两种高浓度静注人免疫球蛋白中IgA残留量检测方法的验证及比较  

Verification and comparison of two methods for determination of residual IgA content in high concentration human immunoglobulin for intravenous injection

作　　者：刘勇 李泽秀 唐良玉 邓靖 张尧 余雨蓉 陈云华 赵学梅 LIU Yong;LIZe-xiu;TANG Liang-yu;DENGJing;ZHANG Yao;YU Yu-rong;CHEN Yun-hua;ZHAO Xue-mei(Guizhou TaiBang Biological Products Co.Ltd.,Guiyang 550025,Guizhou Province,China)

机构地区：[1]贵州泰邦生物制品有限公司,贵州贵阳550025

出　　处：《中国生物制品学杂志》2021年第12期1477-1481,共5页Chinese Journal of Biologicals

基　　金：贵州省科技计划项目:黔科合成果(20204Y019)。

摘　　要：目的对酶联免疫法与散射比浊法检测高浓度静注人免疫球蛋白(human immunoglobulin for intravenous injection,IVIG)中IgA残留量进行验证及比较。方法分别验证两种方法的线性范围、准确度、重复性、中间精密性、专属性,并对两种方法进行比对分析。用两种方法检测7批次高浓度IVIG中的IgA残留量,并与中国食品药品检定研究院检测结果进行比对。结果酶联免疫法IgA浓度在12.5~800 ng/mL范围内与A450呈良好的线性关系(r=0.99996),散射比浊法IgA浓度在0.261~8.35 mg/L范围内标准曲线均值偏差为0.56%;两种方法的加样回收率分别为103.32%和89.82%;重复性和中间精密性的RSD均小于8%;甘氨酸辅料对两种方法测定IgA残留量干扰较小。两种方法测定3批IVIG中IgA残留量结果差异无统计学意义(P>0.05);委外检测的7批次高浓度IVIG中IgA残留量略低于企业自检结果。结论酶联免疫法与散射比浊法均可快速、简便、准确地测定高浓度IVIG中IgA残留量,可用于产品质量控制。Objective To verify and compare enzyme-linked immunosorbent assay(ELISA)and nephelometry assay for determination of residual IgA content in high concentration human immunoglobulin for intravenous injection(IVIG).Methods The two methods were verified for linear range,accuracy,reproducibility,intermediate precision and specificity,then compared.The residual IgA contents in seven batches of high concentration human were determined by the two methods,and compared with the test results by the National Institutes for Food and Drug Control.Results The IgA concentration at a range of 12.5~800 ng/mL,determined by ELISA,showed good linear relationship with A450(r=0.99996).The mean deviation of standard curve of IgA concentration at a range of 0.261~8.35 mg/L by the nephelometry method was 0.56%.The sample recovery rates of the two methods were 103.32%and 89.82%respectively,while the RSDs of reproducibility and intermediate precision were less than 8%.The glycine as an excipient showed little interference to the determination of residual IgA content by the two methods.The determination results of residual IgA content in three batches of IVIG by the two methods showed no significant difference(P>0.05).However,the residual IgA contents in seven batches of high concentration human IVIG outsourced for testing were slightly lower than the determination results by the manufacturer.Conclusion Both ELISA and nephelometry assay may be used for rapid,simple and accurate determination of residual IgA content in high concentration IVIG as well as the product quality control.

关 键 词：高浓度静注人免疫球蛋白 IgA残留量 酶联免疫法 散射比浊法 

分 类 号：K331[历史地理—历史学]