CN105582089A - Composition for preventing and treating pediatric skin diseases and preparation method of composition - Google Patents
Composition for preventing and treating pediatric skin diseases and preparation method of composition Download PDFInfo
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- CN105582089A CN105582089A CN201410640272.8A CN201410640272A CN105582089A CN 105582089 A CN105582089 A CN 105582089A CN 201410640272 A CN201410640272 A CN 201410640272A CN 105582089 A CN105582089 A CN 105582089A
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Abstract
The invention relates to a composition for preventing and treating pediatric skin diseases. The composition is prepared from the following traditional Chinese medicinal materials in parts by weight: 30-70 parts of radix lithospermi, 30-70 parts of rhizoma coptidis, 30-70 parts of radix et rhizoma rhei, and 5-20 parts of borneol. According to the composition, radix lithospermi is taken as the monarch drug, and is matched with the other traditional Chinese medicinal materials to prepare the composition, the composition aims at the tender skin of children, has the efficacies of clearing away heat and toxic materials, as well as removing dampness and relieving itching, and is mild without irritation, irritability is seldom caused, no drug resistance is generated, and the composition is easy to accept by children patients and parents.
Description
Technical field
The present invention relates to a kind of plant to be processed and the composition made, relate in particular to a kind of taking Asian puccoon as monarch drug in a prescriptionChinese medicine composition, for the control of children ' s dermatosis.
Background technology
Infantile eczema is commonly called as infantile eczema, is that caused by many factors a kind of has the scytitis that obviously oozes out tendency and react,Fall ill in the baby in 1～June, affected part itch is hard to bear, makes baby's agitation, the uneasiness of crying and screaming, brings to infant and the head of a familyMany worries. The infant eczema incidence of disease has the trend of rising in recent years, and does not touchingly heal, repeatedly outbreak. Existing marketOn eczema medication divide two kinds, Chinese medicine and Western medicine, Western medicine adopts oral antihistamines and external application steroids Ointment in Treatment more, thoughEffective in cure, but side effect is large, bad reaction is many, and drug withdrawal easily recurs, and is not suitable for baby and uses. Chinese medicine is in theory of traditional Chinese medical scienceUnder guidance, control according to the dialectical opinion of different syndrome type, there is good absorbing, safe and effective, the feature that has no side effect, easily by infant andThe head of a family accepts. But the medicine for the treatment of eczema for infant specially is in the market still for blank.
Diaper dermatitis (red stern) claims again diaper rash, be baby buttocks be subject to urine, ight soil and unclean damp diaper stimulate,After friction, the symptom such as the rubefaction that causes, swelling, papule, blister, erosion, warts, ulcer, makes baby cryingUneasy. Skin damages the position that is often confined to touching diaper, as portions such as buttocks protruded part, external genital, lower abdomen and burst inner sides, itsIt is suitable that scope and diaper hide position. How because diaper is not soaked and do not change in time by stool and urine, during the uremic in urine is defecatedBacterium decompose produce ammonia, chafe produce inflammation. In addition, diaper is not cleaned or is used for a long time Polypropylence Sheet, makes children'sButtocks, for a long time in dampness, also can cause diaper dermatitis.
Diaper rash is common disease in neonate, and almost each infant can be subject to the puzzlement of diaper dermatitis. ByTender and lovely in infant's skin, should not use adult's diaper dermatitis (red stern) medication, more can not use antibiotics and hormoneClass medicine, so will use professional infant's skin medication. The medicine for the treatment of diaper dermatitis (red stern), dermatitis at presentMore, but be mostly Western medicine formula, mainly for adult, to infant inapplicable.
Chinese invention patent application 201010538080.8 discloses a kind of lotion for the treatment of eczema, by rhizoma atractylodis 30-40 part,Bletilla striata 30-40 part, Chinese gall 30-40 part, rheum officinale 10-30 part, grass-leaved sweetflag 20-40 part, golden cypress 10-30 part, purpleGrass 10-30 part, root bark of shaggy-fruited dittany 20-40 part, horse tooth are looked for the kinds of traditional Chinese medicines material such as 20-30 part and kuh-seng 20-40 part and are made, energyFor the treatment of multiple eczema.
