摘要
目的对注射用兰索拉唑进行干扰试验,建立注射用兰索拉唑细菌内毒素检查的试验方法。方法采用《中国药典》2010年版二部附录细菌内毒素检查法进行试验。结果将注射用兰索拉唑稀释至浓度为50μg/ml时,对细菌内毒素检查法无干扰作用。结论应用鲎试剂进行注射用兰索拉唑细菌内毒素检查是可行的。
Objective To establish a method for the determination of bacterial endotoxin of lansoprazole for injection through interference test of lansoprazole for injection. Methods According to method of determination of bacterial endotoxin approved by Chinese Pharmacopoeia （Edition 2010,Vol Ⅱ） . Results The interference on the determination of bacterial endotoxin can be excluded when Lansoprazole for injection was diluted the concentration of 50μg/ml. Conclusion It is feasible to detect the bacteria endotoxin of lansoprazole for injection by the method of determination of tachypleus amebocyte lysate.
出处
《临床合理用药杂志》
2013年第14期42-43,共2页
Chinese Journal of Clinical Rational Drug Use
关键词
注射用兰索拉唑
细菌内毒素检查法
干扰试验
Lansoprazole for Injection
bacterial endotoxin test
Interference test
