鲎试剂用于三磷酸腺苷二钠注射液细菌内毒素检测的探讨  

The Discussion On Bacterial Endotoxin Inspection Method of Monitoring Pyrogen Injection by TAL

作　　者：刘一波[1] 王小慧[1] 

机构地区：[1]广东惠州市药品检验所,惠州516001

出　　处：《中国现代应用药学》2002年第3期217-218,共2页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的 :考察三磷酸腺苷二钠 (ATP)注射液细菌内毒素检查法的可行性。方法 :按中国药典 2 0 0 0年版细菌内毒素检查法和细菌内毒素检查法应用指导原则要求进行试验。结果 :将样品稀释成热原检查浓度 1mg·ml 1无干扰作用。结论 :将样品稀释 10倍 (浓度 1mg·ml 1) ,可用灵敏度 0 .5Eu·ml 1的鲎试剂作细菌内毒素检查。OBJECTIVE:To inspect the feasibility of bacterial endotoxin testing method to monitor pyrogen injection.METHOD:The test was conducted according to becterial endotoxin test method and the application guide request of bacterial endotoxin test method included in the China Pharmacopeia, 2000.RESULTS:There was no interfering with 1mg·ml 1 of the sample solution, as the test density with rabbit. CONCLUSION:monitoring pyrogen injection diluted up 10 times (1mg·ml 1 of the sample solution) could be tested by tachypleus amebocyte lysate of which the sensitivity was 0.5 Eu·ml 1 .

关 键 词：鲎试剂 三磷酸腺苷二钠注射液 细菌内毒素 检测 干扰试验 

分 类 号：R977.3[医药卫生—药品] R927.12[医药卫生—药学]