CN105641094A - Composition for treating children dermatitis and preparation method thereof - Google Patents
Composition for treating children dermatitis and preparation method thereof Download PDFInfo
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- CN105641094A CN105641094A CN201410640259.2A CN201410640259A CN105641094A CN 105641094 A CN105641094 A CN 105641094A CN 201410640259 A CN201410640259 A CN 201410640259A CN 105641094 A CN105641094 A CN 105641094A
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Abstract
Application of a composition in preparation of a drug for prevention and control of children dermatitis is disclosed, the composition comprises, by weight, 30-70 parts of lithospermum, 30-70 parts of coptis chinensis, 30-70 parts of Chinese rhubarb and 5-20 parts of borneol. The composition specifically aims at children dermatitis, has the effects of clearing away heat and toxic materials, removing dampness by dieresis and relieve itching, and the like, and is mild, non-irritating, hypoallergenic, non-drug-resistance, and readily accepted by children and parents.
Description
Technical field
The composition that the present invention relates to a kind of processing by plant and make, particularly relating to a kind of take Asian puccoon as the application in the medicine prevented and treated for the preparation of dermatitis of the Chinese medicinal materials composition of monarch's medicine.
Background technology
To be skin react dermatitis for the alterative inflammation of all materials such as chemical reagent, albumen, bacterium and fungi, be a kind of tetter, and mainly owing to bad living habit cause, the symptoms such as erythema, papule, blister often occurs in patient. The classification more complicated of dermatitis, comprises but is not limited only to contact dermatitis, allergic dermatitis, atopic dermatitis, daylight type dermatitis, neurodermatitis, mosquito bite type dermatitis, hormonal dependent dermatitis etc. Multiple dermatitis has easily repeatedly, is difficult to the features such as healing, brings constant greatly to patient's life, and serious even can crisis life. Particularly infant, after suffering from dermatitis, affected part itch is hard to bear so that infant is irritated, uneasiness of crying and screaming, and brings many worries to infant and the head of a family. Infant's dermatitis sickness rate has the trend of rising in recent years, and kind also expands gradually.
Contact dermatitis is a kind of skin reaction, normally causes because contacting a kind of material, such as food, soap, or vegetables oil, such as ivy, lacquer tree, Oak Tree. Fash usually starts and is exposed in 48 after causing reactive material hour. Minority case can be occur red swollen block after slight skin rubefaction, and serious reaction may cause swelling, rubescent, serious oedema.
The common feature of allergic dermatitis is dry skin, and strong sense of itching adds measles protruding one by one. Its most common type is eczema. Eczema and dermatitis are often synonymously used to refer to a kind of skin inflammation, represent the atopic reaction of skin for all materials such as chemicals, albumen, bacterium and fungies. Eczema one word does not have special implication, and dermatitis then has the meaning of restriction. If replacing eczema as diagnosis term by dermatitis, then referring to corium, epidermis association response, it can be acute, subacute and chronic. This three can combine existence. The reason causing allergic dermatitis at present is not yet clear and definite, but it may be relevant with the immunity system of sensitivity with individual's allergies, asthma.
It is a kind of intractable, chronic, inflammatory dermatoses that atopic dermatitis (is called for short AD), it is apt to occur in infant and the teenager of allergic constitution, position is throughout face, neck, elbow, knee nest, four limbs dorsal part etc., and trouble portion there will be erythema, skin becomes situation thick, coarse. Due to atopic dermatitis can recurrent exerbation and the hard to bear itch of patient Chang Yinwei and grab scarred with it, not only affect outward appearance, even work, reading, make friends, even mood, sleep all can be influenced, the quality of the life of impact individual and family greatly.
Neurodermatitis is also known as lichen chronicus simplex.It it is the chronic dermatosis turning to feature with paroxysmal skin pruritus and skin liver moss. For common skin diseases, being more common in grownup, children generally do not fall ill. Mental element is it is now recognized that be the main inducing that this disease occurs, and anxious state of mind, overstretched, anxious, the living environment change suddenly of spirit etc. all can make aggravation and repeatedly. In addition, in gastrointestinal dysfunction, endocrine system dysfunction, body, chronic lesion infection, local excitation etc., all may become paathogenic factor.
Daylight type dermatitis is a kind of tardy property photoallergy dermatoses photo-induced by day. Someone thinks and causes primarily of ultraviolet B radiation, and also someone thinks and causes primarily of long wave ultraviolet. Clinical manifestation is that polymorphism fash can have erythema, papule, blister, erosion, the scales of skin that peel off, liver moss sample to become; Normal based on certain fash.
