秋水仙碱双层片体外释放研究  

In vitro release of colchicine double-layer tablets

作　　者：何元田[1,2] 刘文[2] 刘姹[1] 杨大坚[1] 

机构地区：[1]深圳市中药药学及分子药理学研究重点实验室暨香港理工大学现代中药研究所,广东深圳518057 [2]贵阳中医学院,贵阳550002

出　　处：《中南药学》2009年第3期168-171,共4页Central South Pharmacy

基　　金：深圳市科技计划项目(2D200609180044B)

摘　　要：目的建立秋水仙碱双层片体外释放方法，并考察工艺、体外释放条件与缓速释比例对秋水仙碱双层片释药的影响。方法采用相似因子（f2）法评价释药曲线的相似性，并分别用零级、一级、Higuchi、Peppas方程拟合优化处方。结果工艺对秋水仙碱双层片影响较小，浆速对秋水仙碱双层片影响较大。依据最优处方制备的控释片在1～12h呈良好的缓释释放特征，12h累积释药率90％以上。结论建立了较为准确、可靠的秋水仙碱双层片体外释放度测定方法，体外释放度结果符合要求。Objective To establish an in vitro release method for eolchicine double-layer tablets, and to investigate the effect of manufacturing process, in vitro environment and ratio of the two layers, on the release profile. Methods Similarity （or homogenous） factor （f2） was used to evaluate the similarity of the release curve, and the release of optimal formulation fitting by first-order, zero-order, Higuchi, and Peppas equation respectively. Results The process had little effect on the in vitro release while the stirring speed had great influence. The optimal formulation demonstrated satisfactory in vitro drug release profile within 1-12 h, and the accumulated drug release at 12 h exceeded 90%. Conclusion The method is exact and reliable, and the release rate is consistent with the requirement.

关 键 词：秋水仙碱 双层缓释片 相似因子 体外释放 

分 类 号：R944.9[医药卫生—药剂学]