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Monograph: Quercetin

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. Notes: (i) Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion. (ii) The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant. (iii) A claim for traditional use must include the term "Herbal Medicine".

Date: 2012-11-27

NHPID Name

Quercetin (O'Neil et al. 2012)

Proper Name(s)

Common Name(s)

Quercetin ( ChemID 2012 , Merck 2012 )

Source Material


Route Of Administration

Oral

Dosage Form(s)

The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets. This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

Dose(s)

Adults:

Antioxidant
Dose(s): not to exceed 1200 Milligrams per day
Directions For Use: For products providing doses that are 40-1200 mg per day, the following statement is required:
Take in 2 or 3 divided doses. Take with food/meals.

Capillary/blood vessel protectant
Dose(s): 600 - 1200 Milligrams per day
Directions For Use:
  • Take in 2 or 3 divided doses
  • Take with food/meals

Duration of use

For products providing  40 - 1200 Milligrams per day :
For use beyond 12 weeks, consult a health care practitioner  (NS 2012, Harwood et al. 2007, Boyle et al. 2000)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
For products providing 40 - 1200 Milligrams per day:
If pregnant or breastfeeding, consult a health care practitioner prior to use

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
No statement is required

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database and must meet the limitations outlined in the database.

Storage Conditions

Store in a light-resistant container (Ph.Eur. 2013).

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredients Database (NHPID). In addition, the medicinal ingredient may comply with the quality specifications outlined in the Quercetin dihydrate monograph in the British and European Pharmcopoeias.

