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Article(id=1200383182064448258, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1200383177295515678, articleNumber=null, orderNo=null, doi=10.16438/j.0513-4870.2024-0272, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1711382400000, receivedDateStr=2024-03-26, revisedDate=1718035200000, revisedDateStr=2024-06-11, acceptedDate=null, acceptedDateStr=null, onlineDate=1764123252644, onlineDateStr=2025-11-26, pubDate=1723392000000, pubDateStr=2024-08-12, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1764123252644, onlineIssueDateStr=2025-11-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1764123252644, creator=13701087609, updateTime=1764123252644, updator=13701087609, issue=Issue{id=1200383177295515678, tenantId=1146029695717560320, journalId=1189982191388893191, year='2024', volume='59', issue='8', pageStart='2183', pageEnd='2416', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1764123251508, creator=13701087609, updateTime=1764225076631, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1200810262870741499, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1200383177295515678, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1200810262870741500, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1200383177295515678, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=2404, endPage=2411, ext={EN=ArticleExt(id=1200383183368876829, articleId=1200383182064448258, tenantId=1146029695717560320, journalId=1189982191388893191, language=EN, title=The taste correction process of ibuprofen oral solution based on the combination of electronic tongue technology and artificial taste comprehensive evaluation, columnId=null, journalTitle=Acta Pharmaceutica Sinica, columnName=null, runingTitle=null, highlight=null, articleAbstract=

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 = 688.310 11 - 3 023.722 22X1 - 11.477 00X2 + 62.721 67X3 + 14.600 00X1X2 - 179.666 67X1X3 - 3.152 00X2X3 + 4 031.111 11X12 + 0.525 28X22 + 9.772 00X32. 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.

, correspAuthors=Jie BAI, Shou-ying DU, authorNote=null, correspAuthorsNote=null, copyrightStatement=Copyright ©2024 Acta Pharmaceutica Sinica. All rights reserved., copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Rui YUAN, Yun-ping QU, Yan WANG, Ya-xuan ZHANG, Wan-ling ZHONG, Xiao-yu FAN, Hui-juan SHEN, Yun-nan MA, Jin-hong YE, Jie BAI, Shou-ying DU), CN=ArticleExt(id=1200383185214370736, articleId=1200383182064448258, tenantId=1146029695717560320, journalId=1189982191388893191, language=CN, title=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, columnId=1190335348896011050, journalTitle=药学学报, columnName=研究论文, runingTitle=null, highlight=null, articleAbstract=

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 22X1 - 11.477 00X2 + 62.721 67X3 + 14.600 00X1X2 - 179.666 67X1X3 - 3.152 00X2X3 + 4 031.111 11X12 + 0.525 28X22 + 9.772 00X32, 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。

, correspAuthors=白洁, 杜守颖, authorNote=null, correspAuthorsNote=
*白洁, Tel: 86-10-84738657, E-mail: ;
杜守颖, Tel: 86-10-84738615, E-mail:
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A: Contour plot and response surface plot of the combined effect of steviol and xylitol on overall taste scores; B: Contour plot and response surface plot of the combined effect of steviol and methyl-<i>β</i>-cyclodextrin on overall taste scores; C: Contour plot and response surface plot of the effect of xylitol and methyl-<i>β</i>-cyclodextrin on overall taste scores , figureFileSmall=1IPiWCESqBG+C0sDkK6YrQ==, figureFileBig=e1nOcChR3evu35ARkm09yg==, tableContent=null), ArticleFig(id=1200431563981837147, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1200383182064448258, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
Sample Type of corrigent Dosage/g·L-1
Y1 Sucralose 1.5
Y2 Sucralose 2.0
Y3 Sucralose 2.5
Y4 Sucralose 3.0
Y5 Neotame 0.06
Y6 Neotame 0.08
Y7 Neotame 0.10
Y8 Neotame 0.12
Y9 Stevioside 3.5
Y10 Stevioside 4.0
Y11 Stevioside 4.5
Y12 Stevioside 5.0
Y13 Xylitol 50
Y14 Xylitol 75
Y15 Xylitol 100
Y16 Xylitol 125
Y17 Mannitol 50
Y18 Mannitol 75
Y19 Mannitol 100
Y20 Mannitol 125
Y21 Erythritol 50
Y22 Erythritol 75
Y23 Erythritol 100
Y24 Erythritol 125
Y25 M-β-CD 10
Y26 M-β-CD 15
Y27 M-β-CD 20
Y28 M-β-CD 25
Y29 γ-CD 10
Y30 γ-CD 15
Y31 γ-CD 20
Y32 γ-CD 25
Y33 HP-β-CD 10
Y34 HP-β-CD 15
Y35 HP-β-CD 20
Y36 HP-β-CD 25
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Dosage of different types of corrigent

