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眼见为实:时滞宏观成像在固体剂型形态变化中的应用——教学与研究工具

Seeing Is Believing: Time-Lapse Macro-Imaging of Morphological Changes of Solid Dosages as a Teaching and Research Tool.

机构信息

Key Laboratory of Drug-Targeting and Drug Delivery System of the Education Ministry and Sichuan Province, Sichuan Engineering Laboratory for Plant-Sourced Drug and Sichuan Research Center for Drug Precision Industrial Technology, West China School of Pharmacy, Sichuan University, Chengdu, 610041, China.

出版信息

Pharm Res. 2022 May;39(5):1019-1024. doi: 10.1007/s11095-022-03271-5. Epub 2022 Apr 29.

Abstract

PURPOSE

Disintegration kinetics and behaviors are critical for the quality and performance of oral solid dosages. Instead of performing standard disintegration tests, herein, we aim to visualize these kinetic processes in real time.

METHOD

A visual acquisition system is developed to capture the morphological changes of tablets under static conditions via time-lapse macro-imaging. The system consists of: i) a customized quartz chamber, ii) a metal sieve with pore sizes ranging from 1 to 2 mm in diameter to allow rapid settling of the disintegrated particles, and iii) a temperature-controlled water bath. A typical workflow consists of the following steps: i) planning of the experiment to consider the type of the active pharmaceutical ingredient and drug release mechanism; ii) acquisition of photo-imaging data from at least two cameras arranged at different angles over a predetermined time period; iii) post-processing of the image data; iv) production of video clips and image analysis.

RESULTS

Representative works are shown to demonstrate the disintegration phenomenon or the morphological changes of solid drug products of various controlled- and extended-release mechanisms.

CONCLUSION

These video clips are used as teaching materials for students majoring in pharmacy or pharmaceutical chemistry, which also provide an insightful unique perspective of the microprocess during tablet fragmentation, disintegration or drug release.

摘要

目的

崩解动力学和行为对于口服固体制剂的质量和性能至关重要。本文旨在实时观察这些动力学过程,而不是进行标准的崩解测试。

方法

开发了一种可视化采集系统,通过定时宏观成像来捕捉片剂在静态条件下的形态变化。该系统包括:i)定制的石英室,ii)直径为 1 至 2 毫米的金属筛,以允许崩解颗粒快速沉降,iii)控温水浴。典型的工作流程包括以下步骤:i)根据活性药物成分的类型和药物释放机制规划实验;ii)在预定时间内从至少两个不同角度布置的相机获取图像数据;iii)对图像数据进行后处理;iv)制作视频剪辑和图像分析。

结果

展示了代表性的工作,以演示各种控制释放和延长释放机制的固体药物产品的崩解现象或形态变化。

结论

这些视频剪辑可用作药学或药物化学专业学生的教学材料,为片剂碎裂、崩解或药物释放过程中的微观过程提供了独特的深入视角。

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