| Objective: Chinese medicine plastic is composited with the extractive of Chinese medicine and film-forming material which is capable of forming a film after application, while protecting the wound, it can gradual release of the drug contained. This topic prescription is a topical compound made up of Strychnos, Coptis chinensis and other Chinese herbal medicines, because of every medicine,it can clear heat and remove toxic materials,and relieve swelling and pain.therefore,it’s widely used in patients who suffering surface infection,swelling pain,vascular gangrene,and so on.It’s used more often in orthopedics, surgery and peripheral vascular disease subjects, after years of clinical observation,it’s considered effective.But,It has shortcomings,such as outdated preparation technology,imperfect quality standards,inconvenience in clinical application.The aim of our study is to develope a new Chinese medicine external preparation Ma-huang plastic,scientific research ideas and modern technology and methods are applied In this study, we conducted a systematic study on it’s extraction process,preparation process,the transdermal absorption, quality control, pharmacodynamic and skin drug safety. It is capable of forming a film after application, protecting the wound, improving the hydration of skin, promoting drug through the stratum corneum,gradual releasing of the drug contained to improve efficacy.beyond that,it can avoid contaminating clothing and make the usage more convinient.Methods:(1)The study of Mahuang plastic extraction methodology : Combined with characteristics of the preparation and requirements of practical production,we adopt ethanol reflux extract.On the basis of the single factor,the extraction rate of Strychnine,Brucine,berberine hydrochloride extraction were chosen as index,orthogonal design L9(34) was used for sereening extraction parameters.(2)The preparation methodology study :Firstly,with plastic formation time and appearanece quality as index, we chosed plastic-forming material from PVA-0588,PVA-1788,PVA-124.Secondly,through orthogonal test, we chosed the content of PVA-124,glycerin, CMC-Na as variable,optimized the composition of the prescription.Finally,we took the result: 6%PVA-124,4% glycerin, no CMC-Na and a little of Tween-80.(3)The screening of permeation enhancers and study of transcutaneous permeation :We selected the isolated rat skin to study percutaneous absorption by using Franz diffusion cells,tudied the influence of several different permeation enhancers on transcutaneous permeation of Ma-Huang plastic to get an pptimum formula,calculated cumulative penetration and transdermal speed constants.(4)Preliminary stability: The preliminary stability investigation of Ma-huang plastict tested the influencing factors.(5)The quality standard study :In addition to appearance quality,relative density,p H value, the effective and toxicity composition of Ma Huang Plastic were qualitative and quantitative determinded by traditional TLC and micro emulsion TLC,and established quality standards.(6)Pharmacodynamics and safety evaluation of administration to the skin: From the results of anti-inflammation and analgesia test,there were significant differences between treatment group and the control group,so we can say Ma-Huang plastic has the effect of anti-inflammatory pain.Besides,we took dermal irritation and hypersensitive tests on intact skin and damaged skin.as results,there is no No deaths,swelling, bleeding and other phenomena.The results indieate that Ma-Huang plastic has no acute toxicity and apparent irritation when applied to the skin.Results:(1)The study of Mahuang plastic extraction methodology : Tenfold 60% ethanol was added in medicinai meterials to extract three times, every time last for 2 hours.(2)The preparation methodology study :6%PVA-124,4% glycerin, no CMC-Na and a little of Tween-80.(3)The screening of permeation enhancers and study of transcutaneous permeation :based on the experienment result,24 h umulative penetrationwas taken as index,7%1,2-propanediol was choosen as the permeation enhancer.(4)The preliminary stability test showed that the preparation,Kuijieling colonic localization tablet stability at high temperature and high humidity and strong light.Ma-Huang plastic has the effect of anti-inflammatory pain.(5)Pharmacodynamics and safety evaluation of administration to the skin: there is no No deaths, swelling, bleeding and other phenomena.The results indieate that Ma-Huang plastic has no acute toxicity and apparent irritation when applied to the skin... |
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