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Sample Type of corrigent Dosage/g·L-1
Y1 Sucralose 1.5
Y2 Sucralose 2.0
Y3 Sucralose 2.5
Y4 Sucralose 3.0
Y5 Neotame 0.06
Y6 Neotame 0.08
Y7 Neotame 0.10
Y8 Neotame 0.12
Y9 Stevioside 3.5
Y10 Stevioside 4.0
Y11 Stevioside 4.5
Y12 Stevioside 5.0
Y13 Xylitol 50
Y14 Xylitol 75
Y15 Xylitol 100
Y16 Xylitol 125
Y17 Mannitol 50
Y18 Mannitol 75
Y19 Mannitol 100
Y20 Mannitol 125
Y21 Erythritol 50
Y22 Erythritol 75
Y23 Erythritol 100
Y24 Erythritol 125
Y25 M-β-CD 10
Y26 M-β-CD 15
Y27 M-β-CD 20
Y28 M-β-CD 25
Y29 γ-CD 10
Y30 γ-CD 15
Y31 γ-CD 20
Y32 γ-CD 25
Y33 HP-β-CD 10
Y34 HP-β-CD 15
Y35 HP-β-CD 20
Y36 HP-β-CD 25
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Evaluation indicator Sweetness Rich Aftertasting Off-flavor
Sweetness 1 4 1 1
Rich 1/4 1 1/3 1/5
After tasting 1 3 1 1/2
Off-flavor 1 5 2 1
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Decision matrix of paired comparison on indexes

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Evaluation indicator Sweetness Rich Aftertasting Off-flavor
Sweetness 1 4 1 1
Rich 1/4 1 1/3 1/5
After tasting 1 3 1 1/2
Off-flavor 1 5 2 1
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NO. Sweetness Off-flavor After tasting Rich
E G M P E G M P E G M P E G M P
1 12 2 6 0 6 8 5 1 6 11 3 0 5 13 2 0
2 4 6 8 2 4 8 5 3 7 10 2 1 3 12 3 2
3 7 4 8 1 6 5 9 0 6 9 5 0 4 12 3 1
4 7 7 6 0 7 6 6 1 6 7 5 2 5 7 7 1
5 6 7 7 0 7 7 6 0 7 5 7 1 5 8 4 3
6 5 5 8 2 4 7 6 3 5 6 7 2 5 6 5 4
7 6 3 8 3 5 6 7 2 5 7 5 3 6 7 5 2
8 6 2 8 4 6 6 6 2 6 8 4 2 7 6 5 2
9 8 5 3 4 6 7 6 1 5 7 5 3 5 9 4 2
10 8 7 5 0 9 7 3 1 10 7 3 0 11 6 2 1
11 11 5 4 0 10 6 4 0 7 8 4 1 10 9 1 0
12 14 2 4 0 10 8 2 0 7 10 3 0 11 7 2 0
13 9 5 6 0 5 7 5 3 7 5 8 0 7 8 5 0
14 8 5 7 0 6 9 5 0 9 9 2 0 6 9 5 0
15 5 7 6 2 7 6 5 2 7 5 5 3 7 6 5 2
16 11 5 3 1 11 4 3 2 9 6 5 0 12 4 4 0
17 7 6 7 0 7 6 5 2 5 7 5 3 4 9 6 1
Weight 0.30 0.38 0.24 0.08
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Sensory evaluation results of ibuprofen oral solution flavor correction formula. E: Excellent; G: Good; M: Moderate; P: Poor

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NO. Sweetness Off-flavor After tasting Rich
E G M P E G M P E G M P E G M P
1 12 2 6 0 6 8 5 1 6 11 3 0 5 13 2 0
2 4 6 8 2 4 8 5 3 7 10 2 1 3 12 3 2
3 7 4 8 1 6 5 9 0 6 9 5 0 4 12 3 1
4 7 7 6 0 7 6 6 1 6 7 5 2 5 7 7 1
5 6 7 7 0 7 7 6 0 7 5 7 1 5 8 4 3
6 5 5 8 2 4 7 6 3 5 6 7 2 5 6 5 4
7 6 3 8 3 5 6 7 2 5 7 5 3 6 7 5 2
8 6 2 8 4 6 6 6 2 6 8 4 2 7 6 5 2
9 8 5 3 4 6 7 6 1 5 7 5 3 5 9 4 2
10 8 7 5 0 9 7 3 1 10 7 3 0 11 6 2 1
11 11 5 4 0 10 6 4 0 7 8 4 1 10 9 1 0
12 14 2 4 0 10 8 2 0 7 10 3 0 11 7 2 0
13 9 5 6 0 5 7 5 3 7 5 8 0 7 8 5 0
14 8 5 7 0 6 9 5 0 9 9 2 0 6 9 5 0
15 5 7 6 2 7 6 5 2 7 5 5 3 7 6 5 2
16 11 5 3 1 11 4 3 2 9 6 5 0 12 4 4 0
17 7 6 7 0 7 6 5 2 5 7 5 3 4 9 6 1
Weight 0.30 0.38 0.24 0.08
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Sample X1/g·L-1 X2/g·L-1 X3/g·L-1 Score
1 3.7(-1) 100(-1) 25(0) 87.72
2 4.3(1) 100 25 79.5
3 3.7 150(1) 25 82.38
4 4.3 150 25 78.54
5 3.7 125(0) 20(-1) 78.88
6 4.3 125 20 82.44
7 3.7 125 30(1) 85.34
8 4.3 125 30 78.12
9 4(0) 100 30 77.48
10 4 150 30 84.66
11 4 100 20 84.92
12 4 150 20 76.34
13 4 125 25 74.22
14 4 125 25 76.66
15 4 125 25 76.62
16 4 125 25 73.64
17 4 125 25 74.48
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Box-Behnken experimental design and results. X1: Stevioside's dosage; X2: Xylitol′s dosage; X3: M-β-CD's dosage