Chinese invention patent application 201410311388.7 discloses a kind of traditional Chinese medicinal ointment for the treatment of infantile eczema, by Asian puccoon30-35 part, root of large-flowered skullcap 12-18 part, coptis 12-18 part, root of Dahurain angelica 20-25 part, caulis lonicerae 20-25 part, rheum officinale 12-16Part, cape jasmine 12-18 part, peppermint 12-16 part, golden cypress 12-18 part, gypsum 10-15 part, Poria cocos 10-15 part, whiteArt 8-12 part, Fructus Aurantii 8-12 part, fruit of summer cypress 8-12 part, honeysuckle 12-18 part, folium isatidis 12-18 part, fructus amomi 16-18Part, Chinese bulbul 16-18 part and borneol 15-20 part etc. are made, and 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 festeredThing, by 10 grams of Asian puccoons, 6 grams of frankincenses, 6 grams of myrrhs, 8 grams, catechu, 12 grams of the roots of Dahurain angelica, 12 grams of giant knotweeds, the root of large-flowered skullcap 9Gram and 10 grams of rheum officinales wait Chinese medicines, add in boiled peanut oil (or sesame oil), be after coke yellow, leave standstill, treat temperatureDegree drops to after room temperature, more appropriate borneol is added wherein, and makes after stirring. To infant's skin without anyToxic and side effect, successful.
Summary of the invention
One object of the present invention is to provide a kind of Chinese medicine composition, for children ' s dermatosis, as: eczema, urinePrevention and the treatment of cloth rash, furuncle, burn, scald and bite by mosquitos etc.
Another object of the present invention is to provide a kind of composition of being made up of several kinds of Chinese medicinal materials, or taking it as active one-tenthPoint, coordinate and add other auxiliary material, for the preparation of prevention and treatment children ' s dermatosis, as: eczema, diaper rash, furuncle,The preparation of burn, scald and bite by mosquitos etc.
It is a kind of taking several kinds of Chinese medicinal materials as the method that medicine portion produces preparation that a further object of the present invention is to provide, and is convenient toIn the prevention of children ' s dermatosis and treatment, use.
Alleged " prevention " of the present invention refer to before the disease of not assert by clinical criteria, various for preventing that disease from sending outMeans or the measure of raw or development, comprise the method for medical science, physics or chemistry, to stop and to reduce the various symptoms of diseaseOccur or development.
Alleged " treatment " of the present invention refers to generation or the development in order to stop and reduce disease, makes sending out of disease courseOpen up or increase the weight of to be suppressed, contain, alleviate, improve, slow down, stop, postponing or reverse, described maintenance or useVarious indexs disease when medicine, disorderly or pathologic state comprise and alleviate or reduces symptom or complication, or healingOr eliminate a disease, disorder or situation.
Alleged " preparation " of the present invention refers to that containing each Plants provided by the invention and extract and active site thereof hasBe beneficial to the formulation of administration, as: but be not limited only to, aqueous solution injection, powder-injection, pill, powder, tablet, patch,Suppository, emulsion, creme, gel, granule, capsule, aerosol, spray, powder spray, sustained release agent and controlRelease agent etc. These pharmaceutic adjuvants can be both conventional uses in various preparations, as: but be not limited only to isotonic agent, slowRush liquid, flavouring, excipient, filler, adhesive, disintegrant and lubricant etc.; Also can be for described thingMatter adapts and choice for use, as: emulsifying agent, solubilizer, bacteriostatic agent, anodyne and antioxidant etc., this class auxiliary materialCan effectively improve the stability of the contained compound of composition and rate of release and the absorption rate of dissolubility or change compoundDeng, thereby improve the compounds of this invention metabolism in vivo, and then strengthen administering effect. In addition can also be real,Now specific administration object or mode, as: sustained-release administration, controlled release drug administration and pulsatile administration etc., and the auxiliary material using, as:But be not limited only to, gelatin, albumin, shitosan, polyethers and polyesters macromolecular material, as: but be not limited only to, poly-Ethylene glycol, polyurethane, Merlon and copolymer thereof etc. The main manifestations of alleged " being conducive to administration " has: but notOnly limit to improve result for the treatment of, improve bioavilability, reduce toxic and side effect and improve patient's compliance etc.
