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水痘-带状疱疹免疫球蛋白的研制

Development of varicella-zoster immunoglobulin
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摘要 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/U/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、20nm膜过滤、冻干、配制调整、除菌、分装。结果产品效价〉50IU/mL,其余各项目检测均符合《中国药典》20lO年版三部人免疫球蛋白标准,稳定性加速试验合格,20nm膜过滤能使PPV病毒滴度下降4.0log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,20nm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.
作者 郑炎 何毅明 费梅芳 王黎 刁武平 楼觉人 ZHENG Yan,HE Yiming,FEl Meifang, WANG Li,DIAO Wuping,LOU Jucren. Shanghai Institute of Biological Products Co. Ltd. ,Shanghai 200052 ,China.
出处 《中国输血杂志》 CAS CSCD 北大核心 2013年第11期1094-1097,共4页 Chinese Journal of Blood Transfusion
关键词 水痘-带状疱疹免疫球蛋白 纳米过滤 抗体效价 稳定性 varicella-zoster immunoglobulin nanofihration antibody potency stability
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