漢方注射剤の品質一貫性のためのデジタル多次元フィンガープリンティングと単線形法定量

Traditional Chinese medicine (TCM) injections require stringent batch-to-batch quality control. This study established a digital, multidimensional fingerprinting workflow for Ixeris sonchifolia (Bunge) Hance injection (ISHI), integrating: (i) five-wavelength HPLC fusion fingerprints, (ii) UV quantum fingerprints, (iii) equal-weight ratio quantitative fingerprinting with reliability theory, (iv) multi-component assay via a monolinear method, and (v) antioxidant activity profiling. Across 17 batches, the macro-qualitative similarity S_r from HPLC was ≥ 0.99, and the macro-quantitative similarity P_r fell within the accepted range of 89.6-106.0 %. UV quantum fingerprinting classified the batches into three quality tiers (P_r = 89.2-112.1 %). Data fusion (HPLC + UV) reduced result dispersion (RSD 4.07 %) compared to individual methods (HPLC 4.90 %, UV 5.99 %), demonstrating superior robustness. The monolinear multi-component method yielded contents closely matching those from the full calibration curve method and generally showed better agreement than the quantitative analysis of multi-components by a single marker method, enabling cost-efficient routine quantification. Reliability indices for single batches exceeded 0.98 for both macro-qualitative (SR) and macro-quantitative (PR) reliability, and the reference fingerprint exhibited near-ideal reliability. DPPH radical scavenging activity (IC50) correlated with specific fingerprint peaks, notably phenolic acids, linking chemical profiles to biological function. This integrated digital approach provides a practical and scalable strategy for enhancing quality consistency assessment of ISHI and related TCM injections.