Alleged " Asian puccoon " of the present invention is Boraginaceae puccoon, nature and flavor bitter cold, thoughts of returning home envelope, Liver Channel. It entersMedicine can be used for preventing measles, treatment anaphylactoid purpura, treatment thrombocytopenic purpura, treatment herpes simplex, control burning hotWith and due to foaming rot, control ulcer and just close and treat the illnesss such as five subcutaneous ulcers heat are yellow, play clearing heat and detoxicating and promoting blood circulation and cooling bloodEffect. Available its is monarch drug in a prescription, and consumption is 30 weight portion～70 weight portions, especially 50 weight portion～70 weight portions,Cure mainly the diseases such as burn, eczema, erysipelas, large carbuncle and macula, as: but be not limited only to 50 weight portions, 52 weight portions, 55Weight portion, 58 weight portions, 60 weight portions, 62 weight portions, 65 weight portions, 68 weight portions and 70 weight portions.
The present invention alleged " coptis " is Ranunculaceae Coptis herbaceos perennial, bitter cold in nature, the thoughts of returning home, liver, stomachAnd large intestine channel, there is purging intense heat and detonicating and removing dampness and destroying parasites effect, full for damp and hot ruffian, vomit acid regurgitation, rush down dysentery, jaundice, heightHot coma, heart-fire hyperactivity, dysphoria and insomnia, blood-head tell nosebleed, hot eyes, have a toothache, quench one's thirst and the disease such as the swollen furunculosis of carbuncle; Control carbuncle outwardThe diseases such as swollen furunculosis, the wet sore of eczema and empyrosis. Available its is ministerial drug, and consumption is 30 weight portion～70 weight portions, outstandingIt is 30 weight portion～50 weight portions, as: but be not limited only to 30 weight portions, 32 weight portions, 35 weight portions, 38Weight portion, 40 weight portions, 42 weight portions, 45 weight portions, 48 weight portions and 50 weight portions.
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 fireCourage excess fire. External application cures mainly the swollen sore of carbuncle, eczema itch. Available its is ministerial drug, and consumption is 5 weight portion～40 weight portions,Especially 20 weight portion～40 weight portions, as: but be not limited only to 20 weight portions, 22 weight portions, 25 weight portions, 28Weight portion, 30 weight portions, 32 weight portions, 35 weight portions, 38 weight portions and 40 weight portions.
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 intestinl channel.Effect of tool heat-clearing and damp-drying drug, desinsection diuresis. External application cures mainly eczema, pruitus, mange leprosy, trichomonas vaginitis.Available its is ministerial drug, and consumption is 5 weight portion～20 weight portions, as: but be not limited only to 5 weight portions, 7 weight portions, 10Weight portion, 12 weight portions, 15 weight portions, 18 weight portions and 20 weight portions.
The root skin that the present invention's alleged " root bark of shaggy-fruited dittany " is Rutaceae herbaceos perennial shaggy-fruited dittany and Dictamnus angustifolius, nature and flavor hardshipCold, return spleen and stomach warp, there is heat-clearing and damp-drying drug and timid wind detoxicating functions. Cure mainly rubella, eczema, scabies due to the wet poison of wind-heatThe diseases such as tinea, jaundice and damp-heat arthralgia. Available its is ministerial drug, and consumption is 5 weight portion～20 weight portions, as: but not only forIn 5 weight portions, 7 weight portions, 10 weight portions, 12 weight portions, 15 weight portions, 18 weight portions and 20 weight portions.
The perennial plant that the present invention's alleged " rheum officinale " is polygonaceae Rheum, wherein todaiwo,rhizoma Chang Zuowei is medicinal, againName RADIX ET RHIZOMA RHEI OFFICILALIS, nature and flavor bitter cold, returns stomach, large intestine and Liver Channel, have attack stagnant, clearing away damp-heat, purging intense heat, cool blood, the stasis of blood of dispelling andThe effects such as removing toxic substances. Available its is adjutant, and consumption is 30 weight portion～70 weight portions, especially 30 weight portion～50 weightsAmount part, as: but be not limited only to 30 weight portions, 32 weight portions, 35 weight portions, 38 weight portions, 40 weight portions, 42Weight portion, 45 weight portions, 48 weight portions and 50 weight portions.
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 heatRelieving restlessness, reducing fever and causing diuresis, removing pattogenic heat from the blood and toxic material from the body, protect the effects such as liver, cholagogic, step-down, calmness, hemostasis and detumescence. External application cures mainlyFire sore does not rise, sore swells and ache, burn, pathogenic fire,toxin and furuncles and bruise pain etc. Available its is adjutant, consumption be 5 weight portions～30 weight portions, especially 10 weight portion～30 weight portions, as: but be not limited only to 10 weight portions, 12 weight portions, 15Weight portion, 18 weight portions, 20 weight portions, 22 weight portions, 25 weight portions, 28 weight portions and 30 weight portions.
