The authors regret that an error in Fig.3E in this article was found while we reviewing the published data.An inadvertent mistake occurred in the process of assembling images.The picture of the Ms215μg/mL group was w...The authors regret that an error in Fig.3E in this article was found while we reviewing the published data.An inadvertent mistake occurred in the process of assembling images.The picture of the Ms215μg/mL group was wrongly placed.展开更多
目的:对比辛酸法和低温乙醇法制备静注人免疫球蛋白(Human Immunoglobulin for Intravenous Injection,IVIG)粗制品在杂质去除效果与产品质量方面的差异,筛选适宜的粗制工艺。方法:分别采用辛酸法与低温乙醇法制备静注人免疫球蛋白粗制...目的:对比辛酸法和低温乙醇法制备静注人免疫球蛋白(Human Immunoglobulin for Intravenous Injection,IVIG)粗制品在杂质去除效果与产品质量方面的差异,筛选适宜的粗制工艺。方法:分别采用辛酸法与低温乙醇法制备静注人免疫球蛋白粗制品,对比其活化凝血因子Ⅺ含量、免疫球蛋白A(Immunoglobulin A,IgA)含量、抗A与抗B血凝素、纯度、收率、抗-HBs效价、Fc片段活性及抗体谱。结果:低温乙醇法制备的粗制品在活化凝血因子Ⅺ含量、IgA含量及抗A与抗B血凝素方面均显著低于辛酸法,且纯度在93%以上;辛酸法则在收率方面表现较优,在72%以上。两种工艺在抗-HBs效价、Fc片段活性及抗体谱上无显著差异。结论:低温乙醇法作为静注人免疫球蛋白的粗制工艺,在关键杂质控制方面优于辛酸法,更有利于为下一步层析法制备高纯度静注人免疫球蛋白提供纯化基础。展开更多
文摘The authors regret that an error in Fig.3E in this article was found while we reviewing the published data.An inadvertent mistake occurred in the process of assembling images.The picture of the Ms215μg/mL group was wrongly placed.
