利奈唑胺注射液细菌内毒素检查法的考察

Bacterial Endotoxin Test of Linezolid Injection

目的研究利奈唑胺注射液细菌内毒素检查(BET)方法,建立用BET代替热原检查法(PT)。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。结果利奈唑胺注射液(2.0mg·ml-1)稀释12倍(0.167mg·ml-1)后,用灵敏度0.06EU·ml-1的鲎试剂经干扰试验无增强、抑制作用。结论细菌内毒素检查法适用于检测利奈唑胺注射液中的内毒素。

Aim To study a method which involves using tachypleus amebocyte lysate （TAL） for testing the bacterial endotoxin in Linezolid Injection in order to establish a method for bacterial endotoxin test （BET） to replace the pyrogen test （PT）. Methods The tests were conducted according to appendix IX E of Chp 2005. Results Neither inhibition nor enhancement was found in the bacterial endotoxin test after the drug （Linezolid injection 2.0mg·ml^-1） was diluted to 12. Conclusion Bacterial endotoxin test is suitable for the detection of bacterial endotoxin in Linezolid Injection.