多变量分析模型在固体制剂全过程控制的应用

Application of multivariate models in whole process control of solid preparations

固体制剂生产过程是一个多单元、多步骤系统,是一个全过程链整体,其质量受物料性质与工艺参数等诸多因素的影响。多变量模型作为重要的分析工具,在制药过程监控中起着重要作用,采用多变量模型可以全面而深入地理解物料属性、工艺参数和产品质量属性之间的多因素关系,继而可以促进工艺过程全程优化,把控制药生产质量。该文总结了常用的多变量分析模型在固体制剂全过程控制中的应用,为中药固体制剂过程控制建立模型提供一定的参考。

The production of solid preparations is a multi-unit and multi-step system and is a whole process chain. Its quality is affected by many factors such as material properties and process parameters. As an important analysis tool, multivariate models play an important role in pharmaceutical monitoring. Besides, multivariate models can comprehensively understand the multi-factor relationship between material properties, process parameters, and quality attributes of products, thereby promoting the whole process optimization and controlling the drug production quality. This paper summarized the application of commonly used multivariate models in the process of solid preparations, which provides a certain reference for the process modeling of Chinese medicinal preparations.