血液透析浓缩物化学原辅料质量控制要求初探  

A preliminary study on the quality control of chemical raw materials and excipients of concentrates for hemodialysis

作　　者：叶晓燕[1,2] 骆庆峰 黄敏菊 曲亚南[1,2] 黄麒谕 YE Xiao-yan;LUO Qing-feng;HUANG Min-ju;QU Ya-nan;HUANG Qi-yu(Guangdong Medical Devices Quality Surveillance and Test Institute,Key Laboratory for Extracorporeal Circulation Devices,National Medical Products Administration,Guangzhou 510663,China;Center for Medical Device Evaluation,National Medical Products Administration,Beijing 100081,China)

机构地区：[1]广东省医疗器械质量监督检验所,广州510663 [2]国家药品监督管理局体外循环器械重点实验室,广州510663 [3]国家药品监督管理局医疗器械技术审评中心,北京100081

出　　处：《中国血液净化》2022年第11期862-864,共3页Chinese Journal of Blood Purification

基　　金：广东省药品监督管理局科技创新项目(2018ZDZ04)。

摘　　要：本文通过对比血液透析浓缩物中化学原辅料的相关国际标准、行业标准及药典,就现行法规政策,对血液透析浓缩物的化学原辅料质量控制要求进行初探。同时阐述了血液透析用原辅料值得关注的附加要求,供相关领域专业人士参考使用。By comparing the related international standards,industry standards and pharmacopoeia of chemical raw materials and excipients of concentrates for hemodialysis,the quality control requirements of chemical raw materials and excipients for hemodialysis concentrates were studied according to the current regulations and policies.At the same time,the additional requirements of raw materials and excipients for hemodialysis were described,for reference of the professionals in related fields.

关 键 词：血液透析浓缩物 化学原辅料 碳酸氢钠 氯化镁 

分 类 号：R459.5[医药卫生—治疗学]