测定静脉注射人免疫球蛋白IgG含量的三种方法比较  

A Comparison of Three Methods for Determination of the Content of IgG in Human Immunoglobulin Preparations for Intravenous Injection(IVIG)

作　　者：王淼[1] 薛巧如[1] 姚敏菲[2] 谢正福[3] 

机构地区：[1]广东省药品检验所生化室,广东广州510180 [2]中山大学化学与化学工程学院,广东广州510275 [3]广东省食品药品监督管理局审评认证中心,广东广州510080

出　　处：《解放军药学学报》2010年第6期517-520,共4页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的对检测静脉注射人免疫球蛋白中IgG含量的3种方法进行比较。方法采用紫外分光光度法、酶联免疫法、高效亲和色谱法对静脉注射人免疫球蛋白进行IgG含量测定。结果紫外分光光度法与高效亲和色谱法及酶联免疫法之间有显著性差异,高效亲和色谱法与酶联免疫法之间无显著性差异,高效亲和色谱法的重复性较好,RSD为0.8%。结论为选定静脉注射人免疫球蛋白中IgG含量测定方法提供了依据。Objective To compare three methods for determination of the content of IgG in intravenous injection.Methods High-performance affinity,the enzyme-linked immunosorbent assay and ultraviolet spectrophotometry were used to determine the content of IgG in intravenous injection.Results The statistical analysis showed that there was significant difference between the results obtained from ultraviolet spectrophotometry,high-performance affinity and the enzyme-linked immunosorbent assay,but no significant difference between the results of high-performance affinity and the enzyme-linked immunosorbent assay.The result of the reproducible test from high-performance affinity was the best among the three methods.Conclusion This study helps choose a proper method to determine the content of IgG in intravenous injection.

关 键 词：IGG 高效亲和色谱法 紫外分光光度法 酶联免疫法 

分 类 号：R927.2[医药卫生—药学]