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目的:通过研究湿疹乳膏透皮与释药两个过程的药物动力学特性,为湿疹乳膏药效、毒理试验及临床给药方案设计研究提供理论依据。方法:以有效成分丹皮酚、苦参碱及氧化苦参碱、盐酸小檗碱累积透皮百分率为测定指标,用改良的Franz扩散池及离体猪耳皮进行实验,高效液相测定不同时间透皮接收液中各成分的含量。比较透皮与释药速度、透皮量与释药量及各成分皮肤储量的差别。结果:湿疹乳膏释药速度快于透皮速度,释药速度(t50%)是透皮速度的2倍以上;释药量高于透皮量,最大释药量是透皮量(Qmax)的2倍以上,皮内储存量(以丹皮酚计)占透皮总量的50%以上。结论:湿疹乳膏属于皮肤限速型乳膏,基质对药物的透皮有促进作用,各项透皮参数可满足湿疹局部治疗需要,透皮特性达到临床局部治疗目的;每天用药1次或给药间隔时间确定为15.16-28.40h,科学、合理、可行。
OBJECTIVE: To study the pharmacokinetics of transdermal and drug delivery of eczema cream, and provide the theoretical basis for the research of drug efficacy, toxicology test and clinical drug design of eczema cream. Methods: The active ingredients of paeonol, matrine and oxymatrine, berberine cumulative transdermal percentage as a measure of indicators, using a modified Franz diffusion cell and pig porcine ear experiments, high-performance liquid phase determination Time transdermally receiving liquid content of each component. Comparison of transdermal and drug release rate, transdermal volume and drug release and skin composition of the difference between the reserves. Results: The drug release rate of eczema cream was faster than transdermal rate, the rate of drug release (t50%) was more than 2 times higher than that of transdermal rate. The release rate was higher than transdermal volume, More than 2 times, intradermal storage (to paeonol meter) accounted for more than 50% of the total transdermal volume. Conclusion: The eczema cream belongs to the skin speed-limiting cream, and the matrix can promote the transdermal penetration of the drug. The transdermal parameters can meet the need of local treatment of eczema and the transdermal properties reach the goal of clinical treatment. Drug interval was determined as 15.16-28.40h, scientific, reasonable and feasible.