星点设计-效应面法优化单硝酸异山梨酯微孔渗透泵片处方

Optimization of isosorbide mononitrate microporosity osmotic pump tablets formulation using response surface methodology

目的:应用星点设计-效应面法优化单硝酸异山梨酯微孔渗透泵片处方。方法:以渗透压活性物质用量、致孔剂用量、包衣增重量为影响片剂释放的主要因素,2、4、7、9、12 h的药物累积释药量为效应值,应用DesignExpert进行处方优化,并对优化处方进行验证。结果:成功找到了最优释药区域;优化处方呈零级释放特性。结论:通过星点设计-效应面法成功建立了处方优化模型,实现了单硝酸异山梨酯微孔渗透泵片的处方筛选。

Objective ：To optimize isosorbide mononitrate microporosity osmotic pump tablets formulation using response surface methodology. Methods： Design Expert^⑩was used to optimize the experimental conditions, evaluate critical parameters such as response and osmotic agent level, pore former level and coating weight gain were studied to , and then make a validation for the best formulations. Results ： Successfully found the optimization area and the best formulations follow zero-order property. Conclusions ： A reliable model is established using response surface methodology and thereby formulation of isosorbide mononitrate microporosity controlled osmotic pump tablet could be optimized.