CN103405624A - 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 PDFInfo
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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
Technical field
The present invention relates to a kind of Chinese medicine composition for the treatment of seborrheic alopecia and alopecia areata and preparation method thereof, belong to the pharmaceutical preparations technology field.
Background technology
The seborrheic alopecia traditional Chinese medical science is called " seborrhea ichthyosis ", and doctor trained in Western medicine claims again male pattern alopecia, the androgen alopecia, and the dispersivity alopecia, be the alopecia that neck after adolescence, temporo, top are made slow progress, men and women's both sexes all can occur, but more common with the male patient.Being also the clinical commonly encountered diseases of department of dermatologry, frequently-occurring disease, 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 morely 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 appearancely, often to the patient, bring very large stress and mental burden, therefore the treatment of primary disease also seemed to particularly important.But, for seborrheic alopecia and alopecia areata disease, more effective Therapeutic Method is not also arranged at present.Clinical drug therapy is mainly androgen receptor blocker (as spironolactone, cyproterone acetate etc.) and 5-alpha reductase inhibitor (as finasteride, progestogen etc.) at present.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.Yet Chinese medicine is delaying, aspect the primary disease development, more definite curative effect is arranged.
From Chinese medicine, analyze the pathogeny of seborrheic alopecia, 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 again ailment said due to cold or exposure, be converted into for a long time dry, and then hematozemia impairment of YIN, cloudy blood can not on reach the top, mountain peak, and the flourish hair of supporting, Rhizoma Imperatae is dry, comes off therefore send out Jiao.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, the water cohesion heat-transformation of wetting, cause damp and hot upper steaming to be pushed up to mountain peak, corrode root of hair, white slurry, root of hair gradually are corroded and cause that scalp is sticky and come off or innate deficiency, excessive thinking, impairment caused by overstrain Liver and kidney and cause day by day virtual loss of cloudy blood, hair lose to moisten and support and cause and come off.Or do not control because of prolonged illness, a hair network is obstructed, and stagnation of QI-blood is in the hair network, so that the scalp 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, the Herba Ecliptae liver and kidney tonifying, the Cacumen Platycladi heat clearing away is nourished blood, the black hair three is monarch drug altogether, the Radix Rehmanniae Preparata enriching yin and nourishing kidney, the Radix Rehmanniae YIN nourishing and the production of body fluid promoting is ministerial drug, and Rhizoma Dioscoreae, Radix Ginseng, Radix Codonopsis, invigorating the spleen and replenishing QI, are let out deficiency-heat clearly at Cortex Moutan, the Rhizoma Anemarrhenae, Cortex Lycii, Radix Stellariae, the 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, and temperature and not dry has to mend to have and rushes down, and nourishing the liver and kidney is arranged, replenishing YIN and removing heat, the 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 and the alopecia areata that cause have significant curative effect.
Between this, for this Chinese medicine composition application a patent of invention, its publication number is CN1343516A, open day is on April 10th, 2002, this patent of invention file is from different amounts of components prescription, the aspects such as preparation technology disclose, protection, but in the clinical practice application process, we find that the effect of the Chinese medicine composition of being made by above-mentioned preparation method is desirable not enough, and the application's patent is to grope by great many of experiments, further optimize process of preparing, and better preparation technology's flow process and parameter have been found, more remarkable by the clinical trial proving effect, therefore, we take and improve preparation stability and bioavailability is purpose, and creationary a kind of Chinese medicine composition for the treatment of seborrheic alopecia and alopecia areata of succeeding 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 is treated 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 comprised of the raw material of following weight proportion: 282～424 parts of Radix Polygoni Multiflori Preparatas, 253～332 parts of Herba Ecliptaes, 229～343 parts of Cacumen Platycladis, 117～175 parts of Radix Rehmanniae Preparata, 106～158 parts of Radix Rehmanniae, 51～77 parts of Fructus Corni, 46～69 parts of Rhizoma Dioscoreaes, 42～62 parts of Radix Ginsengs, 37～55 parts of Radix Codonopsis, 28～42 parts, Poria, 17～25 parts of Cortex Moutans, 26～38 parts of Rhizoma Alismatis, 19～28 parts of the Rhizoma Anemarrhenaes, 14～22 parts of Cortex Lycii, 13～19 parts of Radix Stellariaes.
The concrete raw material prescription proportioning of this Chinese medicine composition is: 353 parts of Radix Polygoni Multiflori Preparatas, 292 parts of Herba Ecliptaes, 286 parts of Cacumen Platycladis, 146 parts of Radix Rehmanniae Preparata, 132 parts of Radix Rehmanniae, 64 parts of Fructus Corni, 58 parts of Rhizoma Dioscoreaes, 52 parts of Radix Ginsengs, 46 parts of Radix Codonopsis, 35 parts, Poria, 21 parts of Cortex Moutans, 32 parts of Rhizoma Alismatis, 24 parts of the Rhizoma Anemarrhenaes, 18 parts of Cortex Lycii, 16 parts of Radix Stellariaes.
The prescription proportioning of this Chinese medicine composition can be: 424 parts of Radix Polygoni Multiflori Preparatas, 287 parts of Herba Ecliptaes, 229 parts of Cacumen Platycladis, 162 parts of Radix Rehmanniae Preparata, 158 parts of Radix Rehmanniae, 51 parts of Fructus Corni, 69 parts of Rhizoma Dioscoreaes, 47 parts of Radix Ginsengs, 37 parts of Radix Codonopsis, 42 parts, Poria, 19 parts of Cortex Moutans, 26 parts of Rhizoma Alismatis, 22 parts of the Rhizoma Anemarrhenaes, 17 parts of Cortex Lycii, 13 parts of Radix Stellariaes.