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Sample X1/g·L-1 X2/g·L-1 X3/g·L-1 Score
1 3.7(-1) 100(-1) 25(0) 87.72
2 4.3(1) 100 25 79.5
3 3.7 150(1) 25 82.38
4 4.3 150 25 78.54
5 3.7 125(0) 20(-1) 78.88
6 4.3 125 20 82.44
7 3.7 125 30(1) 85.34
8 4.3 125 30 78.12
9 4(0) 100 30 77.48
10 4 150 30 84.66
11 4 100 20 84.92
12 4 150 20 76.34
13 4 125 25 74.22
14 4 125 25 76.66
15 4 125 25 76.62
16 4 125 25 73.64
17 4 125 25 74.48
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Source Sum of squares df F P Significance
Model 274.66 9 10.18 0.002 9 **
X1 30.89 1 10.30 0.014 9 *
X2 7.41 1 2.47 0.159 9 -
X3 0.198 4 1 0.066 2 0.804 4 -
X1X2 4.80 1 1.60 0.246 5 -
X1X3 29.05 1 9.69 0.017 0 *
X2X3 62.09 1 20.71 0.002 6 **
X12 55.42 1 18.48 0.003 6 **
X22 45.38 1 15.13 0.006 0 **
X32 25.13 1 8.38 0.023 2 *
Lack of fit 12.96 3 2.15 0.236 5 -
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Results of Box-Behnken design analysis of variance. *P < 0.05, **P < 0.01

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Source Sum of squares df F P Significance
Model 274.66 9 10.18 0.002 9 **
X1 30.89 1 10.30 0.014 9 *
X2 7.41 1 2.47 0.159 9 -
X3 0.198 4 1 0.066 2 0.804 4 -
X1X2 4.80 1 1.60 0.246 5 -
X1X3 29.05 1 9.69 0.017 0 *
X2X3 62.09 1 20.71 0.002 6 **
X12 55.42 1 18.48 0.003 6 **
X22 45.38 1 15.13 0.006 0 **
X32 25.13 1 8.38 0.023 2 *
Lack of fit 12.96 3 2.15 0.236 5 -
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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
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苑蕊 1 , 屈云萍 2 , 王艳 2 , 张雅宣 1 , 钟宛凌 1 , 樊箫雨 1 , 沈慧娟 1 , 马韫楠 1 , 叶津宏 1 , 白洁 1, * , 杜守颖 1, *
药学学报 | 研究论文 2024,59(8): 2404-2411
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药学学报 | 研究论文 2024, 59(8): 2404-2411
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
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苑蕊1, 屈云萍2, 王艳2, 张雅宣1, 钟宛凌1, 樊箫雨1, 沈慧娟1, 马韫楠1, 叶津宏1, 白洁1, * , 杜守颖1, *
作者信息
  • 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

通讯作者:

*白洁, Tel: 86-10-84738657, E-mail: ;
杜守颖, Tel: 86-10-84738615, E-mail:
The taste correction process of ibuprofen oral solution based on the combination of electronic tongue technology and artificial taste comprehensive evaluation
Rui YUAN1, Yun-ping QU2, Yan WANG2, Ya-xuan ZHANG1, Wan-ling ZHONG1, Xiao-yu FAN1, Hui-juan SHEN1, Yun-nan MA1, Jin-hong YE1, Jie BAI1, * , Shou-ying DU1, *
Affiliations
  • 1. School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China
  • 2. Shenwei Pharmaceutical Group Co., Ltd., Shijiazhuang 051430, China
出版时间: 2024-08-12 doi: 10.16438/j.0513-4870.2024-0272
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摘要
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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 22X1 - 11.477 00X2 + 62.721 67X3 + 14.600 00X1X2 - 179.666 67X1X3 - 3.152 00X2X3 + 4 031.111 11X12 + 0.525 28X22 + 9.772 00X32, 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。

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

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 = 688.310 11 - 3 023.722 22X1 - 11.477 00X2 + 62.721 67X3 + 14.600 00X1X2 - 179.666 67X1X3 - 3.152 00X2X3 + 4 031.111 11X12 + 0.525 28X22 + 9.772 00X32. 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.

