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Monograph: Propolis - Oral

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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. Notes: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicant's discretion.

Date: 2014-01-07

NHPID Name

Propolis (ITIS 2007)

Proper Name(s)

Propolis ( Lofty 2006 , PRC 2005 )

Common Name(s)

Source Material

Secretion ( Ramos et al. 2007 , Burdock 1998 )

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

Dose(s): not to exceed 0.6 Grams per day
Relief of mouth/throat infections
Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 0.2 - 0.6 Grams per day

Duration of use

Consult a health care practitioner for use beyond 1 month  (Jasprica et al. 2007)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
Hypersensitivity, such as allergy, has been known to occur; in which case, discontinue use immediately  (Scully 2006, PRC 2005, Hsu et al. 2004, Teraki and Shiohara 2001, Machackova 1988, Hausen et al. 1987, Valsecchi and Cainelli 1984, Melli et al. 1983, Rudzki and Grzywa 1983)

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 Propolis monograph published in the Pharmacopoeia of the People's Republic of China.

References cited

  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Castalado S, Capasso F. 2002. Propolis, an old remedy used in modern medicine. Fitotherapia 73(S1):S1-S6
  • Hausen BM et al. 1987. Propolis allergy (II): the sensitizing properties of 1,1-dimethylallyl caffeic acid ester. Contact Dermatitis 17:171-177.
  • Hsu CY, Chiang WC, Weng TI, Chen WJ, Yuan A. 2004. Laryngeal edema and anaphalactic shock after topical propolis use for acute pharyngitis. American Journal of Emergency Medicine 22(5):432-433.
  • Ichikawa H, Satoh K, Tobe K, Yasuda I, Ushio F, Matsumoto K, Endo K, Ookubo C. 2002. Free radical scavenging activity of propolis. Redox Report 7(5): 347-350.
  • Jasprica I, Mornar A, Debeljak Z, Molcic-Bubalo A, Medic-Saric M, Mayer L, Romic Z, Bucan K, Balog T, Sobocanec S, Sverko V. 2007. In vivo study of propolis supplementation effects on antioxidative status and red blood cells. Journal of Ethnopharmacology 110:548-554.
  • Kwon YS, Park DH, Shin EJ, Kwon MS, Ko KH, Kim WK, Jhoo JH, Hjoo WK, Wie MB, Jung BD, Kim HC. 2004. Antioxidant propolis attenuates kainite-induced neurotoxicity via adenosine A1 receptor modulation in the rat. Neuroscience Letters; 355:231-235.
  • Lotfy M. 2006. Review: Biological activity of bee propolis in health and disease. Asian Pacific Journal of Cancer Prevention 7:22-31.
  • Machackova J. 1988. The incidence of allergy to propolis in 605 consecutive patients patch tested in Prague. Contact Dermatitis 18:210-212.
  • Marcucci MC. 1995. Propolis: chemical composition, biological properties and therapeutic activity. Apidologie 26:83-89.
  • Melli MC, Giorgini S, Sertoli A. 1983. Occupational dermatitis in a bee-keeper. Contact Dermatitis 9(5):427-428.
  • Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
  • Peirce A. Practical Guide to Natural Medicines. New York (NY): The Stonesong Press, Inc; 1999.
  • PPRC 2005: Pharmacopoeia of the People's Republic of China, Volume I. Beijing (CN): Chinese Pharmacopoeia Commission.
  • Ramos AFN, Miranda JL. 2007. Propolis: a review of its anti-inflammatory and healing actions. J. Venom. Anim. Toxins incl. Trop. Dis. 13(4):697-710.
  • Rudzki E, Grzywa Z. 1983. Dermatitis from propolis. Contact Dermatitis 9(1):40-45.
  • Salatino A, Teixeira EW, Negri G, Message D. 2005. Review: Origin and chemical variation of Brazilian propolis. Oxford University Press eCAM 2(1):33-38.
  • Samet N, Laurent C, Susarla SM, Samet-Rubinsteen N. 2007. The effect of bee propolis on recurrent aphthous stomatitis: a pilot study. Clinical Oral Investigation 11:143-147.
  • Scully C. 2006. Propolis: A background (Letter). British Dental Journal 200(7):359-360.
  • Teraki Y and Shiohara T. 2001. Propolis-induced granulomatous contact dermatitis accompanied by marked lymphadenopathy. British Journal of Dermatology 144:1277-1278.
  • Tilgner S. Herbal Medicine from the Heart of the Earth. Creswell (OR): Wise Acre Press; 1999.
  • Valsecchi R, Cainelli T. 1984. Dermatitis from propolis. Contact Dermatitis 11(5):317.

