【摘要】 目的为了提高静脉注射人免疫球蛋白(IVIG)制品的病毒安全性,探索其巴氏灭活的可行性。方法在不加保护剂的条件下,调整不同的蛋白浓度、pH、电导,对IVIG液体样品进行巴氏灭活,并作各种理化性质分析。结果以制品分子大小分布为主要指标,优选出蛋白浓度1.0%~1.5%、pH3.8~4.2、电导值低于0.3ms的巴氏灭活条件。结论所用条件可在不加保护剂的情况下进行巴氏灭活时,加热对静脉注射人免疫球蛋白制品性质影响最小。更多还原

【Abstract】 OBJECTIVE To enhance the viral safety of human immunoglobulin for intravenous injection(IVIG) products and discuss the feasibility of pasteurization of IVIG products. METHODS We performanced a series of experiments with different protein concentrations,pH values and conductivity, and analyzed the effects on the characterizations of IVIG.RESULTS The best condition for pasteurization of IVIG was found.CONCLUSION This condition may make the effection of the characterizations of IVIG minimum.更多还原