ibuprofen oral solution  /  corrigent  /  fuzzy mathematics evaluation  /  analytic hierarchy process  /  Box-Behnken design-response surface method
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, 杜守颖. 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. 药学学报, 2024 , 59 (8) : 2404 -2411 . DOI: 10.16438/j.0513-4870.2024-0272
Rui YUAN, Yun-ping QU, Yan WANG, Ya-xuan ZHANG, Wan-ling ZHONG, Xiao-yu FAN, Hui-juan SHEN, Yun-nan MA, Jin-hong YE, Jie BAI, Shou-ying DU. The taste correction process of ibuprofen oral solution based on the combination of electronic tongue technology and artificial taste comprehensive evaluation[J]. Acta Pharmaceutica Sinica, 2024 , 59 (8) : 2404 -2411 . DOI: 10.16438/j.0513-4870.2024-0272
正文
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口服给药作为最常用的临床给药方式, 适口性是影响口服制剂临床应用的重要因素之一[1], 儿童因其生理和心理发育特点, 味觉的感知力更加敏感, 儿童药物良好的适口性可提高给药剂量的准确性和给药方案的依从性[2,3], 因此, 良好的口感设计和评价在儿童用药研发过程中具有重要的临床意义和价值。
布洛芬是世界卫生组织、美国食品药品监督管理局(Food and Drug Administration, FDA) 唯一共同推荐的儿童退烧药, 是公认的儿童首选抗炎药。目前临床上使用的布洛芬以混悬剂、片剂、胶囊剂为主, 混悬剂中的药物的溶解度较低, 难溶性药物微粒容易发生沉淀, 制备工艺比较复杂, 且剂量准确性相对较差, 可能会影响药物的服用。片剂、胶囊剂对于儿童及吞咽困难的患者来说服用不方便, 口服液体制剂易吞服、分剂量方便, 并且质地均匀能够很好地控制给药量, 在使用上备受广大医师和儿童家长的青睐。但目前上市的布洛芬口服液口感较差, 在服用过程中异味明显, 具有一定的刺激性, 对于儿童来说直接服用更加难以接受, 因此有必要采用相应的矫味技术掩盖布洛芬的强烈刺激性味道, 改善其适口性[4]。矫味剂的使用可以混淆大脑味觉、嗅觉感受, 以此掩盖药物苦味与不良口感, 从而提升布洛芬口服液口感。其中高效甜味剂的添加能有效改善制剂的苦味、酸味和残留, 低效甜味剂会带来特殊的口感(清凉感) 用以混淆味觉, 而对于布洛芬这种化学药物, 不仅有苦味、涩味等, 还有甜味难以掩盖的金属味等化学味道, 因此需要掩味剂(如环糊精) 去掩盖这些不良口感, 与甜味剂能够达到协同增效的作用。本文在上市产品原处方与用药安全的基础上选取了3种矫味剂相互配合, 从不同方面改善布洛芬口服液的口感, 以改善儿童用药服从性。
电子舌是一种用于模拟人类味觉系统的技术, 可以快速、准确地对不同食品或药物的液体样品进行定性定量分析, 通过模式识别算法和多变量分析方法对阵列数据进行处理[5], 来反映样品的整体滋味“指纹”信息[6], 研发效率高, 并具有较高的重复性和稳定性, 目前广泛应用于各大领域。人工口尝法是一种简便易行且能直观反映人体真实感受的评价方法, 在口服制剂的口感评价中最为常用[6], 可以综合考虑口感、味道、气味等多个感官维度, 直接评估人体的感官感受, 更贴近实际口味体验。人工口尝法全面评估产品的口味质量, 根据受试者的反馈进行调查和分析, 为口感矫正提供有针对性的改进建议。
本实验使用电子舌技术单因素筛选3种不同种类的矫味剂, 利用AHP层次分析与模糊数学法综合评价布洛芬口服液的矫味配方人工口尝结果, 应用数学方法将主观感受变换成客观的数字[7], 使结果更具有可信度更加科学准确, 采用Box-Behnken响应面预测最佳配方并加以验证, 以获得最佳矫味处方。
材料与方法
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仪器  赛多利斯BSA223S电子分析天平、MC京制0000026号电子天平[赛多利斯科学仪器(北京) 有限公司]; JM-B100002电子天平(余姚市纪铭称重校验设备有限公司); HH-6型电热恒温水浴锅(北京科伟永兴仪器有限公司); 屹立QE-200型高速万能离心机; TS-5000Z型电子舌(日本INSENT公司); SB25-12DTD型超声波清洗机(宁波新芝生物科技股份有限公司)。
