An evaluation strategy of high-quality traditional Chinese patent medicines with consistency as the core: A case study of Huoxiang Zhengqi Shui

To promote the development of high-quality Chinese patent medicine (CPM), we previously proposed a quality consistency evaluation (QCE) strategy based on intra- and inter-batch differences. In this study, Ultra-high performance liquid chromatography coupled with triple quadrupole mass spectrometry and gas chromatography coupled with triple quadrupole mass spectrometry (UPLC/GC-QQQ-MS) were separately developed and applied to determine non-volatile and volatile index components’ contents, representing the quality attributes of different raw medicines from Huoxiang Zhengqi Shui (HXZQS). Furthermore, the LPS-induced RAW264.7 cell model was applied to evaluate NO inhibitory activity, which ranged from 24.52% to 76.95%. Then the QCE strategy was applied to distinguish between superior and inferior levels from different manufacturer′s products based on the consistency of chemical contents and bioactivity. The results showed that intra-batch consistency (11.96% ‒ 47.93%) was better than inter-batch consistency (8.53% ‒ 131.25%), and inter-batch difference was the key factor affecting the quality consistency. The correlation coefficient (0.516) of chemical contents and NO inhibition rate suggested that their consistency basically followed a similar trend. The results were further graded by PCA analysis, where M7, M15, M6, M16, M3, and M5 were the best six manufacturers, and M7 had the highest content. Whereas M12 and M13 had the worst consistency and the lowest content. This study aimed to guide manufacturers to focus on process design and quality control, which not only improves the quality and safety of CPM but also promotes innovation and development of the pharmaceutical industry.