星点设计-效应面法优化五酯缓释片处方

Optimization of the Formulation of Wuzhi Sustained-release Tablets by Central Composite Design/Response Surface Methodology

目的:优化五酯缓释片的处方。方法:以羟丙甲基纤维素、磷酸氢钙的用量为考察因素,分别以3、8、14、22h取样时间点的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,并对该结果进行验证。结果:优化的处方为羟丙甲基纤维素、磷酸氢钙的用量分别为13.30%～30.00%、14.14%～17.07%。结论:通过星点设计-效应面法建立的模型可用于五酯缓释片处方的优化,所建立的数学模型具有准确的预测性。

OBJECTIVE：To optimize the formulation of Wuzhi sustained-release tablets.METHODS：The formulation of Wuzhi sustained-release tablets was optimized by central composite design/response surface methodology using the amount of hydroxypropylmethylcellulose and calcium monohydrogen phosphate as factors and with accumulative release rate at sampling time of 3 h,8 h,14 h and 22 h as index.Optimized results were validated.RESULTS：Optimized formulation was 13.30%～30.00% hydroxypropylmethylcellulose and 14.14%～17.07% calcium monohydrogen phosphate.CONCLUSION：Model developed by central composite design/response surface methodology can be used for the optimization of Wuzhi sustained-release tablets formulation.Established model deliver predictive accuracy.