Physicochemical and Microbiological Assays for Quality Evaluation of a Brand of Mentha piperita Tisanes in Costa Rica Market: Employment of the Central American Technical Regulation
Abstract
Mentha piperita is a natural hybrid of water mint (Mentha aquatica) and spearmint (Mentha spicata L.), that are consumed as tisanes. For that reason, the present work evaluated physicochemical and microbiological aspects for the quality control of a commercial brand of Mentha piperita herbal tea distributed in Costa Rica, using assays established by the Central American Technical Regulation (RTCA) 11.03.56.09 (Pharmaceutical products. Natural medicinal products for human use. Quality verification), and determined if they have uniformity for different batches of this brand. To verify the quality of three batches of this product, the following assays were done: Labeling requirements, organoleptic, minimum fill, foreign organic matter, loss on drying, total ash, acid-insoluble ash, lead and arsenic limits, microbial enumerations and specific microorganisms (E. coli and Salmonella sp.) assays. As conclusion, the batches were in compliance for all the assays, except for labeling test, since information corresponding to the primary (batch number and expiration date) and secondary packaging (qualitative-quantitative composition of active ingredients interactions and adverse effects) were not presented. Furthermore, one of the batches did not have information about the employment, contraindications and warnings. Also, the manufacturing company maintained a good reproducibility between one batch and another, and the improvements that can be made are in the product labeling and better controls in its filling.
Keywords: Natural product, Mentha piperita, quality control, tisane, pharmacopoeia, Central American Technical Regulation.
Keywords:
Mentha piperita
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References
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2. Hayat K, Iqbal H, Malik U, Bilal U, Mushtaq S. Tea and Its Consumption: Benefits and Risks. Crit Rev Food Sci Nutri. 2015; 55(7):939-954.
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9. Singh R, Shushni MAM, Belkheir A. Antibacterial and antioxidant activities of Mentha piperita L. Arabian J Chem. 2015; 8:322-328.
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12. Pohl P, Dzimitrowicz A, Jedrycyzo D, Szymczycha-Madeja A, Welna M, Jamroz P. The determination of elements in herbal teas and medicinal plant formulations and their tisanes. J Pharm Biomed Anal. 2016; 130:326-335.
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24. Newsome R, Balestrini CG, Baum MD, Corby J, Fisher W, Goodburn K et al. Applications and Perceptions of Date Labeling of Food. Compr Rev Food Sci Food Saf. 2014; 13(4):745-769.
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26. McKay DL, Blumberg JB. A review of the bioactivity and potential health benefits of peppermint tea (Mentha piperita L). Phytother Res. 2006; 20(8):619-633.
27. Ulbricht CE. Natural Standard Herb & Supplement Guide: An Evidence-Based Reference. United States; Mosby, Inc.: 2010.
28. Samojlik I, Petković S, Mimica-Dukić N, Božin B. Acute and Chronic Pretreatment with Essential Oil of Peppermint (Mentha x piperita L., Lamiaceae) Influences Drug Effects. Phytother Res. 2012; 26(8):820-825.
29. Moeinipour A, Abbassi Teshnizi M, Manafi B, Yavari H, Moeinipour Y, Hoseinikhah H. Posible interaction of warfarin with peppermint herbal tea: a case report. Reviews in Clinical Medicine. 2017; 4(2):83-86.
30. Nath SS, Pandey C, Roy D. A near fatal case of high dose peppermint oil ingestion-Lessons learnt. Indian J Anaesth. 2012; 56(6):582-584.
31. Shams R, Oldfield EC, Copare J, Johnson DA. Peppermint Oil: Clinical Uses in the Treatment of Gastrointestinal Diseases. JSM Gastroenterol Hepatol. 2015; 3(1):1035.
32. Gardner Z, McGuffin M, editors. Botanical Safety Handbook. 2nd edition. Florida: Taylor & Francis Group; 2003.
33. Dadzie BK, Orchard JE. Evaluación rutinaria postcosecha de híbridos de bananos y plátanos: criterios y métodos. Montpellier: Red Internacional para el Mejoramiento del Banano y el Plátano; 1997.
