近红外光谱法在兽药生产全过程质量控制中的应用展望

Prospects for the Application of Near-Infrared Spectrometry in Process Quality Control of Veterinary Drugs

关键词:  近红外光谱法  药物分析  质量控制  全过程分析技术

Key words:  Near-infrared spectrometry (NIRS)  pharmaceutical analysis  quality control  process analytical technology (PAT)

摘要:

近红外光谱法（Near-Infrared Spectrometry, NIRS）作为全过程分析技术（Process Analytical Technology, PAT）的关键工具，自2004年美国食品药品监督管理局提出以来，在制药领域应用广泛。然而，在兽药生产质量控制中，NIRS的应用尚不充分。本文综述了NIRS的基本原理，并探讨了其在药品生产全过程质量控制中的应用现状。通过分析NIRS在原料检验、生产过程监控及成品检测中的应用，展现了其在提高生产效率、确保药品质量方面的潜力。同时，文章展望了NIRS技术在兽药生产中的未来发展趋势，包括技术优化、标准建立及多领域融合应用，以期为兽药行业的智能化、精准化生产提供技术支持。

Abstract:

Near-Infrared Spectrometry (NIRS), as a key tool of Process Analytical Technology (PAT), has been widely applied in the pharmaceutical field since it was proposed by the U.S. Food and Drug Administration in 2004. However, the application of NIRS in the quality control of veterinary drug production is still insufficient. This paper summarizes the basic principles of NIRS and discusses the current status of its application in the quality control of the whole process of pharmaceutical production. By analyzing the application of NIRS in raw material inspection, production process monitoring and finished product inspection, it shows its potential in improving production efficiency and ensuring drug quality. At the same time, the article looks forward to the future development trend of NIRS technology in veterinary medicine production, including technology optimization, standard establishment and multidisciplinary integration application, with a view to providing technical support for intelligent and precise production in the veterinary medicine industry.