中国药典2020年版细菌内毒素检查法补充方法应用研究

Study on the Application of Supplementary Methods of Bacterial Endotoxin Test in Chinese Pharmacopoeia 2020 Edition

关键词:  细菌内毒素检查法  补充方法  鲎试剂  重组C因子

Key words:  bacterial endotoxin test method  supplementary method  limulus reagent  recombinant factor C

摘要:

目的 为了促进中国药典使用者对新增的内毒素检查方法的理解,保障中国药典2020年版顺利执行,介绍重组C因子法和微量凝胶法起草背景、增订和应用的相关内容。方法 结合9251细菌内毒素检查法应用指导原则和重组C因子与微量凝胶法的研究,梳理2种方法相关内容。结果 结合内毒素检查法与鲎资源现状以及补充方法分类,讨论重组C因子法和微量凝胶法简介、应用现状及使用,详细介绍2种补充方法。结论按照中国药典的要求使用重组C因子法和微量凝胶法,可缓解鲎资源短缺带来的问题,保障注射剂的质量安全。

Abstract:

OBJECTIVE To promote the understanding of users of the Chinese Pharmacopoeia on the supplementary methods of the new endotoxin test method and ensure the implementation of the Chinese Pharmacopoeia 2020 edition, introduced the relevant content of the drafting background, revision and application of the recombinant factor C method and the micro-gel method. METHODS Combined the 9251 bacterial endotoxin test application guidelines principle and the research data of recombinant factor C and microgel method, the two methods were clarified. RESULTS Combined with the endotoxin inspection method and current status of horseshoe crab resources, classification of supplementary methods. The introduction, application status and use of recombinant factor C method and microgel method were discussed, and the two supplementary methods were introduced in detail. CONCLUSION The use of recombinant factor C method and microgel method in accordance with the requirements of the Chinese Pharmacopoeia can alleviate the problems caused by the shortage of horseshoe crab resources and ensure the quality and safety of injections.