甘露醇注射液中细菌内毒素的检查研究  

Study on the Test of Bacterial Endotoxin for Mannitol Injection by TAL

作　　者：刘腊娥[1] 陈铖[1] 陈立新[1] 

机构地区：[1]中国人民解放军第163中心医院药剂科,湖南长沙410003

出　　处：《解放军药学学报》2003年第4期296-298,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的　探讨甘露醇注射液中细菌内毒素检查的可行性。方法　参照中国药典 2 0 0 0年版细菌内毒素检查法及热原检查法。结果　多批样品的细菌内毒素检查结果与热原检查结果一致。结论　选用灵敏度为 0 .12 5EU·ml-1的鲎试剂以 1∶4稀释 ,采用细菌内毒素检查法替代热原检查法是可行的。Aim To investigate the feasibility of the test of bacterial endotoxin for mannitol injection by TAL.Methods The bacterial endotoxin test and pyrogen test in Chinese Pharmaccpoeia 2000 were used.Results The results of the bacterial endotoxin test and pyrogen test for many batches of samples were identical.Conclusion After the 20% mannitol injection was diluted by 1∶4,Using bacterial endotoxin test as a substitute for pyrogen test is feasible.

关 键 词：甘露醇注射液 热原检查 细菌内毒素检查 鲎试剂 

分 类 号：R983.1[医药卫生—药品]