References reviewed

  • Bankova V. 2005. Review: Recent trends and important developments in propolis research. Oxford University Press eCAM 2(1):29-32.
  • Botushanov PI, Grigorov GI, Aleksandrov GA. 2001. A clinical study of a silicate toothpaste with extract from propolis. Endodontology and Parodontology 43(1-2):28-30.
  • Burdock GA. 1998. Review of the biological properties and toxicity of bee propolis (propolis). Food and Chemical Toxicology 36:347-363.
  • Cairo do Amaral R, Gomes RT, Rocha WMS, Abreu SLR, Santos VR. 2006. Periodontitis treatment with Brazilian green propolis gel. Pharmacologyonline 3:336-341.
  • Coelho LG, Bastos EMAF, Resende CC, Paula e Silva CM, Sanches BSF, Castro FJ, Moretzsohn LD, Vieira WLS, Trinidade OR. 2007. Brazilian green propolis on Helicobacter pylori infection. A pilot clinical study. Helicobacter 12:572-574.
  • Crisan I, Zaharia CN, Popovici F, Jucu V, Belu O, Dascalu C, Mutiu A, Petrescu A. 1995. Natural propolis extract NIVCRISOL in the treatment of acute and chronic rhinopharyngitis in children. Romanian Journal of Virology 46(3-4):115-133.
  • El-Khatib AS, Agha AM, Mahran LG, Khayyal MT. 2002. Prophylactic effect of aqueous propolis extract against acute experimental hepatotoxicity in vivo. Verlag der Zeitschrift fur Naturforsch 57c:379-385.
  • Fuliang HU, Hepburn HR, Xuan H, Chen M, Daya S, Radloff SE. 2005. Effects of propolis on blood glucose, blood lipid and free radicals in rats with diabetes mellitus. Pharmacological Research 51:147-152.
  • Gabrys J, Konecki J, Krol W, Scheller S, Shani J. 1986. Free amino acids in bee hive product (propolis) as identified and quantified by gas-liquid chromatography. Pharmacological Research Communications 18(6):513-518.
  • Gambelunghe C, Rossi R, Sommavilla M, Ferranti C, Rossi R, Ciculi C, Gizzi S, Micheletti A, Rufini S. 2003. Effects of Chrysin on Urinary Testosterone Levels in Human Males. Journal of Medicinal Food;6(4):387-390.
  • Gebara ECE, Pustiglioni AN, de Lima LAPA, Mayer MPA. 2003. Propolis extract as an adjuvant to periodontal treatment. Oral Health and Preventative Dentistry 1(1):29-35.
  • Ghisalberti EL. 1979. Propolis: a review. Bee World 60:59-84.
  • Giusti F, Miglietta R, Pepe P, Seidenari S. 2004. Sensitization to propolis in 1255 children undergoing patch testing. Contact Dermatitis 51:255-258.
  • Gregory SR, Piccolo N, Piccolo MT, Piccolo MS, Heggers JP. 2002. Comparison of Propolis Skin Cream to Silver Sulfadiazine: A Naturopathic Alternative to Antibiotics in Treatment of Minor Burns. The Journal of Alternative and Complementary Medicine 8(1):77-83.
  • Imhof M, Lipovac M, Kurz Ch, Barta J, Verhoeven HC, Huber JC. 2005. Propolis solution for the treatment of chronic vaginitis. International Journal of Gynecology and Obstetrics 89:127-132.
  • ITIS 2009: Integrated Taxonomic Information System, Canadian Biodiversity Information Facility, Government of Canada [Accessed 2009-10-21]. Available from: http://www.cbif.gc.ca/pls/itisca/taxaget?p_ifx=cbif
