摘要
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 and identify a novel intravenous immunoglobulin（IVIG）. Methods Eight batches of10% IVIG were prepared by ultrafiltration. Glycine was used as a stabilizer instead of sugar,of which the concentration was optimized（12 - 18 g / L）. The 10% IVIG was tested for overall quality,Ig G subclass distribution,Fc activity and stability. Results The optimal concentration of glycine was 15 g / L. The overall quality of 10% IVIG met the relevant requirements,while the Ig G subclass distribution,Fc activity and stability were similar to those of 5% IVIG. The overall quality of 10% IVIG met the relevant requirements after storage at 25 ℃ for 6 months and at 2 -8 ℃ for 6 years.Conclusion The 10% IVIG showed good quality and stability.
出处
《中国生物制品学杂志》
CAS
CSCD
2015年第12期1282-1284,1293,共4页
Chinese Journal of Biologicals
基金
国家863计划(2012AA021094)
国家科技重大专项(2011-ZX09201-301-02)
四川省科技支撑项目(2014SZ0123)
关键词
静注人免疫球蛋白
稳定剂
Fc活性
IG
G亚类分布
Intravenous immunoglobulin（IVIG）
Stability
Fc activity
Ig G subclasses distribution
