Researches on detection of related substances in drugs

Abstract

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.