinical treatment situation.
3. criterion of therapeutical effect and therapeutic outcome
3.1 seborrheic alopecia criterions of therapeutical effect: effective: comb is sent out test and (advised patient to wash hair weekly 2 times, within the 2nd day after hair washing, sent out 10 times by comb before backward with wooden comb) alopecia radical comparatively treat before minimizing more than 50%, sebum secretion, dandruff obviously reduce, scalp itch obviously alleviates, and alopecia district has new sending out to grow.Effective: comb is sent out before alopecia radical in test is comparatively treated and reduced 20% ~ 50%, and sebum secretion, dandruff and scalp itch make moderate progress.Invalid: comb send out test in alopecia radical comparatively treat before reduce be less than 20%, the symptoms such as sebum secretion, dandruff and scalp itch are all not improved.
3.2 alopecia areata criterions of therapeutical effect: recovery from illness: new sending out all grows, chroma of hair, thickness and density recover normal, hair pulling test (-).Effective: more than 70% kainogenesis is long, hair thickness, color and luster are close normal, hair pulling test (-).Effective: 10% ~ 70% kainogenesis is long, no longer occurs depilation phenomenon.Invalid: to have no growth through 2 course of therapy hairs, or hair is long comes off on the contrary.
The comparitive study of table 3 each test group treatment seborrheic alopecia
From the experimental result of table 3, after the clinical treatment of 2 courses for the treatment of, there is sebum secretion in Most patients, dandruff obviously reduces, and scalp itch obviously alleviates, the situation that alopecia radical reduces, and the state of an illness is taken a turn for the better.Patient takes test 1 group, the medicine total effective rate of 2 groups, 3 groups, 4 groups reaches more than 75%, and the effective percentage of CN1343516A medicine group and YANGXUE SHENGFA JIAONANG group is respectively 66.7%, 63.4%, the explanation of above clinical efficacy result, Chinese medicine composition prepared by technical solution of the present invention is in treatment seborrheic alopecia, have curing protrusion effect, its curative effect is all better than CN1343516A medicine group and YANGXUE SHENGFA JIAONANG group, and each test group medicine does not all occur untoward reaction.
The comparitive study of table 4 each test group treatment alopecia areata
From the experimental result of table 4,6 groups of patients are after the treatment of 2 courses for the treatment of of medicine, and growing of the newborn hair of its Most patients, and thick and black, without the situation of alopecia, comparatively before medication, symptom all improves significantly.Test 1 group, 2 groups, 3 groups, 4 groups total effective rates and be respectively 82.8%, 76.9%, 77.4%, 78.6%, and the effective percentage of matched group CN1343516A medicine group and Sanguis Draxonis sheet group is only 65.6%, 63.0%, above clinical efficacy result confirms, with the comparitive study of CN1343516A medicine group and Sanguis Draxonis sheet group, Chinese medicine composition prepared by technical solution of the present invention has obvious therapeutic effect in treatment alopecia areata, and over the course for the treatment of, does not find the untoward reaction of each test group medicine.
In sum: Chinese medicine composition prepared by technical solution of the present invention has obvious therapeutic effect in treatment seborrheic alopecia and alopecia areata disease, and the medicine of each test group all has curing protrusion effect.Result shows, Chinese medicine composition of the present invention has the advantages such as preparation technology's simple possible, stable curative effect be reliable, its beneficial effect is no matter from the preparation technology and purifying process of medical material, or on the forming technique of finished product preparation, all effectively ensure that the excellent results of Chinese medicine composition of the present invention, this proves further, Chinese medicine composition of the present invention is a kind of determined curative effect, prevent and treat the medicine of seborrheic alopecia and alopecia areata safely and effectively, there is huge market potential, be worth further genralrlization.

