水痘-带状疱疹免疫球蛋白的研制

Development of varicella-zoster immunoglobulin

目的探索水痘-带状疱疹免疫球蛋白的制备工艺和病毒灭活方法。方法选取抗体效价大于5 IU/mL的血浆作为投料血浆,通过压滤获得组份Ⅱ沉淀,经过溶解、超滤、低pH法病毒灭活、20 nm膜过滤、冻干、配制调整、除菌、分装。结果产品效价>50 IU/mL,其余各项目检测均符合《中国药典》2010年版三部人免疫球蛋白标准,稳定性加速试验合格,20 nm膜过滤能使PPV病毒滴度下降4.0 log以上。结论本工艺是1种简单的生产水痘-带状疱疹免疫球蛋白方法,20 nm膜过滤的使用增加了该制品的安全性。

Objective To study the manufacturing process and the virus inactivation of variceUa-zoster immunoglobu- lin. Methods Plasma in which the antibody potency was greater than 5 IU/mL was selected for manufacturing use. By pres- sure filtration, the precipitate of component Ⅱ was obtained. After dissolution of the precipitate, it was treated by uhrafiltra- tion, viral inactivation in low pH and 20 nm nanofiltration, and then it was lyophilized, adjusted, bacteria eliminated and final- ly filled and metered. Results Product potency was greater than 50 IU/mL. All other tests were in accordance with the standards of Chinese Pharmacopoeia （2010 edition, part Ⅲ ） for human immunoglobulin. Accelerated stability test was accept- able. 20 nm nanofihration can reduce PPV viral titer above 4. Ol og. Conclusion This process is a simple method for varlcel- la-zoster immunoglobulin manufacture. The use of 20 nm nanofihration increases the safety of this product.