CN101391013B - Traditional Chinese medicine composition for treating skin disease and preparation method thereof - Google Patents

Traditional Chinese medicine composition for treating skin disease and preparation method thereof Download PDF

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CN101391013B
CN101391013B CN2008101726852A CN200810172685A CN101391013B CN 101391013 B CN101391013 B CN 101391013B CN 2008101726852 A CN2008101726852 A CN 2008101726852A CN 200810172685 A CN200810172685 A CN 200810172685A CN 101391013 B CN101391013 B CN 101391013B
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tinea
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罗川
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DONGTAI PHARMACEUTICAL Co Ltd SHAANXI PROV
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Abstract

The invention relates to Chinese traditional medicine for curing skin disease and a preparing method thereof; the medicine is characterized in that the preparation is composed of human placentae, Humifuse Euphorbia Herb, terminalia diachyma, chaulmoogra seed, Scammonia resin, aloe and Tenninlia chebula. Compared with prior Chinese traditional medicine for curing psoriasis, tinea manuum, tinea pedis and tinea corporis, the medicine has no side effect, has more reasonable preparation and high recovery ratio; and the medicine has efficacy of clearing abnormal phlegm, gallbladder hygroplasm and sepsis, reducing swelling and alleviating tickle as well as improving the skin immunity; the medicine is mainly applied to curing the psoriasis, tinea manuum, tinea pedis and tinea corporis, pityriasis versicolor, psoriasis, allergic dermatitis and herpes zoster.

Description

Dermopathic Chinese medicine preparation of a kind of treatment and preparation method thereof
Technical field
The present invention relates to dermopathic Chinese medicine preparation of a kind of treatment and preparation method thereof, this medicine is mainly used in dermatosis such as the tinea manuum, tinea corporis, tinea pedis, tinea versicolor, psoriasis, herpes zoster, belongs to field of traditional Chinese medicine pharmacy.
Technical background
The tinea manuum, tinea corporis, tinea pedis, tinea versicolor, psoriasis, allergic dermatitis, herpes zoster, acne is the skin commonly encountered diseases, frequently-occurring disease.The tinea manuum, tinea corporis, tinea pedis, tinea versicolor, psoriasis, main performance such as allergic dermatitis erythra, skin pruritus, desquamation, not only painful but also influence attractive in appearance.Herpes zoster mainly shows as and has an intense pain, with burning sensation, in case take place then have a strong impact on patient's routine work and life.Acne is more common in teenager, and good sending out in face, has a strong impact on attractive in appearance.At present, the western medical treatment tinea manuum, tinea corporis, tinea pedis, tinea versicolor, psoriasis, allergic dermatitis, herpes zoster, acne is with hormone, and antifungal agent, antiviral agents treatment are main, and certain curative effect is arranged, but it cures the symptoms, not the disease, and relapse rate is very high, and toxic and side effects is obvious.Chinese medicine has also been obtained certain curative effect aspect treating skin disease, but is treating the poisonous disease with poisonous drugs mostly, and toxicity medical material consumption is big; Though also have some toxicity medical materials few, curative effect is very poor, and side effect is also a lot.
In the prior art, it is more to be used for the treatment of dermopathic Chinese patent medicine, cure the symptoms, not the disease mostly, and cure rate is very poor." Drug Standard of Ministry of Public Health of the Peoples Republic of China Uigurs medicine fascicle " 98 editions, WS 3" hundred tinea xiatare tablets " and the disclosed patent No. of patent gazette are under-the BW-0124-98 item: xiatare tablet of 02140443.7 and preparation method thereof; It has obtained certain clinical efficacy, but also found many problems through clinical practice for many years: 1, under normal dosage, can occur feeling sick, untoward reaction such as stomach discomfort and dosage form urticaria, and also relatively more serious.2, curative effect instability, its cure rate is very low.
In order to solve the existing in prior technology defective, by excavating the abundant natural resources of Chinese medicinal materials of motherland, in conjunction with a large amount of traditional Chinese medical science prescription theory and Study on clinical pharmacodynamics, unexpected find to reduce under normal dose, can not occur feeling sick behind the aloetic consumption, untoward reaction such as stomach discomfort and urticaria.After once having added simply Placenta Hominis on the former prescription basis, its cure rate to dermatosis significantly improves, and has received beyond thought effect.
Up to now, put down in writing the concrete proportioning raw materials relation of medicine under the present invention without any report, also nobody disclosed and selects the made medicine of proportioning raw materials relation of the present invention to have beat all therapeutic effect.
Summary of the invention
The purpose of this invention is to provide a kind ofly has excellent curative and Chinese medicine preparation without any side effects to above-mentioned dermatosis.
Another order of the present invention provides a kind of dermopathic Chinese medicinal preparation method of above-mentioned treatment that is used for.
