摘要
目的 :建立以凝胶法检查盐酸左氧氟沙星注射液中细菌内毒素的方法。方法 :以不同厂家的鲎试剂对3批盐酸左氧氟沙星注射液分别进行干扰试验。结果 :盐酸左氧氟沙星注射液稀释至1 0mg/ml时可消除对试验的干扰。3批盐酸左氧氟沙星注射液细菌内毒素检查结果均符合规定。结论 :盐酸左氧氟沙星注射液的热原检查可用细菌内毒素检查法替代家兔升温法。
OBJECTIVE:To establish the method for assaying bacterial endotoxins in levofloxacin hydrochloride injecˉtion.METHODS:The interference test of3batches of levofloxacin hydrochloride injection with2kinds of limulus test agent was studied.RESULTS:The interference between the samples and limulus test agents was eliminable(below1.0mg/ml).The detection results were up to standard.CONCLUSION:The bacterial endotoxin in the sample can be examined by limulus test instead of pyrogen test in rabbits.
出处
《中国药房》
CAS
CSCD
北大核心
2005年第1期59-60,共2页
China Pharmacy
关键词
盐酸左氧氟沙星注射液
细菌内毒素
鲎试剂
干扰试验
Levofloxacin hydrochloric injection
Bacterial endotoxin
Limulus test agent
Interference test
