目的  分析使用两种纳米膜（A、B）除病毒过滤对静注人免疫球蛋白生产的影响。方法  选取使用A和B纳米膜过滤的静注人免疫球蛋白各10批次，比较过滤流速、产品收率及产品主要质量指标（蛋白含量、pH值、纯度、抗补体活性、分子大小分布）。结果  B纳米膜单位膜面积过滤流速高于A纳米膜（t=16.98，P=0.000）。在一个全批次量的静注人免疫球蛋白纳米膜过滤中，使用B纳米膜的产品收率高于使用A纳米膜（t=8.87，P=0.000）。使用两种纳米膜过滤后，产品的蛋白含量（t=1.49，P=0.171）、pH值（t=0.19，P=0.853）、纯度（t=0.00，P=1.000）、抗补体活性（t=0.08，P=0.934）和分子大小分布（t=0.21，P=0.840）无统计学差异。结论  在静注人免疫球蛋白进行除病毒过滤生产过程中，使用B纳米膜的过滤效率高于使用A纳米膜。两种纳米膜过滤后的产品质量无显著差异。

Objective  To analyze the influence of virus-removal by two tapes (A and B) of nanofiltration membranes on intravenous immunoglobulin (IVIG) production.  Methods  Ten batches of IVIG each, filtered through A or B nanofiltration membranes, were compared for filtration velocity, yield, and product quality (including protein content, pH, purity, anticomplement activity, and molecular size distribution).  Results  The mean filtration velocity per unit area by B membrane was faster than A (t=16.98, P=0.000), and the product yield in average batch production by B was also higher (t=8.87, P=0.000). The protein content (t=1.49, P=0.171), pH (t=0.19, P=0.853), purity (t=0.00, P=1.000), anticomplement activity (t=0.08, P=0.934), and molecular size distribution (t=0.21, P=0.840) of products through A or B showed no significant difference. Conclusion  In the manufacturing application of IVIG nanofiltration, the production efficiency by B was higher, and the product quality difference between A and B was not significant.