儿童直肠给药系统的研发策略及思考  

Development strategy and thinking of children's rectal drug delivery system

作　　者：李佳乐 李蒙 王坚成[3] 王晓玲[4] 梅冬 王汀[1] 郑爱萍 LI Jia-le;LI Meng;WANG Jian-cheng;WANG Xiao-ling;MEI Dong;WANG Ting;ZHENG Ai-ping(School of Pharmacy,Anhui Medical University,Anhui Hefei 230032,China;Institute of Pharmacology and Toxicology,Academy of Military Medical Sciences,Academy of Military Sciences,Beijing 100850,China;School of Pharmaceutical Sciences,Peking University,Beijing 100191,China;Beijing Children's Hospital,Capital Medical University,Beijing 100045,China)

机构地区：[1]安徽医科大学药学院,安徽合肥230032 [2]军事科学院军事医学研究院毒物药物研究所,北京100850 [3]北京大学药学院药剂学系,北京100191 [4]首都医科大学附属北京儿童医院,北京100045

出　　处：《中国医院药学杂志》2021年第23期2500-2506,共7页Chinese Journal of Hospital Pharmacy

基　　金：“十三五”重大新药创制科技重大专项(编号:2018ZX09721003-007)。

摘　　要：随着儿童人口及儿科门诊人数的不断增加,儿童用药安全性与特殊性引起广泛关注。儿童用药需依据儿童生理特点及用药特征有针对性地设计给药系统,研发重点是新剂型、新品种的设计。直肠给药系统(rectal drug delivery systems,RDDS)凭借其顺应性强、安全性高、适用药物范围广等特点,成为儿童给药的一种理想途径。近年来,儿童用直肠制剂发展迅速,临床需求大,成为广大药学研究者设计研发儿童药物制剂的热点。本文就儿童用药特点及我国儿童用直肠制剂现状进行阐述,对儿童直肠药物的剂型设计、药物吸收、药械一体化及辅料安全性等问题进行讨论,分析我国儿童直肠制剂发展中存在的问题,并提出相应的解决策略,以期对我国儿童直肠药物的研发提供参考。With the continuous increase in the children population and the number of pediatric clinics,the safety and particularity for children medication has attracted widespread attention.Children's medications need to be designed using a drug delivery system that is in accordance with children's physiological and administration characteristics,the focus of research and development is the design of new dosage forms and new varieties.Rectal drug delivery systems have become an ideal way for developing children's medications as they have a good compliance,high safety and wide range of applicable drugs.In recent years,rectal preparations for children have developed rapidly as a result of a large clinical demand,and become a hot spot for the majority of pharmaceutical researchers to design and develop children's pharmaceutical preparations.This article describes the characteristics of children's medications and summarizes the status quo of children's rectal preparations in China.In addition,it also discusses the issues involving dosage design,drug absorption problems,drug-device integration and safety of excipients for children's rectal drugs,analyze the problems existing in the development of rectal preparations for children in China,and propose corresponding solutions,so that it may provide a useful reference to the development of children's rectal drugs in China.

关 键 词：直肠给药系统 儿童用药 新剂型 安全性 药械一体化 

分 类 号：R452[医药卫生—治疗学]