The prescription proportioning of this Chinese medicine composition can also be: 282 parts of Radix Polygoni Multiflori Preparatas, 332 parts of Herba Ecliptaes, 301 parts of Cacumen Platycladis, 175 parts of Radix Rehmanniae Preparata, 126 parts of Radix Rehmanniae, 77 parts of Fructus Corni, 46 parts of Rhizoma Dioscoreaes, 42 parts of Radix Ginsengs, 50 parts of Radix Codonopsis, 28 parts, Poria, 25 parts of Cortex Moutans, 38 parts of Rhizoma Alismatis, 19 parts of the Rhizoma Anemarrhenaes, 14 parts of Cortex Lycii, 19 parts of Radix Stellariaes.
Its Chinese medicine composition proportioning can be again: 327 parts of Radix Polygoni Multiflori Preparatas, 253 parts of Herba Ecliptaes, 343 parts of Cacumen Platycladis, 117 parts of Radix Rehmanniae Preparata, 106 parts of Radix Rehmanniae, 61 parts of Fructus Corni, 53 parts of Rhizoma Dioscoreaes, 62 parts of Radix Ginsengs, 55 parts of Radix Codonopsis, 33 parts, Poria, 17 parts of Cortex Moutans, 34 parts of Rhizoma Alismatis, 28 parts of the Rhizoma Anemarrhenaes, 22 parts of Cortex Lycii, 17 parts of Radix Stellariaes.
The Chinese medicine composition for the treatment of described in technique scheme seborrheic alopecia and alopecia areata, finally can the granulation agent, hard capsule, drop pill or tablet.
Granule: by the gained Traditional Chinese drug mixture, dextrin, sucrose with appropriate, mix, granulates, and drying, granulation agent.
Hard capsule: by the gained Traditional Chinese drug mixture, add suitable adjuvant, granulate, encapsulated, make hard capsule.
Drop pill: by the gained Traditional Chinese drug mixture, the substrate hot melt with suitable, stir, and carry out dripping, makes drop pill.
Tablet: by the gained Traditional Chinese drug mixture, mix with appropriate amount of starch, dextrin, granulate, be pressed into tablet.
Technical solution of the present invention is a kind of Chinese medicine composition that is used for the treatment of seborrheic alopecia and alopecia areata, and it is to be prepared from by the following method:
(1) Radix Polygoni Multiflori Preparata, Rhizoma Dioscoreae, Poria powder are broken into to coarse powder, then superfine powder is broken into the medicated powder that is less than 100 μ m, standby;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, ginseng crude drug, adding the medical material weight ratio is 8～10 times of amount 50%～80% ethanol, reflux, extract, 1～3 time, each 1～3 h, filter, and merging filtrate also reclaims ethanol to nothing alcohol flavor, after the medicinal liquid concentrate drying, and be ground into dried cream powder, and sieving, medicinal residues are standby;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae medical material, adding with the medical material weight ratio is 8～11 times of water gagings, adopt vapor distillation 0.5～2h, it is standby after the beta-cyclodextrin inclusion compound of 4～7 times of amounts collecting volatile oil and using with the volatile oil weight ratio, by the aqueous solution after distillation, filter, after the filtrate decompression concentrate drying, dry cream and medicinal residues are standby;
(4) (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii medical material again, the decocting that adds the medical material weight ratio and be 8～12 times of amounts boils 1～3 time, 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, be ground into dried cream powder, sieve, standby;
(5) get medicated powder in above-mentioned (1), and (2), (3), (4) in dried cream powder, with above-mentioned (3) in the volatile oil clathrate compound that makes, after fully mixing, obtain Traditional Chinese drug mixture, then add adjuvant commonly used on pharmaceutics to make various different oral formulations.
Technical solution of the present invention is a kind of Chinese medicine composition that is used for the treatment of seborrheic alopecia and alopecia areata, and it specifically is prepared from by the following method:
(1) by 353 parts of Radix Polygoni Multiflori Preparatas, 58 parts of Rhizoma Dioscoreaes, 35 parts, Poria, be ground into coarse powder, then superfine powder is broken into the medicated powder that is less than 100 μ m, standby;
(2) get 292 parts of Herba Ecliptaes, 64 parts of Fructus Corni, 46 parts of Radix Codonopsis, 24 parts of the Rhizoma Anemarrhenaes, 32 parts of Rhizoma Alismatis, 52 parts of Radix Ginsengs, adding the medical material weight ratio is 9 times of amount 70% ethanol, reflux, extract, 2 times, each 2h, filter, and merging filtrate also reclaims ethanol to nothing alcohol flavor, after the medicinal liquid concentrate drying, and be ground into dried cream powder, and sieving, medicinal residues are standby;
(3) get 286 parts of Cacumen Platycladis, 21 parts of Cortex Moutans, 16 parts of Radix Stellariaes, adding with the medical material weight ratio is 10 times of water gagings, adopt vapor distillation 1h, it is standby after the beta-cyclodextrin inclusion compound of 5 times of amounts collecting volatile oil and using with the volatile oil weight ratio, by the aqueous solution after distillation, filter, after the filtrate decompression concentrate drying, dry cream and medicinal residues are standby;
By (2) and (3) medicinal residues again with 146 parts of Radix Rehmanniae Preparata, 132 parts of Radix Rehmanniae, 18 parts of merging of Cortex Lycii, the decocting that adds the medical material weight ratio and be 10 times of amounts boils 2 times, 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, be ground into dried cream powder, sieve, standby;
(5) get medicated powder in above-mentioned (1), and (2), (3), (4) in dried cream powder and above-mentioned (3) in the volatile oil clathrate compound that makes, after fully mixing, obtain Traditional Chinese drug mixture, then add the adjuvant of commonly using on pharmaceutics, the granulation agent, obtain.
The present invention is in the middle of the practical study process; than the disclosure of the invention in first to file number for the CN1343516A protection is common oral preparation; the main creation point of technical solution of the present invention is preparation and the purifying process aspect of medical material; brought thus significant technological progress, its main beneficial effect is as follows.