The present invention's alleged " rhizoma et Radix Baphicacanthis Cusiae " is Acanthaceae herbaceos perennial, nature and flavor hardship, cold, the thoughts of returning home, liver and stomachWarp, has clearing heat and detoxicating and cool blood detumescence effect. Cure mainly febrile virulent maculae, the headache of high heat, major part pestilence, erysipelas, mumps,The diseases such as the swollen and bleb of virus hepatitis, influenza, pneumonia, sore. It is decocted dose in soup and is generally 15 grams～30Gram, heavy dose of available to 60 grams～120 grams. Or appropriate, smash and apply or decoct that soup is smoked washes external application. Available its is adjutant,Consumption is 5 weight portion～20 weight portions, as: but be not limited only to 5 weight portions, 7 weight portions, 10 weight portions, 12 weightsAmount part, 15 weight portions, 18 weight portions and 20 weight portions.
The present invention's alleged " borneol " is by composite family Blumea balsamifera cauline leaf or canella borneol camphor tree branches and leaves through steam distillation alsoBe recrystallized and obtain, also claiming borneol or 2-borneol (CAS:507-70-0). Taste is pungent, bitter, is slightly cold; The thoughts of returning home, liver, lungWarp; Delicate fragrance a surname is loose, has the inducing resuscitation of having one's ideas straightened out, the loose poison of heat-clearing, and effect of removing nebula, cures mainly pyreticosis unconsciousness due to high fever, apoplexyComa due to blocking of the respiratory system is shied epilepsy, and summer-heat and damp is hoodwinked key clearly, larynx numbness deafness, and aphtha tooth is swollen, sore carbuncle infantile malnutrition due to digestive disturbances or intestinalparasites hemorrhoid, red eye, swell pain, pterygium. CanBe adjutant with it, consumption is 5 weight portion～20 weight portions, as: but be not limited only to 5 weight portions, 7 weight portions, 10Weight portion, 12 weight portions, 15 weight portions, 18 weight portions and 20 weight portions.
Children are the body of blood-head, bear a pretty, delicate skin, and infect foul gas, invade stain skin and send out as diaper dermatitis, therefore with purpleGrass heat-clearing, cool blood and removing toxic substances are main ingredient. Again because children's the liver being liable to excess, nice sweet food and fragrant dry thing in addition, interior life is long-pendingHeat, hot poison accumulates steaming skin, feels again the heresy of rheumatism, damp and hot Jusheng, rich knot skin forms eczema, therefore select kuh-seng, the coptis,Rough gentian and root bark of shaggy-fruited dittany heat-clearing and damp-drying drug, the removing toxic substances of dispeling the wind are ministerial drug altogether. Intimately flourishing, heat heap soil or fertilizer over and around the roots muscle is sent out as furuncle, is to separateThe necessary purging intense heat of poison, therefore select cape jasmine, rheum officinale and rhizoma et Radix Baphicacanthis Cusiae to let out its fire poison, borneol also has swelling and pain relieving and antisepsis,Be adjutant altogether. Full side share, and bitter cold is directly rolled over, and fire-evil is gone and heat poison solution, all disease self-healing.
A kind of composition provided by the invention, is Chinese medicine 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 medicine composition, by weight, comprises
Asian puccoon 30～70, the coptis 30～70, rough gentian 5～40, kuh-seng 5～20, the root bark of shaggy-fruited dittany 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 medicine 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, the root bark of shaggy-fruited dittany10 and borneol 10.
Another kind of composition provided by the invention, is Chinese medicine composition, by weight, comprises
Monarch drug in a prescription: 60 parts of Asian puccoons; With
Ministerial drug: 40 parts of RHIZOMA COPTIDIS from Sichuan of China; With
Adjutant: 40 parts of rheum officinales; And
Make medicine: 10 parts of borneols.
Another kind of composition provided by the invention, is Chinese medicine composition, by weight, comprises
Monarch drug in a prescription: Asian puccoon 30～70; With
Ministerial drug: the coptis 30～70, rough gentian 5～40, kuh-seng 5～20, the root bark of shaggy-fruited dittany 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, and all disease self-healing, is suitable forEczema and furuncle etc. due to treatment children's (comprising baby, child and children's etc.) blood poison, heat poison, wet poison, and burnThe disease of skin such as wound, scald and bite by mosquitos.
