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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。
Objective To improve the safety of intravenous injection of human immunoglobulin (IVIG) preparations and investigate the feasibility of its inactivation. Methods Different concentrations of protein, pH and conductance were adjusted without preservatives, and the IVIG liquid samples were pasteurized and analyzed for various physical and chemical properties. Results The size distribution of the product as the main index, preferably the protein concentration of 1.0% to 1.5%, pH 3.8 ~ 4.2, conductance value of less than 0.3ms pasteurization conditions. CONCLUSIONS The conditions used can be pasteurized without preservatives and heating has the least effect on the properties of intravenous human immunoglobulin preparations.