人巨细胞病毒免疫球蛋白的研制及其临床应用

Preparation and Clinical Application of Human Cytomegalovirus-IgG

制备人源性高效价人巨细胞病毒 (HCMV)特异免疫球蛋白 (IgG)。采用ELISA从检定合格的血浆中筛选出滴度≥ 1∶5 0 0 0的血浆 ,合并后按低温乙醇法制备HCMV IgG ,再次检定后应用于临床。结果显示 ,按人免疫球蛋白标准检定 ,所制备的HCMV IgG全部合格 ,HCMV IgG滴度为 1∶15 0 0 0 0。临床应用结果表明 ,2批高效价HCMV IgG均可明显降低先天性HCMV感染率。

HCMV-IgG with high titers from human plasma was prepared in this study. High titers of anti-HCMV-IgG (≥1∶5 000) from the qualified plasma was screened by ELISA. The screened plasma was combined and then used to prepare high titer of HCMV-IgG by using Cohn 6/9 method. The product of HCMV-IgG was examined again and applied in clinic. According to the criteria of human plasma globulin for muscle injection in “The Chinese protocol of biological products 2000”, all the prepared HCMV-IgG was qualified. The titer of HCMV-IgG was as high as 1∶150 000. The results in clinical application of two batches of the HCMV-IgG with high titers indicated that the HCMV-IgG could decrease the connate infection proportion of HCMV.;