Dermatitis medication in existing market divides Chinese medicine and two kinds, Western medicine, Western medicine many employings oral antihistamines and external application hormones Ointment in Treatment, antihistamine drug for oral administration comprises diphenhydramine, promethazine hydrochloride, Toldrin, Cyproheptadine etc., both can alone or coupling, also can share with tranquilizer, vitamin c etc. Externally applied agent, such as compound dexamethason acetate emulsifiable paste (999 PIYANPING), fluocinonide ointment Tacrolimus paste, pimecrolimus ointment etc., can directly spread upon affected part. The symptoms such as the epidermis caused by acute dermatitis festers generally first are rinsed with local physiological saline, 3% boric acid or 1: 2000��1: 10000 potassium permanganate solutions, soak, calamine lotion convergence, protection. Secondary infection person's added with antibiotic preparation.
Chinese invention patent application 201210551183.7 discloses one and treats neurodermatitis mixed concentrated liquid, this mixed concentrated liquid of every agent comprises snake slough 10 grams, Asian puccoon 10 grams, Fructus Hordei Germinatus 15 grams, the spot insect destructive of the roots of seedlings 15 grams, 15 grams, sulphur, aster 15 grams, dried orange peel 10 grams, 10 grams, Radix Glycyrrhizae and Chinese torreyanut 10 grams etc., can be used for the treatment of neurodermatitis.
Chinese invention patent application 200510104364.5 discloses a kind of medicine treating contact dermatitis, comprises Fructus Atriplicis Sibiricae 18 grams, Asian puccoon 18 grams, 10 grams, safflower, flea not 13 grams, 7 grams, Radix Glycyrrhizae and cicada slough 10 grams. It has effect of heat-clearing and fire-purging, enriching blood and moistening for dryness and removing pattogenic heat from the blood and toxic material from the body, can alleviate rapidly contact dermatitis symptom.
Chinese invention patent application 201410311388.7 discloses a kind of traditional Chinese medicinal ointment treating infantile eczema, by Asian puccoon 30-35 part, root of large-flowered skullcap 12-18 part, coptis 12-18 part, root of Dahurain angelica 20-25 part, Japanese Honeysuckle Stem 20-25 part, rheum officinale 12-16 part, cape jasmine 12-18 part, peppermint 12-16 part, golden cypress 12-18 part, gypsum 10-15 part, Poria cocos 10-15 part, bighead atractylodes rhizome 8-12 part, Fructus Aurantii 8-12 part, Fruit of Belveder 8-12 part, Japanese Honeysuckle 12-18 part, Leaf of Indigowoad 12-18 part, fructus amomi 16-18 part, Root of Chinese Pulsatilla 16-18 part and borneol 15-20 part etc. are made, the improvement rate of infantile eczema is reached more than 95%.
The medicine that Chinese invention patent application 201210300607.2 discloses a kind of infant's for the treatment of erythema, eczema and festers, by Chinese medicinal materialss such as Asian puccoon 10 grams, frankincense 6 grams, myrrh 6 grams, 8 grams, catechu, the root of Dahurain angelica 12 grams, giant knotweed 12 grams, the root of large-flowered skullcap 9 grams and rheum officinales 10 grams, add in boiled peanut oil (or sesame oil), after coke yellow, leave standstill, after temperature decrease to room temperature, more appropriate borneol is added wherein, and stir and evenly obtain afterwards. Infant's skin is without any side effects, successful.
Chinese invention patent ZL03138778.0 discloses a kind of infant allergic dermatitis ointment, by Asian puccoon 20 grams, Calamine 20-30 gram, 10-20 gram, zinc oxide, the plaster of Paris 6 grams, vitamin-E 500 milligrams, Toldrin 40 milligrams and meticorten 250 milligrams, finally reconcile into paste in right amount with Vaseline.Effect that this medicine has antipruritic, anti-inflammatory, desensitization, cool blood dispel spot and hygroscopic, for infant allergic dermatitis or other dermatitis of causing by allergy.
Chinese invention patent application 200810143721.2 discloses a kind of Oleum Radix Arnebiae (Oleum Radix Lithospermi) and its preparation method, it is made up of by 1: 3 ratio of component Asian puccoon and sesame oil or rape oil, adopt and clean chopping, mixing is soaked, Steam by water bath boils, sterile filtration and deposit method for subsequent use preparation, solve the problem for the treatment of baby's low diaper dermatitis without effective Chinese medicine preparation economic and practical, convenient, do not need to take medicine, economical convenient, have no adverse reaction and side effect, infant dermatitis can be used for the treatment of.
Though Western medicine is effective in cure, but side effect is big, and untoward reaction is many, and stops medicine and easily recur, and is not suitable for baby and uses. Chinese medicine according to different syndrome type dialectical treatmert, has good absorption, safe and effective, the feature that has no side effect, is easily accepted by infant and the head of a family under instruction of Chinese Medicine theory. Although having obtained the technical scheme that some are relevant, but in existing market, the special medicine for infant's dermatitis is still blank.