For the whole beneficial effect of technical solution of the present invention more intuitively is described, we have carried out a series of pharmacy comparative experimental research, and its particular content is as follows:
Whole beneficial effect in 1 technical solution of the present invention:
1.1 the technological merit of prescription proportioning:
Medicament composing prescription proportioning of the present invention is the improvement on publication number CN1343516A application basis, in process of clinical application, obtained unexpected effect, this prescription proportioning is that we accidentally obtain in long-term clinical practice, the characteristics of its consumption proportion are monarch drug Radix Polygoni Multiflori in raising side, Herba Ecliptae, the ratio share of Cacumen Platycladi medical material, strengthened the liver and kidney tonifying of medicine, black hair and the heat clearing away effect that nourishes blood, suitably reduce simultaneously most of assistant, make the ratio share of medicine, can so that the efficacy of drugs high concentration in the treatment of primary symptom, the clinical treatment purposes that more meets thus medicine.Through large quantity research, grope, the prescription proportioning of medicine has obtained preferably effect on curative effect of medication.
1.2 preparation technology's technological merit:
The superfine communication technique beneficial effect:
Modern study shows, Radix Polygoni Multiflori Preparata, Rhizoma Dioscoreae, in the Poria medical material, effective ingredient is: stilbene glucoside, Anthraquinones, phospholipid, Chinese yam polysaccharide, Rhizoma Dioscoreae starch, the Rhizoma Dioscoreae ethanol extract, the chemical compositions such as pachyman, adopt conventional solvent extraction process to obtain the Chinese crude drug active component, need through infiltrating, swelling, infiltration and the stripping of diffusion ability, intracellular active component need pass several even dozens of cell wall and just can enter in solvent, and, and quite a few is arranged directly with Chinese crude drug or coarse powder, intracellular active component is difficult to pass cell wall and enters solvent, by solvent extraction, cause extraction ratio not high, can not bring into play to greatest extent drug effect.
Chinese crude drug is after micronizing, physicochemical property and microstructure occur significantly to change, after cell wall breaking, in born of the same parents, active component can fully come out, and can improve the burst size of active component, due to low temperature, closed and 100% result of pulverizing (without medicinal residues), retained 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 the mixture of Radix Polygoni Multiflori Preparata (282～424 g), Rhizoma Dioscoreae (46～69 g), 3 kinds of crude drugs of Poria (28～42 g), adopt superfine powder to be broken into the micropowders that is less than 100 μ m, carry out common flour and be broken into 120 order fine powders, obtain working sample; Adopt the phenol sulfuric acid process, the glucose of take is reference substance, measures the content of total polysaccharides; Adopt the phosphomolybdic acid method 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, and acetonitrile: the water=23:77 of take is mobile phase, and the detection wavelength is 320nm, measures the stilbene glucoside content in medicated powder.
Table 1 mixes assay in medical material and compares
As can be known by experimental result, mix medical material superfine powder and common fine powder relatively, total polysaccharides in medicine, lecithin, stilbene glucoside content all is greatly improved, mix medical material after micronizing, can increase effective ingredient stripping in medical material, modern pharmacological research shows, lecithin is to form nervous tissue, encephalomyelic main component particularly, also the important composition raw material of cell membrane simultaneously, and can promote the newborn of cell and grow, 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, due to core innovative point of the present invention be and the preparation and purifying process of medical material on, in selection process, we carry out a large amount of tests and grope, for the reasonable and feasibility of technical solution of the present invention is described, therefore select representative prescription proportioning as trial drug of the present invention, we take the technical scheme of publication number CN1343516A and are immediate correlation technique, research level in conjunction with modern pharmacology, and test by equity, illustrated fully the pharmacodynamics curative effect of Drug therapy seborrheic alopecia of the present invention and alopecia areata.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, thereby the creativeness of the outstanding technical solution of the present invention of science more, so this can derive for those skilled in the art fully thus, understands the beneficial effect of other parameter point technical scheme in the application, so the technology of the present invention content and drug effect result never are limited to this scope.
1. the preparation of trial drug:
A. the preparation of trial drug of the present invention: namely a., 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 that is less than 100 μ m, standby, b. get Herba Ecliptae 292 g, Fructus Corni 64g, Radix Codonopsis 46g, Rhizoma Anemarrhenae 24g, Rhizoma Alismatis 32g, Radix Ginseng 52g, adding the medical material weight ratio is 9 times of amount 70% ethanol, reflux, extract, 2 times, each 2h, filter, merging filtrate also reclaims ethanol to nothing alcohol flavor, after the medicinal liquid concentrate drying, and be ground into dried cream powder, sieve, the standby c. of medicinal residues gets Cacumen Platycladi 286g, Cortex Moutan 21g, Radix Stellariae 16g, adding with the medical material weight ratio is 9 times of water gagings, adopt vapor distillation 2h, it is standby after the beta-cyclodextrin inclusion compound of 4 times of amounts collecting volatile oil and using with the volatile oil weight ratio, by the aqueous solution after distillation, filter, after the filtrate decompression concentrate drying, dry cream and medicinal residues are standby, d. (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata 146g, Radix Rehmanniae 132g, Cortex Lycii 18g again, the decocting that adds the medical material weight ratio and be 12 times of amounts boils 1 time, 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, be ground into dried cream powder, sieve, standby, get dried cream powder in medicated powder in above-mentioned a, b, c, d, with above-mentioned c in the volatile oil clathrate compound that makes, after fully 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: soon 1. Radix Polygoni Multiflori Preparata 208g, Radix Ginseng 28g will be ground into respectively to fine powder, sterilizing, continue to employ, 1/3 amount of 2. getting respectively Rhizoma Dioscoreae 69g, Cacumen Platycladi 139g, Poria 56g, Cortex Moutan 49g, Cortex Lycii 42g is ground into fine powder, sterilizing, continues to employ, 3. get remaining Rhizoma Dioscoreae, 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, add for the first time with the crude drug weight ratio is the water of 8 times of amounts, soak 30min, decoct 1.5h, add for the second time with the crude drug weight ratio is the water of 6 times of amounts, decoct 1h, add for the third time with the crude drug weight ratio is the water of 6 times of amounts, decoct 1h, collecting decoction, filter, it is 1.35-1.45 that filtrate is concentrated into relative density in 55 ℃, add above-mentioned 2. in whole Rhizoma Dioscoreaes, the Poria fine powder reaches 1. middle part Radix Polygoni Multiflori Preparata fine powder and is total to 177g, mix, in 70 ℃ of dryings and be ground into fine powder, continue to employ, 4. get Radix Rehmanniae Preparata 208g, Radix Rehmanniae 208g, add for the first time with the crude drug weight ratio is the water of 8 times of amounts, soak 30min, decoct 1.5h, add for the second time with the crude drug weight ratio is the water of 6 times of amounts, decoct 1h, add for the third time with the crude drug weight ratio is the water of 6 times of amounts, decoct 1h, collecting decoction, filter, it is 1.20 that filtrate is concentrated into relative density in 50 ℃, while being chilled to 40 ℃, add ethanol to make to contain the alcohol amount to reach 80%, the standing 24h of cold preservation, filter and reclaim ethanol, it is 1.35-1.45 that filtrate is concentrated into relative density in 50 ℃, remaining Radix Polygoni Multiflori Preparata medicated powder in adding 1., mix, in 70 ℃ of dryings and be ground into fine powder, continue to employ, 5. the Radix Ginseng in will be 1., the Cacumen Platycladi in 2., Cortex Moutan, Cortex Lycii and 3., the medicated powder continued to employ in 4. mixes, and be ground into dried cream powder, before use, adding distil water is mixed with the concentration liquid be equal to the middle product group of the invention described above, obtains the middle product group of CN1343516A.
1.2 experimental animal: 40 of Wistar rats, weight (220 ± 20) kg, male and female half and half, provided by The Fourth Military Medical University's Experimental Animal Center.
1.3 statistical procedures: experimental result with
Mean, adopt the t check, measure the significance of group difference.
2 test methods and result:
Get 40 of rats, after adaptability fed for 1 week, be divided at random Normal group, seborrheic alopecia model group, the middle product group of CN1343516A, product group in the middle of medicine of the present invention, totally 4 groups, 10 every group.Front every the rat of experiment is chosen the fur of back 7cm * 5cm area, with 3% picric acid solution stained yellow, to determine the depilation district.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, cause the seborrheic alopecia model, subcutaneous injection equal-volume normal saline after normal control treated animal neck.Administration in the time of modeling, in the middle of medicine group of the present invention, the middle product group of product group and CN1343516A is pressed 2.12g crude drug/kg dosage gavage, gavage normal saline Normal group and seborrheic alopecia model group, the administration volume is identical with test administration group, and each organizes equal every day of gavage 1 time, and the 3rd week of experiment plays a single cage and raises, use magnifier observed and recorded dyed hair dropping situations every day, after successive administration 60 days, get blood from posterior vena cava, detect testosterone (T), the estradiol (E in each treated animal serum with putting the method for exempting from
2).Result is carried out statistical procedures with the t check.
The impact of table 2 on rat unit area day dose,epilation, serum testosterone and estradiol
Annotate: with Normal group, compare,
* *P<0.001; With product group in the middle of CN1343516A, compare,
△ △P<0.01,
△ △ △P<0.001.
Model group rat continuous subcutaneous injection testosterone propionate is after 3 weeks, the back hair color is gloomy, tarnish, after 4 weeks, engender alopecia, that remaining hair becomes is very thin, matter is crisp, with Normal group relatively, the unit plane day of year dose,epilation of seborrheic alopecia model group rat, serum testosterone T, serum estradiol have significant difference (P<0.001), and the rat alopecia model success of setting up is described.As can be known from experimental result, with product group in the middle of CN1343516A, compare, in the middle of medicine of the present invention, the product group is improved seborrheic alopecia rat model unit plane day of year dose,epilation symptom obviously (P<0.001); With product group in the middle of CN1343516A, compare, in the middle of medicine of the present invention, product group reduction rat blood serum testosterone and rising serum estradiol level have significant difference (P<0.01), this shows, in the middle of medicine of the present invention, the product group can be regulated androgen and estrogenic level in the rat body, improves the alopecia phenomenon of seborrheic alopecia rat model.
In sum, in the middle of medicine of the present invention, the middle product group of product group and CN1343516A all can be improved seborrheic alopecia model group rat depilation symptom, and the effects such as reduction rat blood serum testosterone and rising 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 with near correlation technique, compare and have outstanding beneficial effect.
We also carry out the sample stability test that keeps sample to this, 25 ± 2 ℃ of temperature, under RH65% ± 5% condition, place after 12 months, experimental result is found, significant change does not occur 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 be removed protein with employing AB-8 type macroporous resin in the present technique scheme of the invention, and the purification of the impurity such as phlegmatic temperament is relevant, and medicine that this explanation technical solution of the present invention is made has the advantages that quality stability is good.
The specific embodiment
Be below the specific embodiment of content of the present invention, for setting forth present specification, want the technical scheme of technical solution problem, help those skilled in the art to understand content of the present invention, but the realization of technical solution of the present invention is not limited to these embodiment.