For achieving the above object, the present invention adopts following technical scheme: it is made up of following materials of weight proportions:
Herba Euphorbiae Humifusae 450g terminalia flesh 75g Fructus Terminaliae Billericae 75g Placenta Hominis 250g
Scammonia resin 37.5g Aloe 42g FRUCTUS TERMINALIAE IMMATURUS 75g
The preparation method of preparation of the present invention:
More than seven the flavor, get Herba Euphorbiae Humifusae and add 70% soak with ethanol 24 hours of 10 times of amounts, heating and refluxing extraction 3 times, each 1 hour, merge extractive liquid,, filter, decompression recycling ethanol (0.08Mpa, 80 ℃) is to relative density 1.08~1.12 (50 ℃), medicinal residues and terminalia flesh, Fructus Terminaliae Billericae, FRUCTUS TERMINALIAE IMMATURUS is mixed and is added 10 times of water gagings decoctions 3 times, each 1 hour, filter, merging filtrate, filtrate decompression concentrates (0.08Mpa, 80 ℃) to relative density be 1.08~1.12 (50 ℃), merge two kinds of concentrated solutions, regulating relative density is 1.08~1.12 (50 ℃), spray drying (120 ± 5 ℃ of inlet temperature, 85 ± 5 ℃ of leaving air temps), the dry powder of must spraying is standby; Get Aloe, Placenta Hominis, Scammonia resin and be ground into fine powder, cross 100 mesh sieves,, granulate with above-mentioned spray drying powder and appropriate amount of starch or dextrin mixing, drying, both preparation of the present invention.
Theory of Chinese medical science is thought:
The tinea manuum, tinea corporis, tinea pedis, tinea versicolor, psoriasis, allergic dermatitis, herpes zoster, acne belongs to " tinea ", " white arrange " " herpes zoster " " acne " scope of the traditional Chinese medical science.Ancient Chinese medicine doctor is more to the argumentation of " tinea ", " white arrange " " herpes zoster " " acne "; Tinea is the common skin disease, and TCM Document is early on the books, as existing record with treatment tinea such as Realgar, Alumen, hydrargyrum, Cortex Phellodendris in " Liu Juanzi Guiyi Fang, Liu Juanzi "." General Treatise on the Cause and Symptoms of Diseases tinea time " said: " shape of tinea, latent gizzard of skin and flesh such as money literary composition increase gradually, and be round or oblique, the pain of itching, Guo rectifies ".Also tinea is divided into nine kinds of chronic eczema, exudative dermatitis, tinea corporis, tinea alba, cattle tinea, tinea circinata, psoriasis, passeris montani saturati mycotic infection of the eyelid, cutter tinea etc.White arrange is the chronic and recurring skin diseases that occur the dry squama of multiple white on the skin repeatedly.Golden Mirror of Medicine is said: " shape such as the rash furuncle of white arrange, Se Bai and how unhappyly itch.So ailment said due to cold or exposure visitor skin is arranged, by outside the dry difficult honor of blood." Clinical symptoms of white arrange described.Herpes zoster is a kind of cluster vesicle that occurs on skin, the acute herpetic dermatosis that pain as fire burn." surgery opens profound volume seven " said: " this skin ulcer is born between skin, and is similar to the water nest, light red and the pain, five or seven one-tenth are collected together, and also can sprout out." acne are that face, breast, the back of the body etc. locate to give birth to pimple as thorn, can extrude the white sample powder juice of cracking rice, so be acne.Point out in " General Treatise on the Cause and Symptoms of Diseases ": " the acne vulgaris person has wind heat gas to give birth to skin ulcer on the meaning face, head as rice are big, and also big as paddy, white person is.”
The tinea manuum, tinea corporis, tinea pedis, tinea versicolor, psoriasis, allergic dermatitis, herpes zoster, acne belongs to " tinea ", " white arrange " " herpes zoster " " acne " scope of the traditional Chinese medical science.Its main etiology and pathogenesis can be summarized as follows: the etiology and pathology of (one) acne is that (1) wind heat blood is dry: the heresy of wind heat is outer attacks, and strongly fragrant then blood is dry for a long time, and blood deficiency is then given birth to wind, the wind-dryness pathogenic heat is accumulate the resistance skin, skin lose moisten foster so that pachylosis, drying, performance is based on the dryness skin lesion.(2) etiology and pathology of herpes zoster: because depression of liver-QI, for a long time and fire-transformation is recklessly acted, spleen channel retention of damp-heat in the interior, excessive skin and giving birth to; The accidental cause sense poison of holding concurrently is evil, so that damp and hot fire-toxin accumulates long-pending skin and forms.Old person, often because of blood-deficiency leading to hyperactivity of the liver, damp and hot poison is contained, and with the passing of time coagulation of QI-blood, so that sharp ache could disappear.(3) etiology and pathology of tinea: the body of fat phlegm-damp is subjected to the heresy of wind heat outward and accumulates due to the long-pending skin; Or contact unclean thing and cause.(4) etiology and pathogenesis of white arrange: always by the nutrient blood loss, living dry humorously, failure of skin and muscle to be nourished forms primary disease.From the beginning of the heresy invasion and attack skin of holding wind and cold or wind heat under the arm more, so that seek to defend and become estranged, QI and blood is not smooth, hinders in skin and gives birth to; Also having holds concurrently accumulates long-pendingly because of damp and hot, can not lead off outward, and interior can not profit leading hindered in the flesh table and sent out; Sick lingering pathogenic wind is cold, wind heat, damp and hot heresy ownization, and QI and blood consumes wound, and then blood-deficiency and wind-dry, failure of skin and muscle to be nourished more appear; Or because of nutrient QI and blood being insufficient, QI and blood is followed row and is obstructed, so that stasis of blood resistance flesh table forms; Or because of deficiency of the liver and kindey, Chong and Ren channel disorder causes the nutrient blood loss; Minority can be improper because of recuperating under medical treatment, and the sense poison of holding concurrently is evil, the wind and cold heat-transformation, damp pathogen converting into dryness, so that scorching one-tenths is malicious, pyretic toxicity is fled, and goes into nutrient blood, in invade internal organs, cause the syndrome of intense heat in both QI and blood systems.