Claims (10)

1. treat a Chinese medicine composition for seborrheic alopecia and alopecia areata, it is characterized in that it is made up of the raw material of following weight proportion: Radix Polygoni Multiflori Preparata 282 ~ 424 parts, Herba Ecliptae 253 ~ 332 parts, Cacumen Platycladi 229 ~ 343 parts, Radix Rehmanniae Preparata 117 ~ 175 parts, Radix Rehmanniae 106 ~ 158 parts, Fructus Corni 51 ~ 77 parts, Rhizoma Dioscoreae 46 ~ 69 parts, Radix Ginseng 42 ~ 62 parts, Radix Codonopsis 37 ~ 55 parts, 28 ~ 42 parts, Poria, Cortex Moutan 17 ~ 25 parts, Rhizoma Alismatis 26 ~ 38 parts, the Rhizoma Anemarrhenae 19 ~ 28 parts, Cortex Lycii 14 ~ 22 parts, Radix Stellariae 13 ~ 19 parts;
Preparation method is:
(1) Radix Polygoni Multiflori Preparata, Rhizoma Dioscoreae, Poria powder are broken into coarse powder, then superfine powder is broken into the medicated powder being less than 100 μm, for subsequent use;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, ginseng crude drug, adding with medical material weight ratio is 8 ~ 10 times amount 50% ~ 80% ethanol, reflux, extract, 1 ~ 3 time, each 1 ~ 3h, filters, and merging filtrate also reclaims ethanol extremely without after alcohol taste, concentration of liquid medicine is dry, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae medical material, add with medical material weight ratio is 8 ~ 11 times of water gagings, adopt vapor distillation 0.5 ~ 2h, collect volatile oil and with being for subsequent use after the beta-cyclodextrin inclusion compound of 4 ~ 7 times amount with volatile oil weight ratio, by the aqueous solution after distillation, filter, after filtrate reduced in volume drying, dry cream and medicinal residues for subsequent use;
(4) the medicinal residues in (2) and (3) are merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii medical material again, adding with medical material weight ratio is the soak by water 1 ~ 3 time of 8 ~ 12 times amount, each 0.5 ~ 2h, filter, merge to obtain filtrate, filtrate upper prop concentration is 0.1 ~ 0.2g medical material/ml, crosses AB-8 type macroporous resin, flow velocity be 2 ~ 4 times of column volumes/hour, after absorption, with distilled water eluting impurity, then use 40% ~ 60% ethanol elution, collect eluent, decompression recycling ethanol, after concentrate drying, is ground into dried cream powder, sieve for subsequent use;
(5) get the dried cream powder in medicated powder in above-mentioned (1) and the dried cream powder in (2), the dry cream in (3), (4), with volatile oil clathrate compound obtained in above-mentioned (3), after abundant mixing, obtain Traditional Chinese drug mixture, then to add on pharmaceutics conventional adjuvant and make various different oral formulations.
2. the Chinese medicine composition for the treatment of seborrheic alopecia as claimed in claim 1 and alopecia areata, is characterized in that it is made up of the raw material of following weight proportion: Radix Polygoni Multiflori Preparata 353 parts, Herba Ecliptae 292 parts, Cacumen Platycladi 286 parts, Radix Rehmanniae Preparata 146 parts, Radix Rehmanniae 132 parts, Fructus Corni 64 parts, Rhizoma Dioscoreae 58 parts, Radix Ginseng 52 parts, Radix Codonopsis 46 parts, 35 parts, Poria, Cortex Moutan 21 parts, Rhizoma Alismatis 32 parts, the Rhizoma Anemarrhenae 24 parts, Cortex Lycii 18 parts, Radix Stellariae 16 parts.
3. the Chinese medicine composition for the treatment of seborrheic alopecia as claimed in claim 1 and alopecia areata, is characterized in that it is made up of the raw material of following weight proportion: Radix Polygoni Multiflori Preparata 424 parts, Herba Ecliptae 287 parts, Cacumen Platycladi 229 parts, Radix Rehmanniae Preparata 162 parts, Radix Rehmanniae 158 parts, Fructus Corni 51 parts, Rhizoma Dioscoreae 69 parts, Radix Ginseng 47 parts, Radix Codonopsis 37 parts, 42 parts, Poria, Cortex Moutan 19 parts, Rhizoma Alismatis 26 parts, the Rhizoma Anemarrhenae 22 parts, Cortex Lycii 17 parts, Radix Stellariae 13 parts.
4. the Chinese medicine composition for the treatment of seborrheic alopecia as claimed in claim 1 and alopecia areata, is characterized in that it is made up of the raw material of following weight proportion: Radix Polygoni Multiflori Preparata 282 parts, Herba Ecliptae 332 parts, Cacumen Platycladi 301 parts, Radix Rehmanniae Preparata 175 parts, Radix Rehmanniae 126 parts, Fructus Corni 77 parts, Rhizoma Dioscoreae 46 parts, Radix Ginseng 42 parts, Radix Codonopsis 50 parts, 28 parts, Poria, Cortex Moutan 25 parts, Rhizoma Alismatis 38 parts, the Rhizoma Anemarrhenae 19 parts, Cortex Lycii 14 parts, Radix Stellariae 19 parts.
5. the treatment seborrheic alopecia as described in as arbitrary in claim 1-4 and the Chinese medicine composition of alopecia areata, is characterized in that this Chinese medicine composition is granule, hard capsule, drop pill or tablet.
