基于物理化学及生物评价的中药生药粉灭菌技术研究进展

中药生药粉是中药制剂重要的中间体,针对中药生药粉的灭菌操作是必不可少的关键操作单元,直接影响着药品的安全性、有效性及质量稳定性。从有关中药生药粉的应用、特点、重要地位、灭菌的必要性进行概述,并对现有中药生药粉灭菌技术的分类、优缺点和应用等方面进行系统分析,进一步从灭菌率、物理化学及生物评价、化学残留等角度切入,提出健全中药生药粉灭菌工艺的评价体系。结合中药生药粉粉体学性质,进行多维质量评价,选用适当的灭菌方法,才能达到既保证灭菌后的中药生药粉内在质量,又达到微生物限度的要求。

Research progress on sterilization technology of Chinese materia medica powder based on physicochemical and biological evaluation

Chinese materia medica powder (CMMP) is an important intermediate in the preparation of Chinese materia medica (CMM). Sterilization of CMMP is an essential key operation unit, which directly affects the safety, effectiveness and quality stability of CMM. In this paper, the applications, characteristics, important status and the necessity of sterilization of CMMP were summarized, and the classification, advantages and disadvantages and application of existing sterilization technology of CMMP were systematically analyzed from the perspective of sterilization rate, physicochemical and biological evaluation, and chemical residue, so as to further improve the evaluation system of sterilization technology of CMMP. Only by combining the characteristics of CMMP, adopting a multidimensional quality evaluation and selecting appropriate sterilization methods, the internal quality and sterility of CMMP after sterilization can be guaranteed.