中国血液净化

中国血液净化 ›› 2022, Vol. 21 ›› Issue (11): 862-864.doi: 10.3969/j.issn.1671-4091.2022.11.016

• 血液净化中心管理 • 上一篇    

血液透析浓缩物化学原辅料质量控制要求初探

叶晓燕   骆庆峰   黄敏菊   曲亚南   黄麒谕   

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

  • 收稿日期:2022-07-05 修回日期:2022-09-01 出版日期:2022-11-11 发布日期:2022-11-12
  • 通讯作者: 叶晓燕 E-mail:107781964@qq.com
  • 基金资助:
    广东省药品监督管理局科技创新项目(2018ZDZ04)

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

YE Xiao-yan, LUO Qing-feng, HUANG Min-ju, QU Ya-nan, HUANG Qi-yu   

  1. Guangdong Medical Devices Quality Surveillance and Test Institute; Key Laboratory for Extracorporeal Circulation Devices, National Medical Products Administration, Guangzhou 510663, China; 2Center for Medical Device Evaluation, National Medical Products Administration, Beijing 100081, China
  • Received:2022-07-05 Revised:2022-09-01 Online:2022-11-11 Published:2022-11-12
  • Contact: 510663 广州，广东省医疗器械质量监督检验所；国家药品监督管理局体外循环器械重点实验室 E-mail:107781964@qq.com

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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。

关键词: 血液透析浓缩物, 化学原辅料, 碳酸氢钠, 氯化镁

Abstract: 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.

Key words: Concentrates for hemodialysis, Chemical raw materials and excipients, Sodium bicarbonate, Magnesium chloride

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