6. the preparation method of the treatment seborrheic alopecia as described in as arbitrary in claim 1-4 and the Chinese medicine composition of alopecia areata, is characterized in that:
(1) Radix Polygoni Multiflori Preparata, Rhizoma Dioscoreae, Poria powder are broken into coarse powder, then superfine powder is broken into the medicated powder being less than 100 μm, for subsequent use;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, ginseng crude drug, adding with medical material weight ratio is 8 ~ 10 times amount 50% ~ 80% ethanol, reflux, extract, 1 ~ 3 time, each 1 ~ 3h, filters, and merging filtrate also reclaims ethanol extremely without after alcohol taste, concentration of liquid medicine is dry, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae medical material, add with medical material weight ratio is 8 ~ 11 times of water gagings, adopt vapor distillation 0.5 ~ 2h, collect volatile oil and with being for subsequent use after the beta-cyclodextrin inclusion compound of 4 ~ 7 times amount with volatile oil weight ratio, by the aqueous solution after distillation, filter, after filtrate reduced in volume drying, dry cream and medicinal residues for subsequent use;
(4) the medicinal residues in (2) and (3) are merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii medical material again, adding with medical material weight ratio is the soak by water 1 ~ 3 time of 8 ~ 12 times amount, each 0.5 ~ 2h, filter, merge to obtain filtrate, filtrate upper prop concentration is 0.1 ~ 0.2g medical material/ml, crosses AB-8 type macroporous resin, flow velocity be 2 ~ 4 times of column volumes/hour, after absorption, with distilled water eluting impurity, then use 40% ~ 60% ethanol elution, collect eluent, decompression recycling ethanol, after concentrate drying, is ground into dried cream powder, sieve for subsequent use;
(5) get the dried cream powder in medicated powder in above-mentioned (1) and the dried cream powder in (2), the dry cream in (3), (4), with volatile oil clathrate compound obtained in above-mentioned (3), after abundant mixing, obtain Traditional Chinese drug mixture, then to add on pharmaceutics conventional adjuvant and make various different oral formulations.
7. the preparation method of the Chinese medicine composition for the treatment of seborrheic alopecia as claimed in claim 6 and alopecia areata, is characterized in that:
(1) by Radix Polygoni Multiflori Preparata, Rhizoma Dioscoreae, Poria, be ground into coarse powder, then superfine powder is broken into the medicated powder being less than 100 μm, for subsequent use;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, Radix Ginseng, adding with medical material weight ratio is 9 times amount 70% ethanol, reflux, extract, 2 times, each 2h, filter, merging filtrate also reclaims ethanol extremely without after alcohol taste, and concentration of liquid medicine is dry, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae, add with medical material weight ratio is 10 times of water gagings, adopt vapor distillation 1h, collect volatile oil and with being for subsequent use after the beta-cyclodextrin inclusion compound of 5 times amount with volatile oil weight ratio, by the aqueous solution after distillation, filter, after filtrate reduced in volume drying, dry cream and medicinal residues for subsequent use;
(4) merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii by the medicinal residues in (2) and (3), adding with medical material weight ratio is the soak by water 2 times of 10 times amount, each 1h again, filter, merge to obtain filtrate, filtrate upper prop concentration is 0.15g medical material/ml, cross AB-8 type macroporous resin, flow velocity be 3 times of column volumes/hour, after absorption, with distilled water eluting impurity, then use 50% ethanol elution, collect eluent, decompression recycling ethanol, after concentrate drying, is ground into dried cream powder, sieve for subsequent use;
(5) get the dried cream powder in medicated powder in above-mentioned (1) and the dried cream powder in (2), the dry cream in (3), (4), with volatile oil clathrate compound obtained in above-mentioned (3), after abundant mixing, obtain Traditional Chinese drug mixture, add adjuvant conventional on pharmaceutics again, make granule, to obtain final product.
