基于感官评价和电子舌法的甘草锌颗粒处方筛选与掩味作用分析  

Formulation optimization and analysis of taste-masking effect of licorzine granules based on sensory evaluation and electronic tongue method

作　　者：王利民 戚淑叶 张威风 沈鹏 宁保明[2] 史大勇 吴学萍 杨杰 WANG Li-min;QI Shu-ye;ZHANG Wei-feng;SHEN Peng;NING Bao-ming;SHI Da-yong;WU Xue-ping;YANG Jie(Shandong DYNE Marine Biopharmaceutical Co.,Ltd.,Weihai 264300,China;National Institutes for Food and Drug Control,Beijing 102629,China;Beijing DYNE High-tech Pediatric Pharmaceutical R&D Institute Co.,Ltd.,Beijing 100176,China)

机构地区：[1]山东达因海洋生物制药股份有限公司,山东威海264300 [2]中国食品药品检定研究院,北京102629 [3]北京达因高科儿童药物研究院有限公司,北京100176

出　　处：《药学学报》2023年第11期3191-3197,共7页Acta Pharmaceutica Sinica

基　　金：中国博士后科学基金(2020M672078);山东省自然科学基金青年项目(ZR2021QH360)。

摘　　要：甘草锌颗粒是治疗儿童锌缺乏症的常用制剂,但因其用药疗程较长,口感成为影响临床服药依从性的主要因素。目前尚未有针对甘草锌颗粒的味觉评价研究。本文联用人体感官和仿生电子舌两种评价技术,对甘草锌颗粒处方进行筛选,从体内外不同角度对原辅料及优选处方进行味觉评价。结果表明,优选处方的不良口感主要是苦味与涩味,由甘草锌药物本身产生;辅料成分中,黄原胶是主要的掩味成分,使甘草锌颗粒相较于甘草锌原料的苦度和涩度至少下降1个等级。感官评价与电子舌评价结果具有良好的相关性,两种评价方式相互结合更有利于得到客观合理的结论。本文成人感官味觉评价实验属于研究性质的临床试验,已按照药物临床试验质量管理规范的伦理要求,经所有受试者知情同意。Licorzine granules are common preparations for children zinc deficiency.Considering the long course of treatment,the taste of licorzine granules may become a main factor affecting medication adherence.To date there have been no taste evaluation research into licorzine granules yet.In this study,both sensory evaluation and electronic tongue method were utilized to optimize licorzine granules formulations,evaluate the tastes of licorzine,excipients,optimized formulation in vivo and in vitro.As the results show,bitterness and astringency are the main unpleasant tastes generating from licorzine.Xanthan gum is the main taste-masking excipient,lowering down the bitterness and astringency of licorzine by at least one grade.Good correlation exists between the results of sensory evaluation and electronic tongue method,and an integrated combination of the two helps to obtain objective and rational research conclusions.The adult sensory evaluation study was a research-based clinical trial conducted with informed consent from all subjects in accordance with the ethical requirements of Good Clinical Practice.

关 键 词：甘草锌 颗粒剂 感官评价 电子舌 处方筛选 掩味 黄原胶 

分 类 号：R943[医药卫生—药剂学]