We are suitable for the tinea manuum, tinea corporis, and tinea pedis, tinea versicolor, psoriasis, allergic dermatitis, herpes zoster, acne, function is for removing unusual phlegmatic temperament, bile juice and deteriorated blood, repellent antipruritic.Wherein the Herba Euphorbiae Humifusae heat-clearing and toxic substances removing is treated tinea, and gets analogy by the traditional Chinese medical science and think that mutually it can be walked skin outward and control tinea; Placenta Hominis has good therapeutical effect to psoriasis, tinea class, can strengthen skin immunization power; The extract of terminalia flesh and Fructus Terminaliae Billericae all has excellent antibiotic and antifungic action; And the Aloe clearing heat and relieving fidgetness, parasite killing is treated infantile malnutrition, and the FRUCTUS TERMINALIAE IMMATURUS parasite killing is treated the tinea pain relieving.Full side plays the effect of heat-clearing and toxic substances removing, repellent antipruritic, raising immunity altogether.
In the prior art, it is more to be used for the treatment of dermopathic Chinese patent medicine, cure the symptoms, not the disease mostly, and cure rate is very poor." Drug Standard of Ministry of Public Health of the Peoples Republic of China Uigurs medicine fascicle " 98 editions, WS 3" hundred tinea xiatare tablets " and the disclosed patent No. of patent gazette are under-the BW-0124-98 item: xiatare tablet of 02140443.7 and preparation method thereof; It has obtained certain clinical efficacy, but also found many problems through clinical practice for many years: 1, under normal dosage, can occur feeling sick, untoward reaction such as stomach discomfort and dosage form urticaria, and also relatively more serious.2, curative effect instability, its cure rate is very low.In order to solve the existing in prior technology defective, by excavating the abundant natural resources of Chinese medicinal materials of motherland, in conjunction with a large amount of traditional Chinese medical science prescription theory and Study on clinical pharmacodynamics, unexpected find to reduce under normal dose, can not occur feeling sick behind the aloetic consumption, untoward reaction such as stomach discomfort and urticaria.After once having added simply Placenta Hominis on the former prescription basis, its cure rate to dermatosis significantly improves, and has received beyond thought effect.
For confirming that product of the present invention has effective therapeutic effect, we have carried out a series of pharmacodynamic studies;
Now contrast hundred tinea xiatare tablets, its main pharmacodynamics be described with capsule of the present invention:
The experiment medicine:
Capsule of the present invention is the medicine of the embodiment of the invention 1 method preparation.
Hundred tinea xiatare tablets are to buy on the market.
One, to the influence of homology rat skin anaphylaxis (PCA)
Get 5 of SD rats, albuminate aqueous solution (10mg/kg) intramuscular injection is in the rat hindlimb both sides, and the lumbar injection daytime is coughed triple vaccine 2 * 10 simultaneously 10/ only.Behind the 14d, the blood sampling separation of serum and measure tiring of antialbumin antibody rearmounted 4 ℃ standby.Other gets 50 of SD rats, male and female half and half, and body weight 180~220g is divided into 5 groups at random, 10 every group.Matched group is irritated the normal saline of stomach with volume; Hundred tinea xiatare tablet group gastric infusion 0.8g medical material/kg; Capsules group of the present invention is gastric infusion 0.2,0.4,0.8g medical material/kg respectively.Successive administration 10d, every day 1 time, with 2h after the 10d administration, in the 20% antiserum sensitization of every Mus back cropping place intradermal injection with normal saline dilution, totally 4 points, every some 0.1ml.The Evans blue1ml that the injection of 48h posterior vein contains 5mg albuminous 0.5% carries out antigen attack, 30min administration before antigen is attacked.Antigen is attacked back 30min, the sacrificed by decapitation rat, the skin locus coeruleus cut place in vitro, add 1mol/LKOH1ml, 37 ℃ of digestion 15h add phosphoric acid acetone mixed liquor 3.75ml, then after concussion is extracted, the centrifugal 10min of 2500r/min gets supernatant and measures the OD value with 721 type spectrophotometers (640nm).See Table 1
The table 1 pair anaphylactoid influence of homology rat skin (x ± s)
Figure G2008101726852D00041
Compare with matched group: * * P<0.01; Compare with hundred tinea xiatare tablet groups: △ P<0.05, #P 0.05.
The result: Capsules group of the present invention and hundred tinea xiatare tablet groups have the obvious suppression effect to rat homology skin allergy, have compared significant difference with matched group.Capsules group of the present invention is stronger than the anti-allergic effects of hundred tinea xiatare tablet groups.