Composition provided by the invention, makes various preparations by the common concocting method of traditional Chinese medicine, as: but be not limited only toDecoction, powder, paste and patch etc.
For ease of using, the present invention preferentially selects ointment, comprises above-mentioned various composition, and pharmaceutically acceptsCommon process of preparing Chinese medicine of auxiliary material form, pharmaceutically the auxiliary material of accepting as: but be not limited only to glycerine, ethylparaben, triethanolamine,Stearic acid, albolene, paraffin, atoleine, lanolin and deionized water. A kind of ointment provided by the inventionPreparation method, specific as follows:
Take Asian puccoon, rheum officinale, the coptis and borneol etc. by formula, Asian puccoon beats powder, borneol and grinding powdered, except Asian puccoon,All taste medicinal materials outside borneol, add the ethanol (as: concentration of 50v/v%～95v/v%) of debita spissitudo to decoct three times,Decocting liquid filter, merge, being concentrated into relative density is the concentrate of 1.15～1.25 (60 DEG C～65 DEG C), by 1w/w%～2w/w% triethanolamine, 5w/w%～20w/w% glycerine, 0.1w/w% ethylparaben, and surplus is that water is to containerMix, obtain water, be heated to 80 DEG C of insulations; Separately get 10w/w%～16w/w% stearic acid, 10w/w%～20w/w%The mixture of vaseline and paraffin or liquid paraffin and 1w/w%～5w/w% lanolin, put another vessel in heating melting,Obtain oil phase, be incubated 80 DEG C; Oil phase and water total amount are 100w/w%, supply surplus with water. (in thread shape mode)Oil phase is added in water, and the stirring of same direction, be cooled to 45 DEG C～50 DEG C, add Asian puccoon, borneol powder, stirMix evenly, be down to room temperature and get final product. Before use, lotion is filling, be stored in shady and cool ventilation place.
The beneficial effect that technical solution of the present invention realizes:
Various composition provided by the invention, taking Asian puccoon as monarch drug in a prescription, makes with borneol, coordinates other several kinds of Chinese medicinal materials to form,There is bitter cold and directly roll over, fire-evil is gone and effect of heat poison solution.
Various composition provided by the invention, special in the tender and lovely skin of children, clearing heat and detoxicating, dampness removing is antipruritic, temperatureWith non-stimulated, be difficult for allergy, have no drug resistance, be easy to be accepted by infant and the head of a family.
Various composition provided by the invention, adopts natural plant material as medicine portion treatment infant eczema, furuncleAnd the disease of skin such as burn, scald and bite by mosquitos is evident in efficacy, containing stimulation component, be conducive to protect infant tenderTender skin, safety is gentle, has no side effect, and curative effect is clear and definite, easy to use, and the prices of raw and semifnished materials are cheap, are suitable for facingLarge-scale promotion on bed.
Detailed description of the invention
Below describe technical scheme of the present invention in detail. The embodiment of the present invention is only in order to illustrate technical scheme of the present inventionUnrestricted, although the present invention is had been described in detail with reference to preferred embodiment, those of ordinary skill in the art should manageSeparate, can to invention technical scheme modify or be equal to replacement, and do not depart from technical solution of the present invention spirit andScope, it all should be encompassed in claim scope of the present invention.
Embodiment 1
Get by weight Asian puccoon 30～70 and borneol 5～20, Asian puccoon beats powder, borneol and grinding powdered. Put into by weightThe coptis 30～70 and rheum officinale 30～70, add the ethanol of concentration 50v/v%～95v/v% to decoct three times, and decocting liquid filters, and closesAnd being concentrated into relative density is the concentrate of 1.15～1.25 (60 DEG C～65 DEG C), by 1w/w%～2w/w% tri-ethanolAmine, 5w/w%～20w/w% glycerine, 0.1w/w% ethylparaben, and surplus is that water mixes to container, obtains water,Be heated to 80 DEG C of insulations; Separately get 10w/w%～16w/w% stearic acid, 10w/w%～20w/w% vaseline and paraffin or liquidThe mixture of shape paraffin and 1w/w%～5w/w% lanolin, put another vessel in heating melting, obtains oil phase, insulation 80DEG C oil phase and water total amount are 100w/w, supply surplus with water. Oil phase is added in water with thread shape, and same sideTo stirring, be cooled to 45 DEG C～50 DEG C, add 30～70 weight portion Asian puccoons, 5～20 weight portion borneol powder, stir allEven, be down to room temperature and get final product. Before use, lotion is filling, be stored in shady and cool ventilation place.
