摘要
建立甲磺酸帕珠沙星注射剂的细菌内毒素检查法,替代热原检查法。参照《中国药典》2000年版(二部)收载的细菌内毒素检查法及其指导原则进行干扰试验。对样品进行8倍稀释后采用灵敏度为006EU·ml-1的鲎试剂,或调节样品pH值至67～70用灵敏度为025EU·ml-1的鲎试剂,可消除样品对鲎试剂与内毒素的凝集反应干扰。甲磺酸帕珠沙星注射剂可以用细菌内毒素检查法取代热原检查法。
A bacterial Endotoxin testing method for Pazufloxacin Mesilate Injection was established to replace pyrogen test. Interference test was made according to the method and guideline described in China Pharmacopoeia 2000 version (Ⅱ). The interference could be eliminated when the sample was diluted by 8 times and tested by limulus reagent with sensitivity of 0 06EU·ml -1 , or when the sample was adjusted to pH 6 7～7 0 and tested by limulus reagent with sensitivity of 0 25EU·ml -1 . Bacterial endotoxin test could be used for Pazufloxacin Mesilate Injection.
出处
《中国药事》
CAS
2004年第11期680-682,共3页
Chinese Pharmaceutical Affairs
