动态浊度法测定注射用阿莫西林钠克拉维酸钾细菌内毒素含量  

Content Determination of Bacterial Endotoxin in Amoxicillin Sodium and Clavulanate Potassium for Injection by Kinetic Turbidimetric Method

作　　者：李慧 张彦丽 崔晓燕 刘琳 刘云 

机构地区：[1]河北省石家庄市食品药品检验中心,河北石家庄050031 [2]河北省药品检验研究院,河北石家庄050011

出　　处：《中国药业》2017年第9期26-28,共3页China Pharmaceuticals

摘　　要：目的建立测定注射用阿莫西林钠克拉维酸钾细菌内毒素含量的方法。方法按照2015年版《中国药典(四部)》,采用动态浊度法进行干扰试验,测定样品中细菌内毒素的含量。结果当供试品稀释质量浓度为60 g/L时,无干扰作用,细菌内毒素回收率为50%~200%。结论动态浊度法定量检测样品中细菌内毒素,细菌内毒素含量均远低于药典规定的0.25 EU/mg,现有标准可作进一步提高。Objective To establish a method for determining the content of bacterial endotoxin in Amoxicillin Sodium and Clavulanate Potassium for Injection. Methods According to the Chinese Pharmacopoeia 2015 Edition fourth section, kinetic turbidimetric method was used for the interference test of Amoxicillin Sodium and Clavulanate Potassium for Injection and determining the content of bacterial endotoxin in samples. Results The interference was eliminated when the sample was diluted to 60 g/L, the recovery rate of bacterial endotoxin was within 50% -200%. Conclusion Dynamic turbidimetry can be used for bacterial endotoxin in test of Potassium Clavu- lanate and Amoxicillin for Injection, the content of bacterial endotoxin is less than the standard of Chinese Pharmacopoeia O. 25 EU/mg, and the current standard can be further improved.

关 键 词：注射用阿莫西林钠克拉维酸钾 细菌内毒素 动态浊度法 

分 类 号：R446.5[医药卫生—诊断学]