Overall quality control of the chemical and bioactive consistency of ShengMai Formula.

ABSTRACT

ShengMai Formula (SMF), a famous traditional Chinese medicine (TCM) formula, has been extensively used for treating the diseases caused by Qi-Yin deficiency for almost 1000 years. However, few studies are elucidated about its batch-to-batch quality control system and the quality control markers remain largely unrevealed, which have hindered the development and utilization of SMF. In this study, we aimed to screen the optimal quality control markers to evaluate the overall quality consistency of SMF. High-performance liquid chromatography (HPLC) fingerprint coupled with similarity analysis (SA), principal components analysis (PCA) and hierarchical cluster analysis (HCA) was firstly established to hunt for the discriminant components that resulting in the chemical inconsistence among different batches of SMF. Subsequently, different batches of samples were selected to explore their immunomodulatory activities by neutral red method, Cell Counting Kit-8 (CCK-8) assay and enzyme-linked immunosorbent assay (ELISA). Finally, the fingerprint-efficacy relationships were further illuminated to discover the major bioactive compositions using grey relational analysis (GRA), partial least squares regression (PLSR) analysis and artificial neural network (ANN) analysis. As a result, schisandrol A, schisandrol B, methylophiopogonanone A, schisandrin B, ginsenoside Rf, ginsenoside Rb1, ginsenoside Rg2 and ginsenoside Rb2 were selected as the quality control markers and thus their simultaneous quantification was performed to both evaluate the batch-to-batch chemical and bioactive consistency among different batches of SMF. Our investigation not only stresses the necessity of consistency in efficacy besides chemical consistency, but also provides a comprehensive and powerful quality assessment approach, which is promising to monitor the overall quality consistency of SMF.