不同工艺制备的静注人免疫球蛋白产品质量对比研究

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。

Comparative study on the quality of intravenous injection human immunoglobulin products prepared by different processes

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.