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Drugs and Health Products

Monograph: Goldenseal - Buccal

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Note: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicant's discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.

Date: 2010-01-11

NHPID Name

Hydrastis canadensis (USDA 2008)

Proper Name(s)

Hydrastis canadensis L. (Ranunculaceae) ( USDA 2005 )

Common Name(s)

Goldenseal ( McGuffin et al. 2000 , Wiersema and León 1999 )

Source Material

Root and rhizome ( Blumenthal et al. 2003 , Hoffmann 2003 , Bradley 1992 )
Goldenseal is a "threatened" plant in the wild (EC 2005; JC 2003); thus only the root and rhizome from the cultivated plant are acceptable source material. See Specifications for further details.

Route Of Administration

Buccal

Dosage Form(s)

The acceptable dosage forms suited to buccal administration.

Use(s) or Purpose(s)

Statement(s) to the effect of:

Traditionally used in Herbal Medicine to help relieve mucous membrane inflammations of the mouth  (Bradley 1992, Ellingwood 1983[1919], Grieve 1971[1931])

Dose(s)

Adults:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 0.6 - 3 Grams per day, dried root and rhizome
Directions For Use: Rinse as needed. Do not exceed maximum daily dose


See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

May take up to one week to produce beneficial effects  (Bradley 1992)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Consult a health care practitioner if symptoms persist.
  • Consult a health care practitioner if symptoms worsen.
  • Consult a health care practitioner prior to use if you have a kidney disorder  (Brinker 2001)
  • Consult a health care practitioner prior to use if you have blood pressure problems  (Brinker 2010, Hoffmann 2003)
  • Consumption of Goldenseal with alcohol, other medications and/or natural health products with sedative properties is not recommended  (Boon and Smith 2004, Brinker 2001)

Contraindication(s):
Do not use if you are pregnant or breastfeeding  (Barnes et al. 2007, Mills and Bone 2005, Boon and Smith 2004, Hoffmann 2003, Brinker 2001, Bradley 1992)

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.

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 manufacturer must have proof of sale or a permit of the cultivated Hydrastis canadensis (Goldenseal) because the wild population is threatened: (i) Hydrastis canadensis is listed in Schedule 1 of the Species at Risk Act (SARA) as a "threatened" species and is afforded protection under this Act. Under section 32(2) of SARA, no person shall possess, collect, buy, sell or trade an individual of a wildlife species that is listed as an extirpated species, an endangered species or a threatened species, or any part or derivative of such an individual (JC 2003). Proof of purchase of cultivated Hydrastis canadensis is required. (ii) The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) sets controls on the movement of animal and plant species that are, or may be, "threatened" due to excessive commercial exploitation. To import Hydrastis canadensis (including the whole, part of, or the powdered root and/or rhizome) into Canada requires an accompanying CITES export permit from exporting countries. For permit information see http://www.cites.ec.gc.ca/eng/sct3/sct3_4_e.cfm (EC 2005).
  • The medicinal ingredient may comply with the specifications outlined in the 'Goldenseal root' monograph of the British Pharmacopoeia, the 'Goldenseal rhizome' monograph of the European Pharmacopoeia and the 'Goldenseal', 'Powdered Goldenseal' and 'Powdered Goldenseal Extract' monographs of the American Pharmacopoeia.

References cited

  • Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): Pharmaceutical Press.
  • Blumenthal M, Hall T, Goldberg A, Kunz T, Kinda K, editors. 2003. The ABC Clinical Guide to Herbs. Austin (TX): American Botanical Council
  • Boon H, Smith MJ. 2004. The Complete Natural Medicine Guide to the 50 Most Common Medicinal Herbs, 2nd edition. Toronto (ON): Robert Rose Inc.
  • BP 2008: British Pharmacopoeia Commission. 2008. British Pharmacopoeia 2009, Volume II. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA).
  • Bradley PR, editor. 1992. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (GB): British Herbal Medicine Association.
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Brinker F. 2010. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Updated 2010 July 13; Accessed 2013 January 30]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • EC 2002: Environment Canada. Species at Risk Act (SARA 2002), Schedule 1 "Threatened". Hydrastis canadensis (Goldenseal) [on line]. Ottawa: Canadian Wildlife Service, Environment Canada. [Accessed 2009 December 4]. Available from: http://www.sararegistry.gc.ca/search/advSearchResults_e.cfm?stype=species&lng=e&advkeywords=goldenseal&op=1&locid=0&taxid=0&desid=0&schid=0&
  • EC 2005: Environment Canada. Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), Schedule II. Hydrastis canadensis (Goldenseal) [on line]. Ottawa (ON): Canadian Wildlife Service, Environment Canada. [Accessed 2009 December 4]. Available from: http://www.cites.ec.gc.ca/eng/sct3/sct3_4_e.cfm
  • Ellingwood F. 1983. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications [Reprint of 1919 original].
  • Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].
  • Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
  • JC 2015: Department of Justice Canada. Species at Risk Act. Ottawa (ON): Department of Justice Canada. [Accessed 2015 June 4]. Available from :http://laws-lois.justice.gc.ca/eng/acts/S-15.3/index.html.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
  • Moerman DE . 1998. Native American Ethnobotany. Portland (OR): Timber Press.
  • Ph. Eur. 2008: European Pharmacopoeia Commission. European Pharmacopoeia 2009, 6th edition, Supplement 6.3. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).
  • USDA 2005: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Hydrastis candensis L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008 April 1]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • USP 32 : United States Pharmacopeial Convention. 2009. United States Pharmacopeia and the National Formulary (USP 32 - NF 27). Rockville (MD): The United States Pharmacopeial Convention.
  • Wiersema J, León B. 1999. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC.
  • Wren RC. 1907. Potter's Cyclopedia of Botanical Drugs and Preparations. London (GB): Potter and Clark.

References reviewed

  • Barnes J, Anderson LA, Philipson JD. 2002. Herbal Medicines: A Guide for Healthcare Professionals, 2nd edition. London (GB): The Pharmaceutical Press.
  • Bown D. 1995. The Herb Society of North America Encyclopedia of Modern Herbs & Their Uses. New York (NY): Dorling Kindersley Publishing Incorporated.
  • Chevallier A. 1996. The Encyclopaedia of Medicinal Plants. New York (NY): Dorling Kindersley.
  • Duke JA, Bogenschutz-Godwin MJ, DuCellier J, Duke PK. 2002. Handbook of Medicinal Herbs, 2nd edition. Boca Raton (FL): CRC Press.
  • Felter HW, Lloyd JU. 1983. King's American Dispensatory, Volume 2, 18th edition. Sandy (OR): Eclectic Medical Publications [Reprint of 1898 original].
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
  • Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
  • Small E, Catling PM. 1999. Canadian Medicinal Crops. Ottawa (ON): National Research Council of Canada Monograph Publishing Program, NRC Research Press.

Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use

BUCCAL:

Dried root and rhizome:

0.5 - 1 g, 3 times per day (Bradley 1992)

Fluid extract:

0.3 - 1 g dried equivalent, 3 times per day (1:1, 60% ethanol, 0.3-1 ml) (Bradley 1992)

Tincture:

0.2 - 0.4 g dried equivalent, 3 times per day (1:10, 60% ethanol, 2-4 ml) (Bradley 1992)

Directions for use:

  • Rinse as needed.
  • Do not exceed maximum daily dose.