Research Article AMetabolomics-Based Strategy for the Quality Control of Traditional ChineseMedicine: Shengmai Injection as a Case Study

Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Quality control of traditional Chinese medicines (TCMs) used clinically is becoming a challenge and has limited the development of TCM due to the high variability in concentration levels of active ingredients and markers as well as the lack of well-established criteria. �sing Shengmai in�ection, which is a well-established TCM, as an example, we developed an integrated pro�ling approach that simultaneously captures the entire spectrum of ingredients and quantitatively determines the levels of seven key ingredients in the TCM product. A multivariate statistical model was constructed to establish a “seven-marker- ” based quality standard that quali�ed the ma�ority of samples in this study. is newly developed strategy showed that a panel of key ingredients or markers in the TCM product were relatively consistent within a statistically acceptable range. erefore, this metabolomics-based approach will complement the current quality control standard using the concentration of several key ingredients or their total content and help improve the consistency and clinic efficacy of TCM products. 1