The pharmacokinetic characters of simvastatin after co-administration with Shexiang Baoxin Pill in healthy volunteers’ plasma

• Investigated the interaction of pharmacokinetcs of Shexiang Baoxin Pill (SBP) and simvastatin.
• The MRT(0–∞), T1/2 and Tmax values of simvastatin were significantly increased by SBP.
• The AUC(0–t) and Cmax values of smivastatin were also significantly decreased by SBP.
• The potential drug–drug interaction should be noted in the future clinical practice.

To investigate the effect of Shexiang Baoxin Pill (SBP), a tranditional Chinese medicine, on the pharmacokinetic (PK) parameters of simvastatin in healthy volunteers’ plasma, a quantitative method was developed using an Agilent G6410A rapid performance liquid chromatography (RPLC) coupled with triple quadrupole mass spectrometry system. The established method was rapid with high extraction recovery and successfully applied for the determination of simvastatin in plasma of 16 healthy volunteers. The results demonstrated that the MRT(0–∞), T1/2 and Tmax value of simvastatin were significantly decreased, while the AUC(0–t) and Cmax values of smivastatin were increased by SBP. The pharmacokinetic study demonstrated that the metabolism parameters of simvastatin could be affected by SBP and the potential drug–drug interaction should be noted in the future clinical practice.