Summary of the invention
It is an object of the present invention to provide the application of a kind of composition in the medicine prevented and treated for the preparation of dermatitis.
Another object of the present invention is that providing a kind of is the method that medicine portion produces preparation taking several kinds of Chinese medicinal materials, is convenient in the prevention and therapy of children's dermatitis and uses.
" prevention " alleged by the present invention refers to before the disease do not assert by clinical criteria, various for preventing means or the measure of disease generation or development, comprises the method for medical science, physics or chemistry, to stop and to reduce generation or the development of the various symptom of disease.
" treatment " alleged by the present invention refers to generation or the development in order to stop and reduce disease, make the development of disease course or increase the weight of to be suppressed, contain, alleviate, improve, slow down, stop, postponing or reverse, various indexs that are disease when described maintenance or medication, disorderly or pathologic state comprise and alleviate or reduces symptom or complication, or cure or elimination disease, disorder or situation.
" preparation " alleged by the present invention refers to the formulation being conducive to administration containing each kind of plant provided by the invention and extract thereof and reactive site, as: but be not limited only to, aqueous solution injection, powder injection, pill, powder, tablet, patch, suppository, emulsion, frost agent, gelifying agent, granule, capsule, aerosol, sprays, powder inhalation, sustained release dosage and control-released agent etc. These pharmaceutical excipients both can be conventional in various preparation use, as: but be not limited only to, wait penetration enhancer, damping fluid, correctives, vehicle, weighting agent, tackiness agent, disintegrating agent and lubricant etc.; Can also in order to adapt and choice for use with described material, as: emulsifying agent, solubilizing agent, fungistat, pain killer and oxidation inhibitor etc., this kind of auxiliary material can effectively improve the stability of compound contained by composition and the rate of release of solvability or change compound and uptake rate etc., thus improve the metabolism of the compounds of this invention in organism, and then strengthen administering effect. In addition, can also for realizing specific administration object or mode, as: sustained-release administration, controlled release drug administration and pulsatile administration etc., and the auxiliary material used, as: but be not limited only to, gelatin, albumin, chitosan, polyethers and polyester macromolecular material, as: but be not limited only to, polyoxyethylene glycol, urethane, polycarbonate and multipolymer thereof etc. The main performance of alleged " being conducive to administration " has: but be not limited only to improve result for the treatment of, raising bioavailability, reduce toxic side effect and improve patient's conformability etc.
" Asian puccoon " alleged by the present invention is Boraginaceae Lithospermum plant, nature and flavor bitter cold, thoughts of returning home envelope, Liver Channel. It is used as medicine and can be used for prevention measles, treatment anaphylactoid purpura, treatment thrombopenic purpura, treatment herpes simplex, controls burning hot and caused by it foaming and rot, controls ulcer and just close and treat the illnesss such as five subcutaneous ulcers heat are yellow, plays clearing heat and detoxicating with effect that is promoting blood circulation and cooling blood. Available its is monarch's medicine, consumption is 30 weight part��70 weight parts, especially 50 weight part��70 weight part, cure mainly the diseases such as burn, eczema, erysipelas, large carbuncle and macula, as: but it is not limited only to 50 weight parts, 52 weight parts, 55 weight parts, 58 weight parts, 60 weight parts, 62 weight parts, 65 weight parts, 68 weight parts and 70 weight parts.
The present invention alleged " coptis " is Ranunculaceae Coptis per nnial herb, bitter cold in nature, the thoughts of returning home, liver, stomach and large intestine channel, there is eliminating fire and detoxication and removing dampness and killing parasites effect, full for damp and hot ruffian, vomit acid regurgitation, rush down dysentery, jaundice, unconsciousness due to high fever, hyperactivity of heart-fire, dysphoria and insomnia, blood-head tell nosebleed, hot eyes, have a toothache, quench one's thirst and carbuncle swells the diseases such as furunculosis; Control the swollen furunculosis of carbuncle, the wet disease such as sore and empyrosis of eczema outward. Available its is ministerial drug, consumption is 30 weight part��70 weight parts, especially 30 weight part��50 weight part, as: but it is not limited only to 30 weight parts, 32 weight parts, 35 weight parts, 38 weight parts, 40 weight parts, 42 weight parts, 45 weight parts, 48 weight parts and 50 weight parts.
