鲎试剂法检测注射用盐酸丙帕他莫中细菌内毒素  

Detection of Bacterial Endotoxins in Propacetamol Hydrochloride for Injection by Tachypleus Amebocyte Lysate Test

作　　者：罗丽萍[1] 郭咸希[1] 黄砚青[1] 

机构地区：[1]武汉大学人民医院药学部,武汉430060

出　　处：《中国药师》2011年第4期511-513,共3页China Pharmacist

摘　　要：目的:考察鲎试剂方法检测注射用盐酸丙帕他莫中细菌内毒素的可行性。方法:参照《中国药典》2010年版(二部)附录ⅪE细菌内毒素检查法对注射用盐酸丙帕他莫进行细菌内毒素检测。结果:质量浓度为5.0 mg·ml^(-1)的样品溶液对凝集反应有抑制作用,质量浓度稀释至2.5 mg·ml^(-1)时,用灵敏度λ为0.25 EU·ml^(-1)的鲎试剂进行试验,干扰作用消失。结论:注射用盐酸丙帕他莫可用鲎试剂方法进行细菌内毒素检测。Objective： To establish a method for detection of bacterial endotoxins in propaeetamol hydrochloride for injection. Method： The experiments were carried nut according to the bacterial endotoxins test speeified in appendix XI E,volume two,Chinese pharmacopoeia 2010 edition. Result： Samples with the concentration of 5.0 mg·ml-1 had inhibitive effect on the bacterial endotoxins test,however the interference was eliminated when the samples were diluted to the eoneentration of 2. 5 mg· ml-1 ,detected by taehypleus amebocyte lysates with the sensitivity of 0. 25 EU·ml-1. Conclusion： Tachypleus amebocyte lysate test is feasible/or detecting bacterial endotoxins in propacetamol hydrochloride for injection.

关 键 词：注射用盐酸丙帕他莫 细菌内毒素 鲎试剂 

分 类 号：R927.12[医药卫生—药学]