近红外光谱分析技术具有原位无损分析、分析成本低、速度快、易实现在线检测等特点，对于提高药品质量控制，实现生产过程在线监控具有重要意义。通过查阅近年来国内外文献并进行归纳总结，综述了近红外光谱分析技术在原料药与辅料质量控制、药物理化参数分析、药物活性组分分析等领域的应用，为原料药的质量控制与药物生产的在线监控提供参考。

As a nondestructive, low cost, fast acquisition and on-line analytical technique, near-infared reflectance spectroscopy had significant meaning for strengthening the quality control of drug manufacturing and improving the on-line monitoring of production process. The author arrangemented the documents to review the research progress on application of near-infrared reflectance spectroscopy in quality control of raw material, drug physicochemical analysis, active pharmaceutical ingredient analysis, and provide references for controlling of raw material and on-line monitoring of pharmaceutical production.

“十二五”国家科技计划——创新中药关键技术国家重点实验室，国家自然科学基金资助项目（21275162）