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

Abstract

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.