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
The prescription proportioning of getting above-mentioned a prescription forms, and by being prepared as follows the 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 that is less than 100 μ m, standby;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, Radix Ginseng, adding the medical material weight ratio is 9 times of amount 70% ethanol, reflux, extract, 2 times, each 2h, filter, merging filtrate also reclaims ethanol to nothing alcohol flavor, after the medicinal liquid concentrate drying, and be ground into dried cream powder, and sieving, medicinal residues are standby;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae, adding with the medical material weight ratio is 10 times of water gagings, adopt vapor distillation 1h, it is standby after the beta-cyclodextrin inclusion compound of 5 times of amounts collecting volatile oil and using with the volatile oil weight ratio, by the aqueous solution after distillation, filter, after the filtrate decompression concentrate drying, dry cream and medicinal residues are standby;
(4) (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii again, the decocting that adds the medical material weight ratio and be 10 times of amounts boils 2 times, 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, be ground into dried cream powder, sieve, standby;
(5) get medicated powder in above-mentioned (1), and (2), (3), (4) in dried cream powder, with the above-mentioned volatile oil clathrate compound made in (3), after fully mixing, obtain Traditional Chinese drug mixture, add appropriate dextrin, sucrose, then mix, granulate, drying, make the 1000g granule.
Embodiment 2
Get the described weight proportion medical material of above-mentioned prescription b, the preparation method preparation according to " embodiment 1 ", obtain.
Embodiment 3
Get the described weight proportion medical material of above-mentioned prescription c, the preparation method preparation according to " embodiment 1 ", obtain.
Embodiment 4
Get the described weight proportion medical material of above-mentioned prescription d, the preparation method preparation according to " embodiment 1 ", obtain.
Embodiment 5
The prescription proportioning of getting above-mentioned a prescription forms, and by being prepared as follows the 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 that is less than 100 μ m, standby;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, Radix Ginseng, adding the medical material weight ratio is 9 times of amount 50% ethanol, reflux, extract, 1 time, each 3h, filter, merging filtrate also reclaims ethanol to nothing alcohol flavor, after the medicinal liquid concentrate drying, and be ground into dried cream powder, and sieving, medicinal residues are standby;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae, adding with the medical material weight ratio is 11 times of water gagings, adopt vapor distillation 0.5h, it is standby after the beta-cyclodextrin inclusion compound of 6 times of amounts collecting volatile oil and using with the volatile oil weight ratio, by the aqueous solution after distillation, filter, after the filtrate decompression concentrate drying, dry cream and medicinal residues are standby;
(4) (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii again, the decocting that adds the medical material weight ratio and be 8 times of amounts boils 3 times, 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, be ground into dried cream powder, sieve, standby;
(5) get medicated powder in above-mentioned (1), and (2), (3), (4) in dried cream powder, with the above-mentioned volatile oil clathrate compound made in (3), after fully mixing, obtain Traditional Chinese drug mixture, add appropriate dextrin, granulate, encapsulated, make 1000 hard capsules.
Embodiment 6
Get the described weight proportion medical material of above-mentioned prescription b, the preparation method preparation according to " embodiment 5 ", obtain.
Embodiment 7
Get the described weight proportion medical material of above-mentioned prescription c, the preparation method preparation according to " embodiment 5 ", obtain.
Embodiment 8
Get the described weight proportion medical material of above-mentioned prescription d, the preparation method preparation according to " embodiment 5 ", obtain.
Embodiment 9
The prescription proportioning of getting above-mentioned a prescription forms, and by being prepared as follows the 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 that is less than 100 μ m, standby;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, Radix Ginseng, adding the medical material weight ratio is 8 times of amount 80% ethanol, reflux, extract, 3 times, each 1h, filter, merging filtrate also reclaims ethanol to nothing alcohol flavor, after the medicinal liquid concentrate drying, and be ground into dried cream powder, and sieving, medicinal residues are standby;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae, adding with the medical material weight ratio is 8 times of water gagings, adopt vapor distillation 1.5h, it is standby after the beta-cyclodextrin inclusion compound of 7 times of amounts collecting volatile oil and using with the volatile oil weight ratio, by the aqueous solution after distillation, filter, after the filtrate decompression concentrate drying, dry cream and medicinal residues are standby;
(4) (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii again, the decocting that adds the medical material weight ratio and be 9 times of amounts boils 2 times, 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, be ground into dried cream powder, sieve, standby;
(5) get medicated powder in above-mentioned (1), and (2), (3), (4) in dried cream powder, with the above-mentioned volatile oil clathrate compound made in (3), after fully mixing, obtain Traditional Chinese drug mixture, with suitable substrate hot melt, stir, and carry out dripping, make 1000 drop pill.
Embodiment 10
Get the described weight proportion medical material of above-mentioned prescription b, the preparation method preparation according to " embodiment 9 ", obtain.
Embodiment 11
Get the described weight proportion medical material of above-mentioned prescription c, the preparation method preparation according to " embodiment 9 ", obtain.
Embodiment 12
Get the described weight proportion medical material of above-mentioned prescription d, the preparation method preparation according to " embodiment 9 ", obtain.
Embodiment 13
The prescription proportioning of getting above-mentioned a prescription forms, and by being prepared as follows the 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 that is less than 100 μ m, standby;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, Radix Ginseng, adding the medical material weight ratio is 10 times of amount 60% ethanol, reflux, extract, 2 times, each 1h, filter, merging filtrate also reclaims ethanol to nothing alcohol flavor, after the medicinal liquid concentrate drying, and be ground into dried cream powder, and sieving, medicinal residues are standby;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae, adding with the medical material weight ratio is 9 times of water gagings, adopt vapor distillation 2h, it is standby after the beta-cyclodextrin inclusion compound of 4 times of amounts collecting volatile oil and using with the volatile oil weight ratio, by the aqueous solution after distillation, filter, after the filtrate decompression concentrate drying, dry cream and medicinal residues are standby;
(4) (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii again, the decocting that adds the medical material weight ratio and be 12 times of amounts boils 1 time, 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, be ground into dried cream powder, sieve, standby;
(5) get medicated powder in above-mentioned (1), and (2), (3), (4) in dried cream powder, with the above-mentioned volatile oil clathrate compound made in (3), after fully mixing, obtain Traditional Chinese drug mixture, add appropriate amylum pregelatinisatum, granulate, in flakes, coating is made 1000 tablets in compacting.