34. Ghorbani A, Saeedi Y, de Boer HJ. Unidentifiable by morphology: DNA barcoding of plant material in local markets in Iran. PLOS ONE. 2017; 12(4):e0175722.
35. Valmorbida J, Fernandes Boaro CS. Growth and Development of Mentha piperita L. in Nutrient Solution as Affected by Rates of Potassium. Braz Arch Biol Technol. 2007; 50(3):379-384.
36. Tamargo J, Le Heuzey J, Mabo P. Narrow therapeutic index drugs: a clinical pharmacological consideration to flecainide. Eur J Clin Pharmacol. 2015; 71(5):549-567.
37. European Medicines Agency. Assessement report on Mentha x piperita L., folium. Londres; European Medicines Agency: 2008.
38. Cholayudth P. Establishing Acceptance Limits for Uniformity of Dosage Units. Pharm Technol. 2016; 40(12):34-43.
39. World Health Organization. Quality control methods for herbal materials. Geneva: WHO; 2011
40. Mahapatra A, Nguyen CN. Drying of medicinal plants. Acta Hortic. 2007; 756(756): 47-54.
41. Kunle OF, Egharevba HO, Ahmadu PO. Standarization of herbal medicines - A review. Int J Biodivers Conserv. 2012; 4(3):101-112.
42. Kripanand S, Guruguntla S, Korra S. Effect of Various Drying on Quality and Flavor Characteristics of Mint Leaves (Mentha spicata L.). J Food Pharm Sci. 2015; 3:38-45
43. Vidaurre Martínez MF, Querevalú García LM, de los Ríos Martínez E, Ruiz Reyes SG. Caacterísticas farmacognósticas de las hojas de Capparis Avicennifolia. Rev Med Vallejiana. 2007; 4(2):122-131.
44. Miranda M. Farmacognosia y Productos naturales. 2001. Cuba: Editorial Félix Varela; 2001.
45. Rao Y, Xiang B. Determination of Total Ash and Acid-insoluble Ash of Chinese Herbal Medicine Prunellae Spica by Near Infrared Spectroscopy. Yakugaku Zasshi. 2009; 129(7):881-886.
46. Chandel HS, Pathak, AK, Tailang M. Standardization of some herbal antidiabetic drugs in polyherbal formulation. Pharmacogn Res. 2011; 3(1):49-56.
47. Genuis SJ, Schwalfenberg G, Siy AJ, Rodushkin I. Toxic Element Contamination of Natural Health Products and Pharmaceutical Preparations. PLOS ONE. 2012; 7(11):e49676.
48. Shaban NS, Abdou KA, Hassan NEY. Impact of toxic heavy metals and pesticide residues in herbal products. Beni-Seuf Univ J Appl Sci. 2016; 5:102-106.
49. Gunturu KS, Nagarajan P, McPhedran P, Goodman TR, Hodsdon ME, Strout MP. Ayurvedic herbal medicine and lead poisoning. J Hematol Oncol. 2011; 4(51).
50. Khalid M, Karim T. Lead Poisoning due to Herbal Remedies for Infertility. Gulf Med J. 2015; 4(1):46-48.
51. Franco L, Castillo N, González MJ, Santillán JM, Vázquez M, Botto I. Arsénico y Medio Ambiente: Efectos del Riego con Aguas Conteniendo As sobre Cultivos Hortícolas. La Plata: Actas Sétimo Congreso de Medio Ambiente AUGM; 2012.
52. Chung J, Yu S, Hong Y. Enviromental Source of Arsenic Exposure. J Prev Med Public Health. 2014; 47:253-257.
53. Shankar S, Shanker U, Shikha. Arsenic Contamination of Groundwater: A Review of Sources, Prevalence, Health Risks, and Strategies for Mitigation. Sci World J. 2014; 2014.
54. Steinmaus CM, Ferreccio C, Acevedo Romo J, Yuan Y, Cortes S, Marshall G et al. Drinking Water Arsenic in Northern Chile: High Cancer Risks 40 Years after Exposure Cessation. Cancer Epidemiol Biomarkers Prev. 2013; 22(4):623-630.
