目的 对比用低温乙醇蛋白分离工艺制备的静注人免疫球蛋白（pH4）和两步阴离子交换层析制备的静注人免疫球蛋白（10%）产品质量指标，分析制备工艺对产品质量的影响。方法 对2种工艺的产品进行IgA含量、分子大小分布、抗-HBs效价、蛋白空间结构、Fc片段活性、抗体谱和IgG亚型分布等指标的检测和对比分析。结果 两步阴离子交换层析制备的静注人免疫球蛋白的IgA含量（5.30 μg/ml）明显低于低温乙醇分离制备的（281.95 μg/ml），而分子大小分布、抗-HBs效价、蛋白空间结构、Fc片段活性、抗体谱、亚型分布指标没有明显差别。结论 两步阴离子交换层析制备的静注人免疫球蛋白（10%）具有更高的安全性。

Objective  To compare and analyze the quality of human immunoglobulin for intravenous injection (IVIG) (pH4) prepared by two-step low-temperature ethanol protein separation and that of IVIG (10%) prepared by two-step anion exchange chromatography. Methods  The IgA content, molecular size distribution, anti-HBs titer, protein spatial structure, Fc fragment activity, antibody spectrum and IgG subtype distribution of IVIGs prepared by 2 different processes were detected and compared. Results  The IgA content of IVIG from two-step anion exchange chromatography (5.30 μg/ml) was significantly lower than that of IVIG from low-temperature ethanol separation (281.95 μg/ml), and there was no significant difference in molecular size distribution, anti-HBs titer, protein spatial structure, Fc fragment activity, antibody spectrum and IgG subtype distribution indexes. Conclusion  IVIG (10%) prepared by two-step anion exchange chromatography has better safety.