热力法快速灭活冻干IgG制品中病毒的可行性研究

STUDY ON FEASIBILITY OF RAPID INACTIVATION OFVIRUS IN LYOPHILIZED IgG BY HEAT

采用病毒细胞感染和免疫化学等试验观察了１００℃干热法快速灭活冻干ＩｇＧ中病毒的可行性。结果表明，１００℃处理３０ｍｉｎ可灭活ＩｇＧ中的水泡性口炎病毒（１０８２ＴＣＩＤ５０）和人类免疫缺陷病毒１型（１０４５～１０５２ＴＣＩＤ５０）。处理后ＩｇＧ的外观色泽和复溶效果均未见明显变化，抗原及抗体活性与未处理组相近，β－折叠构象仍然存在；但分子聚合体含量略有升高。如能找到减缓ＩｇＧ分子热聚合速度的方法，１００℃干热法有望用于快速灭活冻干ＩｇＧ中的病毒。

easibility of rapid inactivation of virus in lyophilized IgG product by 100℃ dry heat was observed experimentally using techniques such as virus infection of cells and immunochemistry The results indicated that exposure to 100℃ dry heat for 30 min could inactivating completely the vesicular stomatitis virus (1082 TCID50) and HIV-1 (1045～1052 TCID50) in lyophilized IgG After exposure to 100℃ dry heat, the IgG product showed no obvious change in external color and redissolution efficacy The antigen and antibody activity approximated that in the control group without exposure to heat and their secondary spatial structure still existed, but the molecular polymer content increased to 81% which was slightly higher than the quality control requirement of IgG products stated in science of biological products If a method for lowering the speed of heat polymerization of IgG molecules can be found, it is promising that 100℃ dry heat can be used for rapid inactivation of virus in lyophilized IgG products