中心复合设计法优化秋水仙碱双层片处方的研究  

Formulation optimization of colchicines double-layer tablet by central composite design

作　　者：何元田[1,2] 刘文[2] 刘姹[1] 杨大坚[1] 周伟[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,广东深圳518057 [2]贵阳中医学院,贵州贵阳550002

出　　处：《中草药》2010年第5期710-713,共4页Chinese Traditional and Herbal Drugs

基　　金：深圳市科技计划项目(2D200609180044B)

摘　　要：目的制备秋水仙碱双层片,考察片芯组分对体外释药行为的影响,对片芯处方进行优化。方法采用相似因子法评价释药曲线的相似性,经单因素考察确定影响体外释药行为的主要因素,利用中心复合设计优化片芯处方。结果片芯缓释层中HPMCk15、PEO700对秋水仙碱双层片的体外释药行为有显著影响。依据最优处方制备的控释片在1～12h内呈良好的缓释释放特征,12h累积释药率达到90%以上。结论本方法适用于秋水仙碱双层片的处方优选。Objective To investigate the optimal formulation and drug release profile of colchicine doublelayer tablets. Methods The key influencing factors and optimal formulation were studied based on the cumulative drug release rate at different time points and homogenous factor （f2） and optimization of the formulation by central composite design. Results The drug release profile in vitro was influenced by amount of HPMC k15 and PEO700. The optimal in vitro drug release profile presented extended-release character significantly within 1-12 h, and drug released at 12 h reached more than 90%. Conclusion The method is suitable to optimize the formulation of colchicine double-layer tablets.

关 键 词：秋水仙碱 双层片 相似因子 中心复合设计 

分 类 号：R284.2[医药卫生—中药学] R286.02[医药卫生—中医学]