[关键词]
[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。
[Key word]
[Abstract]
Objective To investigate the optimal formulation and drug release profile of colchicine double-layer 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.
[中图分类号]
[基金项目]
深圳市科技计划项目(2D200609180044B)