目的 初步筛选去除血浆组分II溶解液中IgA效果最佳的pH条件和滤膜载量。方法 以不同pH组分Ⅱ溶解液进行过滤,比较浊度、IgA含量、分子大小分布、纯度。结果 pH7.25~7.90,滤膜载量300~400 L/m2,组分Ⅱ溶解液经滤膜组合过滤后滤液浊度下降45.8%~60.5%、IgA含量下降68.0%~80.0%、分子大小分布为100%、纯度为100%。结论 组分Ⅱ溶解液在pH7.25~7.90,载量≤400 L/m2条件下,经滤膜过滤后不仅能有效去除IgA,而且其他质量指标保持不变,可为规模化生产工艺改进提供参考。
Objective To preliminarily screen pH conditions and filter capacity with optimal effect on the removal of IgA from component Ⅱ dissolving solution. Methods The dissolving solutions of component II with different pH were used for filtration, and the turbidity, IgA content, molecular size distribution and purity were compared. Results The dissolution solution of component II at pH7.25-7.90, and filter capacity is 300-400 L/m2, after filtering through filter combination the filtrate turbidity decreased by 45.8%-60.5%, the IgA content decreased by 68.0%-80.0%, the molecular size distribution was 100%,and the purity was 100%. Conclusion Under the condition of pH7.25-7.90 and filter capacity ≤400 L/m2, after filtering through the filter membrane, not only can IgA be effectively removed, but also other quality indicators remain stable. It can provide reference for the improvement of large-scale production process.