摘要
目的研究注射用亚胺培南西司他丁钠细菌内毒素的检查法。方法用两个不同生产厂家、不同标示灵敏度鲎试剂进行研究,按《中国药典》2005年版(二部)附录ⅪE进行试验和结果判断。结果注射用亚胺培南西司他丁钠的最大不干扰浓度为1.47mg.ml-1,对两个不同厂家六批样品进行检查均无干扰作用,其细菌内毒素均小于0.17EU.mg-1。结论本品细菌内毒素检查法(凝胶法)控制细菌内毒素的含量可行。
OBJECTIVE To set up the the test method of bacterial endotoxin for Imipenem and Cilasatin Sodium for Injection. METHODS Two taehypleus amebocyte lysate reagents,supplied by two company and with different sensitivity,were used and the experiment was done and the result judegment was made according to the appendix XI E of Chinese Pharmacopoeia 2005 Edition,vol Ⅱ . RESULTS The uninterferenc concentration of Imipenem and Cilasatin Sodium for Injection was 1.47mg · ml^-1. The endotoxin content was even less than the limit （0. 17EU · mg^-1 ） in each of six batches of Imipenem and Cilasatin Sodium for Injection produced by two factories. CONCLUSION Tachypleus amebocyte lysate method can be used for bacterial endotoxins monitoring of Imipenem and Cilasatin Sodium for Injection.
出处
《齐鲁药事》
2006年第11期667-669,共3页
qilu pharmaceutical affairs
