近红外光谱技术在药品质量控制中的应用与研究进展

发布时间：2018-02-04 02:29

本文关键词： 近红外光谱技术来源控制过程控制上市后监控应用研究　出处：《中国药房》2017年33期 　论文类型：期刊论文

【摘要】：目的:为借助近红外光谱技术高效、全面地控制药品质量提供参考。方法:查阅近年发表的近红外光谱技术用于药品质量控制的相关研究文献,进行归纳、总结和综述。结果与结论:近红外光谱技术可广泛用于药品来源的质量控制(包括中药材产地及品种、中药饮片和药品原辅料鉴别)、生产过程的质量控制(包括对中药材有效成分的提取、纯化、浓缩和药品混合均匀度的监控)以及上市后监控(包括水分测定、真伪鉴别和非法添加检测)。近红外光谱技术具有操作简便、无损、快速、无需试剂等优点,在药品质量控制中的应用前景广阔,但对于其普及应用的一些制约因素仍需加大研究投入、加以解决。
[Abstract]:Objective: to provide a reference for the comprehensive control of drug quality by means of near infrared spectroscopy (NIR). Methods: to review the literature published in recent years on the application of NIR spectroscopy in drug quality control and summarize it. Results and conclusion: Near-infrared spectroscopy can be widely used in the quality control of drug sources (including the origin and variety of traditional Chinese medicine, the identification of traditional Chinese medicine pieces and pharmaceutical raw materials). Quality control of the production process (including the extraction, purification, concentration and mixture uniformity monitoring of Chinese medicinal materials) and post-marketing monitoring (including moisture determination). Near-infrared spectroscopy (NIR) has the advantages of simple operation, nondestructive, fast and no reagents, so it has a broad application prospect in drug quality control. However, some restrictive factors of its popularization and application still need to increase the research input and solve it.
【作者单位】：西安市食品药品检验所;
【基金】：陕西省中医管理局中医药科研课题资助项目(No.13-ZY004)
【分类号】：O657.33;R927
【正文快照】： 随着人们对物质生活水平的要求越来越高,慢性病发病率逐年攀升。许多中老年人甚至部分年轻人需要每日服用药物来维持正常的生活。近年来,重大药品安全事件时有发生,如“齐二药事件”“欣弗事件”“刺五加事件”“毒胶囊事件”“茯苓山药片假药事件”等,给制药企业、经营单位以

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