首批人血白蛋白国家参考品的研制  

Preparation of the First Chinese National Standard for Human Albumin

作　　者：王敏力[1] 肖林[1] 周倩[1] 杨鹏云[1] 李曼[1] 管利东[1] 郝杰[1] 王箐舟[1] 侯继锋[1] 

机构地区：[1]中国食品药品检定研究院,卫生部生物技术产品检定方法及标准化重点实验室,北京100050

出　　处：《中国药学杂志》2017年第6期480-487,共8页Chinese Pharmaceutical Journal

基　　金：“重大新药创制”科技重大专项课题--生物技术药物质量标准及质量控制技术平台(重组人血白蛋白及凝血因子质量标准及标准研究)资助项目

摘　　要：目的制备首批人血白蛋白国家参考品,用于人血白蛋白产品放行、批签发或注册检验等质量控制工作。方法选择经检验合格的人血白蛋白产品作为原料进行合并、除菌、分装。制备后按照2015年版《中国药典》三部人血白蛋白各论初步选定7个检验项目,包括:蛋白质含量(凯式定氮)、辛酸钠含量测定、多聚体含量、pH测定、吸光度测定、钠离子含量、铝离子含量,在11家实验室进行协作标定,同时进行稳定性监测。结果依据11家实验室协作标定结果确立该批国家参考品的参考值范围分别为:蛋白质含量(193.30±5.08)g·L^(-1);辛酸钠含量(0.162 4±0.009 2)mmol·g(Pro)^(-1);多聚体含量(2.72±0.29)%(HPLC-SEC);pH值(6.71±0.08)[测定温度(22±3)℃];吸光度(0.030±0.005);钠离子含量(134.9±23.6)mmol·L^(-1);铝离子含量协作标定范围为(88.4±30.5)μg·L^(-1),但铝离子含量项目在稳定性监测过程中出现明显上升趋势,因此该项目不纳入参考品最终发布的标定项目。结论该批人血白蛋白参考品符合相关要求,可以作为国家参考品发放。有利于人血白蛋白产品的质量控制。OBJECTIVE To prepare the first batch of Chinese national standard for human albumin used for the test of batch release or other quality control of human albumin products.METHODS The first batch of national standard for human albumin was prepared with certificated human albumin products, mixed and filled under aseptic conditions. The standards were distributed to 11 laboratories for cooperative calibration according to the unified methods published on China Pharmacopeia.Seven test items including total protein content, sodium caprylate, polymers content, pH,absorbance,sodium content, and aluminium content were detected. RESULTS The limits of the six test items except aluminium content were established as follows after the data from 11 collaboration laboratories were received and statistically analyzed： total protein（193.30±5.08）g·L-1;sodium caprylate （0.162 4±0.009 2） mmol·g（Pro）-1; polymers content （2.72±0.29）%（ HPLC-SEC）;pH（6.71±0.08）[temperature （22±3）℃];absorbance 0.030±0.005;sodium content （134.9±23.6）mmol ·L-1.The range of initially established aluminium content was （88.4±30.5）μg·L-1. However,it was observed to increase obviously after 21 months according to the trend analysis, so it was deleted from the test items for the national standard for human albumin ultimately.CONCLUSION The prepared national standard for human albumin met the relevant requirements and may be served as the first generation of national standard for human albumin products.

关 键 词：国家参考品 人血白蛋白 质量控制 血液制品 蛋白质含量 辛酸钠 多聚体含量 钠离子含量 铝离子 

分 类 号：R965[医药卫生—药理学]