Objective: To investigate the improvement in bitter taste of ambroxol hydrochloride by the corrective materials and weight gain of the taste-masking layer, and to establish an objective and scientific taste evaluation method. Methods: The taste-masking effects of corrective materials and taste-masking layer weighting were evaluated using electronic tongue technology, and the palatability between ambroxol hydrochloride direct oral granules and 15 marketed preparations of ambroxol hydrochloride were compared. The electronic tongue datas were subjected to principal component analysis and loadings analysis. Results: The corrective materials were able to mask the bitter taste of ambroxol hydrochloride. The bitter value of the sample solution of ambroxol hydrochloride direct oral granules decreased as the masking layer gained weight. In terms of bitterness and sweetness, ambroxol hydrochloride oral direct granules had a clear advantage over 15 marketed formulations. Conclusion: Using the electronic tongue technology, the taste correction effect and the taste difference between different samples can be accurately assessed, and an evaluation method for the bitter taste masking effect of ambroxol hydrochloride direct oral granules has been established, which provides new ideas and methods for the taste masking study of oral preparations for children.
LIU Meng
,
ZHANG Na
,
XU Hui
,
SHEN Li-ping
,
ZHU Guang-hui
,
CHEN Hua
,
YU Li-ju
. Study on taste masking of ambroxol hydrochloride direct oral granules based on electronic tongue technology*[J]. Chinese Journal of Pharmaceutical Analysis, 2025
, 45(3)
: 537
-542
.
DOI: 10.16155/j.0254-1793.2024-1281
[1] 王国才,张丹,杨漫,等.国产和进口盐酸氨溴索片的人体生物等效性研究[J].中国药业,2011,20(17):14
WANG GC,ZHANG D,YANG M,et al.Study on bioequivalence of ambroxol hydrochloride tablets from domestic and import[J].China Pharm,2011,20(17):14
[2] 王锦刚,蒋海松,朱德志,等.一种稳定的盐酸氨溴索掩味颗粒及其制备方法:201510494639.4[P].2017-02-22
WANG JG,JIANG HS,ZHU DZ,et al.A kind of Stabilized Ambroxol Hydrochloride Masked Flavor Granules and Its Preparation Method:201510494639.4[P].2017-02-22
[3] 张威风,王晓玲,翟光喜,等.儿童用药口感评价方法研究进展[J].中国医药,2021,16(9):1407
ZHANG WF,WANG XL,ZHAI GX,et al.Research progress on taste evaluation methods for pediatric drug products[J].China Med,2021,16(9):1409
[4] 丛端端,孙艳喆,耿莹,等.浅谈儿童用药的口感设计和评价[J].中国医药工业杂志,2022,53(11):1659
CONG DD,SUN YZ,GENG Y,et al.Opinion on the design and evaluation of the oral sensory features of pediatric medications[J].Chin J Pharm,2022,53(11):1659
[5] THOMPSON C,LOMBARDI D,SJOSTEDT P,et al.Best practice recommendations regarding the assessment of palatability and swallowability in the development of oral dosage forms for pediatric patients[J].Ther Innov Regul Sci,2015,49(5):647
[6] WOERTZ K,TISSEN C,KLEINEBUDDE P,et al.Taste sensing systems(electronic tongues)for pharmaceutical applications[J].Int J Pharm,2011,417(1-2):256
[7] HARADA T,UCHIDA T,YOSHIDA M,et al.A new method for evaluating the bitterness of medicines in development using a taste sensor and a disintegration testing apparatus[J].Chem Pharm Bull,2010,58(8):1009
[8] WOERTZ K,TISSEN C,KLEINEBUDDE P,et al.Development of a taste-masked generic ibuprofen suspension:top-down approach guided by electronic tongue measurements[J].J Pharm Sci,2011,100(10):4460
[9] WOERTZ K,TISSEN C,KLEINEBUDDE P,et al.Performance qualification of an electronic tongue based on ICH guideline Q2[J].J Pharm Biomed Anal,2010,51(3):497
[10] WU M,TAO W,XIA X,et al.A novel quantified palatability evaluation method(saliva evaluation combined with electronic tongue evaluation)for traditional Chinese medicine oral formulations based on oral stimulation[J].J Drug Deliv Sci Technol,2022,74:103562
[11] 欧阳辉发,李林致,吴佳颖,等.基于感官评价和电子鼻技术表征2种羌活挥发油气味特征及无损检测模型建立[J].药物分析杂志,2024,44(11):1852
OUYANG HF,LI LZ,WU JY,et al.Flavor characterization of two kinds of Notopterygii Rhizoma et Radix volatile oils based onsensory evalution and electronic nose technology,and establishment of nondestructive detection models[J].Chin J Pharm Anal,2024,44(11):1852
[12] 王利民,戚淑叶,张威风,等.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[J].药学学报,2023,58(11):3191
WANG LM,QI SY,ZHANG WF,et al.Formulation optimization and analysis of taste-masking effect of licorzine granules based on sensory evaluation and electronic tongue method[J].Acta Pharm Sin,2023,58(11):3191
[13] 戚淑叶,耿利华,赵悦,等.电子舌在药品口感评价中的应用进展[J].药学学报,2023,58(11):3151
QI SY,GENG LH,ZHAO Y,et al.Application progress of electronic tongue on taste evaluation for drug products[J].Acta Pharm Sin,2023,58(11):3151
[14] 涂慧丹,郭志鑫,吴学萍,等.浅析儿童口服化学药品药学开发考虑要点[J].中国新药杂志,2024,33(22):232
TU HD,GUO ZX,WU XP,et al.Analysis of key considerations in the development of chemical drug for children[J].Chin J New Drugs,2024,33(22):232
[15] ZHANG YW,WANG YH,LI JS,et al.Population pharmacokinetics and individualized medication of azithromycin for injection in children under 6 years old[J].J Pharm Sci,2024,113(5):1351
[16] 梅冬,游龙泰,张欢,等.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[J].药学学报,2024,59(6):1847
MEI D, YOU LT,ZHANG H,et al.Palatability evaluation of oral iron for children based on in vivo and in vitro evaluation techniques[J].Acta Pharm Sin,2024,59(6):1847
