CN101199652A - Medicament for treating acute, subacute eczema and preparing method thereof - Google Patents
Medicament for treating acute, subacute eczema and preparing method thereof Download PDFInfo
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- CN101199652A CN101199652A CNA2006101368887A CN200610136888A CN101199652A CN 101199652 A CN101199652 A CN 101199652A CN A2006101368887 A CNA2006101368887 A CN A2006101368887A CN 200610136888 A CN200610136888 A CN 200610136888A CN 101199652 A CN101199652 A CN 101199652A
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Abstract
The invention discloses a drug for treating acute and sub-acute eczemas, which is made from chrysanthemum indicum L., scutellaria, fructus forsythiae, radix rehmanniae, red peony root, cortex moutan, angelica sinensis, poria cocos peel and glycyrrhiza as raw materials through processing of procedures of grinding, drying, distillation and refrigeration and decoction in the proportion according to different characteristics of each ingredient of Chinese medicine. The invention has special proportion and preparation method and good curative effect.
Description
Technical field
The present invention relates to a kind of medicine acute, subacute eczema for the treatment of, is the Chinese patent medicine of feedstock production with the Chinese herbal medicine specifically, the invention still further relates to the preparation method of this medicine.
Background technology
Acute, subacute eczema is a kind of typical sociopath, in China is the dermatosis of the common pilosity of a class, can cause by various internal and external factors, comprise mechanicalness, the stimulation of physical property or chemical and spirit and effects on neural system, endocrine disturbance, dysbolismus, intestinal parasitic disease, dyspepsia, rheumatic fever, diabetes, virtuous disease, hepatopathy all can cause the generation of eczema.Eczema is generally divided acute eczema, subacute eczema.Acute eczema is divided into damp-heat type and blood wind type again.Clinical general employing doctor trained in Western medicine means are cured as hormone medicine, though effectively, life-time service causes thinning of skin, and growth retardation, pigmentation, even cause untoward reaction such as body hormone secretion wadding is random.And the traditional Chinese medical science thinks that eczema is to be accumulate the resistance skin and formed by wind, wet, pathogenic heat, though disease shape in outer and real root in interior, endogenous dampness accumulate the wet knot mutually of heat-transformation of a specified duration be disease originally, treatment should be principle with the clearing away heat-damp and promoting diuresis.The Chinese patent medicine for oral administration that is used for the treatment of dermatosis on the current market has: the noxious dampness clearing capsule, and mainly treat skin pruritus and belong to that blood deficiency is wet accumulates skin card person; The wind-repellent itching-relieving electuary is mainly used in the treatment papular urticaria; XUEDU WAN can be treated the various skin malaria, but the pill preparation manipulation is hard to tackle, and the drug content of wayward finished product and dissolving time limit.And treat Chinese patent medicine market acute, subacute eczema almost is blank out.
Summary of the invention
The objective of the invention is specially to develop a kind of sufficient raw and cheap at acute, subacute eczema disease, the quality medicinal herbs most in use of the state-promulgated pharmacopoeia promulgation of control easily is a raw material, the pure oral formulations of making.
Another object of the present invention provides that this treatment is acute, the preparation method of subacute eczema medicine.
" Radix Rehmanniae looses " that solution of the present invention is based in motherland's medical treasure-house for the basis, widely collects the length of respectively curing tame medication at all times, treats the wide Na Zhufangfangyiization sanction of experience acute, subacute eczema for many years in conjunction with hospital dermatology department and forms.According to the principle of traditional Chinese medical science heat clearing away, dehumidifying, removing heat from blood, detoxifcation, fresh breeze, select compositions such as Flos Chrysanthemi Indici, Radix Scutellariae, Radix Rehmanniae, Fructus Forsythiae for use.
