动态浊度法定量检测静脉注射用人免疫球蛋白中细菌内毒素含量

The quantitative detection of bacterial endotoxin in IVIg with kinetic turbidimetric quantitative assay

用鲎试剂动态浊度法定量检测静脉注射用人免疫球蛋白中细菌内毒素含量并与家兔法检测热原的结果进行对比。根据《中华人民共和国》2005年版三部附录中的细菌内毒素动态浊度法制定内毒素限值,用ATi320-06型动态试管仪和该仪器配置的中文软件"生物探针-2002"分析检测结果。静脉注射用人免疫球蛋白经稀释消除了干扰因素,动态浊度法能定量检测出内毒素含量。实验满足2005年版中国药典要求:标准曲线相关系数的绝对值︱r︱≥0.980,回收率:50%≤R≤200%,变异系数符合鲎试剂厂家的建议值CV%<10%。检测结果准确、灵敏、稳定、重现性好,与家兔法检测结果相一致。鲎试剂动态浊度法能定量检测静脉注射用人免疫球蛋白中细菌内毒素含量。

The limitation value of bacterial endotoxin content was determined according to the requirement of＂ Pharmacopoeia of the People＇s Republic of China＂, Section III, edition 2005. The tested results were analyzed using dynamic tube instrument ATi320-06 and its configuration in the Chinese software Bio-probe -2002. The results showed that the interferential factors can be eliminated by diluting human intravenous immunoglobtdin, and the endotoxin can be quantitatively determined by using kinetic turbidimetric method. The experiment has met the requirement of ＂the Chinese Pharmacopoeia＂, eclifton 2005 ：the absolute value of the standard curve correlation coefficient ｜r ｜≥ 0. 980, the recovery rate is 50% ≤R≤ 200%, variation coefficient is in line with the manufacturer＇s recommended value TAL CV% 〈 10%. This test have the advantage that accurate, sensitive, stable, good repeatability and its result is consistent with that of the rabbit pyrogen test.