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

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

Buccal

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 Purposes(s)

(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)

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 products

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

Buccal products, except those not swallowed (e.g. gargles, rinses)

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding.

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, 3^rd 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.
• 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.
• 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 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.
• 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].
• 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 15 October 2008].
• NMQS 2008:  Natural Medicine Quality Standards: The Authority on Integrative Medicine. Propolis. Cambridge (MA): Natural Standard Inc. [Accessed 15 October 2008].
• PasseportSanté.net 2006 : Propolis. 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.