西咪替丁原料药细菌内毒素检查方法的探讨

摘要

Objective To establish a bacterial endotoxin test for cimetidine raw material. Methods According to the method of the bacteria endotoxin test in the Chinese Pharmacopoeia (edition 2010, Vol. II). Results When the mass concentration of sample was diluted to 4.0 mg/mL,no interference effect on the reaction of bacterial endotoxin and TAL was found. The limit value of the bacterial endotoxin was 0. 5 EU/mg. Conclusion It is feasible to detect the bacterial endotoxin of cimetidine raw material by the method of bacterial endotoxin test.%目的 建立西咪替丁原料药的细菌内毒素检查方法.方法 参照2010年版细菌内毒素检查法进行试验.结果 样品质量浓度稀释至4.0 g/L时,对鲎试剂与细菌内毒素的反应无干扰作用.其细菌内毒素限值定为0.5 EU/mg.结论 西咪替丁原料药采用内毒素检查法(鲎试剂法)是可行的.