Pharmacokinetic profiles of active ingredients and its metabolites derived from rikkunshito, a ghrelin enhancer, in healthy Japanese volunteers: A cross-over, randomized study

PLoS ONE

Volumn 10, Issue 7, 2015, Pages

  Kitagawa, Hiroyuki ^a   Munekage, Masaya ^a   Matsumoto, Takashi ^b   Sadakane, Chiharu ^b   Fukutake, Miwako ^b   Aoki, Katsuyuki ^b   Watanabe, Junko ^b   Maemura, Kazuya ^b   Hattori, Tomohisa ^b   Kase, Yosio ^b   Uezono, Yasuhito ^c   Inui, Akio ^d   Hanazaki, Kazuhiro ^a  

^a KOCHI UNIVERSITY   (Japan)

^b TSUMURA AND CO   (Japan)

^c NATIONAL CANCER CENTER RESEARCH INSTITUTE   (Japan)

^d KAGOSHIMA UNIVERSITY   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

3,3',4',5,6,7,8 HEPTAMETHOXYFLAVONE; ATRACTYLODIN; ATRACTYLODIN CARBOXYLIC ACID; GLYCYRRHETINIC ACID; ISOLIQUIRITIGENIN; KAMPO; LIQUIRITIGENIN; NARINGENIN; NOBILETIN; PACHYMIC ACID; PLANT MEDICINAL PRODUCT; RIKKUNSHITO; UNCLASSIFIED DRUG; CHALCONE DERIVATIVE; FLAVONOID; HERBACEOUS AGENT; HESPERIDIN; LIU-JUN-ZI-TANG; TRITERPENE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD ANALYSIS; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG URINE LEVEL; FEMALE; HUMAN; HUMAN EXPERIMENT; JAPANESE (PEOPLE); MALE; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; TRADITIONAL MEDICINE; URINALYSIS; CHEMISTRY;

ADULT; CHALCONES; DRUGS, CHINESE HERBAL; FEMALE; FLAVONOIDS; HEALTHY VOLUNTEERS; HESPERIDIN; HUMANS; MALE; TRITERPENES;

EID: 84941363643     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0133159     Document Type: Article

References (30)

