药物中相关物质的检测研究

Yanjun Hao, Jianzhong Qi, Hongli Wang, Lu Dai, Lei Shi, Haigang Chen
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引用次数: 0

摘要

药品的生产非常复杂。在制备和运输过程中,不可避免地会混合少量的反应原料、中间体和储存降解产物,从而影响药物的质量。药品的质量不仅影响疗效,还会产生不可预测的副作用和毒性,直接关系到人们的生命健康。药品质量检测一直是人们关注的焦点。相关物质研究是药品质量研究的重点项目之一,其含量是药品纯度的直接指标。因此,建立药物相关物质的含量标准和开发相关物质的检测方法具有重要意义。药物的相关物质种类繁多,理化性质不同,降解产物等相关物质的成分需要进一步分析,难以有效应用检测方法。经过多年的研究,相关物质的检测方法不断更新和完善。目前,相关物质的检测方法涉及物理、化学等领域,包括化学方法、色谱法和光谱学。综述了近年来药物中有关物质检测方法的研究进展,总结了检测方法的类型、特点和应用范围,为化学合成药物和中药的质量控制提供参考。因此,这项工作为开发更准确、更高效的检测方法提供了新的思路。
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Researches on detection of related substances in drugs
The production of drugs is very complicated. In the process of preparation and transportation, mixing a small amount of reaction raw materials, intermediates, and storage degradation products is inevitable, which affect the quality of drugs. The quality of drugs not only affects the efficacy, but also produces unpredictable side effects and toxicity, which is directly related to people's life and health. The detection of drug quality has always been the focus of attention. Related substance research is one of the key projects in drug quality research, and its content is a direct indicator of drug purity. Therefore, it is very important to establish the content standard of drug related substances and develop the detection method of related substances. The related substances of drugs are rich in variety, with different physical and chemical properties, and the components of related substances, such as degradation products need further analysis, which makes it difficult to effectively apply the detection methods. After years of research, the detection methods of related substances are constantly updated and improved. At present, the detection methods of related substances involve physical, chemical, and other fields, including chemical methods, chromatography, and spectroscopy. In this paper, the research progress of detection methods for related substances in drugs in recent years was reviewed, and the types, features, and application scope of detection methods were summarized, providing reference for quality control of chemical synthetic drugs and traditional Chinese medicines. Therefore, this work provides new ideas for the development of more accurate and efficient detection methods.
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