References cited

  • Boots AW, Haenen GR, Bast A. Health effects of quercetin: from antioxidant to nutraceutical. European Journal of Pharmacology 2008;582(2-3):325-37.
  • Boots AW, Li H, Schins RP, Duffin R, Heemskerk JW, Bast A, Haenen GR. The quercetin paradox. Toxicology and Applied Pharmacology 2007;222(1):89-96.
  • Boyle SP, Dobson VL, Duthie SJ, Hinselwood DC, Kyle JAM, Collins AR. Bioavailability and efficiency of rutin as an antioxidant: a human supplementation study. European Journal of Clinical Nutrition 2000;54(10):774-784.
  • BP 2012: British Pharmacopoeia 2012. Volume I. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA); 2012.
  • ChemID 2012: ChemIDplus advanced [Internet]. Bethesda (MD): United States National Library of Medicine; 2011. [Quercetin: CAS # 117-39-5; Accessed 2012 May 02]. Available from: http://chem.sis.nlm.nih.gov/chemidplus
  • Duke 1992: Dr. Duke's Phytochemical and Ethnobotanical Databases. Plants containing quercetin, 1992 [Internet]. [Accessed 2012 November 26]. Available from: http://www.ars-grin.gov/duke
  • Duke JA. Handbook of Phytochemical Constituents of GRAS Herbs and Other Economic Plants. Boca Raton (FL): CRC Press; 2001.
  • Egert S, Wolffram S, Bosy-Westphal A, Boesch-Saadatmandi C, Wagner AE, Frank J, Rimbach G, Mueller MJ. Daily quercetin supplementation dose-dependently increases plasma quercetin concentrations in healthy humans. The Journal of Nutrition 2008;138,1615-1621.
  • Egert S, Wolffram S, Schulze B, Langguth P, Hubbermann EM, Schwarz K, Adolphi B, Bosy-Westphal A, Rimbach G, Müller MJ. Enriched cereal bars are more effective in increasing plasma quercetin compared with quercetin from powder-filled hard capsules. The British Journal of Nutrition 2012;107(4):539-546.
  • Erlund I, Marniemi J, Hakala P, Alfthan G, Meririnne E, Aro A. Consumption of black currants, lingonberries and bilberries increases serum quercetin concentrations. European Journal of Clinical Nutrition 2003;57(1):37-42.
  • Hakkinen SH, Kärenlampi SO, Heinonen IM, Mykkänen HM, Törrönen AR. Content of the flavonols quercetin, myricetin, and kaempferol in 25 edible berries. Journal of Agricultural and Food Chemistry 1999;47(6):2274-2279.
  • Harborne JB, Baxter H, Moss GP, editors. Phytochemical Dictionary: A Handbook of Bioactive Compounds from Plants. 2nd edition. Philadelphia (PA): Taylor & Francis Ltd; 1999.
  • Harwood M, Danielewska-Nikiel B, Borzelleca JF, Flamm GW, Williams GM, Lines TC. A critical review of the data related to the safety of quercetin and lack of evidence of in vivo toxicity, including lack of genotoxic/carcinogenic properties. Food and Chemical Toxicology 2007;45(11):2179-2205.
  • Kite GC, Stoneham CA, Veitch NC. Flavonol tetraglycosides and other constituents from leaves of Styphnolobium japonicum (Leguminosae) and related taxa. Phytochemistry 2007;68(10):1407-1416.
  • Lamson DW, Brignall MS. Antioxidants and cancer, part 3: quercetin. Alternative Medicine Review 2000;5(3):196-208.
  • Martindale 2011: Sweetman SC, editor. Martindale: The Complete Drug Reference [Internet]. London (GB): Pharmaceutical Press; 2012. [Quercetin: CAS: 117-39-5, latest modification: 05-Dec-2011; Accessed 2012 May 11]. Available from: http://www.medicinescomplete.com
  • Merck 2012: The Merck Index Version 14.1. [Internet]. Whitehouse Station (NJ): Merck & Co., Inc. Copyright © 2006, 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. [Accessed 2012 November 23]. Available from: http://www.knovel.com
  • Murray MT, Bongiorno PB. Flavonoids—Quercetin, Citrus Flavonoids, and Hydroxyethylrutosides. In: Pizzorno JE, Murray MT, editors. Textbook of Natural Medicine, Third edition, volume 1. St. Louis (MI): Churchill Livingstone Elsevier; 2006. p. 967-973.
  • NS 2012: Natural Standard. Quercetin. Copyright 2012 [Internet]. [Accessed 2012 May 07]. Available from: http://www.naturalstandard.com
  • PDR 2008: Hendler SS, Rorvik D. PDR for Nutritional Supplements. Second edition. Montvale (NJ): Thomson Healthcare; 2008.
  • Ph.Eur. 2013: European Pharmacopoeia. 7th edition. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM); 2012.
  • PubChem 2004: National Center for Biotechnology Information. PubChem Compound Database; CID 5280343 Create Date: 2004-09-16 [Internet]. [Accessed 2012 May 24]. Available from: http://pubchem.ncbi.nlm.nih.gov/
  • Utesch D, Feige K, Dasenbrock J, Broschard TH, Harwood M, Danielewska-Nikiel B, Lines TC. Evaluation of the potential in vivo genotoxicity of quercetin. Mutation Research 2008;654(1):38-44.
  • Wang L, Lee IM, Zhang SM, Blumberg JB, Buring JE, Sesso HD. Dietary intake of selected flavonols, flavones, and flavonoid-rich foods and risk of cancer in middle-aged and older women. Am J Clin Nutr. 2009 Mar;89(3):905-12. Epub 2009 Jan 21.

