因子设计-效应面法优化双氯芬酸钾缓释片处方

Optimized Formulation of Diclofenac Potassium Sustained Release Tablets by Factorial Design/ Response Surface Methodology

目的优化双氯芬酸钾缓释片处方。方法采用32满因子设计试验考察因素羟丙甲基纤维素和十八醇在处方中所占的比例对缓释片在体外1、4、10h的累积释放度的影响,试验数据分别采用线性方程和二次多项式拟合,根据最佳数学模型绘制效应面和等高线图,通过重叠等高线图确定最优处方。结果2个影响因素和3个评价指标之间存在定量关系,最优处方:羟丙甲基纤维素在处方中占25%,十八醇在处方中占9%。优化处方各指标的预测值和目标值非常接近。结论采用因子设计-效应面法完成了双氯芬酸钾缓释片的多目标同步优化。

Ahn To optimize the formulation of diclofenac potassium sustained release tablets. Methods A 32 full factorial design was used to investigate the effect of the weight percentage of HPMC and stearyaleohol on in vitro release pereentage at 1,4 and 10h.The linear model and quadratic model was used to analyze experimental data.The response surface and overlay contour plot were delineated according to best-fit mathematic models. Optimum formulation was selected by the overlay contour plot. Results The quantitative relationships between the two factors and three evaluation indexes were obtained. The optimum formulation was as follows： the weight percentage of HPMC and stearyaleohol was 25 % and 9% respectively. The predicted and observed values of the optimum formualation was close. Conclusion The multi-objective simultaneous optimization of dielofenac potassium sustained release tablets formulation was obtained by the factorial design and response surface methodology.