^(131)Ⅰ依匹必利注射液的细菌内毒素检查  

Bacterial Endotoxin Test of ^(131)Ⅰ- Epidepride Injection

作　　者：黄旭荃[1] 李卫一[1] 杨敏[1] 

机构地区：[1]江苏省原子医学研究所质检科,无锡市214063

出　　处：《中国药房》2006年第5期381-382,共2页China Pharmacy

摘　　要：目的建立^(131)Ⅰ依匹必利注射液的细菌内毒素检查方法。方法将^(131)Ⅰ依匹必利注射液稀释10倍后采用鲎试剂法进行检查,并行验证试验。结果样品经稀释后可消除对鲎试剂的干扰作用,3批样品中细菌内毒素的量均低于50EU/ml。结论本法检查^(131)Ⅰ依匹必利注射液细菌内毒素方法可行。OBJECTIVE： To establish a method for the bacterial endotoxin test of ^131Ⅰ- epidepride injection. METHODS：After dilution with 10 parts of water, ^131Ⅰ- epidepride injection was detected with a method of tachypleus amebocyte lysate（TAL） and subjected to verification test .RESULTS：The interference of the dilute ^131Ⅰ-epidepride injection on TAL can be eliminated after dilution, the bacterial endotoxin levels for 3 batches of ^131Ⅰ-epidepride injection were all below 50EU/ ml.CONCLUSION：The method for the bacterial endotoxin test of ^131Ⅰ-epidepride injection is feasible.

关 键 词：碘 依匹必利 细菌内毒素检查 鲎试剂 干扰试验 

分 类 号：R927.11[医药卫生—药学]