Pharmacokinetics of (-)Epicatechin 3-O-Gallate, Glycyrrhetic Acid and Rhein in Healthy Male Volunteers after a Single Dose Administration of TJ-8117 (Unpito), a Japanese Traditional Medicine for Renal Failure

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概要

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• Aims: Unpito, an herbal medicine extracted from a mixture of five crude medicines (Rhei Rhizoma, Glycyrrhizae Radix, Ginseng Radix, Zingiberis Rhizoma and Aconiti Tuber), has been developed as a drug for chronic renal failure. In general, it is difficult to estimate the absorption and excretion of herbal medicines due to the presence of a wide variety of components. The purpose of the current study was to examine the systemic pharmacokinetics and elimination of Unpito in healthy volunteers as part of the clinical study of the medicine. Methods: Three compounds, (-)epicatechin 3-O-gallate (ECG), glycyrrhetic acid (GA) and rhein (RH) were selected as markers, to examine the clinical pharmacokinetics of Unpito based on their levels in this medicine. The disposition of each compound was evaluated in 32 healthy volunteers receiving single oral doses (2, 4, 8, and 12 capsules). Results: After a single oral administration, ECG and RH exhibited linear pharmacokinetics in AUC and C max, while GA did not exhibit linear pharmacokinetics. A cross-over study was conducted to evaluate the effect of food at a single dose of 4 capsules. The effect of food was observed for the plasma concentrations of ECG and RH, while not for GA. The potential accumulations of δ-(3,4- dihydroxyphenyl)-γ-valerolactone (VL-2), a metabolite of ECG and RH were not observed. GA was not detected in urine. Conclusions: This is the first study presenting pharmacokinetics of ECG, GA and RH derived from Unpito, an herbal medicine, in healthy volunteers after single dose administration.

• 日本臨床薬理学会 = The Japanese Society of Clinical Pharmacology and Therapeuticsの論文
• 2006-01-31

著者

• Yamaguchi Takuji

  ツムラ中央研究所

• 油田 正樹

  Res. Inst. Of Pharmaceutical Sciences Musashino Univ.

• 油田 正樹

  Medicinal Evaluation Laboratory Tsumura Research Institute

• Kase Y

  Tsumura Research Laboratories Tsumura & Co.

• Kase Yoshio

  ツムラ漢方生薬研究所

• Kase Yoshio

  国立長寿医療センター研究所 老年病研究部

• Kase Yoshio

  Central Research Laboratory Tsumura & Co.

• Aburada M

  Fac. Of Pharmacy Musashino Univ.

• Aburada M

  Tsumura Research Inst. Pharmacology Ibaraki Jpn

• 加瀬 義夫

  津村薬理研究所

• TAKIZAWA Yukiho

  Pharmacology Research Department, Central Research Laboratories, R & D Division, Tsumura & Co.

• MIZUHARA Yasuharu

  Pharmacology Research Department, Central Research Laboratories, R & D Division, Tsumura & Co.

• MORITA Toshimi

  Pharmacology Research Department, Central Research Laboratories, R & D Division, Tsumura & Co.

• KASE Yoshio

  Pharmacology Research Department, Central Research Laboratories, R & D Division, Tsumura & Co.

• TAKEDA Shuichi

  Pharmacology Research Department, Central Research Laboratories, R & D Division, Tsumura & Co.

• ABURADA Masaki

  Pharmacology Research Department, Central Research Laboratories, R & D Division, Tsumura & Co.

• Yuzurihara Mitsutoshi

  Tsumura Research Laboratories Tsumura & Co.

• Yuzurihara Mitsutoshi

  Central Research Laboratory Tsumura & Co.

• Yuzurihara Mitsutoshi

  Kampo & Parmacognosy Laboratory Tsumura & Co.

• Miyamoto Ken-ichi

  金沢大学 薬学部臨床薬物情報

• Miyamoto Ken-ichi

  Dep. Of Clinical Pharmacy Graduate School Of Natural Sci. And Technol. Kanazawa Univ.

• Morota Takashi

  Botanical Raw Materials Research Department Tsumura & Co.

• Morota Takashi

  Botanical Raw Materials Research Dept. Tsumura & Co.

• Yanagisawa T

  New Drug Discovery Laboratories R&d Division Tsumura & Co. Ltd.

• 竹田 秀一

  Tsumura & Co. Tsumura Res. Laboratories

• MIYAMOTO Ken-ichi

  Hospital Pharmacy, School of Medicine Kanazawa University

• 油田 正樹

  ツムラ研究本部 医薬評価研究所

• Takizawa Yukiho

  Medicinal Evaluation Laboratory Tsumura & Co.:department Of Medicinal Informatics Graduate Schoo

• Miyaamoto Ken-ichi

  Department Of Medical Informatics Graduate School Of Medical Science Kanazawa University

• Mizuhara Yasuharu

  Medicinal Evaluation Laboratory Tsumura & Co.:department Of Medicinal Informatics Graduate Schoo

• Yanagisawa Toshihiko

  Tsumura&co.

• Yanagisawa Toshihiko

  Central Research Laboratories Tsumura & Co.

• Morota Takashi

  Pharmacognosy And Medicinal Resources Research Department Central Research Laboratories Tsumura &

• Kase Yoshio

  ツムラツムラ研究所

• Miyamoto K

  Department Of Hospital Pharmacy School Of Medicine Kanazawa University

• Miyamoto K

  Kanazawa Univ. Hospital Ishikawa Jpn

• Aburada Masaki

  Musashino Univ. Tokyo Jpn

• Miyamoto Ken'ichi

  Hospital Pharmacy School Of Medicine Kanazawa University

• Miyamoto Ken-ichi

  Department of Clinical Pharmacy, Graduate School of Natural Science and Technology, Kanazawa University

• Kase Yoshihiro

  Pharmacology Research Department, Central Research Laboratories, R & D Division, Tsumura & Co.

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