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Drugs and Health Products

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.

Notes

  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant.

Date

July 31, 2018

Proper name(s), Common name(s), Source material(s)

Table 1.Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s) Source material(s)
Proper name(s) Part(s)
Propolis
  • Bee propolis
  • Feng jiao
  • Propolis
  • Propolis balsam
  • Propolis resin
  • Propolis wax
  • Apis mellifera Secretion

    References: Proper name: Lotfy 2006, PPRC 2005; Common names: O'Neil et al. 2013, Lotfy 2006, PPRC 2005, Salatino et al. 2005, Marcucci 1995; Source material: Ramos et al. 2007, Burdock 1998.

    Route of administration

    Oral

    Dosage form(s)

    This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

    Acceptable dosage forms for the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

    Use(s) or Purpose(s)

    • Source of/Provides antioxidants (Jasprica et al. 2007; Lotfy 2006; PPRC 2005; Kwon et al. 2004; Ichikawa et al. 2002; Tilgner 1999).
    • (Traditionally) used in Herbal Medicine to help relieve sore throat and/or other mouth and throat infections (Castalado and Capasso 2002; Mills and Bone 2000; Tilgner 1999).

    Note
    Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".

    Dose(s)

    Subpopulation(s)

    Adults 18 years and older

    Quantity(ies)

    Antioxidant

    Methods of preparation: Dry, Powder, Non-Standardised Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

    Not to exceed 0.6 grams dried propolis, per day (PPRC 2005)

    Relief of mouth/throat infections

    Methods of preparation: Dry, Powder, Non-Standardised Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

    0.2 - 0.6 grams dried propolis, per day (PPRC 2005)

    Direction(s) for use

    No statement required

    Duration(s) of use

    Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 1 month (Jasprica et al. 2007).

    Risk information

    Caution(s) and warning(s)

    All uses

    Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding or if you are allergic to bee products, poplar tree products, or balsam of Peru, (Brinker 2001; Marcucci 1995; Valsecchi and Cainelli 1984; Melli et al. 1983; Rudzki and Gryzwa 1983).

    All uses except as a source of antioxidants

    Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.

    Contraindication(s)

    No statement required.

    Known adverse reaction(s)

    Stop use immediately if hypersensitivity/allergy occurs (Scully 2006; PPRC 2005; Hsu et al. 2004; Teraki and Shiohara 2001; Machácková 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 (NHPID) and must meet the limitations outlined in the database.

    Storage conditions

    No statement required.

    Specifications

    • The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
    • The medicinal ingredient must comply with the requirements outlined in the NHPID.

    References cited

    • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
    • Burdock GA. 1998. Review of the biological properties and toxicity of bee propolis (propolis). Food and Chemical Toxicology 36:347-363.
    • Castalado S, Capasso F. 2002. Propolis, an old remedy used in modern medicine. Fitotherapia 73(S1):S1-S6.
    • Hausen BM, Wollenweber E, Senff H, Post B. 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 and Bone K. 2000. Principles and Practice of Phytotherapy; Modern Herbal Medicine. London (GB): Churchill Livingstone.
    • O’Neil MJ, Smith A, Heckelman PE, Budavari S, editors.  The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals.  15th edition. Whitehouse Station (NJ): Merck & Co., Inc; 2013.
    • PPRC 2005: Pharmacopoeia of the People’s Republic of China, Volume 1, English edition 2005. Beijing (CN): The State Pharmacopoeia Commission of the People’s Republic of China.
    • 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.
    • Scully C. 2006. Propolis: A background (Letter). British Dental Journal 200(7):359-360.
    • Teraki Y, Shiohara T. 2001. Propolis-induced granulomatous contact dermatitis accompanied by marked lymphadenopathy. British Journal of Dermatology 144:1277-1278.
    • Tilgner S. 1999. Herbal Medicine: From the Heart of the Earth. Creswell (OR): Wise Acres Press Inc.
    • 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.
    • Cairo do Amaral R, Gomes RT, Rocha WMS, Abreu SLR, Santos VR. 2006. Periodontitis treatment with Brazilian green propolis gel. Pharmacologyonline 3:336-341. [Accessed 2013 December 23]. Available from: http://pharmacologyonline.silae.it/files/archives/2006/vol3/026.Santos.pdf
    • 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 89:127132.
    • 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 2008 October 31]. Available from: http://www.fao.org/docrep/w0076E/w0076E00.htm
    • Machackova J. 1988. The incidence of allergy to propolis in 605 consecutive patients patch tested in Prague. Contact Dermatitis 18:210-212.
    • 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.
    • NMCD 2008: Natural Medicines Comprehensive Database. Propolis [online]. Stockton (CA): Therapeutic Research Faculty; 1995-2008. [Accessed 2008 October 15]. Available from: http://www.naturaldatabase.com/(S(rmsj0i45yh1x1nv212frlvid))/nd/Search.aspx?cs=&s=ND&pt=100&id=390&ds=
    • NMQS 2008: Natural Medicine Quality Standards: The Authority on Integrative Medicine. Propolis. Cambridge (MA): Natural Standard Inc. [Accessed 2008 October 15]. Available from:  http://www.naturalstandard.com/index-abstract.asp?createabstract=/monographs/herbssupplements/patient-propolis.asp
    • PasseportSanté.net 2006 : Propolis. [online]. Montréal (QC) : PasseportSanté.net, Totalmédia Inc. [Accessed 2009 January 28]. Available from :http://www.passeportsante.net/fr/Solutions/PlantesSupplements/Fiche.aspx?doc=propolis_ps
    • 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.