抗生素质量标准的发展及关注点  

Development and concerns on antibiotic specifications

作　　者：胡昌勤[1] 姚尚辰[1] 冯艳春[1] Hu Changqin;Yao Shangchen;Feng Yanchun(National Institutes for Food and Drug Control,Beijing 102629)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国抗生素杂志》2025年第3期241-255,共15页Chinese Journal of Antibiotics

摘　　要：药品质量标准服务于药品监管,是药品监督检验人员、质量管理人员和产品生产者判断产品质量的法律/法规性文件,其随着社会的发展和科学技术的进步而变化。本文从论述抗生素质量标准的发展规律着手,探讨当前抗生素标准的热点问题。通过精准的定性与定量分析,有效地表征/控制药物的安全性与有效性,利用精准的化学分析替代传统的生物学分析是当代抗生素质量标准的发展方向。Drug specifications play a crucial role in drug supervision.It is the legal/regulatory documents to judge product quality for drug inspectors,quality management personnel and product producers,which change with the development of society and the progress of science and technology.In this paper,starting from discussing the development of knowledge more generally of antibiotic specification,the current hot issues were explored.Through accurate qualitative and quantitative analysis to effective characterization/control of drug safety and effectiveness,the use of accurate chemical analysis instead of traditional biological analysis could be the way forward for contemporary antibiotic specifications.

关 键 词：抗生素 质量标准 药典 质量控制 

分 类 号：R978.1[医药卫生—药品]