Abstract
An attempt was made to characterize the pharmacokinetic profiles of Qishen Keli (QSKL) that has been widely proved to be effective in clinical practice. A method using ultra-high performance liquid chromatography coupled with tandem mass spectrometry (UHPLC-MS/MS) for the simultaneous determination of 25 analytes in rat plasma was developed and validated. Satisfactory chromatographic separation was achieved on an ACQUITY UPLC HSS T3 column with gradient elution using mobile phase consisting of 0.02% aqueous formic acid (A) and acetonitrile fortified with 0.02% formic acid (B), and analyte detection was carried out using polarity-switching multiple reaction monitoring mode. Method validation assays in terms of selectivity, linearity, inter- and intra-day variations, matrix effect, and recovery demonstrated the newly developed method to be specific, sensitive, accurate, and precise. Following the oral administration of QSKL at a single dose, the qualified method was successfully applied for pharmacokinetic investigations in sham and model rats. Mild differences occurred for the pharmacokinetic patterns of most components between those two groups, whereas significant differences were observed for glycyrrhizic acid and glycyrrhetic acid. The obtained findings could provide meaningful information for the clarification of the effective material basis of QSKL.
Highlights
Traditional Chinese medicines (TCMs) are playing an increasingly crucial role for the treatment of various chronic disorders, because they are multi-component and multi-target agents, leading to a holistically therapeutic action for multi-factorial diseases [1,2,3,4,5]
It is very difficult to achieve chromatographic profiles for TCM-treated endogenous substances found satisfactory in plasma
The positive and negative ionization modes were compared, and the results proved that the positive mode could provide higher responses for some analytes, such as benzoylmesaconine, benzoylhypaconine, aconitine, hypaconitine, dihydrotanshinone I, cryptotanshinone, tanshinone I and tanshinone IIA, and IS2, whereas the other analytes including harpagide, morroniside, sweroside, liquiritin apioside, liquiritin, luteoloside, isoacteoside, isoliquiritin, harpagoside, liquiritigenin, luteolin, calycosin, isoliquiritigenin, glycyrrhizic acid, formononetin, licochalcone A, and glycyrrhetic acid, and IS1 were found to be more suitable for negative polarity
Summary
Traditional Chinese medicines (TCMs) are playing an increasingly crucial role for the treatment of various chronic disorders, because they are multi-component and multi-target agents, leading to a holistically therapeutic action for multi-factorial diseases [1,2,3,4,5]. Because exposureto a component in the circulation system is the prerequisite for efficacy in most cases, it is thereby viable to characterize the effective constituents via profiling the compounds and assessing their exposure patterns in plasma. Molecules 2017, 22, 1853 different pharmacokinetic profiles can usually observed between normal and pathological subjects, attributing to their different physiological status; pharmacokinetic comparisons should provide direct clues for the characterization of therapeutic components. Multi-component pharmacokinetic evaluation [6,7,8,9], especially comparison between normal and diseased groups, is a feasible approach to find the ingredients being responsible for TCM efficacy.
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