Work

Construction and Application of an Integrated “Chemical–Biological” Dual‐Core Quality Evaluation System for Salvia miltiorrhiza

Year: 2026

Type: article

Abstract: BACKGROUND AND AIM: Practical implementation of integrated chemical-biological quality control in Traditional Chinese Medicine (TCM) remains challenging. This study used Salvia miltiorrhiza as a model to develop an exploratory integrated quality-evaluation strategy that combines chemical profiling with a standardized in vitro relative-potency assay. METHODS: Chemical characterization of 58 batches included UPLC fingerprinting and quantification of 10 constituents. Relative biological potency was evaluated using a parallel-line assay in an H9c2 cardiomyoblast oxygen-glucose deprivation/reoxygenation (OGD/R) model. RESULTS: Across the 58 commercial batches, fingerprint similarity ranged from 0.469 to 0.997 and the total content of the 10 quantified compounds ranged from 1.36% to 8.27%. Total tanshinones showed greater interbatch variation (CV = 55.2%) than total phenolic acids (CV = 46.2%). Four batches did not satisfy the statistical validity criteria of the parallel-line model and were therefore nonreportable; two of these batches showed no conspicuous abnormality in the routine quantitative indicators. Among the 54 reportable batches, relative potency ranged from 57.6 to 276.5 U/mg and correlated moderately with total quantified content (r = 0.719, p < 0.001). Partial least squares regression identified salvianolic acid B, rosmarinic acid, cryptotanshinone, and tanshinone IIA as chemical variables statistically associated with the in vitro response. The median-based four-quadrant analysis flagged chemical-biological discordance in 10 of 54 batches (18.5%). CONCLUSION: The integration of chemical profiling with a standardized cell-based relative potency assay enabled multidimensional assessment of S. miltiorrhiza quality by simultaneously characterizing batch composition, biological response, and their concordance. This approach provides a practical basis for identifying quality variations that may not be captured by chemical analysis alone and supports the development of more comprehensive quality-evaluation strategies for botanical drugs.

Source: Phytochemical Analysis

DOI: 10.1002/pca.70091