Embodiment 14
Get the described weight proportion medical material of above-mentioned prescription b, the preparation method preparation according to " embodiment 13 ", obtain.
Embodiment 15
Get the described weight proportion medical material of above-mentioned prescription c, the preparation method preparation according to " embodiment 13 ", obtain.
Embodiment 16
Get the described weight proportion medical material of above-mentioned prescription d, the preparation method preparation according to " embodiment 13 ", obtain.
Because pharmacy test research cost cost is larger, we are parallel, science choose following technical scheme: test 1 group and chooses embodiment 1 and with 2 groups of a prescription proportionings, test, choose embodiment 6 and with 3 groups of b prescription proportionings, test, choose embodiment 11 and choose embodiment 16 with the d proportioning of writing out a prescription with 4 groups of c prescription proportionings, test; The clinical effectiveness of the present invention's test, can represent the prescription proportioning in technical solution of the present invention, and 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 tested case 185 examples of in June, 2009～2011 year July at Dermatology Outpatient Department, male's 96 examples wherein, women's 89 examples; 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 was more than 50; 2. the forehead hairline raises; 3. more than 100, hair is tapered in every day in alopecia in continuous 3 months.All 2 of meeting in above-mentioned 3, namely be diagnosed as seborrheic alopecia.Exclusion standard is endocrine alopecia 1., as hypothyroidism or hyperfunction, parathyroid gland or pituitary function is low, 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 medicine of Chinese medicine or inhibition hormone.The patient is divided into to 1 group, 2 groups, 3 groups, 4 groups of tests, CN1343516A medicine group, matched group (YANGXUE SHENGFA JIAONANG) at random; Each group is in physical data such as sex, age, the courses of disease, and Epidemiological Analysis is processed by statistics, and the indifference opposite sex, have comparability (P>0.05).
1.2 alopecia areata
Choose the patient of 173 examples from Dermatology Outpatient Department, all meet the alopecia areata diagnostic criteria.Wherein, male 93 examples, female's 80 examples, at 35～59 years old age, the course of disease is 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, the diabetes aldosterone disease, hypokalemia, hepatic and kidney function obstacle, the anemia of pregnant woman, age of sucking the patient.The patient is divided into to 1 group, 2 groups, 3 groups, 4 groups of tests, CN1343516A medicine group, matched group (Sanguis Draxonis sheet); Each group is in physical data such as sex, age, the courses of disease, and the difference not statistically significant, have comparability (P>0.05).
2. Therapeutic Method
2.1 seborrheic alopecia
The patient of seborrheic alopecia, 1 group, 2 groups, 3 groups, 4 groups for the treatment of group oral tests, CN1343516A medicine group medicine, each serving with 4 dosage units, every day 3 times; Matched group is oral YANGXUE SHENGFA JIAONANG simultaneously, and 4 tablets/times, every day 3 times, all take for 6 groups and be l course for the treatment of in 3 months, treat and judge curative effect 2 courses for the treatment of, observe its clinical efficacy, during treatment, diet be take lightly as main, avoids high heat or fried food.Adhere to scalp massage.
2.2 alopecia areata
Patients with alopecia areata, 1 group, 2 groups, 3 groups, 4 groups for the treatment of group oral tests, CN1343516A medicine group medicine, each serving with 4 dosage units, every day 3 times; 4 piece/timess of the oral Sanguis Draxonis sheets of matched group, every day 3 times, all take for 6 groups and be l course for the treatment of in 3 months, treats and judge curative effect 2 courses for the treatment of, observes its clinical treatment situation.
3. criterion of therapeutical effect and therapeutic outcome
3.1 seborrheic alopecia criterion of therapeutical effect: produce effects: comb is sent out test and (is advised the patient to wash hair weekly 2 times, being sent out 10 times by backward front comb with wooden comb in the 2nd day after hair washing) the alopecia radical is treated front minimizing more than 50%, sebum secretion, dandruff obviously reduce, scalp itch obviously alleviates, and there is new growing in the alopecia district.Effectively: comb is sent out alopecia radical in test and is treated front minimizing 20%～50%, and sebum secretion, dandruff and scalp itch make moderate progress.Invalid: in a comb test, the alopecia radical is treated front minimizing and is less than 20%, and the symptoms such as sebum secretion, dandruff and scalp itch all are not improved.
3.2 alopecia areata criterion of therapeutical effect: recovery from illness: new whole growths, chroma of hair, thickness and density recover normal, hair pulling test (-).Produce effects: new growth more than 70%, hair thickness, color and luster approach normal, hair pulling test (-).Effectively: the alopecia phenomenon no longer appears in 10%～70% new growth.Invalid: as through 2 course of therapy hairs, have no growth, or hair not to be grown and come off on the contrary.
The curative effect of each test group treatment seborrheic alopecia of table 3 relatively
Experimental result by table 3 is as can be known, and after the clinical treatment of 2 courses for the treatment of, Most patients occurs that sebum secretion, dandruff obviously reduce, and scalp itch obviously alleviates, the situation that the alopecia radical reduces, and the state of an illness is taken a turn for the better.The medicine total effective rate that the patient takes 1 group, 2 groups, 3 groups, 4 groups of tests reaches more than 75%, and the effective percentage of CN1343516A medicine group and YANGXUE SHENGFA JIAONANG group is respectively 66.7%, 63.4%, above clinical efficacy presentation of results, Chinese medicine composition prepared by technical solution of the present invention is aspect the treatment seborrheic alopecia, have the curing protrusion effect, its curative effect all is better than CN1343516A medicine group and YANGXUE SHENGFA JIAONANG group, and untoward reaction does not all appear in each test group medicine.
