摘要
目的 应用动态比浊法鲎试验定量测定注射用头孢他啶中的细菌内毒素含量。方法 应用动态比浊法鲎试验 ,通过对样品中定量添加标准内毒素的干扰预试验 ,将头孢他啶 (Lot No 0 10 2 0 2 )制备成 10、5、2、1、0 5 g·L-1浓度系列 ,定量添加标准内毒素 ,其回收率分别为 6 0 0 8%、82 90 %、85 2 2 %、94 0 0 %、92 6 7% ;从中筛选出最佳的检测浓度 1g·L-1,进行 3个批号头孢他啶 (Lot No 0 10 10 3、0 10 10 4、0 10 2 0 2 )正式干扰试验 ,样品中定量添加标准内毒素 ,其回收率分别为 10 9 9%、10 1 7%和 86 5 6 %。结果 标准内毒素使用 5 0 0、0 5 0 0、0 0 5 0 0ZU·L-1,将头孢他啶制备成浓度为 1g·L-1,样品中定量添加标准内毒素 ,回收率均为 5 0 %～ 2 0 0 % ,无干扰作用 ,可用于有效的日常检查。
AIM The kinetic turbidimetric Limulus test was used in the endotoxin assay of Ceftazidime injection. METHODS The validation test was fulfiled ,when the amount of endotoxin spiked in Ceftazidime injection sample(Lot.No.010202) in which concentration of its dilution solution were 10,5,2,1,0 5 g·L -1 . They were recovered in 60 08%, 82 90%, 85 22%, 94 00%, 92 67%; with the amount of endotoxin spiked in Ceftazidime sample (Lot.No. 010103, 010104, 010202),their 1 g·L -1 dilution were recovered in 109 9%, 101 7% and 86 56%. RESULTS With standard endotoxin working curve is 5 00, 0 500, 0 0500 ZU·L -1 . The 1 g·L -1 solution to Ceftazidime was effective to eliminate the interference in Limulus test. CONCLUSION The kinetic turbidimetric Limulus test provide a new way to the detection of endotoxin in Ceftazidime injection.
出处
《中国药理学通报》
CAS
CSCD
北大核心
2002年第3期305-308,共4页
Chinese Pharmacological Bulletin
基金
广东省重点科技攻关项目资助课题 No 2KM 0 5 40 63
关键词
动态比浊法鲎试验
头孢他淀
细菌内毒素
干扰试验
kinetic turbidimetric limulus test
ceftazidime
inhibitory enhancement test
bacterial endotoxin
