摘要
目的建立复合磷酸氢钾注射液的细菌内毒素检测法。方法根据《中国药典》2010年版二部细菌内毒素检查方法及指导原则进行实验。结果复合磷酸氢钾注射液经稀释后可消除对鲎试剂的干扰,用灵敏度为0.06 EU.ml-1的鲎试剂检测内毒素是有效的,并与家兔法的结果一致。结论对复合磷酸氢钾注射液可用内毒素检查法替代家兔法的热原检查。
Objective To establish a method for bacterial endotoxin test in composite potassium hydrogen phosphate injection.Methods The experiment was made according to the guiding principle of endotoxin test method in Chinese Phamacopeia in 2010.Results The interference factors could be excluded by diluting composite potassium hydrogen phosphate injection.It was effective to test endotoxins by amebocyte lysate agent with accuracy of 0.06 EU· ml-1,which achieved the same results by using rabbit method.Conclusion The bacterial endotoxin test can be used instead of dometic rabbit method.
出处
《安徽医药》
CAS
2012年第8期1190-1192,共3页
Anhui Medical and Pharmaceutical Journal
关键词
复合磷酸氢钾注射液
内毒素检查
鲎试剂
composite potassium hydrogen phosphate injection
bacterial endotoxin test
TAL
