凝胶法检测替硝唑葡萄糖注射液的细菌内毒素

Bacterial Endotoxins in Tinidazole and Glucose Injection Determined by Gel-clot Method

目的 :确定凝胶法代替家兔热原检查法检测替硝唑葡萄糖注射液细菌内毒素的可能性。方法 :用 3个批号 4个浓度的替硝唑葡萄糖注射液对鲎试剂进行干扰试验。结果 :3个批号 4个浓度的替硝唑葡萄糖注射液对细菌内毒素的凝集反应均无干扰作用。结论 :初步认为可用凝胶法检查替硝唑葡萄糖注射液的细菌内毒素 ,其细菌内毒素限值定为 0 .

Objective: To study the ability of gel clot method instead of rabbit pyrogen test for the bacterial endotoxin determination of tinidazole and glucose injection.Method: The interfering test was conducted with four comcentration in three groups to TAL. Result: There were no interfering effects in four concentration in three groups to aggregation of bacterial endotoxins.Conclusion: The primary result considered that the method may be used for the bacterial endotoxins test of tinidazole and glucose injection in the limited value of 0.5 Eu·ml -1 .