基于电子舌技术与人工口尝综合评价相结合的布洛芬口服液矫味工艺研究  

The taste correction process of ibuprofen oral solution based on the combination of electronic tongue technology and artificial taste comprehensive evaluation

作　　者：苑蕊 屈云萍 王艳 张雅宣 钟宛凌 樊箫雨 沈慧娟 马韫楠 叶津宏 白洁[1] 杜守颖[1] YUAN Rui;QU Yun-ping;WANG Yan;ZHANG Ya-xuan;ZHONG Wan-ling;FAN Xiao-yu;SHEN Hui-juan;MA Yun-nan;YE Jin-hong;BAI Jie;DU Shou-ying(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China;Shenwei Pharmaceutical Group Co.,Ltd.,Shijiazhuang 051430,China)

机构地区：[1]北京中医药大学中药学院,北京102488 [2]神威药业集团有限公司,河北石家庄051430

出　　处：《药学学报》2024年第8期2404-2411,共8页Acta Pharmaceutica Sinica

基　　金：北京市技术开发类横向课题(2021110031001164);国家中医药管理局高水平建设学科-中药药剂学(zyyzdxk-2023272)。

摘　　要：本实验通过研究不同矫味剂单独使用及联合使用对布洛芬口服液的矫味效果,以优化矫味配方。首先利用电子舌技术广泛筛选矫味剂种类与质量分数,采用人工口尝法并结合AHP-模糊数学法、Box-Behnken设计试验深入综合评价不同矫味剂组合对布洛芬口服液的矫味效果,优化矫味配方并进行验证。研究获得了北京中医药大学审查委员会的伦理批准(伦理号:2024BZYLL0102)。结果显示,通过单因素试验分别筛选出矫味剂质量分数与种类,Box-Behnken响应面连用AHP-模糊数学法拟合得到函数模型:Z=688.310 11-3 023.722 22X_(1)-11.477 00X_(2)+62.721 67X_(3)+14.600 00X_(1)X_(2)-179.666 67X_(1)X_(3)-3.152 00X_(2)X_(3)+4 031.111 11X_(1)^(2)+0.525 28X_(2)^(2)+9.772 00X_(3)^(2),该模型稳定可靠,确定矫味的最佳配方为甜菊苷3.9 g·L^(-1),木糖醇100 g·L^(-1),甲基-β-环糊精30 g·L^(-1),验证试验综合评分均值为88.14,RSD为0.39%,具有可行性。本研究通过客观与主观结合实现了布洛芬口服液口感的改善,并建立了3种类型矫味剂联合使用改善药物口感的方法,筛选出布洛芬口服液的最优矫味配方,极大改善了原制剂的口感,提高了患者的顺应性,可为制剂的不良口感改善提供新思路。This experiment aims to study the taste-masking effects of different kinds of corrigent used individually and in combination on ibuprofen oral solution,in order to optimize the taste-masking formulation.Firstly,a wide range of corrigent and the mass fractions were extensively screened using electronic tongue technology.Subsequently,a combination of sensory evaluation,analytic hierarchy process(AHP)-fuzzy mathematics evaluation,and Box-Behnken experimental design were employed to comprehensively assess the taste-masking effects of different combinations of corrigent on ibuprofen oral solution,optimize the taste-masking formulation,and validate the results.The study received ethical approval from the Review Committee of the Beijing University of Chinese Medicine(ethical code:2024BZYLL0102).The results showed that corrigent fractions and types were screened separately through single-factor experiments.Subsequently,a Box-Behnken response surface design combined with AHP and fuzzy mathematics evaluation was used to fit a functional model:Z=688.31011−3023.72222X_(1)−11.47700X_(2)+62.72167X_(3)+14.60000X_(1)X_(2)−179.66667X_(1)X_(3)−3.15200X_(2)X_(3)+4031.11111X_(1)^(2)+0.52528X_(2)^(2)+9.77200X_(3)^(2).This model is stable and reliable,determining the optimal taste-masking formulation to be 3.9 g·L^(-1)of stevioside,100 g L^(-1)of xylitol,and 30 g L^(-1)of methyl-β-cyclodextrin.The comprehensive score of the verification test is 88.14,with a relative RSD of 0.39%,indicating the feasibility of this model.This study achieved the improvement of the taste of ibuprofen oral solution through a combination of objective and subjective methods.Three types of corrigent were identified for enhancing drug taste,leading to the selection of the optimal taste-masking formulation for ibuprofen oral solution.This significantly enhanced the taste of the original formulation,improved patient compliance,and offered a new approach to mitigating the undesirable taste of formulations.

关 键 词：布洛芬口服液 矫味剂 模糊数学综合评价法 层次分析法 Box-Behnken响应面 

分 类 号：R943[医药卫生—药剂学]