注射用兰索拉唑细菌内毒素检查方法学研究

摘要

目的：建立注射用兰索拉唑细菌内毒素的检查方法。方法采用凝胶法，按《中国药典》2010年版关于细菌内毒素检查法进行结果判断。结果注射用兰索拉唑与鲎试剂及细菌内毒素不存在干扰。结论凝胶法可以用来检测注射用兰索拉唑的细菌内毒素。%Objective To establish a detective method for bacterial endotoxins of Lansoprazole for injection. Methods With Gelation assay, the result was judged according to Chinese pharmacopoeia 2010 edifion of the bacterial endotoxin inspection method. Results There wasn't interference from lansoprazole for injection to bacterial endotoxin in TAL reactio. Conclusion Gel method can be used for detecting bacterial endotoxin of Lansoprazole for injection.