Monograph: Bilberry - Buccal

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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: 2018-10-30

NHPID name

Vaccinium myrtillus ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

Vaccinium myrtillus ( USDA 2008 )

Common name(s)

Bilberry ( McGuffin et al. 2000 )
European blueberry ( Unavailable )
Huckleberry ( Unavailable )
Whortleberry ( Unavailable )

Source material

Fruit ( Blumenthal et al. 2000 )

Route Of administration

Buccal ( Blumenthal et al. 2000 )

Dosage form(s)

Those suited to the allowable route(s) of administration.

Use(s) or purpose(s)

Statement(s) to the effect of:

Used in Herbal Medicine to help relieve mild inflammations of the mucous membranes of the mouth and/or throat.

Dose(s)

Adults:

Preparation:

Decoction

Dose(s):

5 - 10 Grams , dried fruit

(Blumenthal et al. 2000)

Directions for use:

Place crushed dried fruit in 150 ml cold water. Bring to a boil for approximately 10 minutes. Strain while hot. Dilute one part decoction with 10 parts water. ( ESCOP 2003 , Blumenthal et al. 2000 )
Rinse and/or gargle as needed.

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

No statement is required

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s): Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen. 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.

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 may comply with the specifications outlined in the following pharmacopoeial monographs: 'Dried Bilberry' in BP, 'Bilberry Fruit, Dried' and 'Fresh Bilberry Fruit Dry Extract, Refined and Standardised' in Ph. Eur., 'Powdered Bilberry Extract' in USP

References cited

Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): Pharmaceutical Press.
Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
Blumenthal M, Hall T, Goldberg A, Kunz T, Kinda K, editors. 2003. The ABC Clinical Guide to Herbs. Austin (TX): American Botanical Council
BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
European Pharmacopoeia, 6th edition. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).; 2008
Felter HW, Lloyd JU. 1983. King's American Dispensatory, Volume 2, 18th edition. Sandy (OR): Eclectic Medical Publications [Reprint of 1898 original].
Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].
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. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
Morazzoni P, Bombardelli E. 1996. Vaccinium myrtillus L. Fitoterapia 67(1):3-29.
Upton R, editor. 2001. American Herbal Pharmacopoeia and Therapeutic Compendium: Bilberry Fruit Vaccinium mysrtillus L.: Standards of Analysis, Quality Control and Therapeutics. Santa Cruz (CA): American Herbal Pharmacopoeia
USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at 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.

References reviewed

Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
Canter PH, Ernst E. 2004. Anthocyanosides of Vaccinium myritillus (bilberry) for night vision - a systematic review of placebo-controled trials. Survey of Opthalmology 49(1):38-50.
Jang YP, Zhou J, Nakanishi K, Sparrow JR. 2005. Anthocyanins protect against A2E photooxidation and membrane permeabilization in retinal pigment epithelial cells. Photochemistry and Photobiology 81(3):529-536.
Lee J, Lee HK, Kim Y, Hong YJ, Choe CM, You TW and Seong J. 2005. Purified high-dose anthocyanoside oligomer improves nocturnal vision and clinical symptoms in myopia subjects. British Journal of Nutrition 93:895-899.
Levy Y, Glovinski Y. 1998. The effect of anthocyanosides on night vision. Eye 12:967-969.
McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
Muth ER, Laurent JM and Purcell Jasper. 2000. The effect of bilberry nutritional supplementation on night vision acuity and contrast sensitivity. Alternative Medecine Review 5:164-73.
Sparrow JR, Vollmer-Snarr HR, Zhou J, Jang PY, Jockusch. 2003. A2E-epoxides damage DNA in retinal pigment epithelial cells. Journal of Biological Chemistry 278(20):18207-18213.
Steigwalt RD Jr, Gianni B, Paolo M, Bombardelli E, Burki C, Schönlau F. 2008. Effects of Mirtogenol® on ocular blood flow and intraocular hypertension in asymptomatic subjects. Molecular Vision 14:1288-1292.
Zadok D, Levy Y, Glovinski Y. 1999. The effect of anthocyanosides in multiple oral dose on night vision. Eye 13:734-736.

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

GARGLE and/OR BUCCAL:

Decoction:

10% decoction of dried fruit (ESCOP 2003; Blumenthal et al. 2000)

Directions for use:

Gargle and/or rinse as needed.