The present invention's alleged " rough gentian " is gentianaceae plant, and nature and flavor bitter cold, returns liver, gallbladder channel. Heat-clearing and damp-drying drug, can purging the liver of pathogenic fire courage excess fire. External application cures mainly carbuncle swollen sore, eczema itch. Available its is ministerial drug, consumption is 5 weight part��40 weight parts, especially 20 weight part��40 weight part, as: but it is not limited only to 20 weight parts, 22 weight parts, 25 weight parts, 28 weight parts, 30 weight parts, 32 weight parts, 35 weight parts, 38 weight parts and 40 weight parts.
The plant that the present invention's alleged " kuh-seng " belongs to for pulse family kuh-seng, nature and flavor bitter cold, returns liver, kidney, large intestine and small intestine warp. Tool heat-clearing and damp-drying drug, the effect killing worm diuresis. External application cures mainly eczema, skin pruritus, mange leprosy, trichomonal vaginitis. Available its is ministerial drug, and consumption is 5 weight part��20 weight parts, as: but it is not limited only to 5 weight parts, 7 weight parts, 10 weight parts, 12 weight parts, 15 weight parts, 18 weight parts and 20 weight parts.
The present invention's alleged " Root-bark of Densefruit Pittany " is the root skin of Rutaceae per nnial herb shaggy-fruited dittany and Dictamnus angustifolius, and nature and flavor bitter cold, returns spleen and stomach warp, has heat-clearing and damp-drying drug and timid wind detoxicating functions. Cure mainly the diseases such as the rubella caused by the wet poison of wind-heat, eczema, mange, jaundice and damp and hot numbness. Available its is ministerial drug, and consumption is 5 weight part��20 weight parts, as: but it is not limited only to 5 weight parts, 7 weight parts, 10 weight parts, 12 weight parts, 15 weight parts, 18 weight parts and 20 weight parts.
The perennial plant that the present invention's alleged " rheum officinale " is polygonaceae Rheum, wherein water chestnut rheum officinale Chang Zuowei is medicinal, has another name called south rheum officinale, and nature and flavor bitter cold, returns stomach, large intestine and Liver Channel, has and attacks stagnant, clearing away damp-heat, purging intense heat, cool blood, effect such as the stasis of blood and removing toxic substances of dispelling. Available its is adjutant, consumption is 30 weight part��70 weight parts, especially 30 weight part��50 weight part, as: but it is not limited only to 30 weight parts, 32 weight parts, 35 weight parts, 38 weight parts, 40 weight parts, 42 weight parts, 45 weight parts, 48 weight parts and 50 weight parts.
The present invention alleged " cape jasmine " is madder wort, nature and flavor bitter cold, the thoughts of returning home, liver, lung and stomach warp. There is purging intense heat relieving restlessness, clearing away heat and promoting diuresis, removing pattogenic heat from the blood and toxic material from the body, protect liver, profit courage, step-down, calmness, the effect such as hemostasis and detumescence. External application cures mainly fire, and sore does not rise, sore swells and ache, burn, pathogenic fire,toxin and furuncles and sprain and contusion pain etc. Available its is adjutant, consumption is 5 weight part��30 weight parts, especially 10 weight part��30 weight part, as: but it is not limited only to 10 weight parts, 12 weight parts, 15 weight parts, 18 weight parts, 20 weight parts, 22 weight parts, 25 weight parts, 28 weight parts and 30 weight parts.
The present invention's alleged " rhizoma et Radix Baphicacanthis Cusiae " is Acanthaceae per nnial herb, and nature and flavor are bitter, cold, the thoughts of returning home, liver and stomach warp, has clearing heat and detoxicating and cool blood and subsides a swelling effect. Cure mainly maculae caused by violent heat pathogen, the headache of high heat, major part pestilence, erysipelas, mumps, viral hepatitis, influenza, pneumonia, sore swell and the disease such as bleb. In its pan-fried soup, dose is generally 15 grams��30 grams, heavy dose of available to 60 grams��120 grams. Or appropriate, smash and apply or pan-fried soup is smoked washes external application. Available its is adjutant, and consumption is 5 weight part��20 weight parts, as: but it is not limited only to 5 weight parts, 7 weight parts, 10 weight parts, 12 weight parts, 15 weight parts, 18 weight parts and 20 weight parts.
The present invention's alleged " borneol " be by composite family Herba Blumeae Balsamiferae stem leaf or canella borneol camphor tree branches and leaves through steam distillation and recrystallization and obtain, also title borneol or 2-thatch alcohol (CAS:507-70-0). Taste is pungent, bitter, micro-cold; The thoughts of returning home, liver, lung channel; Delicate fragrance a surname is loose, has inducing resuscitation of having one's ideas straightened out, and the loose poison of heat-clearing, effect of improving acuity of vision and removing nebula, cures mainly pyreticosis unconsciousness due to high fever, and apoplexy coma due to blocking of the respiratory system shies epilepsy, and summer-heat and damp hoodwinks key clearly, and larynx numbness is deaf, and aphtha tooth swells, sore carbuncle infantile malnutrition due to digestive disturbances or intestinalparasites hemorrhoid, conjunctival congestion with pain and swelling of the eye, pterygium. Available its is adjutant, and consumption is 5 weight part��20 weight parts, as: but it is not limited only to 5 weight parts, 7 weight parts, 10 weight parts, 12 weight parts, 15 weight parts, 18 weight parts and 20 weight parts.