试剂  布洛芬(批号: 21078)、枸橼酸钠(批号: 001220210207)、苯甲酸钠(批号: 20210301)、薄荷脑(批号: 030100061000)、柠檬黄(批号: 12121009)、甘露醇(批号: F3504)、桔子香精(批号: 20201106)、市售布洛芬口服液来源于神威药业集团有限公司; 甜菊苷(批号: C10798638)、三氯蔗糖(批号: C11114927)、纽甜(货号: N830094)、赤藓糖醇(批号C11926751) 购于上海麦克林生化科技股份有限公司; 甘油(批号: Z11D10Y105693)、甲基-β-环糊精(批号: D22HS204506)、木糖醇(批号: F11HS175170)、羟丙基-γ-环糊精(批号: J12HS184474)、羟基-β-环糊精(批号: J19HS185499) 购于北京拜尔迪生物技术有限公司; B-广泛试纸(批号20230507) 购于上海三爱思试剂有限公司; 无水乙醇(色谱级) 购于Fisher公司; 娃哈哈纯净水(规格: 500 mL/瓶) 购于杭州哇哈哈集团有限公司。
供试品的制备  按照布洛芬口服液的原处方工艺, 制备布洛芬无糖中间体溶液(blank溶液), 即不含有矫味剂的布洛芬口服液, 超声30 min, 5 000 r·min-1离心10 min, 取上清液, 0.45 μm微孔滤膜滤过, 即得供试品溶液。
布洛芬口服液电子舌测试方法的建立  电子舌测试前平衡, 传感器首先浸入正负清洗液中进行清洗90 s, 再浸入参比溶液中进行两次清洗120 s, 清洗后传感器浸入Conditioning平衡位置的参比溶液中检测传感器30 s, 当传感器在平衡位置中两次结果差值小于0.5 mV, 系统认为传感器自检通过, 可以进行样品的测试。测试时间30 s, 在两组参比液中分别短暂清洗3 s, 传感器插入新的参比液中测试回味30 s循环测试4次, 去掉第1次循环, 取后3次平均数据作为测试结果。每次清洗、平衡和测试回味的液体均分布在不同样品杯中。
取市售布洛芬口服液(批准字号: 国药准字H10950111), 按照电子舌SOP连续测定6次, 记录6个传感器(AE1、AAE、CTO、COO、CAO、GL1) 的响应值, 并计算相对标准偏差(relative standard deviation, RSD), 判断电子舌的精密度; 平行制备市售产品6份, 分别测定, 记录6个传感器的响应值, 计算RSD, 判断该方法的重复性。
矫味剂种类与添加量的单因素筛选  根据原处方工艺甜味剂添加量与蔗糖的甜度关系, 并根据美国FDA对矫味剂每日允许摄入量(allowable daily intake, ADI) 的规定, 及2022年国家卫健委制订的《中国7岁以下儿童生长发育参照标准》, 布洛芬口服液日服用最大量为28 mL, 制定不同矫味剂在布洛芬口服液中添加量方案。在用药安全的基础上, 选择三氯蔗糖(sucralose)、甜菊苷(stevioside)、纽甜(neotame) 3种高效甜味剂进行筛选, 选择木糖醇(xylitol)、甘露醇(mannitol)、赤藓糖醇(erythritol) 3种低效甜味剂进行筛选, 环糊精用量一般为3%[8,9], 选择甲基-β-环糊精(methyl-beta-cyclodextrin, M-β-CD)、γ-环糊精(gamma-cyclodextrin, γ-CD)、羟丙基-β-环糊精(hydroxypropyl-beta-cyclodextrin, HP-β-CD) 3种环糊精进行筛选(表 1)。分别向blank溶液中加入表中矫味剂, 得到不同编号的样品, 即Y1-Y36, 且在样品溶解性考察结果显示, 以下矫味剂均未达到溶解最大量, 可完全溶解。将36组样品溶液与blank溶液同时按照“电子舌测试方法”项进行测定, 采用主成分分析(principal component analysis, PCA) 方法处理电子舌传感器响应数据。
模糊数学模型的建立  根据布洛芬口服液综合口感选择甜度(sweetness)、异味(off-flavor)、口腔余味(aftertasting)、口感丰富度(rich) 为口感评价指标, 即因素集(U), U = [甜味口感丰富度口腔余味异味] = [U1 U2 U3 U4]。选择评语集(V) 为优秀(excellent)、良好(good)、中等(moderate)、较差(poor) (优、良、中、差), 采用百分制对矫味配方打分, 设定优100分, 良80分, 中60分, 差40分, 即评语集V = [优良中差] = [V1 (100) V2 (80) V3 (60) V4 (40)]。建立4个单因素评价矩阵, 评议小组即为20位志愿者, 对不同矫味剂配方进行评议。
AHP层次分析法的建立  根据布洛芬口服液原配方的口感与加入矫味剂后的特点, 从影响口感的因素中筛选出甜味、异味、口腔余味、口感丰富度4个评价指标作为准则层, 以口感综合评价作为目标层, 不同矫味配比的处方为方案层, 从而构建多层次结构分析模型。按照公式(2) 计算归一化Wjs。
$W_j=\left(\mathrm{a}_{j 1} \mathrm{a}_{j 2} \cdots \mathrm{a}_{j n}\right)^{1 / n}$
$W_j^s=W_j / \sum_{j=1}^{\mathrm{n}} W_j$
其中, Wj为初始权重系数, ajn表示第j (j = 1, 2, …, n) 个指标因素对第n (n = 1, 2, …, j) 个指标因素的比较结果。
