注射用头孢硫脒细菌内毒素检查方法探讨

On bacterial endotoxin inspection for cefathiamidine injection

目的对注射用头孢硫脒进行鲎试剂检查法实验,以替代热原检查,建立注射用头孢硫脒细菌内毒素检查。方法参照《中国药典》2010版(二)部附录细菌内毒素检查法及其指导原则进行试验。结果注射用头孢硫脒稀释至2.5g/L及以下时可消除对鲎试剂与内毒素凝集反应的干扰。结论注射用头孢硫脒可以通过细菌内毒素检查法来控制细菌内毒素的含量。

Objective To establish bacterial endotoxin test method of the extraction of eefathiamidine injection. Methods According to the Chp 2010 Edt,inhibition or enhancement test for bacterial endotoxin test was carried out of oxiractam injection. Results The interference could be eliminated when cefathiamidine in- jection was diluted by 2.5 g. L-1. Condnsion Bacterial endotoxin test can be used for the extraction of bone- melon injection.