星点设计-效应面法优化硝苯地平分散片处方

目的：以硝苯地平为模型药物，应用星点设计-效应面法优化其分散片处方。方法：采用固体分散技术，以提高硝苯地平的溶解度。以处方中聚乙二醇4000（PEG4000）、交联聚维酮（PVPP）以及交联羧甲基纤维素钠（CCNa）的含量为考察因素，以分散均匀性和10min累积溶出百分率为评价指标，根据星点设计原理进行试验，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，最佳处方为固体分散体中硝苯地平：PEG4000=1：4，PVPP占处方的15％，CCNa占处方的8％。结论：通过星点设计-效应面优化法所建立的模型可以用于硝苯地平分散片处方的优化。

Optimizing the formation of nifedipine dispersible tablets by central composite design - response surface methodology

Objective： To optimize the formulation of dispersible tablets using nifedipine as a model drug by central composite designresponse surface methodology. Methods： Solid dispersion method was applied to improve the solubility of nifedipine. The proportion of PEG4000, PVPP and CCNa were studied based on the theory of central composite deign using dispersible uniformity and 10 min cumulative dissolution as evaluation indexes. The correlation between evaluation indexes and formulation were simulated using multi-linear equation and second-order polynomial equation. The possible optimal formulation was predicted by response surface method. Results： Second-order fitting models were superior to first-order models with better regression coefficients and higher reliability. The optimized formulation was NFP：PEG4000=1： 4 in solid dispersion; the dosage of PVPP and CCNa accounted for 15% and 8% in formulation, respectively. Conclusion： The established model based on the theory of central composite design is suitable for the optimization of nifedipine dispersible tablets.