巴氏法结合低pH孵放法在IVIG制备中的应用

Application of Pasteurization Plus Low pH Incubation during Preparation of Human Intravenous Immunoglobulin

目的 :进一步提高IVIG的安全性和稳定性。方法 :在Cohn’s低温乙醇法分离制备IVIG的基础上 ,引入液态及无保护剂状态下的巴氏法结合低pH孵放法的两次病毒灭活工艺 ,并对该工艺制备的IVIG的IgG纯度、SephadexG 2 0 0层析、SDS PAGE及圆二色谱分析 ,对病毒灭活有效性、制品稳定性及其它生物学活性检测。 结果 :制品的所有质量指标均符合《中国生物制品规程》要求。结论 :巴氏法结合低 pH孵放法病毒灭活效果优于单一的巴氏灭活法或低 pH孵放法以及其它方法 ,IVIG制品在液体状态下具有良好的稳定性。

Objective:To further improve the safety and stability of human intravenous Immunoglobulin.Methods:On the basis of preparation of IVIG by Cohn′s cold alcohol method,a twice virus inactivation technology procedure was developed by using the liquid Pasteurization without protectant in combination with the low pH incubation,and the IgG purity,sephedex G 200 chromatography,SDS PAGE,circular dichroism(CD)spectra were analysed,virus inactivation effectiveness,biologicals stability and other biological activities were examined.Results:All the quality parameters of the IVIG met the requirements stipulated in China Biologicals Regulations.Conclusion:When using the Pasteurization plus low pH Incubation for IVIG preparation,the effectiveness of virus inactivation is higher than that reached by single Pasteurization and single low pH incubation or any other possible methods,and the IVIG in liquid state has good stability.