Embodiment 2
The Chinese medicine composition ointment (being named: the clean ointment of youngster's rash) that the present embodiment 1 makes carries out clinical preliminary experiment, implementsScheme is as follows:
(1) clinical data
1. case source: all research case histories source is Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine Pediatric Clinic infant.
2. case selection standard: (1) is taking 0～3 years old infant as main; (2) position of eczema is mainly with forehead eyebrow, twoCheek, scalp, the auricle women's head-ornaments position such as around, shoulder, the back of the body, four limbs are main; The position of diaper dermatitis (red stern) mainly withButtocks, perineum, hepatic portal, thigh root are main; (3) the lighter's pachylosis is rubescent, and severe one has erythema, papule, blisterThe skin such as rash and bubble damages, and accompanies distending pain, sepage and erosion, local itch and tenderness; (4) companion cry and scream, have the fidgets,The symptom such as sleep not good enough, the severe patient constitutional symptom such as heat, skin ulcer that occurs together.
3. inclusive criteria: (1) is diagnosed as infantile eczema or diaper dermatitis; (2) 3 years old with interior infant; (3) skin risesErythema, papule, bleb and bubble, even erosion is oozed out, and with itch, distending pain, tenderness.
4. exclusion standard: (1) more than 3 years old patient; (2) not medication or add with other medicines in accordance with regulations; (3) get rid of 1In week, accept glucocorticoid and antihistamine drug curer; (4) breakage has erosion, oozes out and suppuration person; (5) treatmentImmunity inoculation person during this time.
5. rejecting standard: to being selected into this clinical research, belong to the one of following situation, as rejecting case: (1)Do not meet inclusive criteria, or the person that meets exclusion standard; (2) not users of medicine; (3) without any keeper.
6. (exiting) standard comes off: to being selected into this clinical research, belong to the one of following situation, as coming offCase: (1) experimenter's compliance is poor, medication according to quantity on time; (2) medicine that uses other influences tolerance to judge;(3) experimenter is unwilling to proceed clinical testing, proposes bolter to physician.
(2) drugs and methods for the treatment of
1. drugs:
Test drug: the ointment formulation of the Chinese medicine composition of the present embodiment 1, by sea, Yangzijiang Pharmaceutical Group Shanghai Buddhist nun's medicine companyCo., Ltd packs and provides, specification 10g/ box, test medication meet quality standard for clinical research (draft) (referring to" GCP ", State Food and Drug Administration makes No. 3).
2. methods for the treatment of: getting this ointment with cotton swab and apply affected part, every day 2～3 times, 7 days is a course for the treatment of.
(3) observation item
1. the relevant performance of infantile eczema, diaper dermatitis (red stern): different times erythema before and after treatment, papule,The symptom such as bleb, tenderness;
2. experimental period bad reaction.
(4) observing time point
Observed with the medical same day, medical the 3rd day, medical the 7th day respectively.
(5) efficacy and safety evaluation criterion
1. the standard of curative effect evaluation:
Recovery from illness: skin damages and disappears, without crying and screaming, sleeps good, oncontacting pain; Total mark is 0 point;
Effective: skin damages and disappears > 90%, without crying and screaming agitation, sleep obviously improves, and the sense of touching a tender spot is not obvious; Total mark reduces>50％；
Take a turn for the better: skin damages and do not disappear or increase increase, and the agitation of crying and screaming, poor sleep do not improve, touch a tender spot sense obviously; Total long-pendingDivide and reduce < 30%.
2. safety evaluatio standard:
Duration of test has or not and occurs adverse events.
(6) adverse events record, quality control and ethics requirement
Strictly undertaken by GCP and relevant laws and regulations, detail is shown in research approach.
(7) data management and analysis
1. researcher must ensure that data are true, complete, accurate;
2. research is recorded all items and is all needed to fill in, must not null term, leak; Doing any corrigendum can only rule, and sidenote changesAfter data, give reasons, and sign and date by researcher, must not obliterating, cover original record;
3. test case completes to observe in latter 3 days and will study the data friendship lead study author examination & verifications such as record, in 10 days, will studyCase is handed over project leader.
