注射用头孢匹胺钠细菌内毒素检查法

Bacterial Endotoxin Test of Cefpiramide Sodium for Injection

目的建立注射用头孢匹胺钠细菌内毒素检查方法。方法按中国药典2005年版附录细菌内毒素检查法要求进行试验。结果注射用头孢匹胺钠最小有效稀释浓度为1.67mg.ml-1,与鲎试剂反应无干扰作用。结论细菌内毒素检查法适用于检测注射用头孢匹胺钠中的内毒素。

Aim To establish a method using tachypleus amebocyte lysate （TAL） for testing the bacterial endotoxin in Cefpiramide Sodium for Injection. Methods The tests were conducted according to the appendix IX E of Chp 2005. Resuits Cefpiramide Sodium for Injection did not interfere with limulus agent in 1.67mg·ml^-1 diluted concentration. Conclusion Bacterial endotoxin test is suitable for the detection of bacterial endotoxin in Cefpiramide Sodium for Injection.