注射用阿奇霉素细菌内毒素检查方法的研究  

Test Method of Bacterial Endotoxins in Azithromycin for Injection

作　　者：吴卫中[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国药事》2007年第4期260-261,共2页Chinese Pharmaceutical Affairs

摘　　要：考察了6批注射用阿奇霉素的细菌内毒素检查法的可行性。按《中国药典》2005年版细菌内毒素检查法。结果可见,浓度为0.2 mg.mL-1的样品稀释液对标示灵敏度为0.25 EU.mL-1的鲎试剂无干扰作用。本品稀释为0.2 mg.mL-1的溶液后,可用灵敏度为0.25 EU.mL-1的鲎试剂进行检测。The bacterial endotoxin test （BET） of six batches of Azithromycin for Injection was carried out according to the method of 2005 edition in Chinese Pharmacopoeia for inspecting the feasibility. The result show that no interferential effect was under the density 0. 2mg · mL^-1 of the dilute test solution. The limulus amebocyte lysate reagent with the sensitivity of 0. 25 EU · mL^-1 could be used in the test.

关 键 词：注射用阿奇霉素 细菌内毒素试验 鲎试剂 干扰 

分 类 号：R927.12[医药卫生—药学]