我国儿童用药辅料的标准现状研究  

Research on the Application and Standard Status of Pharmaceutical Excipients for Pediatric Medicines in China

作　　者：王淼[1] 余少文[1] 林嗣翔 叶秀金[1] 陈蕾[2] 陈英[1] WANG Miao;YU Shaowen;LIN Sixiang;YE Xiujin;CHEN Lei;CHEN Ying(NMPA Key Laboratory of Quality Control and Evaluation of Pharmaceutical Excipients,Guangdong Institute for Drug Control,Guangzhou 510700,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]广东省药品检验所,国家药品监督管理局药用辅料质量控制与评价重点实验室,广州510700 [2]国家药典委员会,北京100061

出　　处：《中国药学杂志》2024年第19期1789-1794,共6页Chinese Pharmaceutical Journal

基　　金：广东省药品监督管理局科技创新项目资助(2023ZDZ04)。

摘　　要：儿童用药是当前医药行业备受关注的热点,药用辅料在儿童用药中的安全合理应用对儿童用药产品质量具有决定性作用。本文概述了我国儿童用药辅料的应用现状及存在的问题,着重对我国儿童用药辅料质量标准应用和收载情况进行深入调研,并对其质量标准体系的完善提出相关建议。科学的儿童用药辅料标准体系可为产品的安全性和规范性应用提供技术保障,充分发挥国家标准对审评审批工作的技术支撑作用,对儿童用药产品质量控制有重要意义。Pediatric medicines are the hot topic in the pharmaceutical industry currently,and the safe and reasonable application of pharmaceutical excipients for pediatric medicines plays a decisive role in the quality control of products.This article provides an overview of the current application status and existing problems of pharmaceutical excipients for pediatric medicines in China.In-depth research was conducted on the application and collection of standards of pharmaceutical excipients for pediatric medicines in China,and suggestions were put forward for improving the quality standard system.A scientific standard system of pharmaceutical excipients for pediatric medicines can ensure the safety and standardization of products,technically support the evaluation and approval process,and have important significance for the quality control of pediatric medicines.

关 键 词：儿童用药 药用辅料 标准现状 关键辅料 标准体系 

分 类 号：R985[医药卫生—药品]