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目的:以天然高分子壳聚糖为成膜材料制备格列美脲壳聚糖贴剂并研究贴剂的透皮吸收行为。方法:分别以壳聚糖、聚乙烯醇为成膜材料制备格列美脲贴剂。以Wistar大鼠皮肤为渗透屏障,建立HPLC法测定格列美脲贴剂体外透皮速率常数,研究2种不同的成膜材料制备的贴剂透皮吸收的特性。结果:建立的高效液相色谱法测定透皮吸收液中格列美脲含量测定方法简单,格列美脲在0.1～6.0 mg.L-1范围内线性关系良好。大鼠离体皮肤透皮吸收试验结果表明,格列美脲-壳聚糖贴剂渗透系数为6.032μg.cm-22,4 h累积渗透量为185μg。2种贴剂体外经皮渗透曲线方程为Q=kt。结论:以壳聚糖为成膜材料制备的格列美脲贴剂药物释放平稳,符合零级动学特征。
OBJECTIVE: To prepare glimepiride chitosan patch with natural polymeric chitosan as film-forming material and to study the transdermal absorbability of patch. Methods: Chitosan and polyvinyl alcohol as film-forming materials were used to prepare glimepiride patch. The permeation barrier of Wistar rat skin was established. The transdermal rate constant of glimepiride patch was determined by HPLC. The transdermal absorption characteristics of two different film-forming materials were studied. Results: The determination method of glimepiride in transdermal absorption liquid established by HPLC was simple, and glimepiride had good linearity in the range of 0.1-6.0 mg.L-1. The results of percutaneous absorption test of isolated rat skin showed that the permeation coefficient of glimepiride-chitosan patch was 6.032μg.cm-22, and the cumulative permeation volume of 185μg was 4 h. The in vitro transdermal permeation curve equation of two kinds of patch was Q = kt. Conclusion: The glimepiride patch prepared with chitosan as a film-forming material released smoothly and conformed to zero-order kinematic characteristics.