Children are the body of blood-head, and skin is tender and lovely, infect foul gas, invade stain skin and then send out as diaper rash, therefore are main medicine with Asian puccoon heat-clearing, cool blood and removing toxic substances. Again because children liver is often had a surplus, nice sweet food and fragrant dry thing in addition, stagnated heat originated endogenously, hot poison accumulates steaming skin, feels again the heresy of rheumatism, damp and hot Jusheng, rich knot skin and become eczema, therefore select kuh-seng, the coptis, rough gentian and Root-bark of Densefruit Pittany heat-clearing and damp-drying drug, removing toxic substances of dispeling the wind be ministerial drug altogether. Intimately flourishing, heat heap soil or fertilizer over and around the roots muscle is then sent out as furuncle, is necessary purging intense heat of detoxifying, therefore selects cape jasmine, rheum officinale and rhizoma et Radix Baphicacanthis Cusiae to let out its fire poison, and borneol also has swelling and pain relieving and preservative activity, is adjutant altogether. Full side share, and bitter cold is directly rolled over, and fire-evil is gone and heat poison solution, then all disease self-healing.
A kind of composition provided by the invention, is Chinese medicinal materials composition, by weight, comprises
Asian puccoon 30��70, the coptis 30��70, rheum officinale 30��70 and borneol 5��20.
Another kind of composition provided by the invention, is Chinese medicinal materials composition, by weight, comprises
Asian puccoon 30��70, the coptis 30��70, rough gentian 5��40, kuh-seng 5��20, Root-bark of Densefruit Pittany 5��20, rheum officinale 30��70, cape jasmine 5��30, rhizoma et Radix Baphicacanthis Cusiae 5��20 and borneol 5��20.
Another kind of composition provided by the invention, is Chinese medicinal materials composition, by weight, comprises
Asian puccoon 60, rheum officinale 40, the coptis 40, rough gentian 30, kuh-seng 15, cape jasmine 20, rhizoma et Radix Baphicacanthis Cusiae 10, Root-bark of Densefruit Pittany 10 and borneol 10.
Another kind of composition provided by the invention, is Chinese medicinal materials composition, by weight, comprises
Monarch's medicine: Asian puccoon 60 parts; With
Ministerial drug: Rhizoma Coptidis 40 parts; With
Adjutant: rheum officinale 40 parts; And
Make medicine: borneol 10 parts.
Another kind of composition provided by the invention, is Chinese medicinal materials composition, by weight, comprises
Monarch's medicine: Asian puccoon 30��70; With
Ministerial drug: the coptis 30��70, rough gentian 5��40, kuh-seng 5��20, Root-bark of Densefruit Pittany 5��20; With
Adjutant: rheum officinale 30��70, cape jasmine 5��30 and rhizoma et Radix Baphicacanthis Cusiae 5��20; And
Make medicine: borneol 5��20.
Various composition provided by the invention, bitter cold is directly rolled over, and fire-evil is gone and heat poison solution, then all disease self-healing, is suitable for treatment children's (comprising baby, child and children's etc.) dermatitis.
Composition provided by the invention, makes various preparation by the common concocting method of Chinese materia medica, as: but it is not limited only to decoction, powder, paste and patch etc.
For ease of using, prioritizing selection ointment of the present invention, comprise above-mentioned various composition, and the auxiliary material pharmaceutically accepted concocted jointly, pharmaceutically accepted auxiliary material as: but be not limited only to glycerine, ethyl p-hydroxybenzoate, trolamine, stearic acid, white vaseline, whiteruss, lanolin and deionized water. A kind of ointment preparation method provided by the invention, specific as follows:
Asian puccoon is taken by formula, rheum officinale, the coptis and borneol etc., Asian puccoon beats powder, borneol and grinding becomes powder, take except Asian puccoon, the medicinal extract that all taste medicinal materials outside borneol are made, with with 5w/w%��10w/w% paraffin, 25w/w%��50w/w% whiteruss, 5w/w% Vaseline, 5w/w% beeswax, 2.5w/w%��10w/w% Arlacel-80, the material heating and meltings such as 10w/w%��12.5w/w% stearin or high fatty alcohol (as: but being not limited only to carbon hexadecanol and carbon stearyl alcohol) mix mutually as oil phase, separately get 1w/w%��5w/w% tween-80, 0.1w/w% ethyl p-hydroxybenzoate, 0.1w/w%��0.5w/w% oxidation inhibitor BHA and water are heated to 80 DEG C as aqueous phase. oil phase and aqueous phase total amount are 100w/w%, supply surplus with water. stir oil phase, first add the aqueous phase of 1/3, after stirring 3 minutes��4 minutes, add remaining aqueous phase again. maintain 80 DEG C, stir 15 minutes, then naturally cooling, when temperature is down to about 40 DEG C, adding Asian puccoon, borneol powder, stirring and evenly mixing, until forming even emulsifiable paste, obtaining final product.
