星点设计-效应面法优化粘胶分散型透皮贴剂的实验研究

Optimized Preparation of Drug in Adhesive Transdermal Patch by Central Composite Design/Response Surface Methodology

目的:优化粘胶分散型透皮贴剂的处方。方法:以大鼠皮肤为实验屏障,初粘力与体外透皮速率常数为评价指标,采用星点设计-效应面法优化贴剂处方中增塑剂、交联剂和促渗剂的最佳配比。结果:各指标的二项式拟合方程均优于多元线性回归方程,优化处方中增塑剂:交联剂:促渗剂所占比例分别为45%,2.8%,7.4%。结论:建立的模型可较好地描述该实验中因素与指标的关系,预测性良好。

Objective：To optimize the preparation of drug in adhesive transdermal patch. Methods：Taking SD mouse skin as protective screen of the experiment and tackness and transdermal speed constant of vitroas evaluation index to optimize the best matching of plasticizer, cross-linking agent and penetration enhancer in transdermal patch. Results： Second-order quadratic models of index are superior to the plural linear regress equation, plasticizer： cross-linking agent ： penetration enhancer is 45 % ： 2.8 % ： 7.4 %. Conclusions： In this experiment, the established model can describe the relation between factor and index and the outcome of prediction is good.