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同时使用 DSC-FTIR 微光谱法在药物分析中的当前和潜在应用。

Current and potential applications of simultaneous DSC-FTIR microspectroscopy for pharmaceutical analysis.

机构信息

Laboratory of Pharmaceutics and Biopharmaceutics, Department of Biotechnology and Pharmaceutical Technology, Yuanpei University of Medical Technology, No. 306, Yuanpei Street, Hsinchu 30015, Taiwan.

出版信息

J Food Drug Anal. 2021 Jun 15;29(2):182-202. doi: 10.38212/2224-6614.3345.

DOI:10.38212/2224-6614.3345
PMID:35696204
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9261823/
Abstract

Quality control (QC) is the most important key issue in the pharmaceutical industry to ensure the quality of drug products. Many analytical instruments and techniques in pharmaceutical analysis are applied to assess the quality and quantity of the drugs. In the current and future trends, a combination of digitization, automation and hyphenation with high throughput on-line performance will be the topics for the future of pharmaceutical QC. The hyphenated analytical techniques have recently received great attention as unique means to solve complex analytical problems in a short period of time. This review article is an update on the recent potential applications of hyphenated technique developed from the coupling of a rapid separation or induction technique (differential scanning calorimetry; DSC) and an on-line spectroscopic (Fourier transform infrared; FTIR) detection technology to carry out an one-step solid-state analysis in pharmaceutical formulation developments, including (1) intramolecular condensation of pharmaceutical polymers, (2) intramolecular cyclization of drugs and sweetener, (3) polymorphic transformation of drugs and excipients, (4) drug-polymer (excipient) interaction, (5) fast cocrystal screening and formation. This simultaneous DSC-FTIR microspectroscopy can also provide an easy and direct method for one-step screening and qualitative detection of drug stability in real time.

摘要

质量控制（QC）是制药行业中确保药物产品质量的最重要关键问题。许多药物分析中的分析仪器和技术都被用于评估药物的质量和数量。在当前和未来的趋势中，数字化、自动化和与高通量在线性能的组合将成为药物 QC 的未来主题。近年来，键合分析技术作为一种独特的手段，在短时间内解决复杂的分析问题，受到了极大的关注。本文综述了快速分离或感应技术（差示扫描量热法；DSC）与在线光谱（傅里叶变换红外；FTIR）检测技术相结合的键合技术的最新潜在应用，用于进行药物制剂开发中的一步固相分析，包括（1）药物聚合物的分子内缩合，（2）药物和甜味剂的分子内环化，（3）药物和赋形剂的多晶型转变，（4）药物-聚合物（赋形剂）相互作用，（5）快速共晶筛选和形成。这种同时的 DSC-FTIR 微光谱学还可以为一步筛选和实时定性检测药物稳定性提供一种简单直接的方法。

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