摘要
目的:建立注射用肌萎灵细菌内毒素的检查方法。方法:按照2010年版《中国药典》(一部)细菌内毒素检查法,用不同厂家的鲎试剂对不同批号的样品进行干扰试验和细菌内毒素检查。结果:注射用肌萎灵供试品初始浓度稀释40倍对细菌内毒素的检测无干扰作用。结论:所建立的方法可用于注射用肌萎灵的细菌内毒素检查。
OBJECTIVE： To establish a method for testing the bacterial endotoxin in Jiweiling for injection. METHODS： Based on the bacterial endotoxin test method stated in volume I of Chinese Pharmacopoeia （2010 edition）, the interference test and bacterial endotoxin test of different batches of samples were conducted using actachypleus amebocyte lysate （TAL） from different companies. RESULTS： No interference was found in the bacterial endotoxin test after Jiweiling for injection was diluted to 40 times. CONCLUSION： Established method is applicable for the bacterial endotoxin test of Jiweiling for injection.
出处
《中国药房》
CAS
CSCD
北大核心
2011年第39期3688-3689,共2页
China Pharmacy
基金
国家科技重大专项课题(2009ZX09102-140)
国际科技合作项目(2008DFA30810)
关键词
注射用肌萎灵
细菌内毒素
鲎试剂
干扰试验
Jiweiling for injection
Bacterial endotoxin
Tachypleus amebocyte lysate
Interference test
