摘要
目的:制备复方地榆提取物凝胶贴膏剂,并研究其体外透皮性、释放特性.方法:通过正交实验优化凝胶贴膏基质配比;采用Franz扩散池及半透膜进行体外经皮渗透实验及体外释放实验,以地榆的主要有效成分没食子酸为检测指标,利用高效液相色谱分析测定.结果:凝胶贴膏的最优基质处方为2.5 g聚丙烯酸钠NP700、1.5 g聚乙烯吡咯烷酮K30(PVP-K30)、4g羧甲基纤维素钠(CMC-Na)、1 g卡波姆.本实验方案样品配制过程可控,重复性、稳定性、回收率良好.复方地榆凝胶贴膏主要成分没食子酸的透皮速率为4.783μg·cm-2·h-1、释药速率为5.89μg·cm-2·h-1.结论:所制备复方地榆凝胶贴膏的基质结构与复方地榆提取物具有较好的相容性,没食子酸的释药速率高于透皮速率,皮肤屏障起到限速作用.
Abstract
Objective:To prepare compound Sanguisorbae Radix extract gel plaster,and study its transdermal and release characteristics in vitro.Methods:The matrix formulation of gel plaster was optimized by orthogonal experiment.Franz diffusion cells and semipermeable membrane were used for in vitro percutaneous penetration and in vitro release experiments.Taking gallic acid,the main active component of Sanguisorbae Radix,as the detection indicator,and was analyzed and determined by high-performance liquid chromatography.Results:The optimal matrix formulation of gel plaster was 2.5 g sodium polyacrylate NP700,1.5 g polyvinylpyrrolidone-K30(PVP-K30),4g carboxymethyl cellulose-Natrium(CMC-Na)and 1g carbomer.The sample preparation process of this experimental scheme was controllable,with good repeatability,stability and recovery rate.The transdermal rate of gallic acid,the main component of compound Sanguisorbae Radix gel plaster,was 4.783 μg·cm-2·h-1,and the drug release rate was 5.89 μg·cm-2·h-1.Conclusions:The prepared matrix structure of the compound Sanguisorbae Radix gel plaster had good compatibility with the compound Sanguisorbae Radix extract.The drug release rate of gallic acid was higher than the transdermal rate,which means the skin barrier played a speed limiting role.
基金项目
中央高校基本科研业务费专项资金(YG2021ZD15)
上海交通大学医工交叉项目(YG2021ZD15)