氨甲环酸氯化钠注射液细菌内毒素检查方法的建立  

Establishment of the Test Method of Bacterial Endotoxin in Tranexamic Acid soldium chloride Injection

作　　者：郝哲[1] 王丽军[1] 宋晓红[1] 

机构地区：[1]中国人民解放军第153中心医院,河南450042

出　　处：《药物与人》2015年第2期2-3,共2页Medicine & People

摘　　要：目的：建立氨甲环酸氯化钠注射液细菌内毒素检查方法。方法 参照《中国药典》2010年版附录中细菌内毒素检查方法进行试验，用不同批号的鲎试剂对氨甲环酸氯化钠注射液进行干扰试验和细菌内毒素检查。结果 浓度稀释到2.5mg·ml-1时对所用细菌内毒素检查法无干扰作用。结论 本法可用于氨甲环酸氯化钠注射液的细菌内毒素检查。ABSTRACT Objective To establish a test method of bacterial endotoxin in tranexamic acid soldium chloride injection. Methods The interference test and bacterial endotoxin test of Tranexamic Acid soldium chloride Injection was carried out in accordance with the bacterial endotoxin test approved by appendix Ⅱ of Chinese Pharmacopeia（2010 edition）. Results Diluted to a concentration of 2.5 mg·mL-1,the samples showed no interference action on bacterial endotoxin test.Conclusion This method could be used for the bacterial endotoxin test of Tranexamic Acid soldium chloride Injection.

关 键 词：氨甲环酸氯化钠注射液 细菌内毒素检查 鲎试剂 

分 类 号：R978.1[医药卫生—药品]