Pharmacokinetics of bioactive components after oral administration of Bojungikgi-tang in Korean subjects
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Journal of Pharmaceutical Investigation https://doi.org/10.1007/s40005-020-00488-7
ORIGINAL ARTICLE
Pharmacokinetics of bioactive components after oral administration of Bojungikgi‑tang in Korean subjects Eun‑Jeong Choi1 · Go‑Wun Choi1 · Ju Hee Kim1 · Sook‑Jin Kim2 · Young‑Dal Kwon3 · Hea‑Young Cho1 Received: 30 November 2019 / Accepted: 25 April 2020 © The Korean Society of Pharmaceutical Sciences and Technology 2020
Abstract Purpose The purpose of this study to establish the safety and efficacy data of 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 noncompartmental (NCA) analyses to assess PK parameters. Results The PK parameters of ginsenoside Rb1 (Rb1) and GL (glycyrrhizin) 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 GLA (glycyrrhetinic acid). 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. Keywords Pharmacokinetics · Clinical trials · Ginsenoside Rb1 · Glycyrrhizin · 18-β-glycyrrhetinic acid · Bojungikgi-tang soft extract; traditional herbal medicineintroduction
Introduction
Eun-Jeong Choi and Go-Wun Choi have contributed equally to this work. * Hea‑Young Cho [email protected] Eun‑Jeong Choi [email protected]
Bojungikgi-tang (BJIGT) is a traditional medicine that has been derived from Bu-Zhong-Yi-Qi-Tang (BJIGT in China) in “Treatise on Spleen and Stomach” by Ligao in 1249. Since then, variations of Bu-Zhong-Yi-Qi-Tang have been used for 1
College of Pharmacy, CHA University, 335 Pangyo‑ro, Bundang‑gu, Seongnam‑si, Gyeonggi‑do 13488, Republic of Korea
2
Herbal Medicine Research Division, Ministry of Food and Drug Safety, National Institute of Food and Drug Safety Evaluation, 187 Osongsaengmyeong 2‑ro, Osong‑eup, Heungdeok‑gu, Cheongju‑si, Chungcheongbuk‑do 28159, Republic of Korea
3
Clinical Trial Center, Gwangju Medical Center, College of Korean Medicine, Wonkwang University, Gwangju, Republic of Korea
Go‑Wun Choi [email protected] Ju Hee Kim [email protected] Sook‑Jin Kim [email protected] Young‑Dal Kwon kwo
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