D-最优混料设计优化三叶片处方及因子作用分析

Optimization of the formulation of Sanye tablets and analysis of factor effect by D-optimal mixture design

目的:采用D-最优混料设计优化三叶片处方,并对各因子的作用进行分析。方法:以磷酸氢钙、微晶纤维素、交联聚维酮和微粉硅胶的用量为考察因素,分别以流化床制粒所得颗粒的颗粒量、松密度以及片剂的崩解时限、抗张强度为指标。选用合适的数学模型预测最优处方,并对最优处方进行验证。结果:磷酸氢钙、微晶纤维素、交联聚维酮和微粉硅胶最优处方配比为23.1%∶0.8%∶3.1%∶2.5%,且可知各项辅料因子所发挥的不同作用。结论:D-最优混料设计可用于三叶片的处方优化,建立的数学模型可以分析出多因素对多指标不同程度的影响,且具有较准确的预测性。

OBJECTIVE To optimize the formulation of Sanye tablets and to analyze the effect of each factor by D-optimal mixture design.METHODS The amounts of calcium hydrogen phosphate,microcrystalline cellulose,crosslinking povidone and colloidal silicon dioxide were respectively used as independent variables,and the yields of granule made by fluidized bed,bulk density and disintegration time,tensile strength of Sanye tablets were used as dependent variables.A suitable mathematical model was selected to predict the optimal prescription,and validation of the optimal prescription was verified.RESULTS Optimized proportion was calcium hydrogen phosphate：microcrystalline cellulose：crosslinking povidone：colloidal silicon dioxide of 23.1%∶0.8%∶3.1%∶2.5%.And the various factors of excipients played by different roles were understood.CONCLUSION D-optimal mixture design facilitates the optimization of Sanye tablet formulation.The established mathematical models can analyze the influence of multiple factors on the multiple indexes in different levels,and are proved to have relatively accurate predictability.