不同工艺制备的静注人免疫球蛋白产品质量对比研究

摘要

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工艺制备的静注人免疫球蛋白的Ig A含量(5.30μg/ml)明显低于低温乙醇分离工艺(281.95μg/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 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 .