[Research progress on quality control detection techniques and limit-based safety risk assessment of toxic components...

The safety quality control of traditional Chinese medicine(TCM) and its preparation has become a key focus in the field of TCM, mainly involving exogenous harmful substances and endogenous toxic components. Exogenous harmful substances are prone to residual presence or exceedance of limits in TCM and its preparation, while endogenous toxic components may lead to toxic residues due to the inherent characteristics of TCM. Although the toxicological properties of the two differ, both require management through scientific safety control measures. This article systematically reviewed the safety quality control measures for toxic components in TCM and its preparation, analyzed the influence of pharmaceutical processes on toxic and harmful substances, and summarized the detection techniques and applicable risk assessment models for toxic components. On this basis, the article identified the existing problems in current safety risk assessment and limit standards and proposed targeted suggestions, aiming to provide technical references for the quality control of toxic components in TCM and its preparation and promote the improvement of their safety control system.