咀嚼片适口性及可咀嚼性的体外口腔模拟评估

钟傲男; 李聪慧; 王增明; 韩晓璐; 张慧; 刘楠; 张郃; 林锦涛; 刘春艳; 郑爱萍

doi:10.6039/j.issn.1001-0408.2024.14.06

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咀嚼片适口性及可咀嚼性的体外口腔模拟评估

药学研究 | 更新时间：2024-07-25

- 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
- 中国药房 2024年35卷第14期页码：1708-1714
- 作者机构：
  
  1.华北理工大学药学院，河北唐山　063210
  2.军事科学院军事医学研究院，北京　100850
- 作者简介：
  
  硕士研究生。研究方向：药物制剂研发。E-mail：zhongaonan0921@163.com
  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
- 基金信息：
  
  国家重点研发计划(2023YFC2706102)
- DOI：10.6039/j.issn.1001-0408.2024.14.06
  中图分类号： R965.3
- 纸质出版日期：2024-07-30，
  
  收稿日期：2024-01-13，
  
  修回日期：2024-04-22，
- 稿件说明：
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钟傲男,李聪慧,王增明等.咀嚼片适口性及可咀嚼性的体外口腔模拟评估 ^Δ[J].中国药房,2024,35(14):1708-1714.

ZHONG Aonan,LI Conghui,WANG Zengming,et al.In vitro oral simulation evaluation of palatability and chewability of chewable tablets[J].ZHONGGUO YAOFANG,2024,35(14):1708-1714.
钟傲男,李聪慧,王增明等.咀嚼片适口性及可咀嚼性的体外口腔模拟评估 ^Δ[J].中国药房,2024,35(14):1708-1714. DOI： 10.6039/j.issn.1001-0408.2024.14.06.

ZHONG Aonan,LI Conghui,WANG Zengming,et al.In vitro oral simulation evaluation of palatability and chewability of chewable tablets[J].ZHONGGUO YAOFANG,2024,35(14):1708-1714. 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。

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， a

nd 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

Keywords

texture analyzerrheometerin vitro simulationoral chewingquality evaluation

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