Comprehensive comparison of the anti‐inflammatory activity and chemical consistency of traditional Chinese medicine formula granules with Ge‐Gen decoction as a representative sample

Abstract Traditional Chinese medicine formula granules (TCMFGs), an advanced dosage form of traditional Chinese medicine, are entering the market on a large scale. However, little attention has been paid to the simultaneous efficacy assessment and quality control of this advanced dosage form. In this study, a comprehensive comparison of the pharmacological activity and chemical consistency of TCMFGs from different manufacturers was performed. Ge‐Gen decoction (GGD) samples were used as the target TCMFG. The in vitro anti‐inflammatory effects among different types of GGDs indicate that all of them showed different abilities to reduce the lipopolysaccharide‐activated production of nitric oxide, interleukin‐1β (IL‐1β), IL‐6 and tumor necrosis factor‐α. The results from a dimethylbenzene‐induced inflammation model in mice indicated that the nine samples in this study showed significant in vivo anti‐inflammatory effects. Qualitative and quantitative analyses were performed by multiwavelength ultra‐high‐performance liquid chromatography with diode array detection and electrospray ionization with quadrupole time‐of‐flight–tandem mass spectrometry. To visually interpret the differences in the chemical materials, a scatter plot analysis was performed. According to the scatter plot analysis, nine compounds were evaluated as important contributors to the differences. This is the first report of TCMFGs on the basis of the spectrum‐effect consistency.