关于原核表达的治疗类重组蛋白制品中避免使用β-内酰胺类抗生素及抗性基因的思考  

Avoid using beta-lactam antibiotics and relevant resistance genes in prokaryotic-expressed therapy recombinant protein products

作　　者：寇雅真 韦薇 程速远 KOU Ya-zhen;WEI Wei;CHENG Su-yuan(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中心,北京100076

出　　处：《中国新药杂志》2025年第6期579-584,共6页Chinese Journal of New Drugs

摘　　要：本文基于当前β-内酰胺类抗生素及抗性基因对人体健康和生态环境影响的研究进展,结合目前国内外重组蛋白制品开发、生产和监管要求,对原核表达的重组蛋白制品中β-内酰胺类抗生素及抗性基因的使用问题进行分析探讨,以期推动此类制品中抗生素及抗性基因的合理使用。This paper reviewed recent research progress in the effects ofβ-lactam antibiotics and resistance genes on human health and the environment,regarding the development,manufacture,and regulatory requirements of recombinant protein products,analyzed the issue of usingβ-lactam antibiotics and resistance genes in prokaryotic-expressed recombinant protein products,hoping to promote rational use of antibiotics and resistance genes in these products.

关 键 词：重组蛋白制品 Β-内酰胺类抗生素 抗性基因 

分 类 号：R95[医药卫生—药学]