Title:Researches on Detection of Related Substances in Drugs
Volume: 19
Issue: 6
Author(s): Jianzhong Qi, Hongli Wang, Lu Dai, Lei Shi, Yanjun Hao*Haigang Chen*
Affiliation:
- Liaoning Academy of Traditional Chinese
Medicine, Liaoning University of Traditional Chinese Medicine, No.79 East Chongshan Road, Shenyang, 110032,
Liaoning, China
- China Resources Chenzhou Pharmaceutical Co. Ltd. Chenzhou, 423000, China
Keywords:
Drugs, related substances, detection methods, research progress, chromatography, spectroscopy.
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.