关于细菌内毒素检查用水内在质量的探讨  

Approach on intrinsic quality of water for bacterial endotoxin test(WBET)

作　　者：王莉 程宾 蔡彤[2] 张国来[2] 高华[2] 

机构地区：[1]云南省食品药品检验所,昆明650011 [2]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2010年第6期1042-1044,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:对在选择细菌内毒素检查用水过程中发现的问题进行探讨。方法:使用不同来源的细菌内毒素检查用水稀释细菌内毒素标准品,用细菌内毒素测定仪检测不同的细菌内毒素检查用水稀释的相同浓度内毒素溶液的反应时间,对结果进行统计学处理。结果:不同来源的细菌内毒素检查用水稀释的相同浓度内毒素溶液的反应时间有显著性差异。结论:并非细菌内毒素含量低的灭菌注射用水就是好的细菌内毒素检查用水,细菌内毒素检查用水的质量要求有待进一步研究。Objective：To study the problem about selection of water for bacterial endotoxin test（WBET）.Methods：To dilute bacterial endotoxin standard samples with different sources of WBET to the same concentration,determinate the reaction time of the diluted solutions with bacterial endotoxin detector,and make a statistic analysis of the results.Results：There are significant differences in the reaction time of the solutions diluted to the same concentration with different sources of WBET.Conclusions：Sterile water for injection with a low proportion of bacterial endotoxin might not be the suitable WBET,so the quality requirements of WBET need to be further researched.

关 键 词：细菌内毒素检查用水 鲎试剂 

分 类 号：R917[医药卫生—药物分析学]