碘帕醇注射液重金属检查方法的改进  

Improvement of Inspection Methods for Heavy Metals in Iopamidol Injections

作　　者：彭茗[1] 陆丹[1] 刘瑾[1] 乐健[1] 杨永健[1] 

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《中国药师》2013年第4期565-566,共2页China Pharmacist

基　　金：2010国家药典委员会药品标准提高研究

摘　　要：目的:改进碘帕醇注射液的重金属检查方法。方法:将碘帕醇注射液水浴蒸干后,采用《中国药典》2010年版二部附录VIII H重金属检查第二法检查。结果:碘帕醇注射液的原辅料均不干扰重金属的检查,6批样品含重金属均低于百万分之二十,符合国家标准的规定。结论:本法无干扰,适用于碘帕醇注射液的重金属检查。Objective： To improve the inspection methods for the heavy metals in iopamidol injections. Method： The injections were dried on a water-bath, and the heavy metals were inspected according to the methods described in the appendix VIII H of ChP 2010 Volume Ⅱ. Result： Iopamidol and the excipients in the injections showed no interferece with the determination of the heavy met-als. The contents of the heavy metals were below 20 ppm in the six batches of samples, which were in line with the national standards of iopamidol injections. Conclusion ： The method is suitable for the inspection of heavy metals in iopamidol injections without interfer-ence.

关 键 词：碘帕醇注射液 重金属 依地酸钙钠 

分 类 号：R917[医药卫生—药物分析学]