(8) statistical analysis
Completed by statistician, content comprises: 1. add up subject enrollment quantity, come off and reject case situation; 2. systemScore is analysed with mean, standard deviation, percentage and is described; 3. safety analysis.
The Chinese medicine composition ointment that the present embodiment 1 makes carries out clinical preliminary experiment, and experimental result is as follows:
(1) totally 57 routine infants are included clinical testing in, and wherein 2 examples come off, and complete case 55 examples, male 27 examples, female's 28 examples.
(2) observation of curative effect:
1. rapid-action, approximately 1 day visible curative effect such as erythema, papule, bleb, poor sleep, itch can take effect half a day,Within approximately 1.5 days, can alleviate completely, in table 1, table 2 and table 3.
Table 1 youngster examines clean Ointment in Treatment infantile eczema, each symptom onset time of diaper rash [± S]
Table 2 youngster examines clean Ointment in Treatment infantile eczema itch onset and extinction time [± S]
Table 3 youngster examines clean Ointment in Treatment infantile eczema itch onset and extinction time [± S]
2. youngster examines clean Ointment in Treatment 3 days, all effective in cure to all observation cases, obvious effective rate 86.7%, and total effective rate 100%,In table 4.
Table 4 youngster examines clean Ointment in Treatment infantile eczema, the 3rd day clinical efficacy [example (%)] of diaper rash
3. youngster examined clean Ointment in Treatment after 7 days, and cure rate is large 80%, and more person's clinical symptoms are obviously alleviated, in table 5.
Table 5 youngster examines the 7th day clinical efficacy [example (%)] of clean treatment infantile eczema
(3) safety analysis:
Through clinical observation in 7 days, do not find bad reaction.
Eczema clinically main harm is that skin damages and very itches unbearably, and outbreak has a strong impact on children's's physical and mental health repeatedly. This realityThe Chinese medicine ointment (youngster examines clean ointment) that executing example provides is having feature rapid-action, evident in efficacy aspect treatment eczema,The itch of serious puzzlement infant can be alleviated completely at approximately 1 day half, and majority of cases can improve obviously within one week in whole body performance.
Diaper rash clinically main harm is that skin damages and touches a tender spot, and outbreak has a strong impact on children's's physical and mental health repeatedly. This enforcementThe Chinese medicine ointment (youngster examines clean ointment) that example provides is having feature rapid-action, evident in efficacy aspect treatment diaper rash,The tenderness of serious puzzlement infant can be alleviated completely at approximately 1 day half, and majority of cases can improve obviously within one week in whole body performance.
Except evident in efficacy, this prescription prescription is entirely Chinese medicine, has characteristic, and none example is bad in experimentationReaction occurs or increases the weight of situation, and potential use value can affirm, but in preliminary experiment process because experimental observation case is less,The reason that time is shorter, the validity of medicine, security require further study test and confirm. For infantile eczema, urineThe pathological characteristic that cloth rash is shown effect repeatedly, should further observe the indexs of correlation such as infant recurrence rate.
The composition that the present embodiment provides is pure Chinese medicinal preparation, not containing hormone, treatment infantile eczema and diaper rash is had obviouslyClinical effectiveness, treatment cycle is short, cure rate is high, without toxic side effect, without unusual odor, is easy to be accepted by the patient head of a family.All effective in cure to all observation cases in Clinical observation, do not find bad reaction. The present invention and traditional treatment eczemaPaste compare and there is clear superiority.
The composition that the present embodiment provides is also applicable to the situations such as burn, scald, furuncle and bite by mosquitos.
Claims (18)
1. a composition, is characterised in that, by weight, comprises
Asian puccoon 30～70, the coptis 30～70, rheum officinale 30～70 and borneol 5～20.
2. composition according to claim 1, is characterized in that, by weight, also adds kuh-seng 5～20, dragonOne or more of courage 5～40 and the root bark of shaggy-fruited dittany 5～20.
3. composition according to claim 2, is characterized in that described kuh-seng is 15 weight portions.
4. composition according to claim 2, is characterized in that described rough gentian is 30 weight portions.
5. composition according to claim 2, is characterized in that described cape jasmine is 20 weight portions.
6. composition according to claim 1, is characterized in that, by weight, also adds cape jasmine 5～30 and southOne or more of Radix Isatidis 5～20.
