基于体内外评价技术对儿童用口服铁剂的适口性评价研究  

Palatability evaluation of oral iron for children based on in vivo and in vitro evaluation techniques

作　　者：梅冬 游龙泰 张欢 王晓玲[1] MEI Dong;YOU Long-tai;ZHANG Huan;WANG Xiao-ling(Department of Pharmacy,Beijing Children's Hospital,Capital Medical University,National Center for Children's Health,Beijing 100045,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

出　　处：《药学学报》2024年第6期1847-1853,共7页Acta Pharmaceutica Sinica

基　　金：国家重点研发计划资助项目(2023YFC2706100);北京市自然科学基金-海淀原始创新联合基金(L212013).

摘　　要：口服铁剂是治疗儿童铁缺乏和缺铁性贫血的常用制剂,但其不良口感成为影响临床服药依从性的主要因素。目前尚未有针对口服铁剂的适口性评价研究。选取13款具有代表性的口服铁剂产品,结合电子舌、FaceReader面部表情分析技术及口感访谈,从体内外不同角度对口服铁剂进行适口性评价。电子舌结果表明,右旋糖酐铁颗粒最接近无味的氯化钾溶液,基本没有苦味和涩味,优于其他产品。FaceReader面部表情结果表明,58.7%的受试者对右旋糖酐铁颗粒的情绪效价值高于蛋白琥珀酸铁口服溶液。在43名年龄≥5岁的参与者中,右旋糖酐铁颗粒的口感偏好率为83.7%,83.7%的参与者选择再次服用右旋糖酐铁颗粒。本研究发现右旋糖酐铁颗粒具有较好的口感,其味道更受儿童的欢迎,为口服铁剂的儿科临床用药提供了参考依据,也为儿童用药的适口性评价提供了新思路。本文的体内适口性评价实验属于研究性质的临床试验,已取得北京儿童医院机构审查委员会批准(编号:2021-149-Y)。Oral iron is a commonly used preparation for the treatment of iron deficiency and iron-deficiency anemia in children,but its undesirable taste has become a major factor affecting clinical adherence to the medication.No studies have been conducted to evaluate the palatability of oral iron supplements.Thirteen representative oral iron supplements were selected to evaluate the palatability of oral iron supplements from different perspectives of in vivo and ex vivo by combining the electronic tongue(e-tongue)test,FaceReader facial expression analysis technology and taste interviews.E-tongue test results showed that iron dextran granlues were closest to odorless potassium chloride solution,basically free of bitterness and astringency,which was superior to the other products.FaceReader facial expression results showed that 58.7%of the subjects valued iron dextran granlues for their emotional efficacy higher than that of iron proteinsuccinylate oral solution.Among 43 participants aged≥5 years,the taste preference for iron dextran granlues was 83.7%,and 83.7%of participants chose to take iron dextran granlues again.This study found that iron dextran granlues have a better taste and their flavor is more popular among children,which provides a reference for pediatric clinical use of oral iron supplementation preparations and a new idea for the evaluation of palatability of medications for children.This in vivo palatability evaluation is an investigational clinical trial that was approved by the Institutional Review Board of the Beijing Children's Hospital(No.2021-149-Y).

关 键 词：口服铁剂 电子舌 面部表情分析 适口性评价 

分 类 号：R943[医药卫生—药剂学]