摘要
目的:检测中国食品药品检定研究院下发的能力验证样品中细菌内毒素的含量。方法:选用光度测定法中的动态显色法,建立细菌内毒素检查的标准曲线,通过测定样品外加内毒素的回收率进行干扰试验,确定样品检测浓度线性范围,并测定样品中的细菌内毒素含量。结果:内毒素检测浓度线性范围为0.005~50 EU·mL^(-1)(|r|值均大于0.980);样品检测与标准曲线检测变异系数(CV)均小于10%;细菌内毒素回收率为50%~200%;两批能力验证检测结果分别为12.21 EU·mL^(-1)和93.24 EU·mL^(-1)。结论:动态显色法测定该能力验证样品的检测方法可靠、结果准确,可用于能力验证的盲样细菌内毒素含量测定。
Objective:To determine the content of bacterial endotoxin in proficiency testing samples.Methods:The dynamic chromogenic method in photometry was selected.The standard curve for bacterial endotoxin test was established,and the interference test was carried out by determining the recovery rate of the sample plus endotoxin to determine the linear range of the sample detection concentration and determine the bacterial endotoxin content in the sample.Results:The linear range of endotoxin test concentration was 0.005~50 EU·mL^(-1)(|r|values were greater than 0.980).The coefficient of variation(CV)of sample detection and standard curve detection are all less than 10%.The recovery rate of bacterial endotoxin was 50%~200%;The test results of two batches of proficiency testing samples were 12.21 EU·mL^(-1) and 93.24 EU·mL^(-1) respectively.Conclusion:The dynamic chromogenc method is reliable and accurate,and determination of the content of bacterial endotoxin in the blind proficiency testing samples.
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)
出处
《中国医药导刊》
2023年第1期91-95,共5页
Chinese Journal of Medicinal Guide
关键词
能力验证样品
细菌内毒素
动态显色法
含量检测
Proficiency testing sample
Bacterial endotoxin
Dynamic chromogenic method
Content determination
