甲氨蝶呤冻干粉针剂细菌内毒素检查方法的研究

Study of bacterial endotoxins test in Methotrexate Injection

目的探讨甲氨蝶呤冻干粉针剂进行细菌内毒素检查的可行性。方法采用凝胶法鲎试验对样品中的细菌内毒素进行检测。结果3批甲氨蝶呤冻干粉针剂在稀释成0.125mg/ml浓度下对细菌内毒素检查均没有干扰作用;所测样品的细菌内毒素含量均小于2.4EU/mg。结论可建立甲氨蝶呤冻干粉针剂的细菌内毒素检查法,日常细菌内毒素检查时可将甲氨蝶呤在冻干粉针剂稀释成0.125mg/ml的水溶液以排除其干扰作用。

Objective To explore the feasibility of test for bacterial endotoxins in Methotrexate injection.Methods Gel-clot limulus test was applied to detect the bacterial endotoxins in Methotrexate lnjection.Results The sample dissolve in a concentration of 0.125 mg/ml by water didn't interfere with the test for bacterial endotoxins;the content of bacterial endotoxins in all samples tested were not more than 2.4 EU/mg.Conclusion Tachypleus amebocyte lysate(TAL)test provides a new way to detect the bacterial endotoxins in Methotrexate injection,samples can be dissolved in a concentration of 0.125 mg/ml by water to avoid their interference effects on detection of bacterial endotoxins.