Study on quality and the determination of main components in Zaoren Anshen Liquid based on fingerprint combined with chemometrics

WANG Shao-qing; SUN Hui-zhu; SU Jian; PAN Mei-lu; LIU Ying-jie; LIU Xue-li

doi:10.20251/j.cnki.1003-3734.2025.13.013

Abstract：Objective:To establish a high-performance liquid chromatography(HPLC)fingerprint and multi-index component content determination method for Zaoren Anshen Liquid,and to evaluate the differences of Zaoren Anshen Liquid between different manufacturers and different batches of the same manufacturer in combination with chemometrics.Methods:HPLC method was adopted with CAPCELL PAK C18 column(250 mm×4.6 mm,5 μm)used with acetonitrile-0.1%phosphoric acid solution as the mobile phase for gradient elution.The flow rate was set at1.0 mL·min-1,and the injection volume was10 μL.The detection wavelength was320 nm and 250 nm,and the column temperature set at 30℃.The similarity evaluation was performed using the"TCM Chromatographic Fingerprint Similarity Evaluation System"(2012 Edition).Combined with cluster analysis in SPSS 27.0 software and orthogonal partial least squares discriminant analysis in SIMCA 14.0 software,the results of sample content determination were analyzed,and the important projection values of analysis variables were used to screen the markers affecting its quality.By comparing with self-made simulated preparations,the sources of differences between different enterprises were explored.Results:The fingerprint of Zaoren Anshen Liquid was established,and 6 characteristic peaks were confirmed.The similarity of the fingerprint from 13 batches of Zaoren Anshen Liquid was above 0.85 except for the sample of A enterprise.The determination method of six characteristic components of spinosin,6‴-feruloylspinosin,rosmarinic acid,salvianolic acid B,schisandrin and schisandrin B was investigated.Chemometric analysis showed that different batches of samples from the same production enterprise could be obviously clustered into one category,and differences appeared in Zaoren Anshen Liquid from different enterprises.The differential components of the samples were schisandrin and spinosin.Compared with the simulated preparation,it was inferred that the decrease of schisandrin B content was caused by the change of pH value during the decoction process.Conclusion:The established HPLC fingerprint and multi-index component determination method are accurate and simple.Combined with chemometric analysis,the quality of Zaoren Anshen Liquid can be comprehensively evaluated.