Medicine of the present invention is made (consumption is a weight portion) by following component
Flos Chrysanthemi Indici 40-58 part Radix Scutellariae 28-36 part Fructus Forsythiae 28-36 part
Radix Rehmanniae 28-36 part Radix Paeoniae Rubra 18-24 part Cortex Moutan 18-24 part
Radix Angelicae Sinensis 18-24 part Cortex Sclerotii Poriae 28-36 part Radix Glycyrrhizae 7-12 part
Preparing pharmaceutical formulation preferred weight ratio range of the present invention is:
Flos Chrysanthemi Indici 40-46 part Radix Scutellariae 30-35 part Fructus Forsythiae 30-35 part
Radix Rehmanniae 30-35 part Radix Paeoniae Rubra 20-24 part Cortex Moutan 20-24 part
Radix Angelicae Sinensis 20-24 part Cortex Sclerotii Poriae 30-35 part Radix Glycyrrhizae 8-12 part
Medicine of the present invention has the optimum weight proportioning to be:
32.5 parts of 32.5 parts of Fructus Forsythiaes of 44 parts of Radix Scutellariaes of Flos Chrysanthemi Indici
22 parts of 22 parts of Cortex Moutans of 32.5 parts of Radix Paeoniae Rubra of Radix Rehmanniae
10 parts in 32.5 portions of Radix Glycyrrhizaes of 22 parts of Cortex Sclerotii Poriae of Radix Angelicae Sinensis
Above-mentioned each component is made medicine production method of the present invention is:
(1) gets the thick sheet that Radix Scutellariae is broken into 25mm, add in 10 times of amount boiling water, decoct each 1 hour 3 times.Merge decocting liquid, put cold back and filter, filtrate is heated to 60 ℃, and regulating pH value with hydrochloric acid is 1-2, and is incubated 30 minutes, and placement is spent the night, and filters, and precipitation is washed to PH4-5, and cold drying is pulverized the back and crossed 100 mesh sieves, promptly gets Radix Scutellariae extract, and is standby;
(2) get and add 8 times of water gagings after Flos Chrysanthemi Indici, Radix Angelicae Sinensis, Fructus Forsythiae, Cortex Moutan mix, soaked 4 hours, extracted 6 hours with steam distillation, collection volatile oil, its aqueous extract and medicinal residues are continued to employ.Get the beta-schardinger dextrin-of 6 times of amounts of volatile oil, be dissolved in the distilled water of 80 times of amounts, be heated to 60 ℃, under constantly stirring, drip volatile oil, restir one hour, cold preservation (4-10 ℃) is spent the night, and filters the precipitation cold drying, pulverize, cross 80 mesh sieves, promptly get β-ring and stick with paste clear inclusion complex, standby;
(3) get all the other four Chinese medicines and add 8 times of amounts of water, decoct twice after, the medicinal residues that add said extracted volatile oil decoct once more jointly, decocting time is each one hour.Merge three times decocting liquid, the water extract behind the adding said extracted volatile oil filters, and it is 1.10-1.15 (50 ℃ of surveys) that filtrate is concentrated into relative density, 6% of total crude drug amount dextrin among the adding place master, and spray drying after the heating for dissolving promptly gets water extract dry powder, and is standby;
(4) get Radix Scutellariae extract, beta-cyclo dextrin included compound and water extract dry powder add 15g steviosin and appropriate amount of auxiliary materials mixing.
Determining of above production method is based on the characteristics of nine flavor Chinese medicines in the component and selected.Wherein: Flos Chrysanthemi Indici is middle monarch drug, and its main chemical is sesquiterpene, chrysanthetriol, yejuhua lactone, flavone compound.Its decoct is for the various skin fungus, and herpesvirus etc. are inhibited.Therefore the almost completely loss in decoction process because of volatile oil in its composition and phenol sexual element, should be adopted and put forward the technology that profit is fried in shallow oil synthetic method, to guarantee the proposition of its chemical constituent.
Ministerial drug in the Radix Scutellariae side of being, its main chemical compositions is a flavone compound, has wider antimicrobial spectrum, its extractum and decoct have antibacterial action to nearly ten kinds of dermatophytess such as trichophyton, Microsporon audouinis.Now many with the use of Radix Scutellariae crude extract replacement Radix Scutellariae, therefore, adopt the method for extracting Radix Scutellariae separately in the technology.
The main chemical of Fructus Forsythiae is volatile component, phenethyl alcohol glycosides, lignanoids etc., has effects such as the pathogenic microorganism of inhibition, antipyretic and anti-inflammatory.According to the character of its chemical analysis, in conjunction with traditional Chinese medical science tradition medication custom, employing is carried profit and is fried in shallow oil the synthetic method extraction.
The main chemical of Radix Rehmanniae is iridoid, monoterpene and glycoside thereof etc.Its decoct has effects such as hemostasis, antiinflammatory, anticancer, diuresis.All be used as medicine traditionally, therefore, adopt decoction alcohol precipitation method to extract in the technology with decocting.
Radix Paeoniae Rubra has effects such as antipathogen, antiinflammatory, and its main chemical is peoniflorin, lactone glucoside of Radix Paeoniae, benzoylpaeoniflorin etc., and composition is water-soluble mostly, and the traditional Chinese medical science often is used as medicine with decocting, can adopt decoction alcohol precipitation method to extract.
