Page 42 - 《中国药房》2024年14期

咀嚼片适口性及可咀嚼性的体外口腔模拟评估
Δ

钟傲男 1， 2＊ ，李聪慧 ，王增明 ，韩晓璐 ，张 慧 ，刘 楠 ，张 郃 ，林锦涛 ，刘春艳 ，郑爱萍 （1.华北理工大学
2 #
2
2
2
2
2
2
1
2
药学院，河北 唐山 063210；2.军事科学院军事医学研究院，北京 100850）
中图分类号 R965.3 文献标志码 A 文章编号 1001-0408（2024）14-1708-07
DOI 10.6039/j.issn.1001-0408.2024.14.06
摘 要 目的 评估咀嚼片的适口性及可咀嚼性，为各类咀嚼片的质量评价提供参考。方法 以自制盐酸氨基葡萄糖咀嚼片为模
型药，并进行质量检测。通过质构仪及流变仪建立咀嚼片体外模拟体系，对咀嚼片进行口腔模拟实验。采用质构仪测定咀嚼片咀
嚼所需的力及模拟静态崩解过程，采用流变仪测定咀嚼片咀嚼过程中的黏弹性、触变性及变形性。结果 自制盐酸氨基葡萄糖咀
嚼片的崩解时限、主成分含量、溶出等结果均符合限度要求。质构仪体外模拟结果显示，自制咀嚼片无论轴向或径向咀嚼均易被
嚼碎，咀嚼所需的力在牙齿咀嚼力承受范围内；咀嚼片不经咀嚼仅含服于口腔中也可在适宜时间内崩解完成。流变仪体外模拟结
果显示，咀嚼片在口腔中通过舌头不断搅动，表现出以弹性为主、黏性为辅的行为，且咀嚼片的黏度会随着舌头的搅动或牙齿咀嚼
而逐渐下降；牙齿咀嚼时，咀嚼片内部应力降低，发生塑性变形被压碎，被嚼碎后形状不可恢复，易于咀嚼吞咽。结论 通过质构仪
及流变仪联合运用模拟口腔咀嚼过程可对自制盐酸氨基葡萄糖咀嚼片的适口性及可咀嚼性进行评估，该模型可为各类咀嚼片的
评价提供参考。
关键词 咀嚼片；质构仪；流变仪；体外模拟；口腔咀嚼；质量评价

In vitro oral simulation evaluation of palatability and chewability of chewable tablets
1， 2
2
2
ZHONG Aonan ，LI Conghui ，WANG Zengming ，HAN Xiaolu ，ZHANG Hui ，LIU Nan ，ZHANG He ，LIN
2
2
2
2
Jintao ，LIU Chunyan ，ZHENG Aiping （1. School of Pharmacy， North China University of Science and
2
2
1
Technology， Hebei Tangshan 063210， China；2. Academy of Military Medicine Sciences， Academy of Military
Sciences， Beijing 100850， China）
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.
KEYWORDS chewable tablets； texture analyzer； rheometer； in vitro simulation； oral chewing； quality evaluation

片剂是现代药物制剂中应用最广泛的重要剂型之
Δ 基金项目 国家重点研发计划（No.2023YFC2706102） 一，但是部分片剂面积较大，服用时较为困难，容易引起
＊第一作者 硕士研究生。研究方向：药物制剂研发。E-mail：
吞咽梗阻感，且大部分人对于长期服用片剂有抗拒心
zhongaonan0921@163.com
理。而咀嚼片是一种可以经口腔咀嚼后直接服下的片
# 通信作者 研究员，博士。研究方向：纳米技术药物、黏膜系统及
3D打印药物。电话：010-66931694。E-mail：apzheng@163.com 剂。咀嚼片服用较为方便，无需用水送服，可以随时随

· 1708 · China Pharmacy 2024 Vol. 35 No. 14 中国药房 2024年第35卷第14期