人血白蛋白中常见可见异物成因及控制分析  

Analysis on cause and control of visible particles in human albumin

作　　者：焦旭雯[1] 梁蔚阳[1] 陈宇堃[1] 蒋玉辉[1] 陈龙少 JIAO Xu-wen;LIANG Wei-yang;CHEN Yu-kun;JIANG Yu-hui;CHEN Long-shao(Guangdong Institute for Drug Control,NMPA Key Laboratory of Quality Control of Blood)

机构地区：[1]广东省药品检验所国家药品监督管理局血液制品质量控制重点实验室,广东广州510663

出　　处：《中国生物制品学杂志》2022年第3期285-288,292,共5页Chinese Journal of Biologicals

基　　金：国家药典委员会2019年国家药品标准提高科研课题(Chpkjyw-2019001);广东省药品监督管理局科技创新项目(2021-ZDZ02)。

摘　　要：目的 分析人血白蛋白中常见可见异物的基本情况及其产生原因。方法 收集不同企业生产的人血白蛋白可见异物阳性样品,通过不溶性微粒、大粒子、多聚体含量、浊度等项目检测,分析可见异物与其他指标的相关性。结果可见异物阳性样品的不溶性微粒、浊度检测结果符合《中国药典》三部(2020版)规定,但二聚体含量、粒径> 50μm的大粒子所占比重呈增加趋势。结论 企业在对人血白蛋白可见异物进行灯检法的同时,可通过测定二聚体含量、粒径> 50μm大粒子所占比重对生产线上产品进行在线监督,以评估产品总体质量。Objective To analyze the basic situation and cause of appearance of visible particles in human albumin.Methods The human albumin from different manufacturers,containing visible particles,were tested for insoluble particles,macroparticles,polymer content and turbidity,and the relationship of visible particles to other indexes were investigated. Results The test results for insoluble particles and turbidity in the samples containing visible particles met the requirement in Chinese Pharmacopoeia(Volume Ⅲ,2020 edition),while the dimer content and the proportion of macroparticles at diameters of more than 50 μm showed increasing trends. Conclusion To evaluate theμproductμquality,the lamp test can be used to test the visible particles in human albumin,and online monitor may also be achieved by a series of complementary methods such as determination of dimer content and the proportion of macroparticles at diameters of more than 50 μm.

关 键 词：人血白蛋白 可见异物 二聚体 多聚体 大粒子 

分 类 号：R921.2[医药卫生—药学]