The main chemical of Cortex Moutan is paeonol, monoterpenes and tannin, has effects such as resisting pathogenic microbes, antiinflammatory, antiallergic action.Because of paeonol is micromolecular phenolic substance, have volatility, therefore, also take to carry profit in the technology and fry in shallow oil the synthetic method extraction.
The main chemical of Radix Angelicae Sinensis is volatile oil, saccharide, organic acid etc., has the promotion body's immunity, antitumor, anti-inflammatory and antalgic, effect such as antibiotic grade.According to the character of its chemical analysis, employing is carried profit and is fried in shallow oil the synthetic method extraction.
The main chemical of Cortex Sclerotii Poriae is polysaccharide, triterpenes, fatty acid etc., has effects such as diuresis, antitumor.The traditional Chinese medical science often is used as medicine with decocting, so adopt decoction alcohol precipitation method to extract in the technology.
The main chemical of Radix Glycyrrhizae is triterpenes, flavonoid, living special bases etc.The traditional Chinese medical science is many is used as medicine with decocting, can adopt decoction alcohol precipitation method to extract.
According to ingredient and part Study data and middle medical drugs custom, Radix Scutellariae adopts and extracts the baicalin crude product separately among this side, Flos Chrysanthemi Indici, Fructus Forsythiae, Cortex Moutan, Radix Angelicae Sinensis employing are carried profit and are fried in shallow oil the synthetic method extraction, volatile oil carries out the beta-schardinger dextrin-parcel again, and Cortex Sclerotii Poriae, Radix Rehmanniae, Radix Paeoniae Rubra, Radix Glycyrrhizae adopt decoction alcohol precipitation method to extract.
Said medicine has been done Pharmacodynamic test of active extract and its result of toxicity research is as follows:
One, Pharmacodynamic test of active extract
With 5.7,11.4,22.8g crude drug/kg irritates stomach and gives rat, with 8.3,16.6,33.2g crude drug/kg irritates stomach and gives mice, with 8.3,16.6,33.2g crude drug/kg irritates stomach and gives mice, with 8.3,16.6,33.2g crude drug/kg irritates stomach and gives rat, with 8.3,16.6,33.2 crude drugs/kg irritates stomach and gives mice, with 8.3,16.6,33.2g crude drug/kg irritates stomach and give Cavia porcellus.Prove by experiment, have:
1, bacteriostasis
At body, 10 strain bacterial strains such as the staphylococcus aureus in the 12 strain bacterial isolateses that tried, pneumobacillus, diphtheroid had in various degree inhibition and killing action; In vivo, to the clinical staphylococcus aureus of mouse infection, has the effect that promotes skin healing and reduce animal dead.
2, antiinflammatory action
Can significantly suppress the auricle edema that dimethylbenzene causes, bullate formation has obvious inhibitory action to rat granuloma.
3, itching-relieving action
For the Cavia porcellus scratchiness due to the histamine phosphate, can increase histamine phosphate's total amount, improve the itch-threshold value, have tangible itching-relieving action.
4, analgesic activity
Stimulation causes the mouse writhing reaction that the mice whipping reacts and acetic acid causes to photoelectricity, and the obvious suppression effect is all arranged.
5, to Immune Effects
Mice specific cellular immunity function and non-specific cell immunologic function are had tangible potentiation, mice specific humoral immunity function is not had tangible potentiation.
In addition, skin injury damp-heat type model test shows that each dosage group all has tangible promoting healing effect to rat epidermis trauma infection contamination, dilute sulfuric acid is burnt rat skin is dermatitis caused to have certain therapeutical effect.
Two, toxicity research
1, acute toxicity test
1.1 the mensuration of the maximum toleration of mouse stomach administration
To irritate maximum suspendible concentration that the stomach syringe needle can extract for No. 16 and maximumly to irritate gastric infusion twice in long-pending one day of the body of stomach, observed continuously 10 days.Its maximum tolerated dose is 279.3g crude drug/kg, is equivalent to 337 times of clinical people's consumption; Minimum lethal dose is 319.2g crude drug/kg, is equivalent to face 385 times that order people's consumption.
1.2 the mensuration of mouse subcutaneous injection administration maximum tolerated dose
With a subcutaneous injection administration of maximum suspendible concentration, observed continuously 10 by No. 7 injection needles.Its maximum tolerated dose is 53.2g crude drug/kg, is equivalent to 64 times of clinical oral administration people consumption; Minimum lethal dose is 66.5g crude drug/kg, is equivalent to 80 times of clinical oral administration people consumption.
