口服溶剂介质在临时调配制剂中的应用  

Application of oral pharmaceutical vehicles in extemporaneous compounding

作　　者：梅冬 塔娜 杨梅 黄旻 杨敏 冯利萍 游龙泰 王晓玲[1] MEI Dong;TANA;YANG Mei;HUANG Min;YANG Min;FENG Li-ping;YOU Long-tai;WANG Xiao-ling(Department of Pharmacy,Beijing Children's Hospital,Capital Medical University,National Center for Children's Health,Beijing 100045,China;School of Basic Medicine and Clinical Pharmacy,China Pharmaceutical University,Nanjing 211198,China;Zhejiang Beiling Biological Medicine Co.,Ltd.,Hangzhou 310051,China)

机构地区：[1]国家儿童医学中心,首都医科大学附属北京儿童医院药学部,北京100045 [2]中国药科大学基础医学与临床药学学院,江苏南京211198 [3]浙江贝灵生物医药有限公司,浙江杭州310051

出　　处：《药学学报》2025年第4期959-964,共6页Acta Pharmaceutica Sinica

基　　金：国家重点研发计划(2023YFC2706100);北京市自然科学基金资助项目(7232246)。

摘　　要：本文概述了口服溶剂介质在解决特殊人群临时调配用药问题中的优势,详细介绍了其在美国的研发、生产、使用和监管经验,以及目前国内口服溶剂介质的研究进展和所面临的挑战。美国在口服溶剂介质领域已经形成一套成熟的体系,我国可以借鉴美国的经验,完善相关法律政策,推动建立口服溶剂介质用于临时调配的技术指导原则及技术标准,加快其在临床的使用。Through literature analysis,the advantages of oral pharmaceutical vehicles in solving the temporary dispensing problems for special populations are summarized.Detailed introduction is made on the research,development,production,use,and regulatory experience of oral pharmaceutical vehicles in the United States,as well as the current research progress,achievements,and challenges faced by domestic oral pharmaceutical vehicles.The United States has formed a mature system in the field of oral pharmaceutical vehicles,and China can learn from the experience of the United States to improve relevant laws and policies,promote the establishment of technical guidance principles and technical standards for the use of oral pharmaceutical vehicles in temporary dispensing,and accelerate its clinical use.

关 键 词：口服溶剂介质 临时调配 个性化给药 分剂量 儿童用药 

分 类 号：R943[医药卫生—药剂学]