Two, to the influence of the inductive mice delayed hypersensitivitys of 2.4 1 dinitrochlorobenzene (DNCB) (DTH)
Get 50 of mices, male and female half and half, body weight 18~22g is divided into 5 groups at random, 10 every group.Matched group is irritated the normal saline of stomach with volume; Hundred tinea xiatare tablet group gastric infusion 1.6g medical material/kg; Capsules group of the present invention is gastric infusion 0.4,0.8,1.6g medical material/kg respectively.Successive administration 10d, every day 1 time, administration 5d, 50 μ l evenly are applied in mouse web portion sensitization with 1%DNCB acetone Oleum Sesami solution, and 5d is applied in mouse right ear with 1%DNCB solution 10 μ l and attacks after the sensitization.Mice is put to death in the cervical vertebra dislocation behind the 24h, takes off diameter 8mm left and right sides auricle with card punch, uses scales/electronic balance weighing.It is auricular concha swelling degree that auris dextra weight deducts left ear weight, extracts thymus simultaneously and spleen is weighed.Ratio with thymus and spleen weight (mg) and body weight 10g is thymus index and index and spleen index.See Table 2
The influence of the inductive mice delayed hypersensitivity of table 2 couple DNCB (x ± s)
Compare with matched group: * * P<0.01; Compare with hundred tinea xiatare tablet groups: △ P<0.05, #P 0.05.
The result: Capsules group of the present invention and hundred tinea xiatare tablet groups have significantly reduced mouse thymus and index and spleen index, and are inhibited to inflammatory reaction, compared significant difference with matched group.It is strong that Capsules group of the present invention suppresses the effect of the inductive mice delayed hypersensitivity of DNCB than hundred tinea xiatare tablet groups.
Three, to the influence of the antibody-mediated mast cell degranulation of rat allogenic cell
SD male rat body weight 180~220g gets 5 of rats, the every sufficient sole of the foot injection 5mg/ml Radix Trichosanthis of every Mus-gel aluminum hydroxide suspension 0.1ml, and lumbar injection bacillus calmette-guerin vaccine 0.1ml/ only strengthens simultaneously.Get blood behind the 5d, centrifugal that variola powder serum is standby.With preceding antiserum is diluted with 1:10.Other gets 5 of rats, preparation rat mesentery specimen, 10 of every Mus, every 1cm 2, put in the people Tai Shi nutritional solution standby.Get 50 in test tube, each pipe adds tyrode's solution 2ml, 1 of mesentery specimen and rat anti Radix Trichosanthis serum 0.2ml, at 37 ℃ of constant temperature bath 30min, make mesentery mastocyte sensitization, then with 37 ℃ of Tai Shi nutritional solution washings 3 times, add above-mentioned nutritional solution 2ml, bathe 10min 37 ℃ of water-bath temperature, to dosing in vitro, matched group adds isopyknic normal saline; Hundred tinea xiatare tablet group administration 0.70mg/ml; Capsules group of the present invention administration 0.15,0.3 respectively, 0.50mg/ml, continue incubation 10min, adding Radix Trichosanthis antigen 0.1ml (containing Radix Trichosanthis 110 μ g) attacks, behind 37 ℃ of constant temperature bath 20min, with the specimen formaldehyde fixed, normal dyeing and mounting are made microscope slide, with 200 cells of microscopic counting and observe antigen and attack back mast cell degranulation situation, calculate and take off granule percentage rate and medicine suppression ratio.See Table 3
Take off granule percentage rate=take off granule mastocyte number/mastocyte sum * 100%;
Medicine suppression ratio=(matched group takes off granule rate-administration group and takes off the granule rate)/matched group takes off granule rate * 100%.
The influence of the table 3 pair mast cell degranulation that the rat allogenic cell is antibody-mediated (x ± s)
Figure G2008101726852D00061
Compare with matched group: * * P<0.01; Compare with hundred tinea xiatare tablet groups: △ P<0.05, #P 0.05.
The result: Capsules group of the present invention and hundred tinea xiatare tablet groups are inhibited to the antibody-mediated mast cell degranulation of rat allogenic cell, have compared significant difference with matched group.Capsules group of the present invention is stronger than the effect that hundred tinea xiatare tablet groups suppress mast cell degranulation.
Four, the Cavia porcellus that histamine phosphate is caused causes the influence of the reaction of itching
50 of Cavia porcelluss, male and female half and half, body weight 200~300g is divided into 5 groups at random, 10 every group.Matched group is irritated the normal saline of stomach with volume; Hundred tinea xiatare tablet group gastric infusion 0.7g medical material/kg; Capsules group of the present invention is gastric infusion 0.2,0.4,0.7g medical material/kg respectively.Successive administration 10d, every day 1 time, 1d before the experiment shaves hair to each the right back instep of group Cavia porcellus portion.Test the same day, abrade right back instep with coarse sandpaper and shave hair place, area 1cm 2, behind last 1 administration 1h, beginning is only dripped 0.01% 0.05ml/ of histamine phosphate at the wound surface place, after this press 0.02%, 0.03%, 0.04% every 3min ... progressive concentration only is 0.05ml/ at every turn.Right back foot occurs later licking until Cavia porcellus, right back histamine phosphate's total amount of being given when sufficient occurring later licking with last Cavia porcellus is itch-threshold.See Table 4
The Cavia porcellus that table 4 pair histamine phosphate causes causes the influence (x ± s) of the reaction of itching
Figure G2008101726852D00071
Compare with matched group: * * P<0.01; Compare with hundred tinea xiatare tablet groups: △ P<0.05, #P 0.05.
