生物制品中抗生素的使用及残留检测方法

Applications of Antibiotics and the Methods for Their Determination in Biological Products

生物制品生产过程中使用抗生素存在其残留物不能被完全清除的风险,从而对人体产生潜在的危害。本文综述了2015版中国药典对抗生素使用的相关规定,归纳了检测抗生素残留的方法(包括培养法、酶联免疫法)及适用的品种,对抗生素残留分析方法研究现状与前景进行了展望。

The use of antibiotics in the production of biological products can lead to the risk of the residuecan not be completely removed, which has a potential harm to the human body. This paper reviews the relevant provisions of the Chinese Pharmacopoeia of 2015 edition for the use of antibiotics, and introduced the methods of detecting antibiotic residues（ including the culture method and enzyme-linked Immunosorbent assay）and the applicable varieties, and prospected of the research on the status and prospects of antibiotic residues.