硫酸奈替米星注射液细菌内毒素定量法(动态比浊法)的研究Application of the kinetic turbidimetric limulus test to netilmicin sulfate injection
林江平,劳海燕
Lin Jiangping;Lao Haiyan(Pharmaceutical department of Guangdong provincial people′s hospital;
摘要(Abstract)：
目的 应用动态比浊法鲎试验定量测定硫酸奈替米星注射液中的细菌内毒素含量。方法 对样品中定量添加标准内毒素进行干扰预试验 ,从回收率判断供试液对鲎试验有无干扰作用。结果 加入标准内毒素 5 .0 0、0 .50 0、0 .0 50 0Eu·ml- 1 ,将硫酸奈替米星制备成浓度为 50 0 0 μ·ml- 1 ,样品中定量添加标准内毒素 ,回收率均为 50 %～ 2 0 0 % ,认为供试液对试验无干扰作用 ,可用于样品检查。结论 动态比浊法可以测定硫酸奈替米星的细菌内毒素含量
Objective The kinetic turbidimetric Limulus test was used in the endotoxin assay of netilmicin sulfate injection.Methods The validation test was fulfiled ,when the amount of endotoxin spiked in netilmicin sulfate injection sample were recovered in 50%～200%.Results With standard endotoxin working curve is 5.00?0.500?0.0500Eu·ml -1 .The 5000u·ml -1 solution to netilmicin sulfate is effective to eliminate the interference in limulus test.Conclusion The kinetic turbidimetric limulus test provide a new way to the detection of endotoxin in netilmicin sulfate injection.
关键词(KeyWords)：
动态比浊法鲎试验;硫酸奈替米星;细菌内毒素;干扰试验
kinetic turbidimetric limulus test; netilmicin sulfate;bacterial endotoxin;inhibition enhancement test
基金项目(Foundation): 广东省重点科技攻关项目项目编号 :2KM0 540 63
作者(Authors):
林江平,劳海燕
Lin Jiangping;Lao Haiyan(Pharmaceutical department of Guangdong provincial people′s hospital;
参考文献(References)：
- 动态比浊法鲎试验
- 硫酸奈替米星
- 细菌内毒素
- 干扰试验
kinetic turbidimetric limulus test - netilmicin sulfate
- bacterial endotoxin
- inhibition enhancement test