中药产品生产全过程动态质量控制技术与发展

Technology and Development of Dynamic Quality Control in the Whole Production Process of Chinese Medicine Products

“有效、安全、可控”是药品的3个基本原则,复杂的处方组成和生产工艺过程使中药产品在保证有效性的同时难以确保稳定的安全性和质量可控性,因此创建一套具有整体性、系统性、符合中药产品自身特征的全过程质量控制技术体系已然成为了中药研究刻不容缓的任务。本文基于“组分结构”理论指导下的多维结构过程动态质量控制技术体系,从中药功效物质基础、安全性和剂型特征3个维度出发,分别从“在线”“离线”2个方面探讨当前中药产品生产过程中的质量控制技术和未来的发展方向。

“Effectiveness,safety and control”are the 3 basic principles of pharmaceutical products,and the complex composition of prescriptions and production processes make it difficult to guarantee the safety and quality of traditional Chinese medicine products.Therefore,creating a whole-process quality control technology system that is holistic,systematic and in line with the characteristics of TCM products has become an urgent task for TCM research.This paper is based on the multi-dimensional structural process dynamic quality control technology system guided by the“component structure”theory,starting from the 3 dimensions of the effective material basis of TCM,safety and dosage form characteristics,and discussing current TCM from the 2 aspects of“online”and“offline”,the quality control technology in the production process and the future development direction.