Zhang Chao, Liu Yuanyuan, Tang Zhiqiang, Chen Xuejun, Zhang Hui, Liu Nan, Huo Changhong, Wang Zengming, Zheng Aiping
College of Pharmacy, Hebei Medical University, Shijiazhuang, 050000, China.
State Key Laboratory of Toxicology and Medical Countermeasures, Beijing Institute of Pharmacology and Toxicology, 27th Taiping Road, Haidian District, Beijing, 100850, China.
Anal Sci. 2025 May 25. doi: 10.1007/s44211-025-00794-w.
NIR is a rapid, non-destructive analytical technique that leverages the absorption properties of molecules in the near-infrared region. This technology has become indispensable in the pharmaceutical industry due to its efficiency in analyzing solids, liquids, and various pharmaceutical preparations across numerous applications, including drug discovery, process monitoring, and quality control. With the advent of portable NIR instruments, the technology has gained a pivotal role in PAT, optimizing manufacturing processes and ensuring consistent product quality for real-time product release. This review reports on the remarkable versatility of NIR spectroscopy in the pharmaceutical field, covering a wide range of qualitative determinations, such as sample identification, crystal morphology, and eutectic analysis. It also addresses the quantitative analysis of samples and in-line applications in continuous manufacturing processes, including granulation, drying, tableting, and coating. The fundamentals of NIR spectroscopy, as well as its applications in botanical and biological products, are discussed. Additionally, the review examines the prospects and challenges associated with using NIR spectroscopic techniques. NIR spectroscopy served as an effective and powerful tool for both qualitative and quantitative analysis of pharmaceuticals and for monitoring continuous production.
近红外光谱（NIR）是一种快速、无损的分析技术，它利用分子在近红外区域的吸收特性。由于该技术在分析固体、液体以及众多应用场景（包括药物发现、过程监测和质量控制）中的各种药物制剂方面具有高效性，已在制药行业变得不可或缺。随着便携式近红外仪器的出现，该技术在过程分析技术（PAT）中发挥了关键作用，优化制造工艺并确保实时产品放行时产品质量的一致性。本综述报道了近红外光谱在制药领域的显著通用性，涵盖了广泛的定性测定，如样品鉴定、晶体形态和共熔分析。它还讨论了样品的定量分析以及在连续制造过程中的在线应用，包括制粒、干燥、压片和包衣。文中探讨了近红外光谱的基本原理及其在植物和生物制品中的应用。此外，该综述研究了使用近红外光谱技术相关的前景和挑战。近红外光谱是药物定性和定量分析以及监测连续生产的有效且强大的工具。
