动态浊度法定量检测注射用头孢噻吩钠中细菌内毒素

摘要

Objective:To develop an assay for determination of becterial endotoxin(BET) in Cefalotin Sodiun for Injection.Methods:BET was determinated by turbidimetric-kinetic method. Results:The content in Cefalotin Sodiun for Injection did not interfere with the quantitation of BET.The recovery of BetwET was been 50%and 200%.Conclusion:The method is proved to be suitable for determination of the BET in Cefalotin Sodiun for Injection and could be used as an alternative for the rabbit pyrogen test to the injection.%　　目的：建立注射用头孢噻吩钠中定量检测细菌内毒素方法试验。细菌内毒素的动态浊度法检测。方法：采用《中国药典》2010年版(二部)附录[1]。结果：该方法准确地检测注射用头孢噻吩钠中细菌内毒素的含量，干扰因素影响得到了排除，在50%~200%范围是细菌内毒素的定量检测回收率。结论：动态浊度法定量检测作为注射用头孢噻吩钠的细菌内毒素检测是可行的[2]，同时又避免了限量法检测细菌内毒素时的干扰，可见用动态浊度法定量检测法代替家兔热原检查法[1]及限量法检测细菌内毒素是准确可靠有效的。