The useful effect that technical solution of the present invention realizes:
Various composition provided by the invention, is monarch's medicine taking Asian puccoon, makes with borneol, coordinating other several kinds of Chinese medicinal materials and become, having bitter cold directly rolls over, and makes effect that fire-evil is gone and heat poison is separated.
Various composition provided by the invention, specially for the skin that children are tender and lovely, clearing heat and detoxicating, profit is wet antipruritic, gentle non-stimulated, not easily irritated, has no drug resistance, is easy to be accepted by infant and the head of a family.
Embodiment
The technical scheme of the present invention is below described in detail. The embodiment of the present invention is only in order to illustrate the technical scheme of the present invention and unrestricted, although with reference to better embodiment to invention has been detailed explanation, it will be understood by those within the art that, the technical scheme of invention can be modified or equivalent replacement, and not departing from the spirit and scope of technical solution of the present invention, it all should be encompassed in the right of the present invention.
Embodiment 1
Getting Asian puccoon 30��70 and borneol 5��20 by weight, Asian puccoon beats powder, and borneol and grinding becomes powder.Put into the coptis 30��70 by weight and medicinal extract that rheum officinale 30��70 is made, with with 5w/w%��10w/w% paraffin, 25w/w%��50w/w% whiteruss, 5w/w% Vaseline, 5w/w% beeswax, 2.5w/w%��10w/w% Arlacel-80, the material heating and meltings such as 10w/w%��12.5w/w% stearin or high fatty alcohol (as: but being not limited only to carbon hexadecanol and carbon stearyl alcohol) mix mutually as oil phase, separately get 1w/w%��5w/w% tween-80, 0.1w/w% ethyl p-hydroxybenzoate, 0.1w/w%��0.5w/w% oxidation inhibitor BHA and water are heated to 80 DEG C as aqueous phase. oil phase and aqueous phase total amount are 100w/w%, supply surplus with water. stir oil phase, first add the aqueous phase of 1/3, after stirring 3 minutes��4 minutes, add remaining aqueous phase again. maintain 80 DEG C, stir 15 minutes, then naturally cooling, when temperature is down to about 40 DEG C, add 30��70 weight part Asian puccoons, 5��20 weight part borneol powder, stir evenly, be down to room temperature and get final product. before using, lotion is filling, it is stored in shady and cool ventilation place.
With above-mentioned same procedure, also adding a kind of medicinal material of rough gentian 5��40, kuh-seng 5��20, Root-bark of Densefruit Pittany 5��20, cape jasmine 5��30 and rhizoma et Radix Baphicacanthis Cusiae 5��20 or the medicinal extract of several medicinal material, the medicinal extract made with the coptis 30��70 and rheum officinale 30��70 is mixed with obtained lotion mutually with oil phase in the lump.
Embodiment 2
The obtained Chinese medicine composition ointment (being named: the clean ointment of youngster's rash) of the present embodiment 1 carries out clinical pre-experiment, and embodiment is as follows:
(1) clinical data
1. case source: all research case histories source is affiliated hospital of Shandong Traditional Chinese Medicine University the 2nd paediatrics outpatient service infant.
2. case selection standard: (1), based on infant, confirms as allergic dermatitis through checking; (2) position of dermatitis is mainly with the women's head-ornaments position such as around volume portion eyebrow, two cheeks, scalp, auricle, and shoulder, the back of the body, four limbs are main; (3) the lighter's pachylosis is rubescent, and severe one has the skins such as erythema, papule and bubble to damage, and accompanies swollen pain, sepage and erosion, local itch and tenderness; (4) companion cry and scream, have the fidgets, the symptom such as not good enough of sleeping, severe patient occurs together the constitutional symptoms such as heat.
3. include standard in: (1) makes a definite diagnosis as dermatitis; (2) infants within 4 years old; (3) skin plays erythema, papule, bubble, and even erosion is oozed out, and with itch.
4. exclusion standard: (1) more than 4 years old patient; (2) not by regulation medication or add and use other medicine; (3) get rid of and in 1 week, accept glucocorticosteroid and antihistamine drug treatment person; (4) breakage has erosion, oozes out and suppuration person; (5) immunization person during treatment.