2, long term toxicity test
Rat is irritated continuous 6 weeks of stomach 48,16g crude drug/kg (be equivalent to clinical medicine dose 58 times and 19 times) respectively, observes for two weeks after the 1/3 rat drug withdrawal.The result shows: except that administration phase 4-6 week male rat the high dose group body weight gain slowly, animal generally in order, each all rat feed amount of eating basically identical, 10 indexs of hematology, serum biochemistry are learned 10 indexs, internal organs system and histopathologic examinations etc., do not see the overt toxicity reaction.
Medicine of the present invention according to clinical II phase, III phase according to the GCP principle, advance the clinical trial protocol design, test is adopted at random, two the region between the heart and the diaphragm dual analog, the positive drug parallel control, the observational technique result of multiple center trial proof has following advantage: 1, the damp and hot skin card (acute eczema, subacute eczema) that accumulates of eczema is had better therapeutical effect, can improve damp and hot pruritus, skin lesion, dry mouth with bitter taste, loose stool or dry stool due to the skin card (acute eczema, subacute eczema), yellowish urine, red tongue, yellow fur or the yellow damp and hot skin card syndrome of accumulateing of the traditional Chinese medical science such as greasy of accumulateing of eczema preferably.2, in the III clinical trial phase process, do not see abnormal change and other obvious adverse reaction that trial drug is relevant.III clinical trial phase conclusion and II clinical trial phase conclusion have concordance, have verified that further clinical drug application of the present invention has therapeutical effect preferably.3, according to the routine blood test, the routine urinalysis that carry out before and after the treatment, the stool routine examination and the heart, liver, virtuous function are observed, and do not see abnormal index and other untoward reaction that clinical meaning is arranged, show that this medicine safety is better.4, acute, subacute eczema after this medicine is cured are difficult for recurrence.
The specific embodiment
Embodiment:
Take by weighing raw material by following proportioning:
Flos Chrysanthemi Indici 44kg Radix Scutellariae 32.5kg Fructus Forsythiae 32.5kg
Radix Rehmanniae 32.5kg Radix Paeoniae Rubra 22kg Cortex Moutan 22kg
Radix Angelicae Sinensis 22kg Cortex Sclerotii Poriae 32.5kg Radix Glycyrrhizae 10kg
Above-mentioned each component is made medicine production method of the present invention is:
1, gets the thick sheet that Radix Scutellariae is broken into 25mm earlier, add in 10 times of amount boiling water, decoct each 1 hour 3 times.Merge decocting liquid, put cold back and filter, filtrate is heated to 60 ℃, and regulating pH value with hydrochloric acid is 1.5, and is incubated 30 minutes, and placement is spent the night, and filters, and precipitation is washed to PH4.5, and cold drying is pulverized the back and crossed 100 mesh sieves, promptly gets Radix Scutellariae extract, and is standby;
2, get again and add 8 times of water gagings after Flos Chrysanthemi Indici, Radix Angelicae Sinensis, Fructus Forsythiae, Cortex Moutan mix, soaked 4 hours, extracted 6 hours with steam distillation, collection volatile oil, its aqueous extract and medicinal residues are continued to employ.Get the beta-schardinger dextrin-of 6 times of amounts of volatile oil, be dissolved in the distilled water of 80 times of amounts, be heated to 60 ℃, under constantly stirring, drip volatile oil, restir one hour, cold preservation is spent the night for 8 ℃, filters the precipitation cold drying, pulverize, cross 80 mesh sieves, promptly get β-ring and stick with paste clear inclusion complex, standby;
3, get all the other four Chinese medicines again and add 8 times of amounts of water, decoct twice after, the medicinal residues that add said extracted volatile oil decoct once more jointly, decocting time is each one hour.Merge three times decocting liquid, the water extract behind the adding said extracted volatile oil filters, and it is 1.10 (50 ℃ of surveys) that filtrate is concentrated into relative density, 6% of total crude drug amount dextrin among the adding place master, and spray drying after the heating for dissolving promptly gets water extract dry powder, and is standby;
4, get Radix Scutellariae extract, beta-cyclo dextrin included compound and water extract dry powder add 15g steviosin and appropriate amount of auxiliary materials mixing.
