利用微透析技术进行青藤碱贴剂的生物等效性研究  

Bioequivalence study of sinomenine patch by microdialysis

作　　者：凌家俊[1] 王岩[2] 谢波[3] 周莉玲[1] 

机构地区：[1]广州中医药大学中药学院,广东广州510006 [2]广东药学院,广东广州510006 [3]广州军区广州总医院肿瘤科,广东广州510010

出　　处：《中国中药杂志》2008年第21期2482-2485,共4页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(30772791);国家自然科学基金项目(30672669);广东省自然科学基金(5300063)

摘　　要：目的:研究不同制剂工艺的青藤碱凝胶贴剂的生物等效性,探讨微透析技术在生物等效性研究中的可行性和优越性。方法:以不同工艺制备青藤碱的普通凝胶贴剂和脂质体凝胶贴剂,以裸鼠为实验动物进行经皮给药后,分别采用组织匀浆法及微透析法对青藤碱的体内药量的进行测定。结果:组织匀浆法的测定结果显示出经过20 h以上的时间后,脂质体凝胶贴剂比普通凝胶贴剂具有更高的皮肤局部剩余药量;而微透析法的检测结果则显示出在整个测定过程中,脂质体凝胶贴剂比普通凝胶贴剂具有更高的皮肤局部瞬间药量,且皮肤局部药时曲线与国际上报道的大多数经皮吸收情况相符。结论:青藤碱的脂质体凝胶贴剂比普通凝胶贴剂具有更高的局部生物利用度,且脂质体可能存在贮库效应;微透析技术可用于制剂的生物利用度及生物等效性研究。Objective： To study bioequivalence of Sinomenine patch made by different preparation process, and to testify feasibility and superiority of microdialysis as a new method in topical bioequivalence study. Method： Normal gel patch and liposome gel patch of sinomenine were prepared by different preparation, nude mouse served as the experimental subjects sampling method of drug in the skin was tissue homogenization microdialysis, and drug concentration in dialysate was determined by HPLC. Result： Results of tissue homogenization showed that liposome gel patch leads more remainder drug in the skin of nude mouse than normal gel patch, and results of microdialysis showed that liposome gel patch led higher instantaneous drug concentration than normal gel patch. Concentrationtime curve of sinomenine in the skin accorded with the results of most dermal delivery systems studies over the world. Conclusion： Topical bioequivalence of liposome gel patch of sinomenine is higher than that of normal gel patch of sinomenine; Microdialysis can be used to study bioavailability and bioequivalence of different preparation.

关 键 词：青藤碱 生物等效性 微透析 组织匀浆法 贴剂 脂质体 

分 类 号：R283[医药卫生—中药学]