注射用盐酸头孢吡肟细菌内毒素检查法

Bacterial Endotoxins Test of Cefepime Hydrochloride for Injection

目的 :研究注射用盐酸头孢吡肟对细菌内毒素检查试验的干扰情况 ,并建立其细菌内毒素检查的方法。方法 :参照中国药典 2 0 0 0年版二部附录XIE细菌内毒素检查法和附录XIXF细菌内毒素检查法应用指导原则进行试验。结果 :供试品在 3.33mg·ml-1稀释浓度下无干扰作用。结论 :获得了可靠的实验数据和结果并建立了本品的细菌内毒素检查法。

Objective: To study if cefepime hydrochloride for injection to inhibit or enhance bacterial endotoxins test and estabish a bacterial endotoxins test method for this specimen. Method:bacterial endotoxins test was conducted fof cefepime hydrochloride for Injection According to the CP 2000. Result:Four fold diluted cefepime hydrochloride for injection didn't inhibit or enhance the test. Conclution:The Bacterial Endotoxins Test method for this specimen is able to be established.