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자료유형
학술저널
저자정보
Choi Eun-Jeong (College of Pharmacy CHA University) 최고운 (차의과학대학교) 김주희 (차의과학대학교) Kim Sook-Jin (Herbal Medicine Research Division Ministry of Food and Drug Safety) Kwon Young-Dal (College of Korean Medicine Wonkwang University) Cho Hea-Young (College of Pharmacy CHA University)
저널정보
한국약제학회 Journal of Pharmaceutical Investigation Journal of Pharmaceutical Investigation 제50권 제6호
발행연도
2020.1
수록면
593 - 602 (10page)

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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 Win- Nonlin (version 8.1, Pharsight ®, a Certara™ Company, Princeton, NJ, USA) was used to conduct compartmental and noncompartmental (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 (AUC 0-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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