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Drugs and Health Products

PROPOLIS-Buccal

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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

  • 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 the statements are synonymous. Either term or statement may be selected by the applicant.

Date

January 8, 2014

Proper name(s)

Propolis (Lotfy 2006; PPRC 2005)

Common name(s)

  • Propolis (Lotfy 2006; PPRC 2005)
  • Bee propolis (Lotfy 2006; PPRC 2005)
  • Propolis resin (Salatino et al. 2005; Marcucci 1995)

Source material(s)

Secretion (of the honey bee Apis mellifera L.) (Apidae) (Ramos et al. 2007; Burdock 1998)

Route(s) of administration

Buccal

Dosage form(s)

Those dosage forms suited to buccal administration which allow for contact between the affected tissue and the medicinal ingredient including but not limited to lozenges, chewables (e.g. gummies, tablets), strips and liquids (such as gargles, rinses).

Use(s) or Purposes(s)

Statement(s) to the effect of:

(Traditionally) used in Herbal Medicine to help relieve sore throat and/or other mouth and throat infections (PPRC 2005; Castalado and Capasso 2002; Mills and Bone 2000; Tilgner 1999).

Dose(s)

Preparations equivalent to 0.2-0.6 g propolis, per day (PPRC 2005)

Duration(s) 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)

  • Consult a health care practitioner prior to use 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).
  • Consult a health care practitioner if symptoms persist or worsen.
  • Oral and/or Buccal products, except those that are not swallowed (e.g. gargles, rinses): Consult a health care practitioner prior to use if you are pregnant or breastfeeding.

Contraindication(s)

No statement required.

Known adverse reaction(s)

Hypersensitivity, such as allergy, has been known to occur; in which case, discontinue use immediately (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 NNHPD 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 NNHPD 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 (PPRC).

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 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 and Bone K. 2000. Principles and Practice of Phytotherapy; Modern Herbal Medicine. London (GB): Churchill Livingstone.
  • Peirce A. 1999. Practical Guide to Natural Medicine. New York (NY): The American Pharmaceutical Association.
  • 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.
  • 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. 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 89:127-132.
  • 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.Next link will take you to another Web site 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].
  • 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.
  • 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: Next link will take you to another Web site Natural Medicines Comprehensive Database. Propolis [online]. Stockton (CA): Therapeutic Research Faculty; 1995-2008. [Accessed 15 October 2008].
  • NMQS 2008: Next link will take you to another Web site Natural Medicine Quality Standards: The Authority on Integrative Medicine. Propolis. Cambridge (MA): Natural Standard Inc. [Accessed 15 October 2008].
  • PasseportSanté.net 2006 : Next link will take you to another Web sitePropolis. Montréal (QC) : PasseportSanté.net, Totalmédia Inc. [Accessed 28 January 2009].
  • 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.