放射性药品细菌内毒素检测方法的研究进展

Research progress on detection methods of bacterial endotoxin in radioactive drugs

细菌内毒素含量是注射型放射性药物的关键质量属性,已标准化的方法包括家兔法和鲎试剂法;新型检测法有试剂盒检测法、磁弹性传感器法、生物传感器法、仪器分析的方法。分别从蛋白类生物传感器、肽类生物传感器、抗体类生物传感器、适体类生物传感器、细胞类生物传感器几个方面着重介绍了生物传感器法,生物传感器法是未来放射性药物细菌内毒素测定的发展趋势。

Bacterial endotoxin content is a key quality attribute of injectable radiopharmaceuticals. The standardized methods include rabbit pyrogen test and Limuluspolyphemus test. The new detection methods include kit detection method, magnetoelastic sensor method, biosensor method, and instrument analysis method. Biosensor methods are introduced from the aspects of protein biosensors, peptide biosensors, antibody biosensors, aptamer biosensors, and cell biosensors. The biosensor method is the future development of radiopharmaceutical bacterial endotoxin detection.