细菌内毒素国家标准品的协作标定  

Collaborative Calibration of the National Standard for Bacterial Endotoxin

作　　者：肖斯婷 李雪梅 曹春然 XIAO Siting;LI Xuemei;CAO Chunran(Beijing Institute for Drug Control,Key Laboratory for Safety Research and Evaluation of Innovative Drugs,NMPA,Beijing Key Laboratory for Analysis and Biological Evaluation of Traditional Chinese Medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验研究院、国家药品监督管理局创新药物安全研究与评价重点实验室、中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《中国医药导刊》2023年第12期1236-1244,共9页Chinese Journal of Medicinal Guide

摘　　要：目的:标定中国食品药品检定研究院细菌内毒素工作标准品(细菌内毒素检测用)。方法:以细菌内毒素国家标准品(9000 EU/支,细菌内毒素检测用)为标准,采用2020年版《中华人民共和国药典》四部1143细菌内毒素检查法中凝胶法和动态浊度法分别对给定的6支细菌内毒素工作标准待标品进行效价标定。结果:待标品预估效价为90 EU/支,标定结果除1支存在偏差外,其余5支效价均在可接受范围。结论:本批待标品采用动态浊度法进行检测时效价较凝胶法测定结果和预估效价均偏低,是否因环境或运输因素使其效价衰减,还有待进一步的实验研究。采用量反应平行线法对动态浊度法测定结果进行尝试计算,结果显示其试品间存在差异,其他全部符合平行,可能是配制时的浓度需要调整。Objective:To calibrate bacterial endotoxin working standard(for bacterial endotoxin detection)in National Institutes for Food and Drug Control.Methods:Using bacterial endotoxin national standard(for bacterial endotoxin detection,9000 EU/dose)as the standard.The gel method and dynamic turbidimetric method in“1143:the test method of bacterial endotoxin”in the fourth part of the Pharmacopoeia of the People′s Republic of China(2020 edition)were used to calibrate the titer of the given 6 bacterial endotoxin working standard samples.Results:The estimated titer of the samples was 90 EU/dose,and the calibration results showed that except for one sample with deviation,the titer of the other 5 samples were all within the acceptable range.Conclusion:In this batch of samples,the titer measured by dynamic turbidity method is lower than that of gel method and the estimated titer.Whether the titer is attenuated due to environmental or transportation factors needs further experimental study.The quantitative reaction parallel line method is used to calculate the results of the dynamic turbidimetric method,and there are significant differences between the samples,which may be due to the need to adjust the concentration during preparation.

关 键 词：细菌内毒素 国家标准品 效价测定 协作标定 凝胶法 动态浊度法 量反应平行线法 

分 类 号：R927.12[医药卫生—药学] R917