中文摘要：

目的：目前驻极体透皮贴剂的体外实验多采用比较低效的单因素实验设计方法。为了更系统和有效地分析各因素之间的影响,本文根据驻极体透皮贴剂的研究目标,提出驻极体透皮贴剂的体外实验的优化方案。方法：由于影响驻极体电荷储存稳定性的因素和水平数较多,首先采用均匀设计与正交试验设计相结合的方法设计筛选电荷储存稳定的驻极体透皮贴剂的实验;在随后的体外实验设计中,先利用双因素析因设计筛选理想表面电位极性和促渗剂的实验,再进一步用正交设计方法研究主药、表面电位和促渗剂的不同水平对透皮吸收的影响。结论：所提方案全面考虑各种因素的影响,采用了多因素的试验设计方法,能够更有效地分析实验数据、减少工作量,是具有一定可行性的优化方案。

英文摘要：

Objective： Currently most researches concerning electret transdermal patches are performed by one-factor experimental design with relatively poor efficiency. To analyze the influencing factors in a more systematical and effective manner,we put forward an optimized design for in vitro experiment with electret transdermal patches. Methods：Due to the great number and various levels of factors impacting the charge storage stability of electrets, we combined uniform design and orthogonal design to optimize the screening for the stable transdermai patch. In the following in vitro study,we optimized the design of percutaneous experiments to screen for charge polarity and penetration enhancers using a two-factor experimental design. And using an orthogonal experimental design, we further studied the influence of different levels of main drug, surface potential and penetration enhancer on transdermal absorption. Conclusion： The present design, taking into consideration of various factors and using multi-factor experimental design, can more effectively analyze data, reduce workload, and is feasible.