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
黄佳慧 1何冬华 1崔碧玲1
作者信息
- 1. 东莞市食品药品检验所,广东 东莞 523000
- 折叠
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 0.0625～1.0 EU/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.
Abstract
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.Vol Ⅳ: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Key words
proficiency testing samples/bacterial endotoxin/kinetic turbidimetric method/content determination引用本文复制引用
出版年
2024
NETL
NSTL
万方数据