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Pharmacokinetics of bioactive components after oral administration of Bojungikgi-tang in Korean subjects

Journal of Pharmaceutical Investigation 2020년 50권 6호 p.593 ~ 602
최은정, 최고운, 김주희, 김숙진, 권영달, 조해영,
소속 상세정보
최은정 ( Choi Eun-Jeong ) - CHA University College of Pharmacy
최고운 ( Choi Go-Wun ) - CHA University College of Pharmacy
김주희 ( Kim Ju-Hee ) - CHA University College of Pharmacy
김숙진 ( Kim Sook-Jin ) - CHA University College of Pharmacy
권영달 ( Kwon Young-Dal ) - Wonkwang University College of Korean Medicine Gwangju Medical Center Clinical Trial center
조해영 ( Cho Hea-Young ) - CHA University College of Pharmacy

Abstract


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.

키워드

Pharmacokinetics; Clinical trials; Ginsenoside Rb1; Glycyrrhizin; 18-β-glycyrrhetinic acid; Bojungikgi-tang soft extract; traditional herbal medicine

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