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Published on: March 11, 2021
Digital characterization and quality assessment of Yangxue Anshen tablet: A combined approach utilizing
Mengfan Bao1, Sha Yang1, Mengfan Zhang1
1School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, Liaoning, 110016, China.
Abstract:
Yangxue Anshen Tablet (YAT), composed of seven traditional Chinese medicines (TCMs) used for the treatment of palpitations, dizziness and insomnia, has not been adequately studied concerning quality control and active ingredient determination. This research developed a multi-dimensional fingerprinting system that integrated chromatographic, spectral, and thermal analyses by combining multiple mathematical models to address this gap and establish a rapid quality assessment strategy. First, a five-wavelength fusion HPLC fingerprint, FTIR fingerprint, and DSC fingerprint were established to evaluate YAT holistically. The similarity of the three fingerprints was assessed using the binary quantified fingerprint method (BQFM). Meanwhile, the FTIR and DSC data were preprocessed using the characteristic concatenation method (CCM) to generate the corresponding quantum fingerprint (QFP). Four components were quantified using standard curve method (SCM) and single linear multi-marker method (SLM). Various preprocessing methods and spectral bands were examined to establish quantitative prediction model for FTIR using the partial least squares regression PLSR (P > 0.7). Antioxidant activity was analyzed using IC50 values, and overall quality was ranked by applying criteria importance through intercriteria correlation (CRITIC). Qualitatively, 17 samples showed high consistency (Sf > 0.88). Quantitatively, 11 batches of samples were categorized into grades 1-3, while another four batches were categorized into grades 4-6 due to lower Pf; two batches were categorized due to higher Pf. In summary, the strategy proposed in this study can enhance the quality control of TCM and other complex drugs, and provide a theoretical basis for the subsequent study of their biological activities.

