在线近红外光谱用于制药工业中的研究进展

Research Progress on the Application of On-Line Near-Infrared Spectroscopy in the Pharmaceutical Industry

摘要: 在线近红外光谱(NIRS)技术是一种简便、快速、无损的分析方法，基于分子振动的倍频与合频吸收，对含氢官能团具有较高灵敏度。结合化学计量学技术，NIRS能够实现复杂体系的定性与定量分析，并可无缝集成于工业现场，实现原辅料检测、生产过程监测及制剂质量控制的实时化与自动化。本文简述了NIRS技术的原理与特点，综述其在中药与化学药制药过程中的典型应用，包括原药材真伪鉴别、处方一致性评价、发酵与提取过程监控、物料混合均匀度判定、水分含量控制及压片与包衣工艺优化等。NIRS在提升制药过程关键工艺参数监控效率、保障药品质量方面展现了显著优势。尽管该技术仍存在建模成本高、专属性不足等挑战，但在连续制造与智能化制药的发展趋势下，尤其在中药现代化和生物制药领域，具有广阔的应用前景与研究价值。

Abstract: On-line near-infrared spectroscopy (NIRS) is a rapid, non-destructive analytical technique based on the overtone and combination absorption of molecular vibrations, showing high sensitivity to hydrogen-containing functional groups. When integrated with chemometric methods, NIRS enables qualitative and quantitative analysis of complex systems and can be seamlessly applied to industrial settings, achieving real-time and automated monitoring of raw materials, manufacturing processes, and product quality. This paper outlines the principles and features of NIRS, and reviews its representative applications in both traditional Chinese medicine (TCM) and chemical drug manufacturing processes, including authenticity identification of raw medicinal materials, evaluation of formulation consistency, monitoring of fermentation and extraction processes, determination of blending uniformity, moisture control during granulation, and optimization of tableting and coating processes. NIRS has demonstrated significant advantages in improving the monitoring of critical process parameters and ensuring pharmaceutical quality. Although challenges such as high modeling costs and limited specificity remain, NIRS shows broad application prospects under the trends of continuous manufacturing and intelligent pharmaceutical production, particularly in the modernization of TCM and quality assurance in biopharmaceuticals.