高浓度维生素B6注射液细菌内毒素检查方法学验证  

Validation of endotoxin test for high concentration vitamin B6 injection

作　　者：沈娟[1] 芦佳月 罗晓茹 王习文[1] SHEN Juan;LU Jiayue;LUO Xiaoru;WANG Xiwen(General Station for Drug&Instrument Supervision and Control,Joint Logistics Support Force,PLA,Beijing 100071,China)

机构地区：[1]中国人民解放军联勤保障部队药品仪器监督检验总站

出　　处：《药学实践杂志》2020年第1期67-70,共4页Journal of Pharmaceutical Practice

摘　　要：目的建立高浓度维生素B6注射液的细菌内毒素检查方法。方法采用《中国药典》2015年版四部通则1143细菌内毒素检查法进行检测。结果用pH6.5~7.5的缓冲液将高浓度维生素B6注射液稀释至1.04 mg/ml,用λ为0.06 EU/ml的鲎试剂可以有效去除干扰。结论该方法可行,可用于高浓度维生素B6注射液的细菌内毒素检查。细菌内毒素的限值确定为0.06 EU/mg。Objective To establish a bacterial endotoxin test method for high concentration vitamin B6 injection.Method The test was taken according to the bacterial endotoxin test in Chinese pharmacopoeia 2015 edition.Result By diluting the sample concentration to 1.04 mg/ml with the buffer of pH6.5-7.5,and usingλ=0.06 EU/ml of TAL reagent,the interference could be effectively avoided.Conclusion The method was useful,which could be used to test the bacterial endotoxin in high concentration vitamin B6 injection.The bacterial endotoxin limit was defined as 0.06 EU/mg.

关 键 词：高浓度维生素B6注射液 细菌内毒素 凝胶法 干扰试验 

分 类 号：R927.11[医药卫生—药学]