中国药房2024，Vol.35Issue(14)：1708-1714,7.DOI:10.6039/j.issn.1001-0408.2024.14.06
咀嚼片适口性及可咀嚼性的体外口腔模拟评估
In vitro oral simulation evaluation of palatability and chewability of chewable tablets
摘要
Abstract
OBJECTIVE To evaluate the palatability and chewability of chewable tablets,and provide reference for the quality evaluation of various types of chewable tablets.METHODS Using self-made Glucosamine hydrochloride chewable tablets as the model drug,the quality test was conducted.The in vitro simulation system for chewable tablets was established by using a texture analyzer and rheometer,and an oral simulation experiment was conducted on chewable tablets.The texture analyzer was used to measure the force required for chewing and simulate the static disintegration process of chewable tablets;the rheometer was adopted to measure the viscoelasticity,thixotropy,and deformability of chewable tablets during the chewing process.RESULTS The disintegration time limit,principal component content,and dissolution of self-made Glucosamine hydrochloride chewable tablets all met the limit requirements.The in vitro simulation results of the texture analyzer showed that self-made chewable tablets were easy to chew in both axial and radial directions,and the force required for chewing was within the range of the chewing force of the teeth;chewable tablets could disintegrate at an appropriate time without being chewed and only taken in the oral cavity.The in vitro simulation results of the rheometer showed that the chewable tablets in the oral cavity exhibited a behavior of elasticity as the main factor and viscosity as the secondary factor through the continuous stirring of the tongue,and the viscosity of the chewable tablets gradually decreased with tongue stirring or tooth chewing;when chewing with teeth,the internal force of the chewing tablets decreased,causing plastic deformation and crushing.After being crushed,the shape couldn't be restored,making it easy to chew and swallow.CONCLUSIONS The combination of texture analyzer and rheometer can be used to simulate the oral chewing process and evaluate the palatability and chewability of self-made Glucosamine hydrochloride chewable tablets.This model can provide reference for the evaluation of various chewable tablets.关键词
咀嚼片/质构仪/流变仪/体外模拟/口腔咀嚼/质量评价Key words
chewable tablets/texture analyzer/rheometer/in vitro simulation/oral chewing/quality evaluation分类
医药卫生引用本文复制引用
钟傲男,郑爱萍,李聪慧,王增明,韩晓璐,张慧,刘楠,张郃,林锦涛,刘春艳..咀嚼片适口性及可咀嚼性的体外口腔模拟评估[J].中国药房,2024,35(14):1708-1714,7.基金项目
国家重点研发计划(No.2023YFC2706102) （No.2023YFC2706102）
