儿童口服液体药物制剂的技术难点及研发策略分析  

Analysis of technical difficulties and new strategies of oral liquid pharmaceutical preparation for children

作　　者：陈鑫[1] 卢安 王向宇 王晓玲[2] 郑爱萍[3] 王坚成[1] CHEN Xin;LU An;WANG Xiang-yu;WANG Xiao-ling;ZHENG Ai-ping;WANG Jian-cheng(School of Pharmaceutical Sciences,Peking University,Beijing 100191,China;Beijing Children's Hospital,Capital Medical University,Beijing 100045,China;Institute of Pharmacology and Toxicology of the Academy of Military Medical Sciences,Beijing 100850,China)

机构地区：[1]北京大学药学院,北京100191 [2]首都医科大学附属北京儿童医院,北京100045 [3]军事医学科学院药物毒物研究所,北京100850

出　　处：《药学学报》2021年第1期130-137,共8页Acta Pharmaceutica Sinica

基　　金：国家重大新药创制科技重大专项资助项目(2018ZX09721003-004).

摘　　要：随着二胎生育政策落实和儿童健康用药需求的不断增长,儿童用药问题引起国家和社会的广泛关注,儿童药物新品种、新规格和新剂型的研发是药学研究工作者和制药企业面临的迫切任务。本文围绕口服药物液体制剂研发中存在药物溶解性、液体制剂稳定性、辅料安全性和服药的顺应性等技术难点,对已上市儿童口服药物液体制剂的技术特征和目前研究所涉及的药物纳米晶体、自微乳、离子交换树脂和Pickering乳剂等新技术在儿童药物液体制剂的研究情况进行讨论分析,以期对儿童口服药物液体制剂的研究开发起到理论指导作用。With the implementation of the two-child policy and the growing demand for child health,pediatric medication has been arousing widespread social concern.To develop the drugs suitable for children,including new compounds,new specifications and new dosage forms,is urgently required for pharmaceutical researchers.In this review,several technical bottlenecks for pediatric oral liquid preparations,as well as the novel strategies involved in drug nanocrystals,self-microemulsion,ion exchange resin and Pickering emulsion were discussed,which may be benefit to play a theoretical guiding role in the research and development of children's oral liquid formulation.

关 键 词：口服药物 儿科学 液体药物制剂 乳剂 离子交换树脂 

分 类 号：R943[医药卫生—药剂学]