5. reject standard: to being selected into this clinical study, belong to the one of following situation, as rejecting case: (1) does not meet the standard of including in, or the person that meets exclusion standard; (2) non-users of medicine; (3) without any keeper.
6. come off (exiting) standard: to being selected into this clinical study, belongs to the one of following situation, as the case that comes off: (1) experimenter's compliance is poor, can not medication according to quantity on time; (2) medicine that other influences tolerance judges is used; (3) experimenter is unwilling to proceed clinical trial, proposes, to physician, the person of exiting.
(2) medicine and methods for the treatment of is studied
1. study medicine:
Test drug: the ointment formulation of the Chinese medicine composition of the present embodiment 1, pack by Yangzijiang Pharmaceutical Group, Shanghai Haini Pharmaceutical Co., Ltd and provide, specification 10g/ box, test medication meets clinical study quality standard (draft) (see " GCP ", State Food and Drug Administration makes No. 3).
2. methods for the treatment of: getting this ointment coating affected part with cotton swab, every day 2��3 times 7 days is a course for the treatment of.
(3) project is observed
1. the relevant performance of dermatitis: the symptoms such as treatment front and back different times skin erythema, papule, bubble, itch, sleep;
2. trial period untoward reaction.
(4) some observing time
Observed with the medical same day, medical 3rd day, medical 7th day respectively.
(5) efficacy and safety judgement criteria
1. the standard of curative effect evaluation:
Recovery from illness: skin damages and disappears, and without crying and screaming, sleeps good; Total mark is 0 point;
Effective: skin damages and disappears > 90%, without crying and screaming agitation, sleep obviously improves; Total mark reduces > 50%;
Take a turn for the better: skin damages and do not disappear or increase increase, and agitation of crying and screaming, poor sleep do not improve; Total mark reduces < 30%.
2. safety evaluation standard:
With or without adverse events occurs between trial period.
(6) adverse events record, quality control and ethics requirement
Strictly being undertaken by GCP and relevant laws and regulations, detail is shown in research approach.
(7) data management and analysis
1. investigator must ensure that data are true, complete, accurate;
2. research record all items all need to fill in, must not null term, leakage item; Do any corrigendum can only rule, sidenote change after data, give reasons, and sign by investigator and date, must not obliterating, cover source recording;
3. test case completes observation and the data such as research record is handed in latter 3 days research responsible official's examination & verification, will study case friendship project responsible official in 10 days.
(8) statistical study
Completing by statistician, content comprises: 1. add up the selected quantity of experimenter, come off and reject case situation; 2. statistical study describes with all numbers, standard deviation, percentage; 3. safety analysis.
The obtained Chinese medicine composition ointment of the present embodiment 1 carries out clinical pre-experiment, and experimental result is as follows:
(1) totally 62 example infants include clinical trial in, and wherein 2 examples come off, and complete case 60 example, man 30 example, female 30 example.
(2) observation of curative effect:
1. rapid-action, about 1 day visible curative effect such as erythema, papule, poor sleep, itch can take effect half a day, within about 1.5 days, gets final product complete incidence graph, in table 1, table 2 and table 3.
Table 1 youngster examines each symptom onset time [�� S] of clean Ointment in Treatment children's's dermatitis
Table 2 youngster examines clean Ointment in Treatment children's's dermatitis itch onset and extinction time [�� S]
2. youngster examines clean Ointment in Treatment 3 days, and all observation cases is all effective in cure, and obvious effective rate 86.7%, always has efficiency 100%, in table 3.
Table 3 youngster examines clean Ointment in Treatment children's's dermatitis the 3rd day clinical efficacy [example (%)]
3. youngster examined clean Ointment in Treatment after 7 days, cure rate big 80%, and more person's clinical symptom is not obviously alleviated, in table 4.
Table 4 youngster examines clean treatment children's's dermatitis the 7th day clinical efficacy [example (%)]
(3) safety analysis:
Through clinical observation in 7 days, do not find untoward reaction.
The clinical upper harm mainly of dermatitis is that skin damages and very itches unbearably, and recurrent exerbation seriously affects children's's physical and mental health. Chinese medicine ointment provided by the invention has feature rapid-action, evident in efficacy in treatment eczema, and the itch of serious puzzlement infant got final product complete incidence graph at about 1 day half, and most case can be improved obviously by general manifestation within one week.
Except evident in efficacy, this prescription prescription is entirely Chinese medicine, has characteristic, and none example untoward reaction occurs or increases the weight of situation in experimentation, potential use value can be affirmed, but owing to experimental observation case is less, the time is shorter in pre-experimentation, the validity of medicine, security require further study test and confirm. For the pathological characteristic of dermatitis recurrent exerbation, the indexs of correlation such as infant recurrence rate should be observed further.