The result: the Cavia porcellus that Capsules group of the present invention and hundred tinea xiatare tablet groups cause histamine phosphate causes the reaction of itching and has significant antagonism, and the rising itch-threshold has been compared significant difference with matched group.Capsules group of the present invention is stronger than the itching-relieving action of hundred tinea xiatare tablet groups.
Five, the influence of xylol induced mice auricle edema
50 of Kunming mouses, male and female half and half, body weight 18~22g is divided into 5 groups at random, 10 every group.Matched group is irritated the normal saline of stomach with volume; Hundred tinea xiatare tablet group gastric infusion 1.6g medical material/kg; Capsules group of the present invention is gastric infusion 0.4,0.8,1.6g medical material/kg respectively.Successive administration 10d behind the last administration 1h, only is applied to the inside and outside two sides of auris dextra with 100% dimethylbenzene 0.2ml/, left side ear is not done any processing, behind the 20min animal etherization is put to death, ears are laid round auricle respectively with 8mm diameter macropore device under subtracting at the same position of mice, and electronic analytical balance is weighed.With the mice ear degree as acutely inflamed swelling index (mice ear degree=auris dextra sheet weight-left auricle weight) due to the dimethylbenzene.See Table 5
The influence of swelling due to the table 5 pair Mice Auricle dimethylbenzene (x ± s)
Compare * * P<0.01 with matched group; With hundred tinea xiatare tablet groups than △ P<0.05, #P 0.05.
The result: the control group mice auris dextra is obviously red and swollen, and thickness increases, and auricle swelling degree is big.Capsules group of the present invention and hundred tinea xiatare tablet groups can obviously suppress dimethylbenzene induced mice ease auricle swelling, have compared significant difference with matched group.Capsules group of the present invention is stronger than the antiinflammatory action of hundred tinea xiatare tablet groups.
Six, analgesic activity
50 of kunming mices, male and female half and half, body weight 18~22g is divided into 5 groups at random, 10 every group.Matched group is irritated the normal saline of stomach with volume; Hundred tinea xiatare tablet group gastric infusion 1.6g medical material/kg; Capsules group of the present invention is gastric infusion 0.4,0.8,1.6g medical material/kg respectively.Successive administration 10d, behind the last administration 2h the equal lumbar injection 0.6% acetic acid 0.2ml/ of every Mus only, mice occurs in the record 15min turns round the body number of times.See Table 6
The influence of table 6 Dichlorodiphenyl Acetate induced mice writhing response (x ± s)
Compare * * P<0.01 with matched group; With hundred tinea xiatare tablet groups than △ P<0.05, #P 0.05.
The result: Capsules group of the present invention and hundred tinea xiatare tablet groups all make the mouse writhing number of times reduce, dose-effect reaction relation is preferably arranged,, turn round the body number of times and reduce along with the increasing of dosage, it is inhibited that the Dichlorodiphenyl Acetate induced mice is turned round body, compares the difference that significance is arranged with matched group.Capsules group of the present invention strengthens than the analgesic activity of hundred tinea xiatare tablet groups.
Seven, to the influence of Turnover of Mouse Peritoneal Macrophages phagocytic function
60 of Kunming mouses, male and female half and half, body weight 18~22g is divided into 6 groups at random, 10 every group.Matched group and model group are irritated the normal saline of stomach with volume; Hundred tinea xiatare tablet group gastric infusion 1.6g medical material/kg; Capsules group of the present invention is gastric infusion 0.4,0.8,1.6g medical material/kg respectively.Successive administration 15d, every day 1 time, the 16th, 17d begins except that control animals, equal intraperitoneal injection of cyclophosphamide (CY) aqueous solution (30mg/kg), simultaneously continuous gastric infusion, the isopyknic normal saline of control animals lumbar injection, the continuous irrigation stomach gives normal saline simultaneously.Continuous use 17d, behind the last administration 1h, every Mus lumbar injection 2% chicken red blood cell (CRBC) normal saline (NS) solution 0.5ml, mice is put to death in the cervical vertebra dislocation behind the 10h, the sterilization abdominal part, cut off abdominal cavity skin, lumbar injection NS2ml, gently rub abdominal part after, draw peritoneal irrigation drop sheet, dry poststaining, phagocytic percentage and phagocytic index are observed and measured to film-making down in oily mirror.See Table 7
The influence of table 7 pair Turnover of Mouse Peritoneal Macrophages phagocytic function (x ± s)
Compare * * P<0.01 with matched group; With hundred tinea xiatare tablet groups than △ P<0.05, #P 0.05.
The result: Capsules group of the present invention and hundred tinea xiatare tablet groups have strengthened the phagocytic function of Turnover of Mouse Peritoneal Macrophages, and phagocytic percentage and phagocytic index obviously raise, and have compared significant difference with matched group.Capsules group of the present invention strengthens than the phagocytic function of hundred tinea xiatare tablet groups to macrophage, and immunity strengthens.
