体外溶出试验在药品适口性评价中的应用进展  

Progress in the Application of in vitro Dissolution Test in the Evaluation of Drug Palatability

作　　者：张威风 李国相 戚淑叶 吴学萍 杨杰 ZHANG Weifeng;LI Guoxiang;QI Shuye;WU Xueping;YANG Jie(Beijing DYNE High-tech Pediatric Pharmaceutical R&D Institute Co.,Ltd.,Beijing 100176;Shandong Dyne Marine Biopharmaceutical Limited Corporation,Rongcheng 264300;National Institutes for Food and Drug Control,Beijing 102629)

机构地区：[1]北京达因高科儿童药物研究院有限公司,北京100176 [2]山东达因海洋生物制药股份有限公司,山东荣成274300 [3]中国食品药品检定研究院,北京102629

出　　处：《中国医药工业杂志》2024年第5期637-644,651,共9页Chinese Journal of Pharmaceuticals

基　　金：国家重点研发计划(2023YFC2706100);中国博士后科学基金面上资助(2020M672078);山东省自然科学基金青年项目(ZR2021QH360);重大新药创制科技重大专项(2018ZX09721003)。

摘　　要：口服给药途径具有诸多优势,但不良口感药物的适口性成为其口服给药的一个关键障碍。建立合适的口感评价方法,是不良口感药物的产品开发和评价的重要环节。体外溶出试验是一种有效的适口性评价方法,具有操作简单、重复性好等优点,在药物掩味效果和药品口感评价中发挥重要作用。文章基于口腔生理特性和应用于药品口感评价的体外溶出试验特点,重点梳理并讨论了所用的溶出装置、溶出介质(组成和体积)、溶出时间,介绍了体外溶出试验在药品口感评价中的应用案例,以期为体外溶出试验在药品适口性评价中的合理应用提供思路和参考。The route of oral administration has many advantages,but the palatability of drugs with unpleasant taste has become a key obstacle to their oral administration.The establishment of appropriate palatability evaluation method is an important procedure in the product development and evaluation of drugs with unpleasant taste.In vitro dissolution test is an effective evaluation method of palatability,with the advantages of simple operation and good repeatability,which plays an important role in the evaluation of taste-masking efficacy and palatability of drug products.Based on physiological characteristics of oral cavity and the characteristics of in vitro dissolution testing methods for palatability evaluation,this review summarizes and discusses the dissolution apparatuses,dissolution media(composition and volume),and sampling times,and introduces case studies of in vitro dissolution test for application in palatability evaluation,in order to provide ideas and references for the rational application of in vitro dissolution testing in palatability evaluation.

关 键 词：体外溶出试验 适口性评价 掩味技术 溶出装置 模拟唾液 

分 类 号：R927.1[医药卫生—药学] R943