摘要
目的:建立氯法拉滨注射液中细菌内毒素的检查方法。方法:利用鲎试剂与细菌内毒素产生凝聚反应的原理对氯法拉滨注射液中的细菌内毒素进行检查。结果:氯法拉滨注射液在浓度为0.05～0.50mg/ml对测定均无干扰作用,限度确定为每毫克氯法拉滨中含内毒素的量应小于2.5EU。结论:氯法拉滨注射液中的细菌内毒素检查可用鲎试验法,此法灵敏可靠,方便经济。
Objective：To establish the determination method of bacterial endotoxin in clofarabin Injection.Methods：Clofarabin injection was examined by principle of TAL and bacterial endotoxin response through cohesion.Results：The sample was diluted to 0.05-0.50 mg/ml without confusion and the limit of bacterial endotoxin should be lower than 2.5 EU/mg.Conclusion：Bacterial endotoxin test is accurate and suitable for the detection of bacterial endotoxin in clofarabin injection.
出处
《中国医药导报》
CAS
2010年第3期52-53,共2页
China Medical Herald
关键词
干扰试验
细菌内毒素
氯法拉滨注射液
Interfere factors
Bacterial endotoxin
Clofarabine Injection
