盐酸普罗帕酮注射液细菌内毒素检查方法的确立

Test of bacterial endotoxin in propafenone hydrochloride injection

目的 :验证盐酸普罗帕酮注射液细菌内毒素检查法的可行性。方法 :通过抑制 /增强试验确定盐酸普罗帕酮注射液的有效稀释浓度和细菌内毒素限值。结果 :0 .35mg/ml的盐酸普罗帕酮溶液无干扰作用 ,其内毒素限值符合规定。 结论 :盐酸普罗帕酮注射液可用细菌内毒素检查法来控制其细菌内毒素含量。

Objective:To verify the feasibility of bacterial endotoxins test in detecting propafenone hydrochloride injection.Methods:The valid concentration of propafenone hydrochloride injection and its bacterial endotoxin limit were determined by inhibiting/enhancing test.Results:Propafenone hydrochloride solution did not at the concentration 0.35 mg/ml interfere with bacterial endotoxin test and its endotoxin limit accords with the regulation.Conclusions:Bacterial endotoxin test can be used to control the content of bacterial endotoxin in propafenone hydrochloride injection. [