用低温乙醇分级分离法纯化的静注免疫球蛋白(IVIG)制剂有很好的病毒安全性,但也有在使用IWIG制剂后传播非甲非乙型肝炎的病 例报道.为了保证IWIG的病毒安全性,作者在原有生产工艺中增加了病毒灭活步骤,即在无稳定剂、低盐、酸性pH的条件下实施巴氏消毒法.研究所用的初始材料为通过低温乙醇工艺抽提制备的肌注破伤风抗毒素IgG,IgG制剂经无菌过滤后,于60℃培育5、7或10小时.用大肠杆菌噬菌体(?)X174作为无包膜病毒模型对此法的病毒灭活效果进行评估,同时对免疫球蛋白制剂的性质进行分析.结果显示,IgG制剂经60C10 小时处理后,病毒滴度降低5log.高压液相层析显示,加热处理后制剂中未测得多聚体,仅测得痕量的二聚体,单体比例大于99%.60C10小时处理前后的IgG制剂的圆二色谱不同,加热处理的IgG的二色性信号较低,表明其二级结构有轻微改变.抗体依赖性细胞介导的细胞毒性抑制试验证实,巴氏消毒处理的IgG的 IVIV preparations purified by cryogenic ethanol fractionation have good virus safety, but there are also reports of cases of non-A, non-B hepatitis transmission after the use of IWIG preparations. In order to ensure the safety of IWIG virus , The author added the virus inactivation step in the original production process, that is, in the absence of stabilizers, low salt, acidic pH pasteurization under the conditions of the initial material used in the study prepared by low-temperature ethanol extraction of intramuscular injection Tetanus antitoxin IgG and IgG preparations were sterilely filtered and incubated for 5, 7 or 10 hours at 60 ° C. The virus inactivation effect of this method was evaluated using E. coli bacteriophage X174 as a non-enveloped virus model The properties of the immunoglobulin preparations were analyzed and the results showed that the titer of the virus was reduced by 5 logs after treatment with IgG for 60 hours.HPLC showed no polymer was detected in the preparations after heat treatment and only traces The amount of dimer, monomer ratio greater than 99% .60C10 hours before and after treatment of IgG preparations circular dichroism, heat-treated IgG dichroism signal is low, indicating that the secondary structure of a slight change in antibody dependence Cell mediated Cytotoxicity inhibition assay confirmed, IgG pasteurization processing