静注人免疫球蛋白细菌内毒素定量检测方法的探讨

Investigation for quantitative detection of bacterial endotoxin in intravenous immunoglobulin

目的探讨动态浊度法定量检测静注人免疫球蛋白细菌内毒素含量。方法参照《中国药典》2010年版三部附录中细菌内毒素检查法的规定,对静注人免疫球蛋白细菌内毒素含量检测方法进行了探讨,制备了标准曲线、进行了可靠性试验和干扰试验,并将动态浊度法检测结果与家兔法的结果进行了比较。结果动态浊度法测定的标准曲线的相关系数均大于0.98,静注人免疫球蛋白经16倍稀释后,干扰试验的回收率在50%～200%之间,完全消除其对鲎试剂与细菌内毒素凝集反应的干扰,并且动态浊度法与家兔法的检测结果一致。结论动态浊度法定量测定静注人免疫球蛋白中细菌内毒素含量,结果准确,操作简单,并且与家兔检查热原的结果一致。

Objective To study on the dynamic turbidity method for quantitative detection of bacterial endotoxin in intrave-nous immunoglobulin（ IVIG）. Methods According to the requirement on quantitative detection of bacterial endotoxin of ＂Pharmacopoeia of the Peoples＂ Republic of China, Section Ⅲ＂, edition 2010,the quantitative detection of bacterial endo-toxin in IVIG was carried out by the dynamic turbidity method, the standard curve, reliable test and interference test were perfomed. Then the result between dynamic turbidity and the rabbit method was compared. Results The correlation coeffi- cient in absolute value of the standard curve for dynamic turbudity method is equal to or higher than 0.98 （ r≥0.98 ）. After the IVIG being diluted into 16 folds, recovery of interference test is 80% to 200%. This method completely eliminates the interference between tachypleus amebocyte lysate and bacterial endotoxin. The result for dynamic turbidity is identical to the rabbit method. Conclusion This test has advantagies such as accurate, sensitive, stable, good repeatability, and its re-sult is consistent with that of the rabbit pyrogen test.