在线红外技术在药物结晶中的应用进展  

Application of in-line infrared spectroscopy in pharmaceutical crystallization

作　　者：李克诚 冯文化[1] LI Ke-cheng;FENG Wen-hua(Institute of Materia Medica,Chinese Academy of Medical Science & Peking Union Medical College ,Beijing 100050,China)

机构地区：[1]中国医学科学院北京协和医学院药物研究所,北京100050

出　　处：《中国新药杂志》2019年第1期44-48,共5页Chinese Journal of New Drugs

基　　金：中国医学科学院医学与健康科技创新工程经费资助项目(2016-I2M-1-002)

摘　　要：结晶是一种历史悠久的分离技术,广泛应用于化工、制药等工业生产领域,可从均质液相中获得一定形状和大小的晶状固体。在原料药(API)的生产过程中,结晶是固体原料药最后必需的步骤,结晶过程使原料药具有特定的纯度、粒度及晶型,而结晶过程控制则是获得这些特征的关键步骤。在线红外技术是以红外光谱原理为基础,对样品进行在线监测和控制的分析手段,能够保证持续稳定地生产出关键质量参数合格的产品。本文综述了近年来在线红外技术在药物结晶过程控制中的应用,为今后的原料药生产开发提供帮助。Crystallization is a separation technology with long history,which is widely used in chemical,pharmaceutical and other industrial fields. The crystalline solids of a desired shape and size can be produced from the homogeneous liquid phase. In the production process of active pharmaceutical ingredient(APIs),crystallization is the final required step for solid APIs. The crystallization process enables solid APIs to have specific purity,particle size,and crystal form,and the process control of crystallization is the key step to obtain these characteristics.Based on the principle of infrared spectroscopy,in-line infrared technology is an analytical method for monitoring and controlling of sample,in order to continuously and steadily produce APIs with the same critical quality parameters.This article reviews the application of in-line infrared technology in the process control of the crystallization of APIs in recent years,and provides help to the development of APIs production in the future.

关 键 词：结晶 过程控制 在线红外 晶体粒度 多晶型 共晶 

分 类 号：R917[医药卫生—药物分析学]