  • Jellin JM. Natural Medicines Comprehensive Database. Stockton (CA): Therapeutic Research Faculty; 1995-2007. [Accessed 2007-09-17]. Available from: http://www.naturaldatabase.com/(S(0hg55rvubxan4r55ymylyij5))/Logon.aspx?li=0&st=2&cs=&s=ND.
  • Khayyal MT, El-Ghazaly MA, El-Khatib AS, Hatem AM, de Vries PJF, El-Shafei S, Khattab MM. 2003. A clinical pharmacological study of the potential beneficial effects of a propolis food product as an adjuvant in asthmatic patients. Fundamental and Clinical Pharmacology 17:93-102.
  • Koo H, Cury JA, Rosalen PL, Ambrosano GMB, Ikegaki M, Park YK. 2002. Effect of a mouthrinse containing selected propolis on 3-day dental plaque accumulation and polysaccharide formation. Caries Research 36(6):445-448.
  • Krell R. 1996. Value-Added Products from Beekeeping [online] Agricultural Services Bulletin No. 124. Rome (IT): Food and Agriculture Organisation of the United Nations, Agriculture and Consumer Protection. [Accessed 31 October 2008]. Available from: http://www.fao.org/docrep/w0076E/w0076E00.htm
  • Magro-Filho O, de Carvalho AC. 1994. Topical effect of propolis in the repair of sulcoplasties by the modified Kazanjian technique. Cytological and clinical evaluation. Journal of the Nihon School of Dentistry 36(2):102-111.
  • Menniti-Ippolito F, Mazzanti G, Vitalone A, Firenzuoli F, Santuccio C. 2008. Surveillance of suspected adverse reactions to natural health products: the case of propolis. Drug Safety 31(5) 419-423.
  • Mirzoeva OK and Calder PC. 1996. The effect of propolis and its components on eicosanoid production during the inflammatory response. Prostaglandins, Leukotrienes and Essential Fatty Acids 55(6):441-449.
  • Murray MC, Worthington HV, Blinkhorn AS. 1997. A study to investigate the effect of a propolis-containing mouthrinse on the inhibition of de novo plaque formation. Journal of Clinical Periodontology 24:796-798.
  • Nakajima Y, Tsuruma K, Shinazawa M, Mishima S, Hara H. 2009. Comparison of bee products based on assays of antioxidant capacities. BMC Complementary and Alternative Medicine 9(1):4.
  • NMQS 2008: Natural Medicine Quality Standards: The Authority on Integrative Medicine. Propolis. Cambridge (MA): Natural Standard Inc. Accessed 15 October 2008]. Available from: http://www.naturalstandard.com/index-abstract.asp?create-abstract=/monographs/herbssupplements/patient-propolis.asp
  • PasseportSanté.net 2007 Montréal (QC): PasseportSanté.net, Totalmédia Inc.; 2008. Disponible en ligne à : http://www.passeportsante.net/fr/Solutions/PlantesSupplements/Index.aspx
  • Santos VR, Pimenta FJGS, Aguiar MCF, do Carmo MAV, Naves MD, Mesquita RA. 2005. Short Communication: Oral Candidiasis Treatment with Brazilian Ethanol Propolis Extract. Phytotherapy Research 19:652-654.
  • Sforcin JM. 2007. Propolis and the immune system: a review. Journal of Ethnopharmacology 113:1-14.
  • Viuda-Martos M, Ruiz-Navajas Y, Fernández-López J, Pérez-Alvarez JA. 2008. Functional properties of honey, propolis, and royal jelly. Journal of Food Science 73(9): R117-124.
  • Vynograd N, Vynograd I, Sosnowski Z. 2000. A comparative multi-centre study on the efficacy of propolis, acyclovir and placebo in the treatment of genital herpes (HSV). Phytomedicine 7(1):1-6.