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近红外光谱技术在制药技术中的应用。

Application of the near-infrared spectroscopy in the pharmaceutical technology.

机构信息

Medical University of Gdansk, Faculty of Pharmacy, Department of Physical Chemistry, Hallera 107, 80-416 Gdansk, Poland.

出版信息

J Pharm Biomed Anal. 2012 Jul;66:1-10. doi: 10.1016/j.jpba.2012.03.009. Epub 2012 Mar 15.

Abstract

Near-infrared (NIR) spectroscopy is currently the fastest-growing and the most versatile analytical method not only in the pharmaceutical sciences but also in the industry. This review focuses on recent NIR applications in the pharmaceutical technology. This article covers monitoring, by NIR, of many manufacturing processes, such as granulation, mixing or drying, in order to determine the end-point of these processes. In this paper, apart from basic theoretical information concerning the NIR spectra, there are included determinations of the quality and quantity of pharmaceutical compounds. Some examples of measurements and control of physicochemical parameters of the final medicinal products, such as hardness, porosity, thickness size, compression strength, disintegration time and potential counterfeit are included. Biotechnology and plant drug analysis using NIR is also described. Moreover, some disadvantages of this method are stressed and future perspectives are anticipated.

摘要

近红外(NIR)光谱学目前是增长最快、用途最广泛的分析方法,不仅在制药科学中,而且在工业中也是如此。本综述重点介绍了近红外在制药技术中的最新应用。本文涵盖了通过 NIR 监测许多制造过程,如造粒、混合或干燥,以确定这些过程的终点。在本文中,除了有关 NIR 光谱的基本理论信息外,还包括对药物化合物的质量和数量的测定。还包括对最终药物的一些物理化学参数的测量和控制的例子,如硬度、孔隙率、厚度尺寸、压缩强度、崩解时间和潜在的假冒品。还描述了使用 NIR 的生物技术和植物药物分析。此外,还强调了该方法的一些缺点,并对未来的发展进行了预测。

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