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利用激光诱导击穿光谱(LIBS)对片剂包衣进行原位分析表征和化学成像。

In situ analytical characterization and chemical imaging of tablet coatings using laser induced breakdown spectroscopy (LIBS).

机构信息

Process Research & Development, MRL, Merck & Co., Inc., Rahway, NJ 07065, USA.

出版信息

Analyst. 2018 Oct 8;143(20):5000-5007. doi: 10.1039/c8an01262h.

Abstract

Laser induced breakdown spectroscopy (LIBS) has emerged as an innovative tool for quantitative and qualitative elemental analysis in pharmaceutical research. Herein, the potential use of LIBS for rapid characterization of tablet coatings is illustrated, including the investigation of coating thickness, coating uniformity and localized coating contamination. The laser shot number required for penetrating the coating correlates well with coating thickness determined from traditional scanning electron microscopy measurements. Each laser shot represents a 2.58 μm coating thickness. The inter-tablet coating uniformity was directly visualized using LIBS-based 3D chemical imaging, and the intra-tablet coating uniformity was quantitatively investigated. To our knowledge, this is the first report of 3D LIBS-based chemical imaging being utilized for quantitative analysis of pharmaceutical tablet coatings. In addition to elemental information, the accurate location of contaminants on the tablet coating was rapidly identified using 2D imaging. These results pave the way for LIBS to be a valuable technique for the analysis of pharmaceutical tablet coatings.

摘要

激光诱导击穿光谱(LIBS)已成为医药研究中定量和定性元素分析的一种创新工具。本文阐述了 LIBS 在快速表征片剂包衣方面的潜在应用,包括对包衣厚度、包衣均匀性和局部包衣污染的研究。穿透包衣所需的激光射击次数与从传统扫描电子显微镜测量确定的包衣厚度密切相关。每个激光射击代表 2.58μm 的涂层厚度。使用基于 LIBS 的 3D 化学成像直接直观地观察片剂之间的包衣均匀性,并对片剂内部的包衣均匀性进行定量研究。据我们所知,这是首次利用基于 3D LIBS 的化学成像进行药物片剂包衣定量分析的报告。除了元素信息外,还可以使用二维成像快速确定片剂包衣上污染物的准确位置。这些结果为 LIBS 成为分析药物片剂包衣的有价值技术铺平了道路。

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