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基于紫外/可见成像的光声断层成像工具,用于在完整片剂中进行药物粒度检测,并由模式识别神经网络提供支持。

UV/VIS imaging-based PAT tool for drug particle size inspection in intact tablets supported by pattern recognition neural networks.

作者信息

Mészáros Lilla Alexandra, Farkas Attila, Madarász Lajos, Bicsár Rozália, Galata Dorián László, Nagy Brigitta, Nagy Zsombor Kristóf

机构信息

Department of Organic Chemistry and Technology, Budapest University of Technology and Economics, H-1111 Budapest, Műegyetem rakpart 3, Hungary.

Department of Organic Chemistry and Technology, Budapest University of Technology and Economics, H-1111 Budapest, Műegyetem rakpart 3, Hungary.

出版信息

Int J Pharm. 2022 May 25;620:121773. doi: 10.1016/j.ijpharm.2022.121773. Epub 2022 Apr 27.

Abstract

The potential of machine vision systems has not currently been exploited for pharmaceutical applications, although expected to provide revolutionary solutions for in-process and final product testing. The presented paper aimed to analyze the particle size of meloxicam, a yellow model active pharmaceutical ingredient, in intact tablets by a digital UV/VIS imaging-based machine vision system. Two image processing algorithms were developed and coupled with pattern recognition neural networks for UV and VIS images for particle size-based classification of the prepared tablets. The developed method can identify tablets containing finer or larger particles than the target with more than 97% accuracy. Two algorithms were developed for UV and VIS images for particle size analysis of the prepared tablets. According to the applied statistical tests, the obtained particle size distributions were similar to the results of the laser diffraction-based reference method. Digital UV/VIS imaging combined with multivariate data analysis can provide a new non-destructive, rapid, in-line tool for particle size analysis in tablets.

摘要

尽管机器视觉系统有望为过程中和最终产品检测提供革命性的解决方案,但目前尚未在制药应用中发挥其潜力。本文旨在通过基于数字紫外/可见成像的机器视觉系统分析完整片剂中黄色模型活性药物成分美洛昔康的粒径。开发了两种图像处理算法,并将其与用于紫外和可见图像的模式识别神经网络相结合,用于对制备的片剂进行基于粒径的分类。所开发的方法能够以超过97%的准确率识别出含有比目标粒径更细或更大颗粒的片剂。针对制备的片剂的粒径分析,为紫外和可见图像开发了两种算法。根据应用的统计测试,所获得的粒径分布与基于激光衍射的参考方法的结果相似。数字紫外/可见成像与多变量数据分析相结合,可以为片剂中的粒径分析提供一种新的无损、快速、在线工具。

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