静注人免疫球蛋白IgG含量测定中的影响因素

Study on the influential factors for detection IgG content of human immunoglobulin preparations for intravenous injection(IVIG)

为了进一步分析静注人免疫球蛋白(IVIG)IgG含量测定中的影响因素,分别以不同的稀释缓冲液、不同的稀释度、不同的稳定剂对IVIG的IgG含量进行测定。结果表明以不同的稀释缓冲液、不同的稳定剂测定的同批IgG含量无显著性差异;而用不同的稀释度测定的同批IgG含量有差异。因此可见,IVIG制品中采用的不同稳定剂对IgG含量测定影响不大;可以用不同的稀释度测定的均值作为该批IVIG制品的IgG含量。

Detect IgG content in IVIG preparations by using the different diluent＇s buffer, different dilution and different stabilizers. There is no significant difference in detection of the same lot IVIG by using the different diluent＇s buffer and different stabilizers, but the difference does exist in the same detection by using different dilutions. Thus the different stabilizers have no much influence in detection of IgG content in IVIG preparations. The average value from detections by using of different dilution could be taken as the IgG content in IVIG preparation.