注射用头孢唑林钠细菌内毒素的检测

Determination of bacterial endotoxins in Cefazolin Sodium for Injection

目的:建立注射用头孢唑林钠细菌内毒素的检查方法。方法:根据《中国药典》2005年版二部细菌内毒素检查法要求进行实验。结果:注射用头孢唑林钠的内毒素限值应定为0.067EU/mg,该药浓度稀释为7.46mg/ml时对细菌内毒素检查无干扰。结论:鲎法检测注射用头孢唑林钠细菌内毒素是可行的。

Objective： To establish a method for the test of bacterial endotoxins in Cefazolin Sodium for Injection. Methods： The experiment was done according to the request of bacterial endotoxins in Apparatus Ⅱ of Chinese Pharmacopoeia 2005 edition. Results： The bacterial endotoxin limit of Cefazolin Sodium for Injection was 0.067 EU/mg. After diluted to 7.46 mg/ml, Cefazolin Sodium for Injection didn＇t interfere with the test for bacterial endotoxins.. Conclusion： The TAL can be used for detection of bacterial endotoxins in Cefazolin Sodium for Injection.