| "Xiaer Fuxie Waifu film " comprise evodiae,cassia,clove,white pepper, which carry out ad secundan vicem exploitation on the basis of prescription praeparatum "Xiaer Fuxie Waifu power", what come from 2005 edition《Chinese pharmacopeia》(primary part) . "Xiaer Fuxie Waifu film " is clinically used to cure abdominal pain,diarrhea, which caused by stomach intestine asthenia cold and dyspepsia , and so on. It prossess the effectiveness of warming the middle warmer,evapning frigidity,depriving the evil wetness,invigorating the spleen,alleviating pain,alleviating diarrhea. "Xiaer Fuxie Waifu film" possesses feature of high-performance active component,delayed release absorption,easy to painting,physio-form film,coverage thoroughly,hadro-permeability,absorption-ible,especially refer to children.It is a ideal external preparation of curing pedo-diarrhea.During the process of advanced development, we make systematic investigation to preparation artwork,quality criteria,stability,toxicology and pharmacodynamics of "Xiaer Fuxie Waifu film " according to the claim of new drug, thereby providing scientific evidence to the ad secundan vicem exploitation of " xiao er wai fu power" .At praeparatum procedure, we deploy double-abstraction in abstraction procedure: first of all, we abstraction aetherolea with water vapor distillation, then abstraction gruffs with alcohol.We deployβ-cyclodextrin clathration procedure clathrate Aetherolea that be extracted, and enact synthetic index with clathration rate and recovery rate, then optimizing clathration procedure with L9(3)4 orthogonal experiment: the proportion of aetherolea and cyclodextrin is 1: 10, clathrate temperature is 40℃, clathrate time is 2h, clthrate rate is 64%; alcohol extraction pheresis make the content of rutacarpine as index, optimizing abstraction procedure with L9(3)4 orthogonal experiment: make 6 times 90% alcohol recirculate abstraction for twice, 1 hour per time.Considerating ground substance compounding composition with form film character and time.Eventually, add admix powder of extractive and clathrate according to the best match fiat plastics.At quality control , we make thin-layer chromatography appreciation to cassia,caryophyllus,white pepper, the speckle effect is good , non-interference to negative control , which certificate the specificity of this the elected method is better.Take content of rutacarpine from evodiae as index, make quantitative analysis and technology investigation with high efficiency liquid chromatography.At the same time , we enact quality criteria according to the correlate regulation of plastics which come from the addendaum of 2005 edition《Chinese pharmacopeia》.We investigate the initial stability of "Xiaer Fuxie Waifu film " plastics on the bass of this quality criteria, make investigation experiment to the plastics with ambient,accelerated test (40℃,relative humidity 75%) and so on.Above investigation indicated that the preparation technology of "Xiaer Fuxie Waifu film plastics is reasonable, and the quality is stabilization.At toxicology, we investigate the toxicity information of "Xiao er wai fu film " plastics by skin acute toxicity test,cutaneous stimulation test,skin hypersensitivity test. The consequence indicated: the toxicity of " Xiaer Fuxie Waifu film plastics is little, non-stimulation to skin.At the research of pharmacodynamics, we make allround investigation to the praeparatum from five aspect: bowels function test,check diarrhea experiment,bacteriostasis experiment,analgesia spasmolysis experiment,relieve fever experiment. Experiment result indicate: the praeparatum obviously outstrip powder at curative effect and employment.The research work was under the direction of the theories of Chinese traditional medicine external therapy, and united with modern preparation technology to exploit a kind of lower dosage,application, lower cutaneous anaphylasis and converient new dosage which could lay the1 foundations of creating more social benefit economical benefit.
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