星点设计–效应面法优化五参分散片的处方研究

Formulation optimization of Wushen Dispersible Tablets by central composite design-response surface method

目的采用星点设计–效应面法优化五参分散片的处方工艺。方法以填充剂微晶纤维素(MCC)用量、崩解剂交联羧甲基纤维素钠(cCMC-Na)用量、交联聚维酮XL(PVPP XL)用量为自变量,崩解时间、溶出度为因变量,对指标与因素进行数学模型拟合,以效应面法预测优化处方并验证。结果优化的最佳成型工艺为MCC用量为35%,cCMC-Na用量为12%,PVPP XL用量为10%,优化处方各设定的预测值和测定值非常接近。结论采用星点设计–效应面法建立了五参分散片处方的优化模型预测性良好。

Objective To optimize the formulation of Wushen Dispersible Tablets by central composite design-response surface method （CCD-RSM）.Methods The amounts of MCC, cCMC-Na, and PVPP XL were regarded as independent variables, and disintegration time and dissolution rate were regarded as dependent variables. The optimal formulation was predicted by response surface method and was verified as well. Results The optimal molding technology was as follows： MCC was 35%, cCMC-Na was 12%, and PVPP XL was 10%. The predicted value was very close to the measured value. Conclusion The mathematical model of Wushen Dispersible Tablets formulation could be achieved by CCD-RSM with the prefect prediction.