非洛地平双层渗透泵片的制备及体外释放度考察

目的对非洛地平双层渗透泵控释片的处方工艺和体外释放度进行研究。方法采用星点设计对处方进行优化,并计算自制片与国外上市缓释片体外释药数据的相似因子。结果最优化处方组成：含药层片芯中氯化钠30mg,助推层聚氧化乙烯110mg,羟丙甲基纤维素7mg,包衣液中醋酸纤维素与聚乙二醇4000（polyethylene glycol4000,PEG4000）的比例为1.8：1、包衣增重为8%。最优处方的3批样品在14h内呈零级释放特征,体外释药特征与国外缓释片相似（f2=65.8）。结论采用星点设计-效应面法,得到了非洛地平双层控释片处方优化模型,实现了该控释片的处方优化。自制片与国外缓释片体外释药行为相似。

Preparation and in vitro Release of Felodipine Two-layer Osmotic Pump Tablets

Objective To study the preparation and in vitro release of felodipine two-layer osomatic pump tablets.Methods The optimal formulation was selected by central composite design.F2 factors were calculated and compared with foreign products.Results The composition of the optimal formulation was as follows.NaCl：30mg,polyethylene oxide（PEO）：110mg,hydroxypropyl methyl cellulose（HPMC）：7mg,the ratio of cellulose to polyethylene glycol 4000（PEG 4000）：1.8：1,tablet weight gain for membrane coating：8%.The preparation had excellent zero-order release profile within 14 hours,and the in vitro drug release profile was similar to that of the foreign products（f2=65.8）.Conclusion The optimization of push-pull osmotic pump controlled release tablets containing felodipine can be achieved by the central composite design and response surface methodology.The drug release profile of the product is similar with the foreign products.