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
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.