星点设计-效应面法优化足宁颗粒处方

Formulation Optimization of Zuning Granules by Central Composite Design-Response Surface Methodology

目的应用星点设计-效应面法优化足宁颗粒制剂处方。方法以处方中浸膏粉的含量及润湿剂加入量为考察因素,以吸湿率、成型率和溶解率为评价指标,根据星点设计原理进行实验,并用多元线性回归和二次多项式方程拟合指标与影响因素之间的数学模型,经效应面法预测最佳处方。结果采用二次多项式拟合的相关系数优于线性方程,具有较高的可信度。综合效应面优化和评估结果,最终选取浸膏粉含量62.50%,湿润剂加入量6.30%。结论通过星点设计-效应面优化法所建立的模型可以用于足宁颗粒处方的优化。

Objective To optimize the formulation of zuning granules by central composite design-response surface methodology.Methods The content of extraction powder in preparation and amount of syndets added were studied on the theory of central composite design with moisture absorption,molding rate and solubility as evaluation indexes.The data were simulated using multi-linear equation and second-order equation polynomial equation.The possible optimal formulation was predicted by response surface method.Results Regression coefficients of second-order quadratic models were superior to those of the first-order model and with higher reliability.The optimized conditions was obtained with the ratio（X1） of the powdered extracts to excipients as 62.50%,the dosage（X2） of wetting agent added as 6.30%.Conclusion The established model based on the theory of central composite design is suitable for preparation optimization of zuning granules.