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Published on: November 4, 2022
Comprehensive evaluation of quality consistency of Kangshou Pills using digital fingerprinting, dissolution behavior
Xuan Li1, Tao Jiang2, Honghui Cheng3
1School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, Liaoning, 110016, China.
Objective:
To overcome the limitations of single-component quality control in traditional Chinese medicine (TCM) formulations, this study developed an integrated chemical-antioxidant activity evaluation strategy for assessing the quality consistency of Kangshou Pills (KSPs).
Methods:
Thirty production batches of KSPs were analyzed using six-wavelength fusion fingerprinting (SWFFP). Chemical consistency was evaluated using the systematic quantitative fingerprint method (SQFM). Additionally, the dissolution profiles of overall compounds were determined by ultraviolet full-wavelength dissolution fingerprinting, and subsequently analyzed using the f2 factor method and dissolution-systematically quantified fingerprint method (DSQFM). The dissolution amount of 2,3,5,4'-tetrahydroxystyrene-2-O-β-d-glucoside (THSG) was measured by HPLC to validate the UV-based results. Furthermore, antioxidant activity was determined using the 1,1-diphenyl-2-picryl-hydrazyl radical (DPPH) radical scavenging assay. Partial least squares (PLS) regression was employed to establish spectrum-effect relationships between chromatographic data and antioxidant efficacy.
Results:
SWFFP identified 26 common peaks with high batch-to-batch consistency (Sm > 0.97; 88.2 < Pm< 121.6 %), as confirmed by SQFM parameters and multivariate analysis. Notably, twenty-four batches showed good dissolution consistency (f2 > 50; 90 % < Pdm < 110 %). THSG dissolution profiles showed excellent correlation between predicted and measured values (r > 0.98). PLS and additional analyses demonstrated that most compounds in KSPs possess antioxidant activity, including two quantitative markers: THSG and emodin.
Conclusion:
The established multi-dimensional approach successfully integrates chemical fingerprinting with antioxidant activity evaluation, thereby providing a scientifically robust framework for quality assessment of KSPs. This strategy enables comprehensive "quality-efficacy" evaluation and offers a reproducible model for quality standardization of TCM formulations.
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