星点设计-效应面法优化鱼腥草素钠缓释片的处方

Optimization of Sodium Houttuyfonate Sustained-release Tablets formulation by central composite design-response surface methodology

目的应用星点设计-效应面法优化鱼腥草素钠缓释片的处方。方法以HPMC和EC的用量为考察因素,分别以鱼腥草素钠在1,4,8和12h的累积释放度为指标,采用星点设计-效应面优化法,确定优化处方区域,并进行优化处方的验证分析。结果最优处方区域为HPMC42～62mg和EC5.8～6.6mg,优化处方的考察指标预测值与观察值非常接近。结论通过星点设计-效应面优化法建立的模型预测性良好,可用于鱼腥草素钠缓释片处方的优化。

Objective To optimize the formulation of sodium houttuy sustained release tables by central composite design-response surface methodology.Methods The independent variables were the amount of HPMC and EC,and the dependent variables were the dissolution of sodium houttuy at 1,4,8 and 12 h.The optimized formulation was determined by the central composite design-response surface methodology.Prediction was assessed by comparing the observed and predicted values.Results Optimized formulations of sustained release tables was proposed to consist of HPMC 42 mg to 62 mg and EC 5.8 mg to 6.6 mg.In vitro release test of three selected optimal formulations indicated that there existed high approximation between the observed and estimated values.Conclusion It shows that the established model is suitable for Sodium Houttuy Sustained Release Tables.