布洛芬口服液人体真实感官评价方法的建立  根据儿童口感偏好设置调查问卷, 通过发放问卷调查表随机打分形式, 实现布洛芬口服液人体真实感官评价, 经北京中医药大学医学伦理委员会审查通过(伦理号: 2024BZYLL0102), 招募感官评价志愿者并通过筛选确定试验志愿者20人, 性别比例接近1∶1, 无严重过敏、遗传病史、无口腔方面的疾病、无不良嗜好及近期无疾病史, 在试验前签订知情同意书。试验前, 志愿者进行操作培训, 具体操作参考GB/T16291.1-2012。
分别取加入不同矫味剂的样品10 mL于一次性口尝纸杯中, 志愿者含于口中保持15 s, 此间口腔做缓慢漱口动作, 使样品分布于口腔, 品味样品口感, 吐出, 回味口腔余味, 漱口5次及以上, 每轮样品间空白时间为15 min。志愿者采用随机、单盲的方法对样品进行感官测试, 在保证只有研究者知晓实验分组的情况下减少志愿者的主观与偏见影响, 从甜度、异味、口腔余味、口感丰富度4个方面, 按照不同等级的标准在表格中评分。
布洛芬口服液矫味剂的Box-Behnken试验设计  根据单因素实验考察结果, 确定甜菊苷、木糖醇、甲基-β-环糊精的添加量范围, 然后采用实验设计软件Design-Expert13进行Box-Behnken设计, 优化选取甜菊苷添加量、木糖醇添加量和甲基-β-环糊精添加量3个影响因素, 3个水平17个实验点的响应面分析, 其中12个析因点, 5个中心点, 共17组样品。采用Design-Expert13对实验结果进行进行ANOVA方差分析。
结果
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1 电子舌检测方法的重现性和重复性
计算电子舌检测方法对布洛芬口服液的测量结果, 同一样品重复检测6次后电子舌6个传感器(AE1、AAE、CTO、COO、CAO、GL1) 的信号响应RSD值分别为0.05%、0.15%、0.65%、0.14%、0.04%、0.52%, RSD值均小于3%, 说明该检测方法的重现性良好。
采用相同的方法检测6份平行样品, 结果显示电子舌6个传感器(AE1、AAE、CTO、COO、CAO、GL1) 信号响应RSD值分别为0.11%、0.14%、2.33%、0.26%、0.13%、0.17%, RSD均小于3%, 说明该检测方法的整体重复性良好, 方法稳定可靠。
2 矫味剂种类与添加量的单因素筛选
利用电子舌技术对实验组进行PCA主成分分析, 根据blank溶液及3种不同矫味剂、不同质量分数样品的电子舌传感器信号值主成分分析结果: 第一成分与第二成分的累计贡献率99.19%, 这说明第一成分和第二成分能够代表主成分分析数据。前期通过志愿者口尝评价发现, 当矫味后的样品与blank溶液之间标准欧氏距离越大时, 样品不良口感越轻微, 可用该指标评价布洛芬口服液的矫味情况。
2.1 高效甜味剂的筛选
根据图 1A, 计算不同样品与blank溶液之间的标准欧氏距离, 可知在3种高效甜味剂中甜菊苷的矫味效果明显优于其他两种矫味剂, 故甜菊苷矫味效果较好, 其中添加量为4.0 g·L-1甜菊苷即Y10最佳, 甜菊苷属于高效甜味剂, 甜度为蔗糖的300~400倍[10], 故甜味效果明显, 缩小范围, 确定响应面甜菊苷添加量低水平和高水平分别为3.7、4.3 g·L-1。
2.2 低效甜味剂的筛选
同理, 根据图 1B, Y16-blank最大, 故木糖醇矫味效果较好, 其中添加量为125 g·L-1木糖醇最佳, 而Y15与Y16矫味效果相差较小, 且糖醇类添加量一般在10%, 故选择最终木糖醇添加量低水平和高水平分别为100、150 g·L-1。
2.3 掩味剂的筛选
根据图 1C, 其中Y28-blank最大, 故在环糊精中甲基-β-环糊精的矫味效果好, 添加量为2.5 g·100 mL-1的甲基-β-环糊精效果最佳, 环糊精一般用量为3%, 且单因素筛选时未出现峰值故确定甲基-β-环糊精添加量的高水平与低水平分别为20、30 g·L-1。
3 AHP层次分析法确定指标权重
3.1 计算主观权重系数(Wjs)
根据AHP理论判断矩阵1~9标度, 判断同一层次指标间的相对重要程度, 构建判断矩阵A (表 2), 首先, 对判断矩阵A进行几何平均(方根法), 按公式(1) 计算得到Wj; 然后, 按照公式(2) 计算归一化Wjs, 得到4个指标的Wjs, 计算得到4个指标的权重分别为甜味0.30、口感丰富度0.08、口腔余味0.24、异味0.38。
3.2 一致性检验
对矩阵进行一致性检验, 根据公式(3) 计算最大特征根λmax, 公式(4) 计算一致性指标(consistency index, CI), 得到CI为0.013 6, 再根据公式(5) 计算一致性比例(consistency ratio, CR) 为0.015, 均小于0.1, 表明该矩阵具有一致性。
$\lambda_{\text {max }}=\left[\sum_{j=1}^{\mathrm{n}}\left(\sum_{j=1}^{\mathrm{n}} \mathrm{a} j W j / W j\right)\right] 1 / n$
$\mathrm{CI}=\left(\lambda_{\max }-n\right) /(n-1)$
$\mathrm{CR}=\mathrm{CI} / \mathrm{RI}$
4 布洛芬口服液人体真实感官评价结果