Eight, to the influence of mouse thymus and spleen anti-oxidation function
50 of kunming mices, male and female half and half, body weight 18~22g is divided into 5 groups at random, 10 every group.Matched group is irritated the isopyknic normal saline of stomach; Hundred tinea xiatare tablet group gastric infusion 1.6g medical material/kg; Capsules group of the present invention is gastric infusion 0.4,0.8,1.6g medical material/kg respectively.Successive administration 10d, every day 1 time, drug withdrawal dislocation next day is put to death.The tissue homogenate of preparation thymus and spleen 10% is measured the content of respectively organizing superoxide dismutase in the sample (SOD) and malonaldehyde (MDA).See Table 8
The influence of table 8 pair mouse thymus and spleen anti-oxidation function (x ± s)
Figure G2008101726852D00092
Compare * * P<0.01 with matched group; With hundred tinea xiatare tablet groups than △ P<0.05, #P 0.05.
The result: Capsules group of the present invention and hundred tinea xiatare tablet groups obviously raise to the active of SOD in mouse thymus and the spleen, reduced the content of MDA, improved the anti-oxidation function of mouse thymus and spleen, reduced the lipid peroxidation injury of active oxygen, compared significant difference with matched group to immune organ.Capsules group of the present invention is stronger than the oxidation resistance of hundred tinea xiatare tablet group human body immunity improving organs.
Acute toxicity testing is the result show, with capsule Cmax of the present invention, maximum volume gastric infusion, successive administration is 2 times in 24h, each 6h at interval, and accumulation medicine total amount reaches 30g/kg, is equivalent to 367 times of the daily dosage of clinical maximum.Mice is movable normal after matched group and the Capsules group administration of the present invention, animal skin gloss, and mouth and nose do not have secretions, and feces is normal.There is not 1 dead mouse.Weigh behind the administration 7d, 8d puts to death every mice perusal heart of back dissection, liver, spleen, lung, kidney, brain, stomach, intestinal, thymus, adrenal gland, testis, uterus etc. and does not all find color and paramophia.Show that this capsule does not have acute toxic reaction.
Long term toxicity test is the result show, the capsular dosage of the present invention is respectively 1,4,7g/kg/d, be equivalent to 12.2,48.9,85.6 times of the daily dosage of clinical maximum, the long term toxicity test in 12 weeks by a definite date, day by day observe the general situation of animal after the administration, weigh weekly 1 time, after 12 weeks of administration, each group is all put to death half rat, remains the rat drug withdrawal in addition and recovers to put to death after 2 weeks.After 12 weeks of administration, capsule of the present invention is to the general situation of animal, and hematology, blood biochemical are learned does not all have significantly influence, the yet no abnormal pathological change of system's dissection, organ coefficient and histopathological examination.2 weeks of drug withdrawal are not seen obvious change yet.So in the rat long term toxicity test in 12 weeks, do not find overt toxicity reaction and delayed toxicity reaction.As seen, this medicine life-time service can not cause the change of housing construction and function, has no side effect, and is safe and reliable.
Conclusion: Capsules group of the present invention and hundred tinea xiatare tablet groups energy obvious suppression rat homology skin allergy; Reduce mouse thymus and index and spleen index, suppressed the inductive mice delayed hypersensitivity of DNCB; Inhibited to the mast cell degranulation that the rat allogenic cell is antibody-mediated; The Cavia porcellus that histamine phosphate is caused causes the reaction of itching and has significant antagonism, rising itch-threshold; It is inhibited that the Dichlorodiphenyl Acetate induced mice is turned round body; Obviously suppress dimethylbenzene induced mice ease auricle swelling; The phagocytic percentage and the phagocytic index of Turnover of Mouse Peritoneal Macrophages obviously raise; The active of SOD in mouse thymus and the spleen obviously raise, reduced the content of MDA.The result shows, capsule anti-allergic effects of the present invention, suppress delayed hypersensitivity, the effect that suppresses mast cell degranulation, itching-relieving action, antiinflammatory action, analgesic activity, to the phagocytic function of macrophage, the pharmacological actions such as oxidation resistance of immunity of organism organ all are better than hundred tinea xiatare tablets.
Clinical trial:
Clinical observation patient of the present invention is totally 254 examples, wherein treats the tinea manuum, tinea corporis, group tinea, tinea versicolor 87 examples, psoriasis 65 examples, allergic dermatitis 70 examples, herpes zoster 42 examples.Carry out clinical observation, observe 2 courses of treatment continuously, the illing skin pruritus alleviates or disappears, and the surface trend is smooth.Pain relief.The palindromia rate reduces.Total effective rate of the present invention is 91%.Surpass therapeutic effect in the past.In the observation process, do not find untoward reaction and anaphylaxis.
