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| DBS method with traditional sampling method for comparative study of human pharmacokinetics test |
| Hits 1789 Download times 1771 Received:October 23, 2014 |
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| DOI
10.11656/j.issn.1672-1519.2015.02.02 |
| Key Words
DBS;Reduning injection;geniposide;pharmacokinetics;comparative study |
| Author Name | Affiliation | E-mail | | NI Tian-qing | Clinical Research Institute Office, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
| | | SI Duan-yun | State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin 300301, China | | | HU Si-yuan | Clinical Research Institute Office, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
| HSY008@163.com | | WEI Guang-li | State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin 300301, China | | | XIA Yuan-yuan | State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin 300301, China | |
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| Abstract
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| [Objective] Application of DBS method in Reduning injection pharmacokinetics test, and comparison of plasma collection results of traditional methods. [Methods] The elbow vein blood taken from the volunteers, some blood was quantitative analysis by LC-MS/MS quantitative analysis. We separated of the remaining blood plasma, analysis of blood drug concentration of geniposide and genipin,shanzhiside gentian diglucoside. Chromatographic column Ecosil C18 (150 mm×4.6 mm, 5 um), the mobile phase methanol, 20 mM ammonium formate, 0.1%formic acid, 10% methanol, Velocity 0.5 mL/min, sample size 10 uL. Mass spectrometric detection using ESI ion source, the MRM positive ion detection mode, acquisition time of 11 min. [Results] A single intravenous infusion of Reduning injection, the blood concentration of blood cell volume determination of three kinds of gardenia component with DBS after correction, geniposide, shanzhiside, genipin gentian diglucoside in peak time (Tmax) were 1.41, 1.47, 1.47 h. The peak concentration (Cmax) were 4.580, 0.285, 0.550 ug/mL. The area under the concentration time curve (AUC0-t) were 9.060, 0.638, 1.200(ug•h)/mL. The average dwell time (MRT0-t) were 1.52, 1.49, 1.45 h. [Conclusion] It is consistent of blood drug concentration and pharmacokinetic parameters about the shanzhiside, genipin gentian diglucoside plasma method and DBS method (after correction). It indicates that DBS method can replace the traditional plasma processing method in pharmacokinetic studies of drug stability ingredient. |
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