基于单因素实验考察结果, 确定甜菊苷、木糖醇、甲基-β-环糊精的质量分数低、中、高3个水平, 分别对应Box-Behnken实验设计中-1、0、1编码值, 考察3种矫味剂的交互作用, 采用实验设计软件Design-Expert13进行Box-Behnken设计出3因素3水平共17次试验, 20位志愿者对样品口尝感知味道并吐出后, 根据综合口感对每一组样品的每一项指标进行评价, 评价结果见表 3。
将表 3中各样品在不同口感评价指标下各等级所得票数折算成比率, 联合所有指标的评价结果, 得各样品的模糊矩阵。例如1号样品的模糊矩阵: R1 = $ \left[\begin{array}{cccc}12/20& 2/20& 6/20& 0\\ 6/20& 8/20& 5/20& 1/20\\ 6/20& 11/20& 3/20& 0\\ 5/20& 13/20& 2/20& 0\end{array}\right] $ = $ \left[\begin{array}{cccc}0.6& 0.1& 0.3& 0\\ 0.3& 0.4& 0.25& 0.05\\ 0.3& 0.55& 0.15& 0\\ 0.25& 0.65& 0.1& 0\end{array}\right] $。经AHP层次分析法计算得到布洛芬口服液感官评价各指标权重向量为: H = (0.30, 0.08, 0.24, 0.38), 根据模糊变换原理可知, Y = H × R, 按乘法-有界算法M (∙, ⊗) 进行计算。则1号样品的综合评价结果为: Y1 = H × R1 = (0.30, 0.08, 0.24, 0.38) × $ \left[\begin{array}{cccc}0.6& 0.1& 0.3& 0\\ 0.3& 0.4& 0.25& 0.05\\ 0.3& 0.55& 0.15& 0\\ 0.25& 0.65& 0.1& 0\end{array}\right] $ = (0.386, 0.366, 0.229, 0.019), 同理Y2 = (0.232, 0.410, 0.251, 0.107), Y3 = (0.307, 0.311, 0.363, 0.019), Y4 = (0.330, 0.331, 0.292, 0.047), Y5 = (0.327, 0.330, 0.319, 0.024), Y6 = (0.267, 0.304, 0.302, 0.127), Y7 = (0.269, 0.271, 0.333, 0.127), Y8 = (0.304, 0.264, 0.302, 0.130), Y9 = (0.314, 0.328, 0.235, 0.123), Y10 = (0.455, 0.346, 0.176, 0.023), Y11 = (0.479, 0.321, 0.188, 0.012), Y12 = (0.528, 0.330, 0.142, 0.000), Y13 = (0.342, 0.300, 0.301, 0.057), Y14 = (0.366, 0.390, 0.244, 0.000), Y15 = (0.320, 0.303, 0.265, 0.112), Y16 = (0.530, 0.239, 0.178, 0.053), Y17 = (0.314, 0.324, 0.284, 0.078)。
根据评语集4个等级对应的分值, 由感官评分Z = Y × V可计算出第一组的感官评分Z1: Z1 = Y1 × V = (0.30, 0.08, 0.24, 0.38) × $ \left|\begin{array}{c}100\\ 80\\ 60\\ 40\end{array}\right| $ = 82.38, 故同理17组样品的组合评价结果: Z2 = 75.34; Z3 = 78.12; Z4 = 78.88; Z5 = 79.50; Z6 = 74.22; Z7 = 73.64; Z8 = 74.48; Z9 = 76.66; Z10 = 84.66; Z11 = 85.34; Z12 = 87.72; Z13 = 78.54; Z14 = 82.44; Z15 = 76.62; Z16 = 84.92; Z17 = 77.48。
5 Box-Behnken模型的建立与显著性检验
将17组样品综合评分填入Box-Behnken实验设计表中(表 4)。
通过Design-Expert13对表 4中数据进行多元回归拟合分析, 可获得感官评分和各因素的回归方程模型: Z = 688.310 11 - 3 023.722 22X1 - 11.477 00X2 + 62.721 67X3 + 14.600 00X1X2 - 179.666 67X1X3 - 3.152 00X2X3 + 4 031.111 11X12 + 0.525 28X22 + 9.772 00X32。对拟合模型进行ANOVA方差分析, 结果如表 5所示, 该模型的方差为0.002 9 (P < 0.01), 极显著; 模型的失拟项为0.235 6 (P > 0.05), 不显著, 方差显著而失拟项不显著, 表明该模型有统计学意义, 且模型与实际值能较好地拟合。将各影响变量的P值与标准对比可知, 二次项X12、X22的P值均小于0.01, 模型的曲面效应极显著(图 2), 一次项X1、交互项X2X3对感官评分的影响极显著(P < 0.01), 二次项X32、交互项X1X3的P值均小于0.05, 对感官评分的影响显著。模型的相关系数R2 = 0.929 0, 调整决定系数Radj2 = 0.837 7, 可信度较好, 可以应用该模型分析。生成综合评分的等高线及响应面分析见图 2, 当两种矫味剂交互作用越强时, 响应面弯曲程度越强。