55. Tournas VH, Katsoudas E, Miracco EJ. Moulds, yeasts and aerobic plate counts in ginseg supplements. Int J Food Microbiol. 2006; 108:178-181.
56. Ratajczak M, Kubicka MM, Kamińska D, Sawicka P, Długaszewska J. Microbiological quality of non-sterile pharmaceutical products. Saudi Pharm J. 2015; 23:303-307.
57. Hebbelstrup Jensen B, Olsen KE, Struve C, Krogfelt KA, Petersen AM. Epidemiology and Clinical Manifestations of Enteroaggregative Escherichia coli. Clin Microbiol Rev. 2014; 27(3):614-630.
58. E. coli, Compilation prepared by the World Health Organization, http://www.who.int/mediacentre/factsheets/fs125/en/
59. Andino A, Hanning I. Salmonella enterica: Survivial, Colonization, and Virulence Differences among Serovars. Sci World J. 2015; 2015.
60. Eng S, Pusparajah P, Ab Mutalib N, Ser H, Chan K, Lee L. Salmonella: A review on pathogenesis, epidemiology and antibiotic resistance. Front Life Sci. 2015; 8(3):284-293.
2. Hayat K, Iqbal H, Malik U, Bilal U, Mushtaq S. Tea and Its Consumption: Benefits and Risks. Crit Rev Food Sci Nutri. 2015; 55(7):939-954.
3. Uribe E, Marín D, Vega-Gálvez A, Quispe-Fuentes I, Rodríguez A. Assessment of vacuum-dried peppermint (Mentha piperita L) as a source of natural oxidants. Food Chem. 2016; 190:559-565.
4. Shalayel MHF, Asaad AM, Qureshi MA, Elhussein AB. Anti-bacterial activity of peppermint (Mentha piperita) extracts against emerging multi-drug resistant human bacterial pathogens. J Herb Med. 2017; 7:27-30.
5. Tsai M, Wu C, Lin T, Lin W, Huang Y, Yang C. Chemical Composition and Biological Properties of Essential Oils of Two Mint Species. Trop J Pharm Res. 2013; 12(4):577-582.
6. Loolaie M, Moasefi N, Rasouli H, Abidi H. Peppermint and its Functionality: A Review. Archives of Clinical Microbiology. 2017; 8(4):54.
7. Tarhan S, Telci I, Tuncay MT, Polatci H. Product quality and energy consumption when drying peppermint by rotary drum dryer. Ind Crops Prod. 2010; 32:420-42
8. Figueroa-Pérez MG, Rocha-Guzmán NE, Pérez-Ramírez IF, Mercado-Silva E, Reynoso-Camacho R. Metabolite Profile, Antioxidant Capacity, and Inhibition of Digestive Enzymes in Infusions of Peppermint (Mentha piperita) Grown under Drought Stress. J. Agric. Food Chem. 2014; 62:12027-12033.
9. Singh R, Shushni MAM, Belkheir A. Antibacterial and antioxidant activities of Mentha piperita L. Arabian J Chem. 2015; 8:322-328.
10. Gaurav N, Singh AP, Srivastava A, Kumar A, Chauhan P. An Experimental Text Book on Phytochemical Analysis and Antimicrobial Activity of Mentha Piperita. Uttar Pradesh: OnlineGatha; 2016.
11. Panda H. Handbook on Ayurvedic Medicines with Formulae, Processes & Their Uses. 2nd ed., New Delhi; Niir Project Consultancy Services: 2013.
12. Pohl P, Dzimitrowicz A, Jedrycyzo D, Szymczycha-Madeja A, Welna M, Jamroz P. The determination of elements in herbal teas and medicinal plant formulations and their tisanes. J Pharm Biomed Anal. 2016; 130:326-335.
13. Carvajal C, Castro P, Mora, JJ. Control de calidad de una marca de tisanas de bolbo comercializada en Costa Rica de acuerdo con los lineamientos del Reglamento Técnico Centroamericano. Revista Médica de la Universida de Costa Rica. 2015; 9(1):78-88.
