星点设计-效应面法优化盐酸普罗帕酮缓释片处方  

Optimization of Propafenone Hydrochloride Sustained-release Tablets by Central Composite Design and Response Surface Methodology

作　　者：王利胜[1] 程龙[1] 吴阳[1] 张升[1] 田瑶[1] 

机构地区：[1]广州中医药大学中药学院,广州510006

出　　处：《中国现代应用药学》2012年第11期998-1001,共4页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的采用星点设计-效应面法优化盐酸普罗帕酮缓释片的处方。方法以羟丙基甲基纤维素、乳糖的用量为考察因素，体外累积释放度为考察指标，选用星点设计-效应面法优化处方，并对结果进行验证。结果优化处方中羟丙基甲基纤维素和乳糖的用量分别为31．19％～32．16％，8．67％～14．7％，预测值与实测值的偏差均在6％以内。结论通过星点设计-效应面法建立的模型可用于盐酸普罗帕酮缓释片的优化，所建立的数学模型具有准确的预测性。OBJECTIVE To optimize the formulation of propafenone hydrochloride sustained-release tablets by central composite design/response surface methodology. METHODS The formulation of propafenone hydrochloride sustained-release tablets was optimized using the amount of HPMC and lactose as factors and with accumulative release rate as index. The optimized results were validated. RESULTS Optimized formulation was 31.19%-32.16% by HPMC and 8.67%-14.7% by lactose. Bias between the observed and predicted values was within 6%. CONCLUSION The model developed by central composite design/response surface methodology can be used for the optimization of propafenone hydrochloride sustained-release tablets formulation. Established model has good predictive accuracy.

关 键 词：盐酸普罗帕酮 星点设计-效应面法 羟丙基甲基纤维 缓释片 

分 类 号：R943[医药卫生—药剂学]