6 矫味工艺的优选与验证
6.1 优选工艺的预测
采用Design-Expert13软件预测出布洛芬口服液的最佳矫味工艺: 甜菊苷添加量为0.39%, 木糖醇添加量为10%, 甲基-β-环糊精添加量为3.0%, 此时感官评分为87.84。
6.2 优选工艺的验证
根据处方工艺平行制备布洛芬无糖中间体溶液3次, 向布洛芬无糖中间体中加入甜菊苷0.39%, 木糖醇10%, 甲基-β-环糊精3.0%, 布洛芬口服液处方工艺制备样品, 得出布洛芬口服液的感官评分平均值为88.14, 3次平行实验计算RSD值为0.39%, 与预测值相差0.3分, 表明该模型对布洛芬口服液的矫味工艺的优化是可行的。
讨论
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本研究针对布洛芬口服液中布洛芬作为化学品的金属味、苦味等不良口感, 选择高效甜味剂、低效甜味剂与掩味剂结合发挥协同作用, 利用甜味剂混淆大脑的味觉中枢[11], 掩盖布洛芬的苦味和异味, 利用环糊精掩盖金属味, 协同配合对布洛芬口服液进行矫味。在本研究的单因素筛选中, 电子舌可以在短时间内对大量样本快速、准确地评估味道, 对各种味道成分进行检测和分析, 提高了筛选效率。采用电子舌PCA主成分分析法将采集到的味觉信号值进行处理, 通过PC1与PC2分析不同矫味剂对布洛芬口服液的矫味效果, 将6个传感器采集到的信息综合化, 整体分析矫味剂对布洛芬口服液的作用, 并筛选出不同种类的矫味剂及其质量分数。与人类感官评价相比, 电子舌不会因为长时间测试而感到疲劳, 从而保持了评价的一致性和准确性[12]。
在确定综合口感时, 人工口尝法在这一过程中可以提供更为丰富和深入的味觉体验, 为电子舌技术提供参考和验证。专业口尝人员通过训练和经验积累, 能够敏锐地察觉到味道中的细微变化, 为调整味道提供有力支持, 人工口尝法还能够考虑到不同人群的口味偏好, 为药品定制提供依据。
为保证结果的客观性与科学性, 本研究应用AHP层次分析法确定各指标权重系数, 将定性分析转化为定量分析[13], 降低了决策者赋权时的主观性, 提高决策的合理性, 结合模糊数学评价方法对各矫味配方的掩味效果进行评价, 并通过Box-Behnken响应面优化布洛芬口服液口感, 将人体主观评价信息数字化、定量化, 所得结果更客观、可靠, 从而筛选出最优口感配方: 甜菊苷0.39%, 木糖醇10%, 甲基-β-环糊精3.0%。
电子舌技术与人工口尝法相结合提高了矫味效率, 弥补了单一技术的不足, 成功改进了布洛芬口服液的口感, 使其更符合儿童口味, 具有真实性和客观性, 通过充分发挥二者在味道评价和调整方面的优势, 为布洛芬口服液儿童用药开发提供理论基础与实践经验。
作者贡献: 苑蕊、屈云萍、王艳负责实验研究、分析数据和文章撰写; 张雅宣、樊箫雨、钟宛凌、沈慧娟、马韫楠、叶津宏负责实验研究; 白洁和杜守颖负责思路指导和对文章的知识性内容进行审阅并提供研究经费。
利益冲突: 本文所有作者声明不存在利益冲突关系。
基金
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  • 北京市技术开发类横向课题(北京市技术开发类横向课题)
  • 国家中医药管理局高水平建设学科-中药药剂学(zyyzdxk-2023272)
文献
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参考文献 引证文献
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2024年第59卷第8期
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doi: 10.16438/j.0513-4870.2024-0272
  • 接收时间：2024-03-26
  • 首发时间：2025-11-26
  • 出版时间：2024-08-12
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  • 收稿日期：2024-03-26
  • 修回日期：2024-06-11
基金
北京市技术开发类横向课题(北京市技术开发类横向课题)
国家中医药管理局高水平建设学科-中药药剂学(zyyzdxk-2023272)
作者信息
    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

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*白洁, Tel: 86-10-84738657, E-mail: ;
杜守颖, Tel: 86-10-84738615, E-mail:
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
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