The technical scheme that the present embodiment provides is pure Chinese medicinal preparation, not containing hormone, treatment dermatitis is had obvious clinical effectiveness, and treatment cycle is short, curative ratio height, and without toxic side effect, smell without exception, is easy to be accepted by the patient head of a family.In Clinical observation all observation cases is all effective in cure, do not find untoward reaction. Compared with the paste of traditional treatment dermatitis, the paste of the present embodiment has clear superiority, has broad application prospects.
Claims (13)
1. composition prevents the application in the medicine of children's dermatitis in preparation, and described composition by weight, comprises
Asian puccoon 30��70, the coptis 30��70, rheum officinale 30��70 and borneol 5��20.
2. purposes according to claim 1, it is characterised in that described composition by weight, also adds one or more of kuh-seng 5��20, rough gentian 5��40 and Root-bark of Densefruit Pittany 5��20.
3. purposes according to claim 2, it is characterised in that described kuh-seng is 15 weight parts.
4. purposes according to claim 2, it is characterised in that described rough gentian is 30 weight parts.
5. purposes according to claim 2, it is characterised in that described cape jasmine is 20 weight parts.
6. purposes according to claim 1, it is characterised in that described composition by weight, also adds one or more of cape jasmine 5��30 and rhizoma et Radix Baphicacanthis Cusiae 5��20.
7. purposes according to claim 6, it is characterised in that described Root-bark of Densefruit Pittany is 10 weight parts.
8. purposes according to claim 6, it is characterised in that described rhizoma et Radix Baphicacanthis Cusiae is 10 weight parts.
9. according to the purposes one of claim 1-8 Suo Shu, it is characterised in that described Asian puccoon is 60 weight parts.
10. according to the purposes one of claim 1-8 Suo Shu, it is characterised in that described rheum officinale is 40 weight parts.
11. according to the purposes one of claim 1-8 Suo Shu, it is characterised in that the described coptis is 40 weight parts.
12. according to the purposes one of claim 1-8 Suo Shu, it is characterised in that described borneol is 10 weight parts.
13. 1 kinds of compositions are in the application prepared in the ointment preventing children's dermatitis, it is characterised in that described ointment is produced as follows:
Taking all taste medicinal materials by the composition one of claim 1-12 Suo Shu, described Asian puccoon beats powder, and described borneol and grinding becomes powder, the medicinal extract that all taste medicinal materials taken except described Asian puccoon and described borneol are made, and mixes mutually with oil phase, phase of separately fetching water; Stir oil phase, first add the aqueous phase of 1/3, add remaining aqueous phase again after stirring 3 minutes��4 minutes, maintain 80 DEG C, stir 15 minutes, then naturally cooling, when temperature is down to about 40 DEG C, add Asian puccoon, borneol powder, stirring and evenly mixing, until forming even emulsifiable paste, to obtain final product;
Described oil phase is obtained by 5w/w%��10w/w% paraffin, 25w/w%��50w/w% whiteruss, 5w/w% Vaseline, 5w/w% beeswax, 2.5w/w%��10w/w% Arlacel-80 and 10w/w%��12.5w/w% stearin or high fatty alcohol heating and melting;
Described aqueous phase is heated to 80 DEG C by 1w/w%��5w/w% tween-80,0.1w/w% ethyl p-hydroxybenzoate, 0.1w/w%��0.5w/w% oxidation inhibitor BHA and water and is obtained;
Described oil phase and described aqueous phase total amount are 100w/w%, supply surplus with water.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109481725A (en) * | 2018-12-12 | 2019-03-19 | 徐子寒 | A kind of instant Glycyrrhiza Oil Compound dressing and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1739638A (en) * | 2005-08-31 | 2006-03-01 | 赵运荣 | Medicine for treating dermatosis and its prepn |
| CN103340965A (en) * | 2013-06-09 | 2013-10-09 | 马应龙药业集团股份有限公司 | External pharmaceutical composition used for treating skin diseases like eczema, dermatitis and tinea and preparation method thereof |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1739638A (en) * | 2005-08-31 | 2006-03-01 | 赵运荣 | Medicine for treating dermatosis and its prepn |
| CN103340965A (en) * | 2013-06-09 | 2013-10-09 | 马应龙药业集团股份有限公司 | External pharmaceutical composition used for treating skin diseases like eczema, dermatitis and tinea and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109481725A (en) * | 2018-12-12 | 2019-03-19 | 徐子寒 | A kind of instant Glycyrrhiza Oil Compound dressing and preparation method thereof |
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Application publication date: 20160608 |