医药质量检测关键技术及其应用综述

Review on key technologies and applications of pharmaceutical quality testing

医药产品种类多样、生产工艺复杂,传统人工检测已不能满足高端医药发展的需求,而迫切需要对医药检测技术进行革新。医药产业是维系国民健康、关涉国计民生的重要产业,故医药质量检测环节必不可少。首先简要介绍了医药检测的对象及标准,重点综述了医药可见异物检测、药物成分检测和包装缺陷等质量检测进展情况,分析了国家药典中多类型药品的现行检测标准。在此基础上,阐述了最新的医药检测关键技术如X射线检测技术、高光谱检测技术、机器视觉的检测技术等,并讨论了医药检测关键技术在多类型药品检测中的应用,最后重点探讨了医药质量检测技术的发展趋势。

Pharmaceuticals are numerous in variety and their production processes are complicated. Traditional manual testing can no longer meet the needs of high-end pharmaceutical development, which necessitates innovation in pharmaceutical testing technology. Pharmaceutical industry is an important industry relating to national health and concerning national economy and people′s livelihood, testing the quality of pharmaceutical is indispensable. Firstly, this paper briefly introduces the objects and standards of pharmaceutical testing, emphasizingly reviews the progress of the quality inspections, including foreign matter testing, pharmaceutical ingredient testing and defective packaging testing, etc., and analyzes the current testing standards for many types of medicines in Chinese Pharmacopoeia. On this basis, this paper expounds the advanced pharmaceutical testing key technologies, such as X-ray testing, hyperspectral testing and machine vision testing, etc. and discusses the applications of the pharmaceutical testing key technologies in the testing of many types of medicines. Finally, the development trend of these pharmaceutical quality testing technologies is explored emphasizingly.