近红外光谱技术在化学药物快速质量控制中应用进展

Research Progress in the Application of Infrared Reflectance Spectroscopy in Quick Quality Control of Chemical Drugs

近红外光谱技术(NIRS)是一种环保、高效、便捷、无损、准确的绿色定性定量分析技术,目前广泛应用于中药、化学药物、生物制剂等药物的定性定量分析、制剂生产过程控制及药品监管多个领域。本文查阅近年来国内外关于NIRS在化学药物质量控制研究文献,总结NIRS在化学药物定性鉴别、定量分析、水分测定、中药添加化学药物、药物制剂过程质量控制及药动学研究等应用情况、存在的问题及发展前景,以期推动NIRS在化学药物快速质量控制中更为广泛的应用。

Near infrared spectroscopy(NIRS)is an eco-friendly,efficient,convenient,non-destructive,accurate and green analysis technology,which is widely used for the quality control,production process control and supervision of traditional Chinese medicine,chemical drugs and biological medicine.In this paper,the literature on application of NIRS method in the qualitative and quantitative analysis of chemical drugs,moisture content determination,chemical drugs added to traditional Chinese medicine,online monitoring of pharmaceutical production processes and pharmacokinetic studies in recent years were reviewed.Moreover,the key problems and prospects of the applications were also discussed,so as to provide help for the quality control of chemical drugs by NIRS in the future.