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KMID : 1146920200500060593
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Journal of Pharmaceutical Investigation
2020 Volume.50 No. 6 p.593 ~ p.602
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Pharmacokinetics of bioactive components after oral administration of Bojungikgi-tang in Korean subjects
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Choi Eun-Jeong
Choi Go-Wun
Kim Ju-Hee
Kim Sook-Jin
Kwon Young-Dal
Cho Hea-Young
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Abstract
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Purpose: 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.
Methods: 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.
Results: 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.
Conclusion: 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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KEYWORD
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Pharmacokinetics, Clinical trials, Ginsenoside Rb1, Glycyrrhizin, 18-β-glycyrrhetinic acid, Bojungikgi-tang soft extract, traditional herbal medicine
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