注射用头孢哌酮钠舒巴坦钠(2∶1)细菌内毒素检查法建立的方法学研究  

Study on the bacterial endotoxin inspection method of cefoperazone/sulbactam(2∶1)for injection

作　　者：杨积平[1] 

机构地区：[1]安徽省蚌埠市第三人民医院药剂科,233000

出　　处：《淮海医药》2005年第6期444-445,共2页Journal of Huaihai Medicine

摘　　要：目的研究注射用头孢哌酮钠舒巴坦钠(2∶1)的细菌内毒素检查方法。方法对照《中国药典2000年版》二部附录F试验方法,采用不同厂家、不同批号的鲎试剂,通过干扰实验来确定注射用头孢哌酮钠舒巴坦钠(2∶1)的有效稀释浓度。结果注射用头孢哌酮钠舒巴坦钠(2∶1)稀释成1.25mg/ml供试品液后,用0.125EU/ml的鲎试剂,对细菌内毒素检查无干扰。结论注射用头孢哌酮钠舒巴坦钠(2∶1)可以通过细菌内毒素检查法来控制其细菌内毒素含量。Objective To validate the feasibility for the bacterial endotoxin inspection method of cefoperazone/sulbactam（2 ： 1） for injection. Methods According to the method in the addendum Ⅺ XF of China pharmacopoeia （Part Two, 2000 edition）, the interference/valldation tests were carried out to explore the effective diluting concentration of cefoperazone/sulbactam（2 ： 1） for injection and the lowest limit of detection of the bacterial endotoxin. Results The cefoperazone/sulbactam（2 ： 1） for injection in concentration of 1.25 mg/ml has no interference to the bacterial endotoxin test ,and the lowest limit of detection of the bacterial endotoxln accords with the regulation. Conclusion It is feasible that the bacterial endotoxin inspection method is applied to control the concentration of the bacterial endotoxln in cefoperazone/sulbactam（2 ： 1）for injection.

关 键 词：注射用头孢哌酮钠舒巴坦钠(2:1) 细菌内毒素检查 鲎试剂 

分 类 号：R927.1[医药卫生—药学]