药物制剂辅料在儿童群体中的安全性考量  

Review of Excipients Safety in Pediatric Patients

作　　者：海莉丽[2] 朱琳[1] 李智平[1] HAI Li-li;ZHU Lin;LI Zhi-ping(Department of Pharmacy, Children s Hospital of Fudan University, Shanghai 201102,China;Department of Pharmacy, Children' s Hospital of Zhengzhou University, Henan Children' s Hospital, Zhengzhou Children's Hospital, Zhengzhou 450000, China)

机构地区：[1]复旦大学附属儿科医院临床药学部,上海201102 [2]郑州大学附属儿童医院,河南省儿童医院,郑州儿童医院药学部,郑州450000

出　　处：《中国药学杂志》2019年第14期1121-1125,共5页Chinese Pharmaceutical Journal

基　　金：中国-世界卫生组织2016~2017双年度合作项目资助:儿童用药安全性和可及性相关因素对策研究资助(2016/647672-0);上海市卫生计生系统薄弱学科建设项目资助(2016ZB0305);2017年上海市临床药学重点专科建设项目资助(沪卫计药资助[2017]5号)

摘　　要：辅料是药物制剂的重要组成,通常认为是惰性成分,较少受到关注。然而,由于儿童群体机体的生长发育及对药物辅料药动学的特殊性,不可否认,儿童正在面临某些药物辅料的危害风险。笔者旨在通过总结对儿童群体确定及可能有危害的药物辅料,回顾国内外药物辅料的使用现状,探讨药物制剂辅料在儿童群体的安全性,以供药师、医生等医务工作者及药品研发生产者参考。Excipients are essential components of pharmaceutical products for use in adults and children. They are generally considered to be inert ingredients and are therefore rarely concerned due to the growth and development of the body of children and the specificity of the pharmacokinetics of pharmaceutical excipients,it is undeniable that children are facing risks of excipient toxicity. This article summarizes some excipients of defined and potential hazardous risks in the pediatric population,and reviews the current status of pediatric use of excipients in China and other countries,therefore to discuss the safety of excipients in children,and to provide a reference to healthcare professionals including pharmacists,physicians,as well as pharmaceutical manufacturers.

关 键 词：辅料 儿童 不良反应 安全性 制剂 药物研发 

分 类 号：R944[医药卫生—药剂学]