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目的制备新型静注人免疫球蛋白(IVIG),并对其质量进行鉴定。方法采用超滤浓缩法制备了8批10%IVIG制品,以甘氨酸代替糖类作为稳定剂的主要配方,并优化其浓度(12~18 g/L)。检测10%IVIG制品的总体质量、Ig G亚类分布、Fc活性及稳定性。结果最佳甘氨酸浓度为15 g/L。10%IVIG制品的总体质量均合格,Ig G亚类分布及Fc活性均与5%IVIG制品相似,且该制品在25℃存放6个月和2~8℃存放6年后的总体质量均合格。结论制备的10%IVIG质量优良,且具有良好的稳定性。
Objective To prepare a new type of intravenous human immunoglobulin (IVIG) and identify its quality. Methods Eight batches of 10% IVIG products were prepared by ultrafiltration concentration method. Glycine was used as the main formulation instead of carbohydrates and its concentration (12-18 g / L) was optimized. The overall quality of 10% IVIG preparations, IgG distribution, Fc activity and stability were examined. The best glycine concentration was 15 g / L. The overall quality of 10% IVIG preparations was qualified, IgG subclass distribution and Fc activity were similar to those of 5% IVIG preparations, and the overall quality of the products was 6 months at 25 ° C and 6 years at 2-8 ° C . Conclusion The prepared 10% IVIG has good quality and good stability.