Assessment of a dry extract from milk thistle (Silybum marianum) for interference with human liver cytochrome-P450 activities

Toxicology in Vitro

Volumn 25, Issue 1, 2011, Pages 21-27

  Doehmer, Johannes ^a   Weiss, Gabriele ^b   McGregor, Gerard P ^b   Appel, Kurt ^c  

^a GenPharmTox BioTech AG   (Germany)

^b Pascoe Pharmazeutische Praeparate GmbH Giessen   (Germany)

^c VIVACELL BIOTECHNOLOGY GMBH   (Germany)

Author keywords

Cytochrome P450; Drug drug interaction; Herbal drugs; Silybum marianum

Indexed keywords

CYTOCHROME P450 3A4; HEPAR PASC; SILYBUM MARIANUM EXTRACT; UNCLASSIFIED DRUG;

ARTICLE; CONCENTRATION PROCESS; CONTROLLED STUDY; CYTOTOXICITY TEST; DRUG ISOLATION; ENZYME ACTIVITY; ENZYME INDUCTION; ENZYME INHIBITION; ENZYME KINETICS; FOOD AND DRUG ADMINISTRATION; HUMAN; LIVER MICROSOME; LIVER TOXICITY; NONHUMAN;

ARYL HYDROCARBON HYDROXYLASES; CELL SURVIVAL; CELLS, CULTURED; CYTOCHROME P-450 ENZYME SYSTEM; ENZYME INDUCTION; ENZYME INHIBITORS; HEPATOCYTES; HERB-DRUG INTERACTIONS; HUMANS; INHIBITORY CONCENTRATION 50; KINETICS; MICROSOMES, LIVER; MILK THISTLE; PLANT EXTRACTS; SEEDS; SILYMARIN;

SILYBUM MARIANUM;

EID: 78650521620     PISSN: 08872333     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.tiv.2010.09.001     Document Type: Article

References (10)

1. Beckmann-Knopp S., Rietbrock S., Weyhenmeyer R., Böcker R.K., Beckurts T., Lang W., Hunz M., Fuhr U. Inhibitory effects of silibinin on cytochrome P450 enzymes in human liver microsomes. Pharmacol. Toxicol. 2000, 86:250-256.
2. BfArM, 2004. Erläuterungen zum Vorgehen bei der Beurteilung von in vitro Untersuchungen pharmakokinetischer Interaktionen mit Phytopharmaka.
3. Bjornsson T.D., Callaghan J.T., Einolf H.J., Fischer V., Gan L., Grimm S., Kao J., King S.P., Miwa G., Ni L., Kumar G., McLeod J., Obach R.S., Roberts S., Roe A., Shah A., Snikeris F., Sullivan J.T., Tweedle D., Vega J.M., Walsh J., Wrighton S.A. The conduct of in vitro and in vivo drug-drug interaction studies: a Pharmaceutical Research and Manufacturers of America (PhRMA) perspective. Drug Metab Dispos. 2003, 31:815-832.
4. EMEA Committee for Proprietary Medicinal Products: Note for Guidance on the Investigation of Drug Interactions (CPMP/EWP/560/95) 1997, The European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit.
5. FDA, 2006. Guidance for Industry: Drug Interaction Studies and Implication for Dosing and Labelling. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072101.pdf.
6. Flora K., Hahn M., Rosen H., Benner K. Milk thistle (Silybum marianum) for the therapy of liver disease. Am. J. Gastroenterol. 1998, 93:139-143.
7. Gazak R., Walterova D., Kren V. Silybin and silymarin-new and emerging applications in medicine. Curr. Med. Chem. 2007, 14:315-338.
8. Izzo A.A., Ernst E. Interactions between herbal medicines and prescribed drugs: an updated systematic review. Drugs 2009, 69:1777-1798.
9. Sridar C., Goosen T.C., Kent U.M., Williams J.A., Hollenberg P.F. Silybin inactivates cytochromes P450 3A4 and 2C9 and inhibits major hepatic glucuronosyltransferases. Drug Metab. Dispos. 2004, 32:587-594.
10. Weyhenmeyer R., Mascher H., Birkmayer J. Study on dose-linearity of the pharmacokinetics of silibinin diastereomers using a new stereospecific assay. Int. J. Clin. Pharmacol. Ther. Toxicol. 1992, 30:134-138.