摘要
目的应用动态浊度法定量检测参麦注射液中的细菌内毒素。方法采用《中国药典》2005年版二部附录细菌内毒素定量检测法。结果将参麦注射液进行1∶20稀释,可排除干扰,回收率在50%-200%,无干扰作用。结论应用动态浊度法测定参麦注射液中的细菌内毒素是可行的,此方法既可避免家兔热原检查法操作复杂的缺点,同时又避免了限量法检测内毒素的干扰。
OBJECTIVE To establish a determination of endotoxin in Shenmai injection by dynamic turbidimetric assay.METHODS Inhibition or enhancement test for bacterial endotoxins test were used according to Chp 2005.RESULTS 1∶20 solution of Shenmai Injection showed no interference on test and the recovery was 50%~200%.CONCLUSION Bacterial endotoxin test for Shenmai injection by turbidimetric assay has been established and could be used as an altermative for the rabbit pyrogen test.
出处
《海峡药学》
2010年第10期54-55,共2页
Strait Pharmaceutical Journal
关键词
动态浊度法
参麦注射液
细菌内毒素
干扰实验
Turbidimetric assay
Shenmai injection
Bacterial endotoxin
interfering test
作者简介
陈华龙,男(1979-).职称:主管药师。研究方向:药品质量检验。联系电话:(0751)8736706。E-mail:xlongs2006@126.com