8., as a preparation method for Chinese medicine composition as described in arbitrary in claim 1-4, it is characterized in that it operates as follows:
(1) by Radix Polygoni Multiflori Preparata, Rhizoma Dioscoreae, Poria, be ground into coarse powder, then superfine powder is broken into the medicated powder being less than 100 μm, for subsequent use;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, Radix Ginseng, adding with medical material weight ratio is 9 times amount 50% ethanol, reflux, extract, 1 time, each 3h, filter, merging filtrate also reclaims ethanol extremely without after alcohol taste, and concentration of liquid medicine is dry, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae, add with medical material weight ratio is 11 times of water gagings, adopt vapor distillation 0.5h, collect volatile oil and with being for subsequent use after the beta-cyclodextrin inclusion compound of 6 times amount with volatile oil weight ratio, by the aqueous solution after distillation, filter, after filtrate reduced in volume drying, dry cream and medicinal residues for subsequent use;
(4) merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii by the medicinal residues in (2) and (3), adding with medical material weight ratio is the soak by water 3 times of 8 times amount, each 0.5h again, filter, merge to obtain filtrate, filtrate upper prop concentration is 0.10g medical material/ml, cross AB-8 type macroporous resin, flow velocity be 2 times of column volumes/hour, after absorption, with distilled water eluting impurity, then use 50% ethanol elution, collect eluent, decompression recycling ethanol, after concentrate drying, is ground into dried cream powder, sieve for subsequent use;
(5) get the dried cream powder in medicated powder in above-mentioned (1) and the dried cream powder in (2), the dry cream in (3), (4), with above-mentioned (3) in obtained volatile oil clathrate compound, after abundant mixing, obtain Traditional Chinese drug mixture, add dextrin, granulate, encapsulated, make hard capsule.
9., as a preparation method for Chinese medicine composition as described in arbitrary in claim 1-4, it is characterized in that it operates as follows:
(1) by Radix Polygoni Multiflori Preparata, Rhizoma Dioscoreae, Poria, be ground into coarse powder, then superfine powder is broken into the medicated powder being less than 100 μm, for subsequent use;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, Radix Ginseng, adding with medical material weight ratio is 8 times amount 80% ethanol, reflux, extract, 3 times, each 1h, filter, merging filtrate also reclaims ethanol extremely without after alcohol taste, and concentration of liquid medicine is dry, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae, add with medical material weight ratio is 8 times of water gagings, adopt vapor distillation 1.5h, collect volatile oil and with being for subsequent use after the beta-cyclodextrin inclusion compound of 7 times amount with volatile oil weight ratio, by the aqueous solution after distillation, filter, after filtrate reduced in volume drying, dry cream and medicinal residues for subsequent use;
(4) merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii by the medicinal residues in (2) and (3), adding with medical material weight ratio is the soak by water 2 times of 9 times amount, each 1h again, filter, merge to obtain filtrate, filtrate upper prop concentration is 0.2g medical material/ml, cross AB-8 type macroporous resin, flow velocity be 4 times of column volumes/hour, after absorption, with distilled water eluting impurity, then use 60% ethanol elution, collect eluent, decompression recycling ethanol, after concentrate drying, is ground into dried cream powder, sieve for subsequent use;
(5) get the dried cream powder in medicated powder in above-mentioned (1) and the dried cream powder in (2), the dry cream in (3), (4), with above-mentioned (3) in obtained volatile oil clathrate compound, after abundant mixing, obtain Traditional Chinese drug mixture, with substrate hot melt, stir, and carry out dripping, make drop pill.
10., as a preparation method for Chinese medicine composition as described in arbitrary in claim 1-4, it is characterized in that it operates as follows:
(1) by Radix Polygoni Multiflori Preparata, Rhizoma Dioscoreae, Poria, be ground into coarse powder, then superfine powder is broken into the medicated powder being less than 100 μm, for subsequent use;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, Radix Ginseng, adding with medical material weight ratio is 10 times amount 60% ethanol, reflux, extract, 2 times, each 1h, filter, merging filtrate also reclaims ethanol extremely without after alcohol taste, and concentration of liquid medicine is dry, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae, add with medical material weight ratio is 9 times of water gagings, adopt vapor distillation 2h, collect volatile oil and with being for subsequent use after the beta-cyclodextrin inclusion compound of 4 times amount with volatile oil weight ratio, by the aqueous solution after distillation, filter, after filtrate reduced in volume drying, dry cream and medicinal residues for subsequent use;
(4) merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii by the medicinal residues in (2) and (3), adding with medical material weight ratio is the soak by water 1 time of 12 times amount, each 2h again, filter, merge to obtain filtrate, filtrate upper prop concentration is 0.15g medical material/ml, cross AB-8 type macroporous resin, flow velocity be 3 times of column volumes/hour, after absorption, with distilled water eluting impurity, then use 40% ethanol elution, collect eluent, decompression recycling ethanol, after concentrate drying, is ground into dried cream powder, sieve for subsequent use;
(5) get the dried cream powder in medicated powder in above-mentioned (1) and the dried cream powder in (2), the dry cream in (3), (4), with above-mentioned (3) in obtained volatile oil clathrate compound, after abundant mixing, obtain Traditional Chinese drug mixture, add amylum pregelatinisatum, granulate, tabletted, tablet made by coating.
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