星点设计-效应面法优化芍甘抗抑郁分散片处方

Optimization of Peony and Licorice Antidepression Dispersible Tablets by Central Design-response Surface Method

目的:目的:优化芍甘抗抑郁分散片处方。方法:以分散片崩解时间、甘草总黄酮和白芍总苷30min内累积溶出率为考察指标,以交联聚乙烯吡咯烷酮(PVPP)、羧甲基淀粉钠(CMS-Na)和微晶纤维素(MCC)所在处方百分量为自变量,采用星点设计试验优化处方,并对结果进行多元线性和二项式非线性拟合,通过效应面确定最优处方。结果:最优处方为PVPP,占处方量9.17%,CMS-Na占处方量5.29%,MCC占处方量21.74%,磷酸氢钙为填充剂。预测值与实测值的偏差为2.58%。结论:星点设计-效应面法可用于芍甘抗抑郁分散片的处方工艺,优选的成型工艺稳定可行。

Objective：To prepare Peony and Licorice antidepression dispersible tablet.Methods：PVPP、CMS-Na and MCC were used as carrier materials to prepare dispersion tablets and then the disintegration time、accumulation of Glycyrrhiza flavonoid dissolution rate and total glucosides of paenony within 30 min were taken as dependent variables.Results：The optimized prescription was：PVPP accounted for 9.17%,CMS-Na accounted for 5.29% and MCC accounted for 21.74% of prescription respectively,calcium hydrophosphate as the filler.Disolution test of optimal formulation indicated that there was low deviation（2.58%）between the predicted value and the measured value.Conclusion：Central composite design-response surface methodology was convenient to optimize molding technology of Peony and Licorice dispersible tablet,optimized molding technology was stable and feasible.