Claims (4)
1. the medicine of acute, the subacute eczema of a treatment is characterized in that it is the medicament of being made by the following weight proportion raw material:
Flos Chrysanthemi Indici 40-58 part Radix Scutellariae 28-36 part Fructus Forsythiae 28-36 part
Radix Rehmanniae 28-36 part Radix Paeoniae Rubra 18-24 part Cortex Moutan 18-24 part
Radix Angelicae Sinensis 18-24 part Cortex Sclerotii Poriae 28-36 part Radix Glycyrrhizae 7-12 part
2. treatment according to claim 1 is acute, the medicine of subacute eczema, and wherein the weight proportion of each raw material is:
Flos Chrysanthemi Indici 40-46 part Radix Scutellariae 30-35 part Fructus Forsythiae 30-35 part
Radix Rehmanniae 30-35 part Radix Paeoniae Rubra 20-24 part Cortex Moutan 20-24 part
Radix Angelicae Sinensis 20-24 part Cortex Sclerotii Poriae 30-35 part Radix Glycyrrhizae 8-12 part
3. treatment according to claim 1 is acute, the medicine of subacute eczema, and wherein the weight proportion of each raw material is:
32.5 parts of 32.5 parts of Fructus Forsythiaes of 44 parts of Radix Scutellariaes of Flos Chrysanthemi Indici
22 parts of 22 parts of Cortex Moutans of 32.5 parts of Radix Paeoniae Rubra of Radix Rehmanniae
10 parts in 32.5 portions of Radix Glycyrrhizaes of 22 parts of Cortex Sclerotii Poriae of Radix Angelicae Sinensis
4. the medicine production method of, subacute eczema acute according to claim 1,2 or 3 described treatments is characterized in that:
(1) gets the thick sheet that Radix Scutellariae is broken into 25mm, add in 10 times of amount boiling water, decoct 3 times, each 1 hour, merge decocting liquid, put cold back and filter, filtrate is heated to 60 ℃, and regulating pH value with hydrochloric acid is 1-2, and is incubated 30 minutes, placement is spent the night, filter, precipitation is washed to PH4-5, cold drying, pulverize the back and cross 100 mesh sieves, promptly get Radix Scutellariae extract;
(2) get and add 8 times of water gagings after Flos Chrysanthemi Indici, Radix Angelicae Sinensis, Fructus Forsythiae, Cortex Moutan mix, soaked 4 hours, extracted 6 hours with steam distillation, collection volatile oil, its aqueous extract and medicinal residues are continued to employ
Get the beta-schardinger dextrin-of 6 times of amounts of volatile oil, be dissolved in the distilled water of 80 times of amounts, be heated to 60 ℃, under constantly stirring, drip volatile oil, restir one hour, cold preservation (4-10 ℃) is spent the night, and filters the precipitation cold drying, pulverize, cross 80 mesh sieves, promptly get β-ring and stick with paste clear inclusion complex, standby;
(3) get all the other four Chinese medicines and add 8 times of amounts of water, decoct twice after, the medicinal residues that add said extracted volatile oil decoct once more jointly, decocting time is each one hour
Merge three times decocting liquid, the water extract behind the adding said extracted volatile oil filters, and it is 1.10-1.15 (50 ℃ of surveys) that filtrate is concentrated into relative density, 6% of total crude drug amount dextrin among the adding place master, and spray drying after the heating for dissolving promptly gets water extract dry powder;
(4) get Radix Scutellariae extract, beta-cyclo dextrin included compound and water extract dry powder add 15g steviosin and appropriate amount of auxiliary materials mixing.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103127322A (en) * | 2011-11-29 | 2013-06-05 | 王莲芬 | Traditional Chinese medicine composition for curing subacute eczema |
| CN103202981A (en) * | 2013-05-08 | 2013-07-17 | 山东新希望六和集团有限公司 | Medicine for treating trauma infectious diseases of animals |
| CN104784293A (en) * | 2015-03-30 | 2015-07-22 | 郭光艳 | Traditional Chinese medicine composition for treating extensive heat type subacute eczema |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100496555C (en) * | 2005-09-22 | 2009-06-10 | 华玉强 | Detoxification and itching-relieving medicine composition and preparing method |
| CN1857573A (en) * | 2006-03-24 | 2006-11-08 | 南凤龙 | Medicine for treating skin diseases |
-
2006
- 2006-12-15 CN CN2006101368887A patent/CN101199652B/en active Active
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103127322A (en) * | 2011-11-29 | 2013-06-05 | 王莲芬 | Traditional Chinese medicine composition for curing subacute eczema |
| CN103202981A (en) * | 2013-05-08 | 2013-07-17 | 山东新希望六和集团有限公司 | Medicine for treating trauma infectious diseases of animals |
| CN103202981B (en) * | 2013-05-08 | 2015-07-01 | 山东新希望六和集团有限公司 | Medicine for treating trauma infectious diseases of animals |
| CN104784293A (en) * | 2015-03-30 | 2015-07-22 | 郭光艳 | Traditional Chinese medicine composition for treating extensive heat type subacute eczema |
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| CN101199652B (en) | 2010-07-14 |
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