头孢孟多酯钠细菌内毒素检查法可行性研究

Investigation of testing method for bacterial endotoxins in cefamandole nafate

建立了头孢孟多酯钠细菌内毒素检查方法。按2005年版中国药典第2部收载的细菌内毒素检查法规定,用2个不同厂家的鲎试剂对其分别进行了检查。结果表明,采用0.5 EU/mL的鲎试剂并将样品质量浓度稀释至3.33 mg/mL时,对该实验无干扰作用,细菌内毒素限值为0.15 EU/mg。头孢孟多酯钠可用细菌内毒素检查法代替热原检查法进行检验,方法灵敏、可靠、方便、经济。

The bacterial endotoxins testing method of Cefamandole Nafate was established in this paper. Using two tachypleus amebocyte lysate from different producers, the interference test of Cefamandole Nafate was conducted according to bacteria endotoxin test in China Pharmacopeia 2005, second section. The results show that there is no interference with bacteria endotoxin test when tachypleus amebocyte lysate of 0.5 EU/mL is used and the solution density of Cefamandole Nafate is diluted to 3.33 mg/ml. The limitation of bacteria endotoxin is 0. 15 EU/mg. Bacteria endotoxin test is accurate and suitable for detection of bacteria endotoxin in Cefamandole Nafate.