中药灭菌工艺研究现状及问题分析

Current situation and problem analysis on sterilization process for Chinese materia medica

灭菌操作作为影响中药及其制剂质量的关键操作单元,直接影响着药品的安全性、有效性及质量稳定性。从有关中药及其制剂灭菌技术的分类、原理、应用现状、优点和存在的问题及对策等方面进行系统分析。中药及其制剂灭菌工艺方法很多,包括干热灭菌、湿热灭菌、辐射灭菌和环氧乙烷气体灭菌等,但是存在较多问题,对中药及其制剂的质量影响非常大。应根据中药及其制剂的性质特征选择适合该中药或剂型的灭菌工艺,加速中药及其制剂灭菌新技术研发和转化。

Sterilization operation, as the key operation unit that affects the quality of Chinese materia medica（CMM） and its preparations, directly affects the safety, effectiveness, quality, and stability of medicine. The classification, principle, application status, advantages, and existing problems and countermeasures of CMM and its preparations were systematically analyzed. There are many sterilization processes for CMM and its preparations, including dry heat sterilization, moist heat sterilization, radiation sterilization, epoxy ethane gas sterilization, and so on, but they all have many problems and greatly affect the quality of CMM and its preparations. A sterilization process should be chosen according to the nature of CMM and its preparations, which is suitable for the CMM or the dosage form, so as to accelerate the development and transformation of new sterilization technique of the CMM and its preparations.