7. composition according to claim 6, is characterized in that the described root bark of shaggy-fruited dittany is 10 weight portions.
8. composition according to claim 6, is characterized in that described rhizoma et Radix Baphicacanthis Cusiae is 10 weight portions.
9. a composition, is characterised in that, by weight, comprises
Monarch drug in a prescription: Asian puccoon 30～70; With
Ministerial drug: the coptis 30～70; With
Adjutant: rheum officinale 30～70; And
Make medicine: borneol 5～20.
10. according to the composition one of claim 1-9 Suo Shu, it is characterized in that described Asian puccoon is 60 weight portions.
11. according to the composition one of claim 1-9 Suo Shu, it is characterized in that described rheum officinale is 40 weight portions.
12. according to the composition one of claim 1-9 Suo Shu, it is characterized in that the described coptis is 40 weight portions.
13. according to the composition one of claim 1-9 Suo Shu, it is characterized in that described borneol is 10 weight portions.
14. prevent and treat eczema, furuncle, burn, scald in preparation according to the composition one of claim 1-9 Suo ShuApplication in the medicine of wound or bite by mosquitos.
15. according to the composition one of claim 1-9 Suo Shu in preparation prevention and treatment infantile eczema or diaper dermatitisApplication in medicine.
16. 1 kinds of preparations, is characterized in that the composition that comprises that one of claim 1-13 is described.
17. preparations according to claim 16, is characterized in that described preparation is ointment.
18. preparations according to claim 17, is characterized in that producing as follows:
Take all taste medicinal materials by the composition one of claim 1-13 Suo Shu, described Asian puccoon beats powder, and described borneol grindsClay into power, all taste medicinal materials except described Asian puccoon and described borneol, add the ethanol of 50v/v%～95v/v% to decoctThree times, decocting liquid filters, and merges, and is concentrated into 60 DEG C～65 DEG C concentrates that relative density is 1.15～1.25, gets 80 DEG C of waterPhase, separately gets 80 DEG C of oil phases, described oil phase is added in described water, and same direction stirs, be cooled to 45 DEG C～50 DEG C, add described Asian puccoon and described borneol powder, stir, be down to room temperature and get final product;
Described water consists of 1w/w%～2w/w% triethanolamine, 5w/w%～20w/w% glycerine and 0.1w/w% nipalginEthyl ester, surplus is water;
Described oil phase consists of 10w/w%～16w/w% stearic acid, 10w/w%～20w/w% vaseline and paraffin or aqueousThe mixture of paraffin, and 1w/w%～5w/w% lanolin, described vaseline consumption be greater than described paraffin or described inLiquid paraffin;
Described oil phase and described water total amount are 100w/w%, supply surplus with water.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106177123A (en) * | 2016-07-07 | 2016-12-07 | 无比滴（广东）药业有限公司 | A kind of infant topical composition for mosquito bite and insect bite of releiving |
| CN106237030A (en) * | 2016-08-25 | 2016-12-21 | 济南市儿童医院 | A kind of Chinese medicine composition treating infant eczema and preparation method thereof |
| CN109172758A (en) * | 2018-10-23 | 2019-01-11 | 陈晋广 | A kind of novel skin disease externally applied drug and preparation method thereof |
| CN110101842A (en) * | 2019-06-03 | 2019-08-09 | 李传峰 | The Chinese medicine composition and its preparation method and application for treating neonate diaper dermatitis |
Citations (1)
| 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 |
-
2014
- 2014-11-13 CN CN201410640272.8A patent/CN105582089A/en active Pending
Patent Citations (1)
| 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 |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106177123A (en) * | 2016-07-07 | 2016-12-07 | 无比滴（广东）药业有限公司 | A kind of infant topical composition for mosquito bite and insect bite of releiving |
| CN106237030A (en) * | 2016-08-25 | 2016-12-21 | 济南市儿童医院 | A kind of Chinese medicine composition treating infant eczema and preparation method thereof |
| CN109172758A (en) * | 2018-10-23 | 2019-01-11 | 陈晋广 | A kind of novel skin disease externally applied drug and preparation method thereof |
| CN110101842A (en) * | 2019-06-03 | 2019-08-09 | 李传峰 | The Chinese medicine composition and its preparation method and application for treating neonate diaper dermatitis |
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Application publication date: 20160518 |