1. Fujitsuka N, Asakawa A, Uezono Y, Minami K, Yamaguchi T, Niijima A, et al. Potentiation of ghrelin signaling attenuates cancer anorexia-cachexia and prolongs survival. Translational Psychiatry. 2011; 1: e23. doi: 10.1038/tp.2011.25 PMID: 22832525
2. Suzuki H, Matsuzaki J, Fukushima Y, Suzaki F, Kasugai K, Nishizawa T, et al. Randomized clinical trial: rikkunshito in the treatment of functional dyspepsia-a multicenter, double-blind, randomized, placebo-controlled study. Neurogastroenterol Motil. 2014; 26: 950-61. doi: 10.1111/nmo.12348 PMID: 24766295.
3. Sakata Y, Tominaga K, Kato M, Takeda H, Shimoyama Y, Takeuchi T, et al. Clinical characteristics of elderly patients with proton pump inhibitor-refractory non-erosive reflux disease from the G-PRIDE study who responded to rikkunshito. BMC Gastroenterol. 2014; 14: 116. doi: 1471-230X-14-116 PMID: 24990161. doi: 10.1186/1471-230X-14-116
4. Tominaga K, Kato M, Takeda H, Shimoyama Y, Umegaki E, Iwakiri R, et al. A randomized, placebo-controlled, double-blind clinical trial of rikkunshito for patients with non-erosive reflux disease refractory to proton-pump inhibitor: the G-PRIDE study. Journal of Gastroenterology. 2014. doi: 10.1007/s00535-013-0896-9 PMID: 24535455.
5. Tokita Y, Satoh K, Sakaguchi M, Endoh Y, Mori I, Yuzurihara M, et al. The preventive effect of Daikenchuto on postoperative adhesion-induced intestinal obstruction in rats. Inflammopharmacology. 2007; 15: 65-6. doi: 10.1007/s10787-006-1552-2 PMID: 17450444.
6. Munekage M, Kitagawa H, Ichikawa K, Watanabe J, Aoki K, Kono T, et al. Pharmacokinetics of daikenchuto, a traditional Japanese medicine (kampo) after single oral administration to healthy Japanese volunteers. Drug Metab Dispos. 2011; 39: 1784-8. doi: 10.1124/dmd.111.040097 PMID: 21724872.
7. Nishi A, Yamaguchi T, Sekiguchi K, Imamura S, Tabuchi M, Kanno H, et al. Geissoschizine methyl ether, an alkaloid in Uncaria hook, is a potent serotonin (1)A receptor agonist and candidate for amelioration of aggressiveness and sociality by yokukansan. Neuroscience. 2012; 207: 124-36. doi: 10.1016/j.neuroscience.2012.01.037 PMID: 22314317.
8. Kushida H, Fukutake M, Tabuchi M, Katsuhara T, Nishimura H, Ikarashi Y, et al. Simultaneous quantitative analyses of indole and oxindole alkaloids of Uncaria Hook in rat plasma and brain after oral administration of the traditional Japanese medicine Yokukansan using high-performance liquid chromatography with tandem mass spectrometry. Biomed Chromatogr. 2013; 27: 1647-56. doi: 10.1002/bmc.2974 PMID: 23813572.
9. Kojima M, Hosoda H, Date Y, Nakazato M, Matsuo H, Kangawa K. Ghrelin is a growth-hormone-releasing acylated peptide from stomach. Nature. 1999; 402: 656-60. PMID: 10604470
10. Asakawa A, Inui A, Kaga T, Yuzuriha H, Nagata T, Ueno N, et al. Ghrelin is an appetite-stimulatory signal from stomach with structural resemblance to motilin. Gastroenterology. 2001; 120: 337-45. PMID: 11159873
11. Nakazato M, Murakami N, Date Y, Kojima M, Matsuo H, Kangawa K, et al. A role for ghrelin in the central regulation of feeding. Nature. 2001; 409: 194-8. PMID: 11196643
12. Wren AM, Small CJ, Ward HL, Murphy KG, Dakin CL, Taheri S, et al. The novel hypothalamic peptide ghrelin stimulates food intake and growth hormone secretion. Endocrinology. 2000; 141: 4325-8. PMID: 11089570
13. Mondal MS, Date Y, Yamaguchi H, Toshinai K, Tsuruta T, Kangawa K, et al. Identification of ghrelin and its receptor in neurons of the rat arcuate nucleus. Regulatory peptides. 2005; 126: 55-9. PMID: 15620414
14. Takeda H, Sadakane C, Hattori T, Katsurada T, Ohkawara T, Nagai K, et al. Rikkunshito, an herbal medicine, suppresses cisplatin-induced anorexia in rats via 5-HT2 receptor antagonism. Gastroenterology. 2008; 134: 2004-13. doi: 10.1053/j.gastro.2008.02.078 PMID: 18439428
15. Yakabi K, Kurosawa S, Tamai M, Yuzurihara M, Nahata M, Ohno S, et al. Rikkunshito and 5-HT2C receptor antagonist improve cisplatin-induced anorexia via hypothalamic ghrelin interaction. Regulatory peptides. 2010; 161: 97-105. doi: S0167-0115(10)00039-X PMID: 20171995. doi: 10.1016/j.regpep.2010.02.003