The curative effect of each test group treatment alopecia areata of table 4 relatively
Experimental result by table 4 is as can be known, 6 groups of patients after the medicine treatment of 2 courses for the treatment of, the growing of the newborn hair of its Most patients, and thick and deceive, without the situation of alopecia, 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 curative effect of CN1343516A medicine group and Sanguis Draxonis sheet group, compare, Chinese medicine composition prepared by technical solution of the present invention is having obvious therapeutic effect aspect the treatment alopecia areata, and, in therapeutic process, does not find the untoward reaction of each test group medicine.
In sum: Chinese medicine composition prepared by technical solution of the present invention is having obvious therapeutic effect aspect treatment seborrheic alopecia and alopecia areata disease, and the medicine of each test group all has the 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, no matter its beneficial effect is from the preparation technology and purifying process of medical material, or on the forming technique of finished product preparation, all effectively guaranteed the excellent results of Chinese medicine composition of the present invention, this further proves, Chinese medicine composition of the present invention is a kind of determined curative effect, prevent and treat safely and effectively the medicine of seborrheic alopecia and alopecia areata, have huge market potential, be worth further promoting.
Claims (10)
1. a Chinese medicine composition for the treatment of seborrheic alopecia and alopecia areata, is characterized in that it is comprised of the raw material of following weight proportion: 282～424 parts of Radix Polygoni Multiflori Preparatas, 253～332 parts of Herba Ecliptaes, 229～343 parts of Cacumen Platycladis, 117～175 parts of Radix Rehmanniae Preparata, 106～158 parts of Radix Rehmanniae, 51～77 parts of Fructus Corni, 46～69 parts of Rhizoma Dioscoreaes, 42～62 parts of Radix Ginsengs, 37～55 parts of Radix Codonopsis, 28～42 parts, Poria, 17～25 parts of Cortex Moutans, 26～38 parts of Rhizoma Alismatis, 19～28 parts of the Rhizoma Anemarrhenaes, 14～22 parts of Cortex Lycii, 13～19 parts of Radix Stellariaes.
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 comprised of the raw material of following weight proportion: 353 parts of Radix Polygoni Multiflori Preparatas, 292 parts of Herba Ecliptaes, 286 parts of Cacumen Platycladis, 146 parts of Radix Rehmanniae Preparata, 132 parts of Radix Rehmanniae, 64 parts of Fructus Corni, 58 parts of Rhizoma Dioscoreaes, 52 parts of Radix Ginsengs, 46 parts of Radix Codonopsis, 35 parts, Poria, 21 parts of Cortex Moutans, 32 parts of Rhizoma Alismatis, 24 parts of the Rhizoma Anemarrhenaes, 18 parts of Cortex Lycii, 16 parts of Radix Stellariaes.
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 comprised of the raw material of following weight proportion: 424 parts of Radix Polygoni Multiflori Preparatas, 287 parts of Herba Ecliptaes, 229 parts of Cacumen Platycladis, 162 parts of Radix Rehmanniae Preparata, 158 parts of Radix Rehmanniae, 51 parts of Fructus Corni, 69 parts of Rhizoma Dioscoreaes, 47 parts of Radix Ginsengs, 37 parts of Radix Codonopsis, 42 parts, Poria, 19 parts of Cortex Moutans, 26 parts of Rhizoma Alismatis, 22 parts of the Rhizoma Anemarrhenaes, 17 parts of Cortex Lycii, 13 parts of Radix Stellariaes.
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 comprised of the raw material of following weight proportion: 282 parts of Radix Polygoni Multiflori Preparatas, 332 parts of Herba Ecliptaes, 301 parts of Cacumen Platycladis, 175 parts of Radix Rehmanniae Preparata, 126 parts of Radix Rehmanniae, 77 parts of Fructus Corni, 46 parts of Rhizoma Dioscoreaes, 42 parts of Radix Ginsengs, 50 parts of Radix Codonopsis, 28 parts, Poria, 25 parts of Cortex Moutans, 38 parts of Rhizoma Alismatis, 19 parts of the Rhizoma Anemarrhenaes, 14 parts of Cortex Lycii, 19 parts of Radix Stellariaes.
5. described treatment seborrheic alopecia as arbitrary as claim 1-4 and alopecia areata Chinese medicine composition, is characterized in that this Chinese medicine composition is granule, hard capsule, drop pill or tablet.
6. the preparation method of the Chinese medicine composition of described treatment seborrheic alopecia as arbitrary as claim 1-4 and alopecia areata is characterized in that:
(1) Radix Polygoni Multiflori Preparata, Rhizoma Dioscoreae, Poria powder are broken into to coarse powder, then superfine powder is broken into the medicated powder that is less than 100 μ m, standby;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, ginseng crude drug, adding the medical material weight ratio is 8～10 times of amount 50%～80% ethanol, reflux, extract, 1～3 time, each 1～3 h, filter, and merging filtrate also reclaims ethanol to nothing alcohol flavor, after the medicinal liquid concentrate drying, and be ground into dried cream powder, and sieving, medicinal residues are standby;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae medical material, adding with the medical material weight ratio is 8～11 times of water gagings, adopt vapor distillation 0.5～2h, it is standby after the beta-cyclodextrin inclusion compound of 4～7 times of amounts collecting volatile oil and using with the volatile oil weight ratio, by the aqueous solution after distillation, filter, after the filtrate decompression concentrate drying, dry cream and medicinal residues are standby;
(4) (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii medical material again, the decocting that adds the medical material weight ratio and be 8～12 times of amounts boils 1～3 time, 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, be ground into dried cream powder, sieve, standby;
(5) the medicated powder of getting in above-mentioned (1) reaches the dried cream powder in (2), (3), (4), and the volatile oil clathrate compound with making in above-mentioned (3), after fully mixing, obtain Traditional Chinese drug mixture, then adds adjuvant commonly used on pharmaceutics to 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 that is less than 100 μ m, standby;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, Radix Ginseng, adding the medical material weight ratio is 9 times of amount 70% ethanol, reflux, extract, 2 times, each 2h, filter, merging filtrate also reclaims ethanol to nothing alcohol flavor, after the medicinal liquid concentrate drying, and be ground into dried cream powder, and sieving, medicinal residues are standby;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae, adding with the medical material weight ratio is 10 times of water gagings, adopt vapor distillation 1h, it is standby after the beta-cyclodextrin inclusion compound of 5 times of amounts collecting volatile oil and using with the volatile oil weight ratio, by the aqueous solution after distillation, filter, after the filtrate decompression concentrate drying, dry cream and medicinal residues are standby;
(4) (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii again, the decocting that adds the medical material weight ratio and be 10 times of amounts boils 2 times, 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, be ground into dried cream powder, sieve, standby;
(5) the medicated powder of getting in above-mentioned (1) reaches the dried cream powder in (2), (3), (4), and the volatile oil clathrate compound with making in above-mentioned (3), after fully mixing, obtain Traditional Chinese drug mixture, then adds adjuvant commonly used on pharmaceutics, and the granulation agent, obtain.
