摘要
随着我国血液透析行业的迅速发展,血液透析器的应用越来越广泛,但与此同时,血液透析器的质量控制技术不够完善,对于透析器中种类繁多的可沥滤物研究较少、检测方法欠缺等问题凸显。该研究先对血液透析器的发展情况进行简述,再从可沥滤物的常见种类、浸提方法的选择、色谱质谱条件的建立等层面进行概述,总结了先确定种类、再制订浸提方案、然后建立检测方法的可沥滤物研究思路。最后展望血液透析器可沥滤物的研究前景,指出随着研究的深入和广泛开展,可以进一步促进血液透析器行业的健康发展。
With the rapid development of my country’s hemodialysis industry,the application of hemodialysis machines has become more and more extensive,but at the same time,the quality control technology of hemodialysis machines is not perfect.Especially for a wide range of leachable substances in dialyzers,there are few studies and detection methods.This study first briefly describes the development of hemodialyzers,and then expounds the common types of leachables,extraction methods,and chromatography and mass spectrometry conditions.It is summarized that the research plan of leachable substances is to determine the type first,then formulate the extraction plan,and then establish the detection method.Finally,we look forward to the research prospects of hemodialyzer leachables,and point out that with the deepening and extensive development of research,it can further promote the healthy development of the hemodialyzer industry.
作者
刘子琪
陈卓颖
付海洋
付步芳
LIU Ziqi;CHEN Zhuoying;FU Haiyang;FU Bufang(National Institutes for Food and Drug Control,Beijing,102629;China Pharmaceutical University,Nanjing,211198;South China University of Technology,Guangzhou,510641)
出处
《中国医疗器械杂志》
2022年第4期417-421,共5页
Chinese Journal of Medical Instrumentation
基金
国家重点研发项目(2017YEC1105000)。
关键词
血液透析器
可沥滤物
浸提
检测技术
hemodialyzer
leachable substance
extraction
detection techniques
