基于聚合物分析系统流感疫苗裂解效果检测方法的建立及验证
Chinese Journal of Biologicals（2022）
Abstract
目的 建立一种基于聚合物分析系统(Aggregates Sizer)的流感疫苗裂解效果检测方法,并进行方法验证.方法 将流感病毒裂解疫苗原液A(由裂解液制得,病毒颗粒已裂解)和B(由裂解前纯化液制得,病毒颗粒未裂解)按一定比例混合,配制成裂解程度为60％、70％、80％、90％和100％的系列工作液,经Aggregates Sizer检测样本中各粒径病毒颗粒的分布丰度和累积分布丰度,以流感病毒颗粒裂解程度为横坐标,颗粒累积分布丰度为纵坐标建立标准曲线,获得标准曲线方程,计算相关系数(r2).另取60％、80％和 100％裂解程度的工作液作为质量控制(quality control,QC)样本,重复检测3次,准确性以相对误差(relative error,RE)表示,精密性以相对标准偏差(relative standard deviation,RSD)表示.结果 工作液在60％-100％裂解程度范围内与病毒颗粒累积分布丰度呈良好线性关系,标准曲线方程为y=-2 600x+2 610,r2为0.995.不同裂解程度QC样本经3次检测的RE均＜2％,RSD均＜0.05％.结论 建立了基于Aggregates Sizer系统的流感疫苗裂解效果检测方法,该方法具有良好的准确性和精密性.
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