16. Fujitsuka N, Asakawa A, Hayashi M, Sameshima M, Amitani H, Kojima S, et al. Selective serotonin reuptake inhibitors modify physiological gastrointestinal motor activities via 5-HT2c receptor and acyl ghrelin. Biological psychiatry. 2009; 65: 748-59. doi: 10.1016/j.biopsych.2008.10.031 PMID: 19058784
17. Sadakane C, Muto S, Nakagawa K, Ohnishi S, Saegusa Y, Nahata M, et al. 10-Gingerol, a component of rikkunshito, improves cisplatin-induced anorexia by inhibiting acylated ghrelin degradation. Biochem Biophys Res Commun. 2011; 412: 506-11. doi: S0006-291X(11)01378-7 PMID: 21846463. doi: 10.1016/j.bbrc.2011.08.002
18. Gardana C, Guarnieri S, Riso P, Simonetti P, Porrini M. Flavanone plasma pharmacokinetics from blood orange juice in human subjects. Br J Nutr. 2007; 98: 165-72. doi: 10.1017/S0007114507699358 PMID: 17367568.
19. Krahenbuhl S, Hasler F, Frey BM, Frey FJ, Brenneisen R, Krapf R. Kinetics and dynamics of orally administered 18 beta-glycyrrhetinic acid in humans. J Clin Endocrinol Metab. 1994; 78: 581-5. doi: 10.1210/jcem.78.3.8126129 PMID: 8126129.
20. Kanaze FI, Bounartzi MI, Georgarakis M, Niopas I. Pharmacokinetics of the citrus flavanone aglycones hesperetin and naringenin after single oral administration in human subjects. European journal of clinical nutrition. 2007; 61: 472-7. doi: 10.1038/sj.ejcn.1602543 PMID: 17047689.
21. Gough K, Hutchison M, Keene O, Byrom B, Ellis S, Lacey L, et al. Assessment of Dose Proportionality: Report from the Statisticians in the Pharmaceutical Industry/Pharmacokinetics UK Joint Working Party. Drug Information Journal. 1995; 29: 1039-48. doi: 10.1177/009286159502900324
22. Smith BP, Vandenhende FR, DeSante KA, Farid NA, Welch PA, Callaghan JT, et al. Confidence interval criteria for assessment of dose proportionality. Pharm Res. 2000; 17: 1278-83. PMID: 11145235.
23. Nahata M, Muto S, Nakagawa K, Ohnishi S, Sadakane C, Saegusa Y, et al. Serotonin 2C receptor antagonism ameliorates novelty-induced hypophagia in aged mice. Psychoneuroendocrinology. 2013. doi: S0306-4530(13)00109-1 PMID: 23583320.
24. Youdim KA, Dobbie MS, Kuhnle G, Proteggente AR, Abbott NJ, Rice-Evans C. Interaction between flavonoids and the blood-brain barrier: in vitro studies. J Neurochem. 2003; 85: 180-92. doi: 1652 PMID: 12641740.
25. Kawakami Z, Ikarashi Y, Kase Y. Glycyrrhizin and its metabolite 18 beta-glycyrrhetinic acid in glycyrrhiza, a constituent herb of yokukansan, ameliorate thiamine deficiency-induced dysfunction of glutamate transport in cultured rat cortical astrocytes. Eur J Pharmacol. 2010; 626: 154-8. doi: 10.1016/j.ejphar.2009.09.046 PMID: 19818347.
26. Lee KK, Omiya Y, Yuzurihara M, Kase Y, Kobayashi H. Antispasmodic effect of shakuyakukanzoto extract on experimental muscle cramps in vivo: role of the active constituents of Glycyrrhizae radix. J Ethnopharmacol. 2013; 145: 286-93. doi: 10.1016/j.jep.2012.11.005 PMID: 23164761.
27. Kanno H, Kawakami Z, Tabuchi M, Mizoguchi K, Ikarashi Y, Kase Y. Protective effects of glycycoumarin and procyanidin B1, active components of traditional Japanese medicine yokukansan, on amyloid beta oligomer-induced neuronal death. J Ethnopharmacol. 2015; 159: 122-8. doi: 10.1016/j.jep.2014.10.058 PMID: 25446602.
28. Conn JW, Rovner DR, Cohen EL. Licorice-induced pseudoaldosteronism. Hypertension, hypokalemia, aldosteronopenia, and suppressed plasma renin activity. JAMA. 1968; 205: 492-6. PMID: 5695305.
29. Makino T. 3-Monoglucuronyl glycyrrhretinic acid is a possible marker compound related to licoriceinduced pseudoaldosteronism. Biol Pharm Bull. 2014; 37: 898-902. doi: DN/JST.JSTAGE/bpb/b13-00997 PMID: 24882402.
30. Hisada T, Maki A, Katori M. Adverse Drug Reaction Frequency Investigation of TSUMURA Yokukansan Extract Granules for Ethical Use. Diagnosis and treatment. 2014; 102: 1577-89.