The specific embodiment of the invention:
The embodiment of the invention 1:
Capsule prescription proportioning of the present invention:
Herba Euphorbiae Humifusae 450g terminalia flesh 75g Fructus Terminaliae Billericae 75g Placenta Hominis 250g
Scammonia resin 37.5g Aloe 42g FRUCTUS TERMINALIAE IMMATURUS 75g
The preparation method of capsule of the present invention:
More than seven the flavor, get Herba Euphorbiae Humifusae and add 70% soak with ethanol 24 hours of 10 times of amounts, heating and refluxing extraction 3 times, each 1 hour, merge extractive liquid,, filter, decompression recycling ethanol (0.08Mpa, 80 ℃) is to relative density 1.08~1.12 (50 ℃), medicinal residues and terminalia flesh, Fructus Terminaliae Billericae, FRUCTUS TERMINALIAE IMMATURUS is mixed and is added 10 times of water gagings decoctions 3 times, each 1 hour, filter, merging filtrate, filtrate decompression concentrates (0.08Mpa, 80 ℃) to relative density be 1.08~1.12 (50 ℃), merge two kinds of concentrated solutions, regulating relative density is 1.08~1.12 (50 ℃), spray drying (120 ± 5 ℃ of inlet temperature, 85 ± 5 ℃ of leaving air temps), the dry powder of must spraying is standby; Get Aloe, Placenta Hominis, Scammonia resin and be ground into fine powder, cross 100 mesh sieves,, granulate with above-mentioned spray drying powder and appropriate amount of starch mixing, drying, encapsulated, both capsule of the present invention.
The embodiment of the invention 2:
Tablet prescription proportioning of the present invention:
Herba Euphorbiae Humifusae 450g terminalia flesh 75g Fructus Terminaliae Billericae 75g Placenta Hominis 250g
Scammonia resin 37.5g Aloe 42g FRUCTUS TERMINALIAE IMMATURUS 75g
The preparation method of tablet of the present invention:
More than seven the flavor, get Herba Euphorbiae Humifusae and add 70% soak with ethanol 24 hours of 10 times of amounts, heating and refluxing extraction 3 times, each 1 hour, merge extractive liquid,, filter, decompression recycling ethanol (0.08Mpa, 80 ℃) is to relative density 1.08~1.12 (50 ℃), medicinal residues and terminalia flesh, Fructus Terminaliae Billericae, FRUCTUS TERMINALIAE IMMATURUS is mixed and is added 10 times of water gagings decoctions 3 times, each 1 hour, filter, merging filtrate, filtrate decompression concentrates (0.08Mpa, 80 ℃) to relative density be 1.08~1.12 (50 ℃), merge two kinds of concentrated solutions, regulating relative density is 1.08~1.12 (50 ℃), spray drying (120 ± 5 ℃ of inlet temperature, 85 ± 5 ℃ of leaving air temps), the dry powder of must spraying is standby; Get Aloe, Placenta Hominis, Scammonia resin and be ground into fine powder, cross 100 mesh sieves,, granulate with above-mentioned spray drying powder and appropriate amount of starch mixing, drying, granulate adds an amount of magnesium stearate tabletting, both tablet of the present invention.
The embodiment of the invention 3:
Granule prescription proportioning of the present invention:
Herba Euphorbiae Humifusae 450g terminalia flesh 75g Fructus Terminaliae Billericae 75g Placenta Hominis 250g
Scammonia resin 37.5g Aloe 42g FRUCTUS TERMINALIAE IMMATURUS 75g
The preparation method of granule of the present invention:
More than seven the flavor, get Herba Euphorbiae Humifusae and add 70% soak with ethanol 24 hours of 10 times of amounts, heating and refluxing extraction 3 times, each 1 hour, merge extractive liquid,, filter, decompression recycling ethanol (0.08Mpa, 80 ℃) is to relative density 1.08~1.12 (50 ℃), medicinal residues and terminalia flesh, Fructus Terminaliae Billericae, FRUCTUS TERMINALIAE IMMATURUS is mixed and is added 10 times of water gagings decoctions 3 times, each 1 hour, filter, merging filtrate, filtrate decompression concentrates (0.08Mpa, 80 ℃) to relative density be 1.08~1.12 (50 ℃), merge two kinds of concentrated solutions, regulating relative density is 1.08~1.12 (50 ℃), spray drying (120 ± 5 ℃ of inlet temperature, 85 ± 5 ℃ of leaving air temps), the dry powder of must spraying is standby; Get Aloe, Placenta Hominis, Scammonia resin and be ground into fine powder, cross 100 mesh sieves,, granulate with above-mentioned spray drying powder and an amount of dextrin mixing, drying, pack, both granule of the present invention.
The embodiment of the invention 4:
Pill prescription proportioning of the present invention:
Herba Euphorbiae Humifusae 450g terminalia flesh 75g Fructus Terminaliae Billericae 75g Placenta Hominis 250g
Scammonia resin 37.5g Aloe 42g FRUCTUS TERMINALIAE IMMATURUS 75g
The preparation method of pill of the present invention:
More than seven the flavor, get Herba Euphorbiae Humifusae and add 70% soak with ethanol 24 hours of 10 times of amounts, heating and refluxing extraction 3 times, each 1 hour, merge extractive liquid,, filter, decompression recycling ethanol (0.08Mpa, 80 ℃) is to relative density 1.08~1.12 (50 ℃), medicinal residues and terminalia flesh, Fructus Terminaliae Billericae, FRUCTUS TERMINALIAE IMMATURUS is mixed and is added 10 times of water gagings decoctions 3 times, each 1 hour, filter, merging filtrate, filtrate decompression concentrates (0.08Mpa, 80 ℃) to relative density be 1.08~1.12 (50 ℃), merge two kinds of concentrated solutions, regulating relative density is 1.08~1.12 (50 ℃), spray drying (120 ± 5 ℃ of inlet temperature, 85 ± 5 ℃ of leaving air temps), the dry powder of must spraying is standby; Get Aloe, Placenta Hominis, Scammonia resin and be ground into fine powder, cross 100 mesh sieves, standby.
