凝胶法检查注射用头孢噻吩钠中的细菌内毒素

目的:建立以凝胶法检查注射用头孢噻吩钠中细菌内毒素的方法。方法:将注射用头孢噻吩钠分别以细菌内毒素检查用水稀释成供试品阴性、阳性对照系列,以考察其最大不干扰浓度;再以细菌内毒素检查用水与样品制备成的供试液分别将细菌内毒素稀释成不同系列浓度的溶液,按鲎试剂灵敏度复核进行干扰性试验。结果:试验中注射用头孢噻吩钠的最大不干扰浓度为6·68mg/ml;另将其稀释至浓度为1·67mg/ml时对细菌内毒素检查无干扰。结论:本方法可代替热原检查中的家兔法以检查注射用头孢噻吩钠中的细菌内毒素。

Test for Bacterial Endotoxins in Cefalotin Sodium for Injection by Gel Clot

OBJECTIVE:To establish a method for test of bacterial endotoxin on cefalotin sodium for injection by gel clot.METHODS:Cefalotin sodium for injection was diluted in water for determination of bacterial endotoxin and allocated to sample negative and sample positive controls to determine its maximum noninterference concentration;Then bacterial endotoxins were diluted into solutions of different concentrations with the test solutions,and interference test was carried out by using tachyˉpleus amebocyte lysate sensitivity compound nucleus.RESULTS:The maximum noninterference concentration of cefalotin sodium for injection was6.68mg/ml;And cefalotin sodium at the concentration of1.67mg/ml did not interfere with the test for bacterial endotoxins.CONCLUSION:The present method can replace pyrogen test with rabbit for examination of bacterial endotoxin in cefalotin sodium for injection.