Paper
WANG Yan, REN Zhiyong, SHI Zhaoyong, WU Tong, OUYANG Danwei,
An ultra-high performance liquid chromatography fingerprint and multi-component determination
method were established for Danshen injection(DSI), and chemical pattern recognition was combined to evaluate the quality
of different batches of DSI. The separation was performed on a Waters ACQUITY UPLC HSS T3 column(2.1 mm×100 mm,
1.8 μm) with gradient elution using 0.5％ phosphoric acid aqueous solution and acetonitrile as the mobile phases at a flow
rate of 0.4 mL/min. The column temperature was 40 ℃ and the detection wavelength was 286 nm. The fingerprints of
13 batches of DSI were established, with inter-batch similarity values all greater than 0.98. A total of 25 common peaks
were calibrated, and 14 of them were identified by reference substances, namely 5-hydroxymethylfurfural(1), salvianic
acid A sodium(2), protocatechuic acid(3), protocatechualdehyde(4), caffeic acid(5), isoferulic acid(6), salvianolic
acid F(7), salvianolic acid D(8), rosmarinic acid(9), salvianolic acid E(10), lithospermic acid(11), salvianolic acid
B(12), salvianolic acid A(13) and salvianolic acid Y(14). The above 14 components were subjected to multi-component
quantitative analysis, and principal component analysis(PCA) and orthogonal partial least squares-discriminant
analysis(OPLS-DA) were applied to screen out the main differential components, which were 1, 3, 6, 7, 9, 12 and 13. The
results showed that DSI from different batches exhibited good quality stability, and the established fingerprint and multicomponent
determination method were stable and reliable, which could provide a scientific basis for quality evaluation and
standard establishment.
