摘要
为探究蛋白重组类生物制品制剂中吐温80含量检测方法,本文采用分子排阻-蒸发光散射法(SEC-ELSD)检测重组人干扰素α2b注射液中吐温80含量。结果显示,吐温80对照品检测保留时间与峰面积RSD分别为0.93%和2.69%;吐温80在0~100μg/mL浓度范围线性关系良好;供试品溶液7个时段检测结果RSD为1.80%;加样回收率99.60%~101.72%,RSD为0.48%。由此可见,SEC-ELSD能准确检测蛋白重组类生物制品制剂中吐温80含量,有利于相关制品安全性控制。
To explore the method for the determination of Tween 80 in recombinant biological products.The content of Tween 80 in recombinant human interferonα2b injection was detected by molecular exclusion-evaporation light scattering(SEC-ELSD)method.The retention time and peak area RSD of Tween 80 were 0.93%and 2.69%,respectively;Tween 80 had a good linear relationship in the rangeμg/mL 0~100;RSD of the test results was 1.80%in 7 periods;99.60%recovery~101.72%,RSD is 0.48.SEC-ELSD can accurately detect the content of Tween 80 in protein recombinant biological products,It is beneficial to the safety control of related products.
作者
郭笑逸
丛天生
赵春雨
杜航
白雪
GUO Xiaoyi;CONG Tiansheng;ZHAO Chunli;DU Hang;BAI Xue(Changchun San Jinno Biopharmaceutical Co.,Ltd.,Changchun Jilin,130000,China)
出处
《质量安全与检验检测》
2021年第3期28-30,共3页
QUALITY SAFETY INSPECTION AND TESTING
作者简介
第一作者:郭笑逸(1984-),男,本科,中级工程师,研究方向为质量检验与数据趋势分析,E-mail:536267990@qq.com;通信作者:丛天生(1979-),男,本科,中级工程师,研究方向为质量检验与数据趋势分析,E-mail:248068339@qq.com。
