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Drugs and Health Products

Monograph: Rutin

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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.

Date: 2012-11-27

NHPID Name

Rutin (O'Neil et al. 2012)

Proper Name(s)

  • 3-((6-O-(6-deoxy-alpha-L-mannopyranosyl)-beta-D-glucopyranosyl)oxy)-2-(3,4-dihydroxyphenyl)-5,7-dihydroxy-4H-1-benzopyran-4-one ( ChemID 2012 )
  • 3-(O-6-deoxy-alpha-l-mannopyranosyl-(1-6)-beta-d-glucopyranosyloxy)-2-(3,4-dihydroxyphenyl)-5,7-dihydroxy-4H-chromen-4-one ( Ph.Eur. 2013 )

Common Name(s)

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 1000 Milligrams per day
Capillary/blood vessel protectant
Dose(s): 400 - 1000 Milligrams per day
Directions For Use: Take twice daily (PDR 2008)

Duration of use

For products providing  Doses greater than or equal to 250 Milligrams per day :
For use beyond 6 weeks, consult a health care practitioner  (Boyle et al. 2000)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
If pregnant or breastfeeding, consult a health care practitioner prior to use  (PDR 2008)

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 Rutin or Rutoside Trihydrate monographs of the British and European Pharmacopoeias.

References cited

  • Balz JP, Das NP. Uncaria elliptica a major source of rutin. Planta Medica 1979;36(6):174-177.
  • 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. [Rutin: CAS # 153-18-4; 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.
  • 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.
  • Harborne JB, Baxter H, Moss GP, editors. Phytochemical Dictionary: A Handbook of Bioactive Compounds from Plants. 2nd edition. Philadelphia (PA): Taylor & Francis Ltd; 1999.
  • 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.
  • Leung AY, Foster S. Encyclopedia of Common Natural Ingredients: Used in Food, Drugs and Cosmetics. Second edition. New York (NY): John Wiley & Sons; 1996.
  • Martindale 2011: Sweetman SC, editor. Martindale: The Complete Drug Reference [Internet]. London (GB): Pharmaceutical Press; 2012. [Rutoside: synonym rutin, CAS: 153-18-4 (anhydrous rutoside), latest modification 05-Dec-2011; Accessed 2012 May 7]. 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. Rutin 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.

References reviewed

  • Dietrych-Szostak D, Oleszek W. Effect of processing on the flavonoid content in buckwheat (Fagopyrum esculentum Möench) grain. Journal of Agriculture and Food Chemistry 1999;47(10):4383-4387.
  • Frankel EN, Waterhouse AL, Teissedre PI. Principal phenolic phytochemicals in selected California wines and their antioxidant activity in inhibiting oxidation of human low-density lipoproteins. Journal of Agriculture and Food Chemistry 1995;43(4): 890-894.
  • United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2012 November 26]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl