摘要
目的:建立定量检测清开灵注射液中细菌内毒素的方法。方法:采用《中国药典》2005年版二部附录中的动态浊度法检测细菌内毒素。结果:用此法检测时无干扰因素影响,内毒素回收率为50%～200%。结论:使用动态浊度法定量检测清开灵注射液中细菌内毒素是可行的,此方法既可避免兔热原检查法操作复杂的缺点,同时又避免了限量法检测内毒素时的干扰。
Objective：To develop an assay for the determination of becterial endotoxin（BET） in Qingkailing Injection. Methods：BET was determinated by turbidimetric-kinetic method. Results：The other components in Qingkailing Injection did not interfere with the quantitation of BET,the recovery of BET was in the range of 50%-200%. Conclusion：The method is proved to be suitable for the determination of BET in Qingkailing Injection and could be used as an alternative for the rabbit pyrogen test.
出处
《中国医药导报》
CAS
2009年第7期57-58,共2页
China Medical Herald
关键词
清开灵注射液
细菌内毒素
动态浊度法
干扰试验
Qingkailing Injection
Bacterial endotoxin
Turbidimetric-kinetic method
Interfere factors test
