高效液相色谱法与凝胶层析法检测人血白蛋白制剂中多聚体的比较  

Comparison of the Determination of Polymer in Human Albumen Preparation by HPLC with Gel Chromatography

作　　者：乔文本 伊林[1] 孙秀春[1] 罗振[2] 

机构地区：[1]山东省血液中心,济南250014 [2]山东医科大学实验中心

出　　处：《中国生化药物杂志》1995年第5期214-216,共3页Chinese Journal of Biochemical Pharmaceutics

摘　　要：对12批人血白蛋白制剂分别以HPLC法重复测定5次及用凝胶层析法重复测定4次.结果表明:HPLC法（RSD 0.23％～2.86％）较凝胶层析法（RSDI.1.41％～5.70％）结果准确;HPLC法作品不稀释,直接进样,每样仅需30 min,操作简便易行,可作为白蛋白制剂中多聚体的含量测定方法。High performance chromatography (HPLC) is used to separate and detect human albumen preparation. 12 batches of human albumen preparations are tested and the coefficient of variation is between 0. 23%-2. 86% (n = 5, average: 1. 23%) in HPLC compared with 1. 41 %-5. 70% (n = 4, average 2. 99%) in gel chromatography. The test results show that HPLC is more simple and prati-cable and can be used as the quality control method for detecting polymer in human albumen preparation.

关 键 词：人血白蛋白 多聚体 高效液相色谱 凝胶层析法 

分 类 号：R977.6[医药卫生—药品] R392-33[医药卫生—药学]