基于电子舌与人感官的小儿清热宁颗粒滋味关键质量属性辨识及配方优化  

Identification of taste critical quality attribute and formulation optimization of Xiaoer Qingrening Granules based on electronic tongue and human senses

作　　者：胡小艳 陆影 王晓萌 马丽娟[2,3] 魏宇楠[2,3] 戴平 马朝富 张瀚 王静 李楠[2,3] 戴幸星 姚璐[4] 徐蓓蕾 徐伟[1] 吴志生[1,2,3] HU Xiao-yan;LU Ying;WANG Xiao-meng;MA Li-juan;WEI Yu-nan;DAI Ping;MA Chao-fu;ZHANG Han;WANG Jing;LI Nan;DAI Xing-xing;YAO Lu;XU Bei-lei;XU Wei;WU Zhi-sheng(School of Pharmacy,Fujian University of Traditional Chinese Medicine,Fuzhou 350122,China;School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China;Engineering Research Center of Chinese Medicine Production and New Drug Development,Beijing 102488,China;Beijing Tongrentang Technology Development Co.,Ltd.,Beijing 100079,China;School of Pharmacy,Harbin University of Commerce,Harbin 150076,China)

机构地区：[1]福建中医药大学药学院,福建福州350122 [2]北京中医药大学中药学院,北京102488 [3]中药制药与新药开发教育部工程研究中心,北京102488 [4]北京同仁堂科技发展股份有限公司,北京100079 [5]哈尔滨商业大学药学院,黑龙江哈尔滨150076

出　　处：《药学学报》2023年第10期2875-2881,共7页Acta Pharmaceutica Sinica

基　　金：国家重点研发计划项目(2022YFC3501902);国家自然科学基金优秀青年科学基金项目(82022073);国家自然科学基金项目(82274110);中央高校基本科研业务费北京中医药大学揭榜挂帅项目(2022-JYB-JBZR-018,2022-JYB-JBZR-019)。

摘　　要：本研究主要针对中药制造口服制剂滋味关键质量属性不明确导致口感不良的科学问题,以小儿清热宁颗粒为范例,成功建立了滋味关键质量属性辨识方法、电子舌与人感官结合的口感改进方法,确定最优口感配方,以提升患者口服用药依从性,研究获得了北京中医药大学医学伦理委员会的伦理批准。结果显示,小儿清热宁颗粒苦味分值占比为61.8%,其苦味级别为3.70,确定苦味是导致小儿清热宁颗粒口感不良的滋味关键质量属性;另外,以最大允许摄入量、溶解度、甜度等为限定条件确定每毫升小儿清热宁无糖中间体的最优口感配方为羟丙基-β-环糊精40 mg、海藻糖180 mg和安赛蜜1.5 mg,该配方的感官评价得分相比于小儿清热宁颗粒提升了37.5分。综上所述,本研究实现了小儿清热宁颗粒的口感改善,形成了一套包括滋味关键质量属性辨识、矫味剂种类和添加量筛选及配方优化的口感改善策略,为其他口服制剂不良口感改进研究提供思路参考,为中药智能制造质量控制提供新视角。This study primarily concentrated on scientific problems of poor taste caused by unclear critical quality attributes of oral preparations manufactured by Chinese materia medica,successfully established an identification method for taste critical quality attribute and a taste improvement method combining electronic tongue with human senses,and determined the optimal taste formula,to improve patients'oral medication compliance.The study received ethical approval from the Review Committee of the Beijing University of Chinese Medicine.The results showed that the proportion of bitterness of Xiaoer Qingrening Granule was 61.8%,and its bitterness grade was 3.70,it was determined that bitterness is the critical quality attribute that caused the poor taste of Xiaoer Qingrening Granule.Additionally,the optimal taste formula per milliliter of Xiaoer Qingrening sugarfree intermediate was determined with allowable daily intake,solubility,and sweetness as the limiting conditions,which was 40 mg hydroxypropylβ-cyclodextrin,180 mg trehalose,and 1.5 mg acesulfame potassium.Compared with the Xiaoer Qingrening Granule,the sensory evaluation score of the optimal taste formula was increased by 37.5 points.In conclusion,this study achieved the taste improvement of Xiaoer Qingrening Granule and formed a set of taste improvement strategies including the identification of taste critical quality attribute,the selection of the type and dosage of corrigent,and the optimization of taste formula,which provided a thought reference for the taste improvement of other oral preparations and a new perspective for quality control of intelligent manufacturing of traditional Chinese medicines.

关 键 词：口服制剂 电子舌 人感官 苦味 关键质量属性 

分 类 号：R283[医药卫生—中药学]