摘要
目的建立榄香烯乳注射液的细菌内毒素检查法,以替代热原检查法。方法参照2000年版《中国药典(二部)》收载的细菌内毒素检查法,确定榄香烯乳注射液的细菌内毒素限值,并应用不同厂家的鲎试剂对榄香烯乳注射液进行干扰试验。结果榄香烯乳注射液对细菌内毒素检查不产生干扰。结论对榄香烯乳注射液使用细菌内毒素方法检测是可行的。
Objective:To investigate the bacterial endotoxin test of Elemene Emulsion injection.Methods:The interference test was carried according to the assigned method and guiding princple for bacterial endotoxin test in Chinese Pharmacopoeia 2000 (Ⅱ).Results:No interference occurred in the bacterial endotoxin test for Elemene Emulsion injection.Conclusion:Elemene Emulsion injection can be examined by bacterial endotoxin test instead of the pyrogen test.
出处
《中国药业》
CAS
2004年第7期31-32,共2页
China Pharmaceuticals
关键词
细菌内毒素检查
干扰试验
榄香烯乳注射液
bacterial endotoxin test
interference test
Elemene Emulsion injection
