过程分析技术在制粒过程中的研究进展

Research Progress of Process Analysis Technology in Granulation

随着对科学技术现代化要求的提高,FDA在2004年建立了过程分析技术指南;2013年德国提出了以智能制造为主导的工业4.0;2015年,我国拟出“中国制造2025”规划,作为我国医药智能化的向导。过程分析技术凭借其快速无损、高效等优点,逐渐成为制药行业新的测量手段,缩短了制药企业的生产周期,提高了生产效率,避免了不合格产品的产生,保障了产品的质量。制粒过程是固体制剂尤为重要的一个工艺单元,对后续压片、胶囊填充等工艺有重要影响。故在此总结了过程分析技术在制粒过程中的一些常用分析技术,及其在制粒过程中的应用,以期为后续的相关研究者予以启迪。

With the increasing demands for science and technology.In 2004,the FDA established guidelines for process analysis techniques.In 2013,Germany introduced the Industry 4.0 which is dominated by smart manufacturing.And in 2015,China introduced the'Made in China 2025'which serves as a guide for the intelligentization of medicine in our country.Process analysis technology has become a new measurement method in the pharmaceutical industry because of its advantages of fast,non-destructive and high efficiency,which makes pharmaceutical enterprises shorten production cycle and improve production efficiency.The production of unqualified products is avoided and the product quality is guaranteed.The granulation process is an important process unit of solid preparation,which has an important influence on the following processes such as tablet pressing and capsule filling.Therefore,some common analytical techniques of process analysis in granulation process and their application in granulation process are summarized in order to provide ideas for the follow-up related research.