注射用头孢尼西钠细菌内毒素检查法的研究

目的研究注射用头孢尼西钠的细菌内毒素检查方法。方法参照《中国药典》2000年版收载的细菌内毒素检查方法及指导原则进行干扰试验。结果注射用头孢尼西钠在药液稀释浓度为1.67mg.ml-1时,对鲎试剂的凝集反应无干扰作用。采用灵敏度为0.25 EU.ml-1的鲎试剂可进行细菌内毒素检查。结论可用细菌内毒素检查法控制注射用头孢尼西钠的质量。本品细菌内毒素限值为0.15EU.mg-1。

Study on the examiantion of bacterial endotoxin in Cefonicid sodium Znjection

Objective To study the method of testing bacterial endotoxin in the Cefonicid sodium Injection.Methods The interference test was performed according to the assigned method and guiding principle for bacterial endotoxin test in Chinese Pharmacopoeia 2000.Results When the proper sensitivity of limulus test agent for bacterial endotoxin test was 0.25 EU·ml~(-1),Cefonicid sodium Injection does not interfere the agglutination response with limulus reagent,whose concentration was diluted to 1.67 mg·ml~(-1).Conclusion Bacterial endotoxin test can be used for quality control of Cefonicid sodium Injection.The bacteral endotoxin limitation is 0.15EU·mg~(-1).