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.

盛迈配方（SMF）是著名的中药（TCM）配方，近1000年来一直广泛用于治疗由气阴两虚引起的疾病。但是，关于其批次间质量控制系统的研究很少阐明，并且质量控制标记仍未显露，这阻碍了SMF的开发和利用。在这项研究中，我们旨在筛选最佳质量控制标记，以评估SMF的整体质量一致性。首次建立了高效液相色谱（HPLC）指纹图谱，并结合了相似性分析（SA），主成分分析（PCA）和层次聚类分析（HCA），以寻找导致不同批次SMF之间化学不一致的可鉴别成分。 。后来，通过中性红法，Cell Counting Kit-8（CCK-8）测定法和酶联免疫吸附测定（ELISA）选择不同批次的样品以探索其免疫调节活性。最后，使用灰色关联分析（GRA），偏最小二乘回归（PLSR）分析和人工神经网络（ANN）分析，进一步阐明了指纹功效关系，以发现主要的生物活性成分。结果，选择了五味子酚A，五味子酚B，甲基邻苯二酚A，五味子素B，人参皂苷Rf，人参皂苷Rb1，人参皂苷Rg2和人参皂苷Rb2作为质量控制指标，因此同时进行了定量分析以评估批次之间的批次。不同批次的SMF之间的化学和生物活性一致性。