8. method prepared as Chinese medicine composition as described in arbitrary in claim 6 is characterized in that it is to operate 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 that is less than 100 μ m, standby;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, Radix Ginseng, adding the medical material weight ratio is 9 times of amount 50% ethanol, reflux, extract, 1 time, each 3h, filter, merging filtrate also reclaims ethanol to nothing alcohol flavor, after the medicinal liquid concentrate drying, and be ground into dried cream powder, and sieving, medicinal residues are standby;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae, adding with the medical material weight ratio is 11 times of water gagings, adopt vapor distillation 0.5h, it is standby after the beta-cyclodextrin inclusion compound of 6 times of amounts collecting volatile oil and using with the volatile oil weight ratio, by the aqueous solution after distillation, filter, after the filtrate decompression concentrate drying, dry cream and medicinal residues are standby;
(4) (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii again, the decocting that adds the medical material weight ratio and be 8 times of amounts boils 3 times, 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, be ground into dried cream powder, sieve, standby;
(5) get medicated powder in above-mentioned (1), and (2), (3), (4) in dried cream powder, with the above-mentioned volatile oil clathrate compound made in (3), after fully mixing, obtain Traditional Chinese drug mixture, add dextrin, granulate, encapsulated, make hard capsule.
9. method prepared as Chinese medicine composition as described in arbitrary in claim 6 is characterized in that it is to operate 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 that is less than 100 μ m, standby;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, Radix Ginseng, adding the medical material weight ratio is 8 times of amount 80% ethanol, reflux, extract, 3 times, each 1h, filter, merging filtrate also reclaims ethanol to nothing alcohol flavor, after the medicinal liquid concentrate drying, and be ground into dried cream powder, and sieving, medicinal residues are standby;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae, adding with the medical material weight ratio is 8 times of water gagings, adopt vapor distillation 1.5h, it is standby after the beta-cyclodextrin inclusion compound of 7 times of amounts collecting volatile oil and using with the volatile oil weight ratio, by the aqueous solution after distillation, filter, after the filtrate decompression concentrate drying, dry cream and medicinal residues are standby;
(4) (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii again, the decocting that adds the medical material weight ratio and be 9 times of amounts boils 2 times, 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, be ground into dried cream powder, sieve, standby;
(5) get medicated powder in above-mentioned (1), and (2), (3), (4) in dried cream powder, with the above-mentioned volatile oil clathrate compound made in (3), after fully mixing, obtain Traditional Chinese drug mixture, with the substrate hot melt, stir, and carry out dripping, make drop pill.
10. method prepared as Chinese medicine composition as described in arbitrary in claim 6 is characterized in that it is to operate 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 that is less than 100 μ m, standby;
(2) get Herba Ecliptae, Fructus Corni, Radix Codonopsis, the Rhizoma Anemarrhenae, Rhizoma Alismatis, Radix Ginseng, adding the medical material weight ratio is 10 times of amount 60% ethanol, reflux, extract, 2 times, each 1h, filter, merging filtrate also reclaims ethanol to nothing alcohol flavor, after the medicinal liquid concentrate drying, and be ground into dried cream powder, and sieving, medicinal residues are standby;
(3) get Cacumen Platycladi, Cortex Moutan, Radix Stellariae, adding with the medical material weight ratio is 9 times of water gagings, adopt vapor distillation 2h, it is standby after the beta-cyclodextrin inclusion compound of 4 times of amounts collecting volatile oil and using with the volatile oil weight ratio, by the aqueous solution after distillation, filter, after the filtrate decompression concentrate drying, dry cream and medicinal residues are standby;
(4) (2) and (3) medicinal residues are merged with Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Lycii again, the decocting that adds the medical material weight ratio and be 12 times of amounts boils 1 time, 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, be ground into dried cream powder, sieve, standby;
(5) get medicated powder in above-mentioned (1), and (2), (3), (4) in dried cream powder, with the above-mentioned volatile oil clathrate compound made in (3), after fully mixing, obtain Traditional Chinese drug mixture, add amylum pregelatinisatum, granulate, in flakes, coating is made tablet in compacting.
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| CN105267705A (en) * | 2015-04-09 | 2016-01-27 | 刘鹏 | Traditional Chinese medicine for treating seborrheic alopecia |
| CN109010182A (en) * | 2018-09-26 | 2018-12-18 | 名臣健康用品股份有限公司 | A kind of Anti-hair loss composition and its application in hair products is washed in preparation |
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| CN109010182A (en) * | 2018-09-26 | 2018-12-18 | 名臣健康用品股份有限公司 | A kind of Anti-hair loss composition and its application in hair products is washed in preparation |
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