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GU Yunshuang, WANG Rui, SU Na, PENG Ying, A Jiye, WANG Guangji, ZHENG Yiwen, SUN Jianguo. Pharmacokinetic study of Erlong Zuoci Pill in rats[J]. Journal of China Pharmaceutical University, 2022, 53(4): 481-489. DOI: 10.11665/j.issn.1000-5048.20220411
Citation: GU Yunshuang, WANG Rui, SU Na, PENG Ying, A Jiye, WANG Guangji, ZHENG Yiwen, SUN Jianguo. Pharmacokinetic study of Erlong Zuoci Pill in rats[J]. Journal of China Pharmaceutical University, 2022, 53(4): 481-489. DOI: 10.11665/j.issn.1000-5048.20220411
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Pharmacokinetic study of Erlong Zuoci Pill in rats

  • 1.

    Jiangsu Provincial Key Laboratory of Drug Metabolism and Pharmacokinetics, Research Unit of PK-PD Based Bioactive Components and Pharmacodynamic Target Discovery of Natural Medicine of Chinese Academy of Medical Sciences, China Pharmaceutical University, Nanjing 210009, China

  • 2.

    Department of Pharmacology and Toxicology, School of Biomedical Sciences, University of Otago, Dunedin 9054, New Zealand

Funds: This study was supported by the National Key R&D Program "Intergovernmental International Cooperation in Science and Technology Innovation" Key Special Funding Project (No.2017YFE0109600) and the Innovation Fund for Medical Sciences of Chinese Academy of Medical Sciences (No.2021-I2M-5-011)
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  • Received Date: April 08, 2022
  • Revised Date: June 13, 2022
    Graphical Abstract
    • Abstract
  • To establish a quantitative LC-MS/MS method for the simultaneous detection of components of Erlong Zuoci Pill in rat plasma: verbascoside, oxypaeoniflorin, echinacoside and benzoylpaeoniflorin, and to evaluate the pharmacokinetic characteristics of Erlong Zuoci Pill in rats, plasma samples were purified by protein precipitation using methanol as a protein precipitant.Methanol was used as the organic phase and aqueous solution containing 0.1% formic acid was used as the water phase.The quantitative analysis method of verbascoside, oxypaeoniflorin, echinacoside and benzoylpaeoniflorin was established in negative ion mode, and the validation of bioanalytical method was carried out.Healthy SD rats were selected, and 20 mL/kg (equivalent to the original drug 10 g/kg dose) of Erlong Zuoci Pill extract was administered by intragastric administration.The plasma concentration of the target compounds at different time intervals after administration was determined using the established method, and the pharmacokinetic parameters was calculated by the Phoenix WinNonlin8.3 software using the non-compartmental model.The method validation results showed that verbascoside (r = 0.993 7) and oxypaeoniflorin (r = 0.994 6) had good linear relationship in the concentration range of 0.5-50 ng/mL, echinacoside (r = 0.993 6) and benzoylpaeoniflorin (r = 0.992 6) had good linear relationship in the concentration range of 1-100 ng/mL.The relative standard deviations of the inter- and intra- batch precision of the four compounds were all less than 15%, and the inter- batch and intra- accuracies were between 85% and 115%.Extraction recovery, matrix effect and stability met the relevant requirements.After a single gavage of Erlong Zuoci Pill extract in rats, all the four compounds were rapidly absorbed and eliminated.Oxypaeoniflorin, echinacoside, and benzoylpaeoniflorin showed two peaks in their drug concentration-time curves.Compared with the other three compounds, oxypaeoniflorin has the highest concentration in rat plasma with cmax1 of (24.40 ± 4.78) ng/mL and cmax2 of (22.50 ± 2.70) ng/mL. The results show that the validation results of this method are in line with the guiding principles of biological sample analysis methods, and it can be used to evaluate the pharmacokinetic characteristics of Erlong Zuoci Pill extract in rats.
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