动态浊度法定量检测能力验证样品中细菌内毒素含量及分析  

The Kinetic Turbidimetric Assay was used to Determine the Content of Bacterial Endotoxin in Samples

作　　者：黄佳慧 何冬华 崔碧玲 Huang Jiahui;He Donghua;Cui Biing(Dongguan Institute for Food and Drug Control,Donguan 523000,China)

机构地区：[1]东莞市食品药品检验所,广东东莞523000

出　　处：《广东化工》2024年第11期167-169,共3页Guangdong Chemical Industry

摘　　要：检测能力验证样品中细菌内毒素的含量和分析检测过程的注意事项。依据《中国药典》2020年版4部通则1143细菌内毒素检查法的光度测定法中的动态浊度法。建立细菌内毒素检查的标准曲线,通过预实验确定样品最佳稀释倍数及预估细菌内毒素含量,并选定最佳稀释倍数对样品中细菌内毒素含量进行独立平行3次检测。细菌内毒素检测浓度线性范围为0.0625~1.0EU/mL,标准曲线为LgT=2.8059+(-0.28966LgC)(|r|值=0.9982);样品在稀释1000倍时对试验无干扰作用;细菌内毒素回收率50%~200%;3次平行检测结果 T1、T2、T3分别为83.80 EU/mL、82.70 EU/mL、83.00 EU/mL。动态浊度法测定该能力验证样品的检测方法可靠、结果准确、稳定。To determinate the concentration of bacterial endotoxin in proficiency testing samples and analyze the matters needing attention in the inspection process.According to the method of ChP 2022.VolⅣ:1143.The kinetic turbidimetric method of photometric determination of bacterial endotoxin.Establish a standard curve of bacterial endotoxin test.The optimal dilution ratio and bacterial endotoxin content were determined by pre-experiment.The optimal dilution ratio was selected to determine the bacterial endotoxin content in the samples for three independent and parallel tests.The linear range of bacterial endotoxin was 0.0625~1.0 EU/mL.The standard curve is LgT=2.8059+(-0.28966LgC)(|r|=0.9982).The endotoxin test wasnt interfered by 1000 times diluted solution.The recovery rate of bacterial endotoxin was 50%~200%.The results of T1,T2 and T3 were 83.80 EU/mL,82.70 EU/mL and 83.00 EU/mL.The kinetic turbidimetric method is reliable,accurate and stable for the proficiency testing samples.

关 键 词：能力验证样品 细菌内毒素 动态浊度法 含量检测 

分 类 号：TQ[化学工程]