A new method for concentration analysis of bacterial endotoxins in perfluorocarbon  

作　　者：Dan-Dan CHEN Xiao-Ming FENG Chun-Ren WANG Qing-Quan HUANG Zhao-Peng YANG Qing-Yuan MENG 

机构地区：[1]National Institutes for Food and Druq Control, Beijing 100050, China [2]School of Materials Science and Engineering, Tsinghua University, Beijing 100084, China

出　　处：《Frontiers of Materials Science》2014年第4期399-402,共4页材料学前沿（英文版）

摘　　要：This communication demonstrates the feasibility of the gel-clot method for the analysis of bacterial endotoxins in water extracts of perfluorocarbon which is a water insoluble liquid medical device. Perfluorocarbon （10 mL） was shaken with 10 mL water for 15 min at 2000 r/min and the endotoxin present was extracted to the aqueous phase without interference inhibition/enhancement of the product and the recovery of endotoxin added to perfluorocarbon was determined, A validation study confirmed that endotoxins presented in perfluorocarbon pass over into the aqueous phase at concentrations of 20, 10 and 5EU/mL with recoveries from 86.8% to 96.8%. Therefore, the gel-clot test is suitable for detecting bacterial endotoxins in perfluorocarbon which is a water insoluble medical device.This communication demonstrates the feasibility of the gel-clot method for the analysis of bacterial endotoxins in water extracts of perfluorocarbon which is a water insoluble liquid medical device. Perfluorocarbon （10 mL） was shaken with 10 mL water for 15 min at 2000 r/min and the endotoxin present was extracted to the aqueous phase without interference inhibition/enhancement of the product and the recovery of endotoxin added to perfluorocarbon was determined, A validation study confirmed that endotoxins presented in perfluorocarbon pass over into the aqueous phase at concentrations of 20, 10 and 5EU/mL with recoveries from 86.8% to 96.8%. Therefore, the gel-clot test is suitable for detecting bacterial endotoxins in perfluorocarbon which is a water insoluble medical device.

关 键 词：PERFLUOROCARBON bacterial endotoxin endotoxin recovery 

分 类 号：TQ460.72[医药卫生—药物分析学] X831[化学工程—制药化工]