鲎试剂法检测注射用美洛西林钠的细菌内毒素

Study on the Determination of Bacterial Endotoxin In Mezlocillin Sodium for Injection By Tachypleus Amebocyte Lysate

目的 建立注射用美洛西林钠的细菌内毒素检查法。方法 参照中国药典 2 0 0 0年版二部收载的细菌内毒素检查法的要求 ,采用有供试品和无供试品同时测定灵敏度 ,并设立供试品阴性对照 ,对其进行细菌内毒素检测。结果 将注射用美洛西林钠稀释至 5mg·ml-1的溶液 ,用标示灵敏度为 0 .2 5Eu·ml-1的鲎试剂作细菌内毒素检查 ,结果可行。结论 可以用鲎法代替家兔法作控制注射用美洛西林钠的热原检查 ,注射用美洛西林钠的细菌内毒素限值为 0 .0 5Eu·mg-1。

Aim To establish the testing method of bacterial endotoxin in Mezlocillin Sodium for Injection.Methods Referring to the demands of testing methods which is recorded in Chinese Medicine(Vollum 2000),we detected the bacterial endotoxin in Mezlocillin Sodium for Injection.Results It is available for test of the bacterial endotoxin to dilute the Mezlocillin Sodium for Injection to 5mg·ml -1 with tachypleus amebocyte lysate,whose sensitivity standard is 0.25Eu·ml -1 .Conclusion It is available to make pyrogen test of Mezlocillin Sodium for Injection with tachypleus amebocyte lysate instead of Rabbit Method and the bacterial endotoxin should be limited within 0.05Eu·mg -1 .