摘要
目的考察甲磺酸帕珠沙星氯化钠注射液的细菌内毒素检查法。方法采用不同厂家、不同批号、不同灵敏度的鲎试剂对甲磺酸帕珠沙星氯化钠注射液进行干扰试验。结果甲磺酸帕珠沙星氯化钠注射液经7倍稀释后,用λ为0.25Eu·ml的鲎试剂,对细菌内毒素检查无干扰。结论甲磺酸帕珠沙星氯化钠注射液的热原检查可以被内毒素检查法取代。
Objective To evaluate the bacterial endotoxins test of Pazufloxacin Mesilate and sodium chloride injection using tachypleus ameboeyte lysate. Methods The intefferential tesl of Pazufloxacin Mesilate and sodium chloride injection were studied using tachy-pleus amebocyte lysate of different factories, different batch numbers and different sensitivities;Results When the taehy-pleus ameboeyte lysate＇s sensitivity （k） is0.25Eu·ml and maximum valid dilution（MVD）is7, the bacterial endo- toxins test isn＇t interferential;Conclusion The bacterial endotoxins test of Pazufloxaein Mesilate and sodium chloride injection can be replaced by the pyrogen test of it.
出处
《中国现代药物应用》
2009年第15期31-32,共2页
Chinese Journal of Modern Drug Application
关键词
甲磺酸帕珠沙星氯化钠注射液
鲎试剂
细菌内毒素检查
Pazufloxacin Mesilate and sodium chloride injection
Tachypleus amebocyte lysate
Bacterial endotoxins test
