中国与美国药典细菌内毒素检查法应用指导原则的比较和解读

Comparison and interpretation of guidelines for the application of bacterial endotoxin tests in Chinese and American Pharmacopoeia

目的为国内细菌内毒素检测、研究和药物警戒工作提供参考。方法参考《美国药典》1085细菌内毒素检查法应用指导原则和《中国药典》9251细菌内毒素检查法应用指导原则,对中国与美国内毒素标准物质管理、质量管理的异同及指导原则中容易误读的要点等相关内容进行介绍和解读。结果中国与美国细菌内毒素检查法应用指导原则均在2020年被首次收载,在背景、检测、工作标准品标定、质量管理、限度计算、替代方法等方面给予了详细指导和论述。结论中国与美国内毒素检查法应用指导原则作为细菌内毒素检测领域的权威指导原则,为内毒素实验室检测人员及《中国药典》修订提供帮助与启示,并将在实践中不断调整和完善。

Objective To provide reference for the detection,research and pharmacovigilance related to bacterial endotoxin in China.Methods USP 1085 and Chinese Pharmacopoeia 9251 were studied,and the similarities and differences in endotoxin reference material management,quality management and sections prone to misinterpretation in the guidelines were introduced and interpreted.Results USP 1085 and Chinese Pharmacopoeia 9251 were included in 2020 for the first time.Practitioners were given detailed guidance and descriptions on the background,testing,working standard calibration,quality management,limit calculation,and alternative methods.Conclusion USP 1085 and Chinese Pharmacopoeia 9251,as an authoritative guideline for bacterial endotoxin detection,is quite helpful for personnel engaged in endotoxin testing and for revision of Chinese Pharmacopoeia.It will be constantly revised and improved in the process of practice.