紫外分光光度法测定体外循环类医疗器械中DEHP溶出量  

Determined DEHP Dissolution in the Medical Devices of Extracorporeal Circuit with UV Spectrophotometry

作　　者：洪良通[1] 刘贻声[1] 

机构地区：[1]国家食品药品监督管理局广州医疗器械质量监督检验中心,广州510663

出　　处：《中国医疗器械信息》2012年第4期67-69,共3页China Medical Device Information

摘　　要：本文介绍一种体外循环类医疗器械中DEHP溶出量的测定方法,根据产品临床使用特点,以乙醇水溶液为浸提溶剂,使用合适的浸提方法,通过紫外分光光度法测定DEHP含量。该方法结果准确可靠,具有良好的线性关系,达到满意的效果。The article discussed a method of DEHP dissolution in the Medical devices of extracorporeal circuit.According to the product features of clinical,The ethanol aqueous solution is served as extra solution,with appropriate extraction method.Determined DEHP dissolution with UV spectrophotometry.The result is accurate and secure.

关 键 词：紫外分光光度法 体外循环 医疗器械 DEHP 

分 类 号：R197.39[医药卫生—卫生事业管理]