低pH孵放、干热处理冻干静脉注射人免疫球蛋白的实验研究  

Study on lyophilized IVIG Incubated at Low pH and Dry-heat Treatment

作　　者：杨红育[1] 陈立新[1] 康辉[1] 张宏超[1] 孙延国[1] 聂荣国[1] 陈维金[1] 刘淑英[1] 

机构地区：[1]长春生物制品研究所,吉林长春130062

出　　处：《微生物学杂志》2004年第2期16-17,共2页Journal of Microbiology

摘　　要：主要介绍冻干静脉注射人免疫球蛋白 (IVIG)分别通过 60℃ 72h,80℃ 72h ,低pH孵放 2 1d处理后 ,IVIG的各项理化及生物活性的变化 ,以及IVIG经过低pH孵放的灭活病毒情况。实验结果表明 ,处理后的IVIG其IgG各组份相对含量、抗补体活性 (ACA)、前激肽释放酶激活剂 (PKA)、白喉抗体、抗 HBs等结果 ,除ACA ,PKA略有下降 ,其他指标无明显变化 ,各项指标均符合 2 0 0 0版《中国生物制品规程》 ;加热后没有新抗原产生。低pH孵放 2 1d通过加指示病毒的实验 ,病毒灭活效果达到 7.0 0logTCID50 / 0 .1mL以上 ,灭活病毒有效。We mostly introduced lyophilized physical IVIG and chemical changes of after it was placed at 60℃ for 72 h,80℃ for 72 h and incubated at low pH for 21 days.We also told IVIG inativated virus after it was incubated at low pH. The experiment results indicated that the relative content of IgG component,ACA,PKA,diphtheria antibody,anti-HBs and so on,were not evidently changed except ACA and PKA were a little drop after IVIG was trented.Every target all according to Requierments for Biologics of China (2000 edition) had not produced new antigen after heating.The inactived virus effect of could be {7.00 logTCID-{50}/0.1 }mL in the experiment while adding indicating virus after it was incubated at low pH for 21 days. It indicated that the inactived virus effect of was efficient.

关 键 词：人免疫球蛋白 血液制剂 病毒污染 安全性 病毒灭活 干热处理 低pH孵放 

分 类 号：R392-33[医药卫生—免疫学]