摘要
目的建立高三尖杉酯碱注射液中细菌内毒素的检测方法。方法参照2010年版《中国药典》二部细菌内毒素检查方法,采用鲎试剂法对3批高三尖杉酯碱注射液进行干扰实验研究。结果高三尖杉酯碱注射液经150倍稀释后,用灵敏度λ为0.5EU.mL-1的鲎试剂进行实验,供试品不干扰细菌内毒素检查。结论建立的高三尖杉酯碱注射液细菌内毒素检查法可行,具有简便、快捷、可靠等优点。
Objective To establish a method for the detection of bacterial endotoxins in Homoharringtonine Injections.Methods The interference experiments of 3 batches of Homoharringtonine Injections were carried out according to bacterial endotoxins test specified in appendix Ⅺ E,volume two,Chinese Pharmacopoeia 2010 edition using tachypleus amebocyte lysates（TAL）.Results By using tachypleus amebocyte lysates whose sensitivity was 0.5 EU·mL-1,the sample did not interfere with the bacterial endotoxins test when it was diluted 150 times.Conclusion The established method of bacterial endotoxin test for Homoharringtonine Injections is feasible,simple,rapid and reliable.
出处
《西北药学杂志》
CAS
2012年第6期574-576,共3页
Northwest Pharmaceutical Journal
关键词
细菌内毒素
高三尖杉酯碱注射液
干扰实验
bacterial endotoxins
Homoharringtonine Injections
interference experiment
