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

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。

Abstract: 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.