The preparation of concentrated pill: above-mentioned described spraying dry powder and Aloe, Placenta Hominis, Scammonia resin fine powder and an amount of microcrystalline Cellulose are carried out mixing, and wherein the consumption of microcrystalline Cellulose is 30% of an extract powder, adds entry and makes plain ball as binding agent.
The Opadry (stomach dissolution type) of selecting above-mentioned plain ball for use Shanghai Ka Lekang (COLORCON) packaging technique company limited is for the coating material of this product carries out coating, concentrated pill of the present invention.
Coating conditions is as follows: selecting water for use is lytic agent; Coating solution concentration is 16%; Coating increases by 3%; Inlet temperature is 88 ℃; The sheet bed tempertaure is: 45 ℃; Atomizing pressure 2.0bar; Coating pan rotating speed 15rmp; Charging flow velocity 3.5g/min.

Claims (5)

1. one kind is used for the treatment of dermopathic Chinese medicine preparation, it is characterized in that it is to be prepared from by following raw materials by weight proportions:
Herba Euphorbiae Humifusae 450g terminalia flesh 75g Fructus Terminaliae Billericae 75g Placenta Hominis 250g
Scammonia resin 37.5g Aloe 42g FRUCTUS TERMINALIAE IMMATURUS 75g.
2. according to the described Chinese medicine preparation of claim 1, it is characterized in that: described Chinese medicine preparation dosage form is capsule, granule, tablet, pill.
3. according to the preparation method of the described Chinese medicine preparation of claim 2, it is characterized in that: above seven flavors, get Herba Euphorbiae Humifusae and add 70% soak with ethanol 24 hours of 10 times of amounts, heating and refluxing extraction 3 times, each 1 hour, merge extractive liquid, filtered,-0.08Mpa, decompression recycling ethanol under 80 ℃ the condition, the relative density during to 50 ℃ is 1.08~1.12, medicinal residues and terminalia flesh, Fructus Terminaliae Billericae, FRUCTUS TERMINALIAE IMMATURUS is mixed and is added 10 times of water gagings decoctions 3 times, each 1 hour, filter, merging filtrate ,-0.08Mpa, concentrating under reduced pressure under 80 ℃ the condition, relative density during to 50 ℃ is 1.08~1.12, merges two kinds of concentrated solutions, and the relative density when being adjusted to 50 ℃ is 1.08~1.12, spray drying, spray-dired inlet temperature are 120 ± 5 ℃, leaving air temp is 85 ± 5 ℃; The dry powder of must spraying is standby; Get Aloe, Placenta Hominis, Scammonia resin is ground into fine powder, crosses 100 mesh sieves, with above-mentioned spray drying powder and appropriate amount of starch or dextrin mixing, granulate, drying, both.
4. according to the described Chinese medicine preparation of claim 1, it is characterized in that described preparation formulation is a capsule.
5. according to the preparation method of the described Chinese medicine preparation of claim 4, it is characterized in that: above seven flavors, get Herba Euphorbiae Humifusae and add 70% soak with ethanol 24 hours of 10 times of amounts, heating and refluxing extraction 3 times, each 1 hour, merge extractive liquid, filtered,-0.08Mpa, decompression recycling ethanol under 80 ℃ the condition, the relative density during to 50 ℃ is 1.08~1.12, medicinal residues and terminalia flesh, Fructus Terminaliae Billericae, FRUCTUS TERMINALIAE IMMATURUS is mixed and is added 10 times of water gagings decoctions 3 times, each 1 hour, filter, merging filtrate ,-0.08Mpa, concentrating under reduced pressure under 80 ℃ the condition, relative density during to 50 ℃ is 1.08~1.12, merges two kinds of concentrated solutions, and the relative density when being adjusted to 50 ℃ is 1.08~1.12, spray drying, spray-dired inlet temperature are 120 ± 5 ℃, leaving air temp is 85 ± 5 ℃; The dry powder of must spraying is standby; Get Aloe, Placenta Hominis, Scammonia resin is ground into fine powder, crosses 100 mesh sieves, with above-mentioned spray drying powder and appropriate amount of starch mixing, granulate, drying, encapsulated, both.
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CN102755498A (en) * 2012-06-26 2012-10-31 武汉长江巨龙药业有限公司 Chinese medicine preparation for treating chronic eczema
CN103735811B (en) * 2014-01-23 2016-04-13 杨国堂 A kind of external-applied ointment and preparation method for the treatment of tinea versicolor
CN115607639B (en) * 2022-11-02 2023-11-28 陕西东泰制药有限公司 A Chinese medicinal composition for treating psoriasis, and its preparation method

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CN1615959A (en) * 2004-09-30 2005-05-18 贵阳济仁堂药业有限公司 Chines medicine capsule preparation for treating skin diseases

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