| 动态浊度法检测乳酸左氧氟沙星氯化钠注射液中的细菌内毒素 |
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| 引用本文： | 李荣,吴玲.动态浊度法检测乳酸左氧氟沙星氯化钠注射液中的细菌内毒素[J].中国药房,2012(9):837-838. |
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| 作者姓名： | 李荣 吴玲 |
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| 作者单位： | 南华大学附属第二医院;衡阳市药品检验所 |
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| 摘 要： | 目的:应用动态浊度法定量测定乳酸左氧氟沙星氯化钠注射液中的细菌内毒素,并与凝胶法比较。方法:按《中国药典》2010年版二部收载的细菌内毒素检查方法及其指导原则进行干扰试验,确定样品最大稀释倍数。结果:当样品作8倍稀释时用动态浊度法的回收率值较高(100%左右),未见干扰作用;与凝胶法检测结果一致,均符合规定。结论:动态浊度法可以有效测定乳酸左氧氟沙星氯化钠注射液中的细菌内毒素含量。
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| 关 键 词： | 动态浊度法 乳酸左氧氟沙星氯化钠注射液 细菌内毒素 干扰试验 |
Determination of Bacterial Endotoxin for Levofloxacin Lactate/Sodium Chloride Injection by Kinetic Turbidimetric Limulus Test |
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| LI RongThe Second Affiliated Hospital of Nanhua University,Hunan Hengyang,China WU Ling.Determination of Bacterial Endotoxin for Levofloxacin Lactate/Sodium Chloride Injection by Kinetic Turbidimetric Limulus Test[J].China Pharmacy,2012(9):837-838. |
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| Authors: | LI RongThe Second Affiliated Hospital of Nanhua University Hunan Hengyang China WU Ling |
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| Institution: | LI Rong(The Second Affiliated Hospital of Nanhua University,Hunan Hengyang 421001,China) WU Ling(Hengyang Institute for Drug Control,Hunan Hengyang 421001,China) |
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| Abstract: | OBJECTIVE:To apply kinetic turbidimetric limulus test for quantitative determination of bacterial endotoxin for Levofloxacin lactate/sodium chloride injection,compared with the gel-clot.METHODS:According to bacterial endotoxin test included in Chinese Pharmacopoeia(2010 Edition),interference test was conducted to determine maximum diluent fold.RESULTS:When the sample was 8-fold diluted,the recovery rate of kinetic turbidimetric limulus was high relatively(about 100%) without interference.The method and gel-clot were consistent and compliance,and both of them were up to the standard.CONCLUSION:Kinetic turbidimetric limulus test can effectively measure bacterial endotoxin for Levofloxacin lactate/sodium chloride injection. |
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| Keywords: | Kinetic turbidimetric limulus test Levofloxacin lactate/sodium chloride injection Bacterial endotoxin Interferential test |
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