References reviewed

  • Bae SC, Jung WJ, Lee EJ, Yu R, Sung MK. Effects of antioxidant supplements intervention on the level of plasma inflammatory molecules and disease severity of rheumatoid arthritis patients. Journal of the American College of Nutrition 2009 Feb;28(1):56-62.
  • Boots AW, Li H, Schins RP, Duffin R, Heemskerk JW, Bast A, Haenen GR. The quercetin paradox. Toxicology and Applied Pharmacology 2007;222(1):89-96.
  • Cai J, Nelson KC, Wu M, Sternberg P Jr, Jones DP. Oxidative damage and protection of the RPE. Progress in Retinal and Eye Research 2000;19(2):205-221.
  • Chan MM, Mattiacci JA, Hwang HS, Shah A, Fong D. Synergy between ethanol and grape polyphenols, quercetin, and resveratrol, in the inhibition of the inducible nitric oxide synthase pathway. Biochemical Pharmacology 2000;60(10):1539-1548.
  • Chuang CC, Martinez K, Xie G, et al. Quercetin is equally or more effective than resveratrol in attenuating tumor necrosis factor-{alpha}-mediated inflammation and insulin resistance in primary human adipocytes. American Journal of Clinical Nutrition 2010; 92(6):1511-21.
  • Edwards RL, Lyon T, Litwin SE, Rabovsky A, Symons JD, Jalili T. Quercetin reduces blood pressure in hypertensive subjects. Journal of Nutrition 2007;137(11):2405-2411.
  • Egert S, Bosy-Westphal A, Seiberl J, Kürbitz C, Settler U, Plachta-Danielzik S, Wagner AE, Frank J, Schrezenmeir J, Rimbach G, Wolffram S, Müller MJ. Quercetin reduces systolic blood pressure and plasma oxidised low-density lipoprotein concentrations in overweight subjects with a high-cardiovascular disease risk phenotype: a double-blinded, placebo-controlled cross-over study. British Journal of Nutrition 2009; 102(7):1065-1074.
  • Feres CA, Madalosso RC, Rocha OA, Leite JP, Guimaraes TM, Toledo VP, Tagliati CA. Acute and chronic toxicological studies of Dimorphandra mollis in experimental animals. Journal of Ethnopharmacology 2006;108(3):450-456.
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  • Giuliani C, Noguchi Y, Harii N, Napolitano G, Tatone D, Bucci I, Piantelli M, Monaco F, Kohn LD. The flavonoid quercetin regulates growth and gene expression in rat FRTL-5 thyroid cells. Endocrinology 2008;149(1):84-92.
  • Guardia T, Rotelli AE, Juarez AO, Pelzer LE. Anti-inflammatory properties of plant flavonoids. Effects of rutin, quercetin, and hesperidin on adjuvant arthritis in rat. Farmaco Journal 2001;56(9):683-687.
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  • Nieman DC, Henson DA, Gross SJ, Jenkins DP, Davis JM, Murphy EA, Carmichael MD, Dumke CL, Utter AC, McAnulty SR, McAnulty LS, Mayer EP. Quercetin reduces illness but not immune perturbations after intensive exerciseMedicine & Science in Sports & Exercise 2007;39(9):1561-1569.
  • Otshudi AL, Foriers A, Vercruysse A, Van Zeebroeck A, Lauwers S. In vitro antimicorbial activity of six medicinal plants traditionally used for the treatment of dysentery and diarrhoea in Democratic Republic of Congo (DRC). Phytomedicine 2000;7(2):167-172.
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  • Ramos S. Effects of dietary flavonoids on apoptotic pathways related to cancer chemoprevention. Journal of Nutritional Biochemistry 2007;18(7):427-42.
  • Ruiz PA, Braune A, Holzlwimmer G, Quintanilla-Fend L, Haller D. Quercetin inhibits TNF-induced NF-kappaB transcription factor recruitment to proinflammatory gene promoters in murine intestinal epithelial cells. Journal of Nutrition 2007;137(5):1208-15.
  • Shoskes DA, Zeitlin SI, Shahed A, Rajfer J.. Quercetin in men with category III chronic prostatitis: a preliminary prospective, double-blind, placebo-controlled trial. Urol 1999;54:960-963.
  • Taepongsorat L, Tangpraprutgul P, Kitana N, Malaivijitnond S. Stimulating effects of quercetin on sperm quality and reproductive organs in adult male rats. Asian J Androl. 2008;10(2):249-58.
  • Thornhill SM, Kelly AM. Natural treatment of perennial allergic rhinitis. Asian Journal of Andrology 2000;5(5):448-454.
  • Xing N, Chen Y, Mitchell SH, Young CY. Quercetin inhibits the expression and function of the androgen receptor in LNCaP prostate cancer cells. Carcinogenesis 2001;22(3):409-414.