星点设计-效应面法优化水杨酸校正片在流通池中的释放

Optimization of release of salicylic acid calibrator tablets in flow-through cell with central composite design

目的:采用水杨酸校正片考察流通池法对非崩解型片剂释放的影响,了解非崩解型片剂在其中的释放行为。方法:以星点设计-效应面法对释放条件进行优化,以溶出介质流速和玻璃珠的用量为考察因素,以水杨酸校正片在30,60,90,120min的释放度为考察指标,采用多元线性回归及二次多项式拟合,建立指标与考察因素之间的数学关系,根据最优数学模型描绘效应面,再根据效应面优选最适条件进行验证。结果:二次多项式是描述指标与因素之间的最佳模型,在选定区域水杨酸校正片释放度的理论预测值与实测值偏差较小,模型具有良好的预测性。结论:所建立的模型可用于考察非崩解型片剂在流通池中的释放行为。

Objective：To study the impact of flow-through cell dissolution method on the release of non-disintegrating tablets using salicylic acid calibrator tablets, and investigate the release behavior of non-disintegrating tablets in flow-through cell.Methods：A central composite design and response surface methodology was employed to optimize the conditions for drug release .Independent variables were medium flow rate and weight of glass beads,while dependent variables were releases of salicylic acid calibrator tablets at 30,60,90and120 minutes.Linear,two order quadratic models were used to estimate the relationship between independent and dependent variables. Response surfaces were delineated according to best-fitted mathematic models. Optimum condition were selected and validated.Results： The quadratic equation was best-fitted mathematic models to describe the relationship between independent and dependent variables. The deviation between observed and predicted values of releases degree in selected areas were negligible, which indicated the high predictability of the fitted model.Conclution：The mathematic models can be used to investigate the release behavior of non-disintegrating tablets in flow-through cell.