Reich Gabriele
Institute for Pharmacy and Molecular Biotechnology, Department of Pharmaceutical Technology and Pharmacology, University of Heidelberg, Im Neuenheimer Feld 366, D-69120 Heidelberg, Germany.
Adv Drug Deliv Rev. 2005 Jun 15;57(8):1109-43. doi: 10.1016/j.addr.2005.01.020.
Near-infrared (NIR) spectroscopy and imaging are fast and nondestructive analytical techniques that provide chemical and physical information of virtually any matrix. In combination with multivariate data analysis these two methods open many interesting perspectives for both qualitative and quantitative analysis. This review focuses on recent pharmaceutical NIR applications and covers (1) basic principles of NIR techniques including chemometric data processing, (2) regulatory issues, (3) raw material identification and qualification, (4) direct analysis of intact solid dosage forms, and (5) process monitoring and process control.
近红外（NIR）光谱和成像技术是快速且无损的分析技术，能提供几乎任何基质的化学和物理信息。这两种方法与多元数据分析相结合，为定性和定量分析开辟了许多有趣的前景。本综述聚焦于近期制药领域的近红外应用，涵盖：（1）近红外技术的基本原理，包括化学计量学数据处理；（2）法规问题；（3）原材料识别与鉴定；（4）完整固体剂型的直接分析；以及（5）过程监测与过程控制。
