化学药物钴60辐射灭菌的药学评价关注点  

The focus of chemical manufacturing and control evaluation of^(60)Co gamma-sterilization on chemical drugs

作　　者：程思绮 张芸 王亚敏 CHENG Si-qi;ZHANG Yun;WANG Ya-min(Yangtze River Delta Center for Drug Evaluation and Inspection of National Medical Products Administration,Shanghai 201210,China;Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评检查长三角分中心,上海201210 [2]国家药品监督管理局药品审评中心,北京100076

出　　处：《中国新药杂志》2024年第12期1219-1223,共5页Chinese Journal of New Drugs

摘　　要：钴60(^(60)Co)γ射线灭菌是较为常用的电离辐射灭菌法之一,该方法具备穿透力强、冷灭菌等特点,在化学药物领域的应用逐渐受到关注。本文梳理了国内外相关技术要求,并基于审评实践,从活性成份及载体辅料降解、降解产物研究、包装材料与药物相容性、灭菌工艺验证等方面探讨了钴60灭菌的药学评价主要关注问题,以期对该方法在化学药物中的应用提供一定参考。^(60)Co-γradiation is considered as one representative ionizing radiation used in sterilization.With advantages such as high-level penetration and cold treatment,it has attracted increasing attention in the area of chemical drugs.In this article,we summarized domestic and global regulatory requirements,as well as our review practices.Furthermore,we discussed the main concerns of gamma-sterilization utilized in chemical medicines from different perspectives,including degradation of active substances or carrier materials,radiolysis products,packaging material compatibility and sterilization process validation.We expect that this article will provide some reference for the application of ^(60)Co-γradiation in chemical drug sterilization.

关 键 词：辐射灭菌 辐射剂量 降解产物 药学评价 

分 类 号：R95[医药卫生—药学]