星点设计-效应面法优化苯甲酸利扎曲普坦片的处方

目的 星点设计-效应面优化法优化苯甲酸利扎曲普坦片的处方。方法 以微晶纤维素的用量和交联聚维酮的用量为考察因素，崩解时间为指标，用线性方程和二次及三次多项式描述崩解时间和两个影响因素之间的数学关系，根据最佳数学模型描绘效应面，选择最佳处方，并进行预测分析。结果 崩解时间与微晶纤维素的用量和交联聚维酮用量间的关系不能用线性方程描述，二次及三次多项式拟合，相关系数分别为0．9924和0．9985，具有较高的可信度。优选的最佳条件为微晶纤维索的用量为3．0g，交联聚维酮的用量为0．3g。最佳处方的崩解时间理论值与预测值差为-2．68％。结论 所建立的模型预测性良好。

Optimized Formulation of Rizatriptan Benzoate Tablet by a Central Composite Design/Response Surface Methodology

Purpose To optimize the formulations of rizatriptan benzoate tablets by a central composite design/response surface methodology. Methods Independent variables were microcrystallinecellulose (MCC) content and crospovidone(PVPP) content,and disintegrating time was dependent variable. Linear or nonlinear mathematic models were used to estimate the relationship between independent and dependent variables. Response surfaces were delineated according to best-fit mathematic models, and optimum formulations were selected thereform. Prediction was carried out through comparing the observed and predicted values. Results Disintegrating time was not linear to MCC ocntent and PVPP content. Regression coefficients of se-cond-order and third-order quadratic models were as high as 0.992 4 and 0.998 5, respectively. Optimum formulation was proposed to contain MCC 3.0 g and PVPP 0. 3 g. Bias between observed and predicted values of disintegrating time was - 2. 68 % . Conclusions It shows that the optimum mathematic model is highly predictive.