过程分析技术在中药注射剂生产过程中的应用研究进展

Review on process analytical technology application in production process of Chinese medicine injection

基于质量源于设计的理念,综述了在中药注射剂的质量控制方面,应该从药材栽培、加工炮制、投料、提取、浓缩、大孔树脂纯化、柱色谱、萃取、醇沉、结晶以及成品检验的过程中引入过程分析技术,并提出了过程分析技术如何在中药注射剂生产的全过程进行控制的方案,旨在透彻地理解并控制注射剂的生产过程,从而确保中药注射剂批次间质量的均一性及工艺的稳定性。

Based on ＂Quality by Design＂ concept, this study summarized that quality control of Chinese materia medica（CMM）injection should introduce the process analytical technology during the processes of herbs cultivation, processing, casting herbs,extraction, concentration, macroporous resin purification, column chromatography, extraction, alcohol precipitation, crystallization,and final examination of product. The control proposal of how to control the production of CMM injection by process analytical technology was also suggested, aimed at a thorough understanding and control of the production process of injection, thereby ensuring uniformity of inter-batch quality and stability of process of CMM injections.