儿童用中药制剂药学研究开发的一般考虑及建议  

General Considerations and Suggestions for Pharmaceutical Research and Development of Pharmaceutical Preparations of Traditional Chinese Medicine for Children

作　　者：王玲玲 唐溱 李计萍 阳长明 WANG Lingling;TANG Zhen;LI Jiping;YANG Changming(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国医药工业杂志》2022年第11期1571-1578,共8页Chinese Journal of Pharmaceuticals

摘　　要：通过对《中华人民共和国药典》2020年版一部、《国家基本药物目录》(2018年版)、近年中药新药临床试验申请的儿童用中药情况分析,总结出儿童用中药制剂存在品种数量少、剂型单一、治疗领域范围窄、缺乏儿童用辅料安全用量数据等问题。结合药品技术审评要求,从中药制剂药学研究基本要求、儿童用药特点、给药途径及剂型选择、剂量准确性、包装系统适宜性、辅料种类及用量、质量控制等方面进行探讨,阐述儿童用中药制剂开发研究的一般考虑,以期为儿童用中药制剂的开发研究提供参考。Based on the analysis of the 2020 edition of Chinese Pharmacopoeia(PartⅠ),the National Essential Drug Catalogue(2018 edition),and the investigational new drug applications of new traditional Chinese medicines(TCMs)for children in recent years,it is concluded that the pharmaceutical preparations of TCMs for children have the some problems,such as lack of pediatric drug fomulations,insufficient dosage forms,narrow range of therapeutic areas,and lack of safety data of excipients for children.According to the basic requirements in drug product technical review,the paper discusses the general considerations for the research and development of TCMs for children,from the following aspects:the basic requirements of pharmaceutical research of pharmaceutical preparations of TCMs,the characteristics of children’s medication,the route of administration and dosage form design,the dosage accuracy,the suitability of packaging systems,the types and dosages of excipients,and quality control.It is hoped to provide some useful references for the development and research of pharmaceutical preparations of TCMs for children.

关 键 词：儿童用中药制剂 药学研究 给药途径 剂型设计 辅料 质量控制 

分 类 号：R985[医药卫生—药品]