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SEM/EDX 和共聚焦 Raman 显微镜作为药物片剂特性分析的互补工具。

SEM/EDX and confocal Raman microscopy as complementary tools for the characterization of pharmaceutical tablets.

机构信息

School of Science, Faculty of Engineering & Science, University of Greenwich, Medway Campus, Chatham Maritime, Kent ME4 4TB, UK.

School of Science, Faculty of Engineering & Science, University of Greenwich, Medway Campus, Chatham Maritime, Kent ME4 4TB, UK.

出版信息

Int J Pharm. 2014 Aug 15;470(1-2):88-98. doi: 10.1016/j.ijpharm.2014.05.007. Epub 2014 May 13.

DOI:10.1016/j.ijpharm.2014.05.007
PMID:24836664
Abstract

The drug distribution on the surface of hot-melt extruded, pre-mixed hot-melt extruded and direct compressed tablet formulations was characterized by using scanning electron microscopy, energy dispersive X-ray spectroscopy (EDX) and confocal Raman spectroscopy. Formulations of paracetamol (PMOL) and Compritol(®) (C-888) were extruded using hot-melt extrusion at different processing temperatures and formulation compositions before being compressed into tablets. EDX and confocal Raman spectroscopy were employed to map the drug and excipient distribution, both qualitatively and quantitatively, on the surface of the tablets. The results from EDX and confocal Raman studies confirmed better uniformity and distribution of PMOL in the pre-mixed extruded formulations compared to both hot-melt extruded formulations and those obtained by means of direct compression. The quantification of the drug composition on the surface of the tablets by both EDX and confocal Raman was in good agreement with the theoretically expected values.

摘要

采用扫描电子显微镜、能量色散 X 射线光谱(EDX)和共聚焦拉曼光谱对热熔挤出、预混合热熔挤出和直接压片制剂表面的药物分布进行了表征。将扑热息痛(PMOL)和 Compritol(®)(C-888)制剂在不同的加工温度和制剂组成下进行热熔挤出,然后压制成片剂。采用 EDX 和共聚焦拉曼光谱对片剂表面药物和赋形剂的分布进行定性和定量映射。EDX 和共聚焦拉曼研究的结果证实,与热熔挤出制剂和直接压片相比,预混合挤出制剂中 PMOL 的均匀性和分布更好。EDX 和共聚焦拉曼对片剂表面药物成分的定量与理论预期值非常吻合。

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