氟马西尼注射液细菌内毒素检查方法的建立

目的:建立氟马西尼注射液细菌内毒素的检查方法。方法:按照2010年版《中国药典》(二部)附录细菌内毒素检查法的要求,采用2个不同厂家的鲎试剂对3批氟马西尼注射液进行干扰预试验和干扰试验。结果:供试品溶液质量浓度为0.02 mg/ml及以下时对鲎试剂与细菌内毒素之间的凝集反应无干扰;样品的细菌内毒素限值确定为25 EU/mg。结论:建立的方法可行,可用于氟马西尼注射液的细菌内毒素检查。

Establishment of Bacterial Endotoxins Test in Flumazenil Injection

OBJECTIVE：To establish a method for the detection of bacterial endotoxins in Flumazenil injection.METHODS：Preliminary interference experiment and interference experiment were carried out by tachypleus amebocyte lysate（TAL）from 2 different manufacturers and 3 batches of Flumazenil injection,according to the requirements of bacterial endotoxin test stated in appendix Ⅱ of Chinese Pharmacopeia（2010 edition）.RESULTS：There was no interference in agglutination reaction between TAL and bacterial endotoxins when the concentration of test sample was 0.02 mg/ml and below it.The limit of bacterial endotoxins was 25 EU/mg.CONCLUSIONS：Established method is feasible for the bacterial endotoxins test of Flumazenil injection.