注射用阿魏酸钠细菌内毒素检查法的建立

Studies on Establishment of Bacterial Endotoxin Test of Sodium Ferulate for Injection

目的建立注射用阿魏酸钠细菌内毒素检查法。方法采用《中国药典》2010年版二部附录细菌内毒素检查法。结果注射用阿魏酸钠稀释至1.25mg·mL-1时,不干扰细菌内毒素试验,其细菌内毒素限值可订为0·4EU·mg-1。结论使用细菌内毒素检查法检查注射用阿魏酸钠中的细菌内毒素是可行的,可用细菌内毒素检查法代替家兔热原检查法。

OBJECTIVE To establish a method for the bacterial endotoxin test of Sodium Ferulate for Injection. METHODS The method of the bacterial endotoxin test approved by the Chinese Pharmacopoeia（ edition2010） was adopted. RESULTS Sodium Ferulate for Injection was diluted to 1. 25mg·mL- 1,does not interfere with the bacterial endotoxin test,the bacterial endotoxin limit can be set for 0. 4EU·mg- 1. CONCLUSION The method is feasible to detect bacterial endotoxin in Sodium Ferulate for Injection,which can replace the rabbit pyrogen test.