The purpose of this study to establish the safety and efficacy data of Bojungikgi-tang (BJIGT) soft extract by determining the clinical pharmacokinetics (PKs) of its main ingredients and their active metabolites after oral administration.
A randomized, open-label, single-dose, single-center study on 12 healthy Korean male subjects was conducted. The plasma concentration of the active ingredients in BJIGT soft extract was determined in UPLC-MS/MS. Phoenix WinNonlin (version 8.1, Pharsight®, a Certara™ Company, Princeton, NJ, USA) was used to conduct compartmental and non-compartmental (NCA) analyses to assess PK parameters.
The PK parameters of ginsenoside Rb1 (Rb1) and glycyrrhizin (GL) were well described with 1-compartment analysis without lag time, and the 1-compartment model with combined transit compartment model and first-order absorption was used to evaluate the parameters of glycyrrhetinic acid (GLA). PK parameters of Rb1, GL and GLA including the clearance (CL/F), the volume of distribution (V/F), the rate of absorption (Ka), the maximum concentration (Cmax), time to reach maximum concentration (Tmax), the area under the curve of a plasma concentration versus time profile (AUC0-inf), and the elimination half-life (T1/2) were successfully estimated.
This is the first report to evaluate the PKs of major active ingredients and their metabolites after oral administration of BJIGT soft extract to Korean subjects.
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This work was supported by a grant of the National Development Institute of Korean Medicine funded by the Korean Ministry of Health and Welfare, Republic of Korea.
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All authors declare that they have no conflict of interest.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the Institutional Review Board of Oriental Medicine Hospital of Wonkwang University (WKIRB approval number:2017–09) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was confirmed by the Institutional Review Board of Oriental Medicine Hospital of Wonkwang University.
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Choi, EJ., Choi, GW., Kim, J.H. et al. Pharmacokinetics of bioactive components after oral administration of Bojungikgi-tang in Korean subjects. J. Pharm. Investig. 50, 593–602 (2020). https://doi.org/10.1007/s40005-020-00488-7
- Clinical trials
- Ginsenoside Rb1
- 18-β-glycyrrhetinic acid
- Bojungikgi-tang soft extract; traditional herbal medicine