中国药房2017，Vol.28Issue(18)：2576-2578,3.DOI:10.6039/j.issn.1001-0408.2017.18.36
凝胶法测定脂肪乳(10%)/氨基酸(15)/葡萄糖(20%)注射液中的细菌内毒素
Determination of Bacterial Endotoxin in Fat Emulsion(10%)/Amino Acid (15)/Glucose (20%) Injection by Gel Method
王文佳 1陈志明 1张纳敏 1周梦颖 1何华红 1李薇1
作者信息
摘要
Abstract
OBJECTIVE:To adopt gel method for the determination of bacterial endotoxin in Fat emulsion(10%)/amino acid (15)/glucose (20%) injection. METHODS:According to the gel method in term of"bacterial endotoxin test method"in Chinese Pharmacopeia(2015 edition),the maximal valid dilution(MVD)of samples were determined through interference test and the vali-dated. The results were compared with chromogenic method. RESULTS:In gel method,the interference to agglutination reaction of TAL and bacterial endotoxin can be excluded when samples were diluted 24 times or less. In chromogenic method,the samples should be diluted 76 times or less. CONCLUSIONS:Gel method can be used for bacterial endotoxin test of Fat emulsion(10%)/amino acid(15)/glucose(20%)injection.关键词
脂肪乳(10%)/氨基酸(15)/葡萄糖(20%)注射液/细菌内毒素/凝胶法/干扰试验/显色基质法Key words
Fat emulsion (10%)/amino acid (15)/glucose (20%) injection/Bacterial endotoxin test/Gel method/Interfer-ence test/Chromogenic method分类
医药卫生引用本文复制引用
王文佳,陈志明,张纳敏,周梦颖,何华红,李薇..凝胶法测定脂肪乳(10%)/氨基酸(15)/葡萄糖(20%)注射液中的细菌内毒素[J].中国药房,2017,28(18):2576-2578,3.
