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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。
OBJECTIVE: In vitro experiments using electret transdermal patches are mostly based on the more inefficient single factor experimental design. In order to more systematically and effectively analyze the impact of various factors, this paper based on the research goal of electret transdermal patch, put forward the optimized scheme of electret transdermal patch in vitro experiment. Methods: Due to the factors affecting the charge storage stability of the electret and the number of levels, the experiment of electret transdermal patch with charge storage stability was first designed by the method of uniform design and orthogonal experimental design. In vitro experimental design, the first use of two factorial factorial design to screen the ideal surface potential polarity and penetration enhancer experiments, and then further orthogonal design method of the main drug, the surface potential and penetration enhancers of different levels of transdermal absorption Impact. Conclusion: The proposed scheme comprehensively considers the influence of various factors and adopts a multi-factor experimental design method, which can analyze the experimental data more effectively and reduce the workload, which is a feasible solution.