14. Mishra P, Kumar A, Nagireddy A, Mani D, Shukla AK, Tiwari R et al. DNA barcoding: an efficient tool to overcome authentication challenges in the herbal market. Plant Biotechnol J. 2016; 14(1):8-21.
15. Consejo de Ministros de Integración Económica Centroamericana. RTCA 11.03.56.09 (Reglamento Técnico Centroamericano de Productos Farmacéuticos. Productos Naturales Medicinales para Uso Humano. Verificación de Calidad). San José; 2011.
16. Consejo de Ministros de Integración Económica Centroamericana. RTCA 11.04.41.06 (Reglamento Técnico Centroamericano. Productos farmacéuticos. Productos naturales medicinales para uso humano. Requisitos de etiquetado). San José; 2011.
17. British Pharmacopeia Comission. British Pharmacopoeia 2015. The Stationery Office Limited on behalf of Medicines and Healthcare Products Regulatory Agency: London; 2014.
18. United States Pharmacopea Convention. Pharmacopoeia 40 and National Formulary 35. United States Pharmacopea Convention: Maryland; 2017.
19. Comisión Permanente de la Farmacopea de los Estados Unidos Mexicanos Farmacopea herbolaria de los Estados Unidos Mexicanos. Secretaría de Salud: Mexico D.F.; 2013.
20. European Pharmacopoeia. 5th ed. Strasbourg: Council of Europe; 2004.
21. Instituto Interamericano de Cooperación para la Agricultura. I Reunión de Consulta para la Armonización de Criterios en Registro y Etiquetado de Plaguicidas para los Paises del Area Sur. Santiago: Centro Interamericano de Documentación e Información Agrícola; 1984.
22. Bologna V. Problemas Relacionados con Medicamentos (PRM): Importancia de la Información en Envases, Rótulos y Prospectos. Administración Nacional De Medicamentos, Alimentos y Tecnología Médica. 2009; 17(1):1-8.
23. Coffey KC. Is There a Role for Expired Medications in Developing Countries? Clin Pediatr. 2013; 52(1):7-9.
24. Newsome R, Balestrini CG, Baum MD, Corby J, Fisher W, Goodburn K et al. Applications and Perceptions of Date Labeling of Food. Compr Rev Food Sci Food Saf. 2014; 13(4):745-769.
25. Aung MM, Chang YS. Traceability in a food supply chain: Safety and quality perspectives. Food Control. 2014; 39:172-184.
26. McKay DL, Blumberg JB. A review of the bioactivity and potential health benefits of peppermint tea (Mentha piperita L). Phytother Res. 2006; 20(8):619-633.
27. Ulbricht CE. Natural Standard Herb & Supplement Guide: An Evidence-Based Reference. United States; Mosby, Inc.: 2010.
28. Samojlik I, Petković S, Mimica-Dukić N, Božin B. Acute and Chronic Pretreatment with Essential Oil of Peppermint (Mentha x piperita L., Lamiaceae) Influences Drug Effects. Phytother Res. 2012; 26(8):820-825.
29. Moeinipour A, Abbassi Teshnizi M, Manafi B, Yavari H, Moeinipour Y, Hoseinikhah H. Posible interaction of warfarin with peppermint herbal tea: a case report. Reviews in Clinical Medicine. 2017; 4(2):83-86.
30. Nath SS, Pandey C, Roy D. A near fatal case of high dose peppermint oil ingestion-Lessons learnt. Indian J Anaesth. 2012; 56(6):582-584.
31. Shams R, Oldfield EC, Copare J, Johnson DA. Peppermint Oil: Clinical Uses in the Treatment of Gastrointestinal Diseases. JSM Gastroenterol Hepatol. 2015; 3(1):1035.
32. Gardner Z, McGuffin M, editors. Botanical Safety Handbook. 2nd edition. Florida: Taylor & Francis Group; 2003.
33. Dadzie BK, Orchard JE. Evaluación rutinaria postcosecha de híbridos de bananos y plátanos: criterios y métodos. Montpellier: Red Internacional para el Mejoramiento del Banano y el Plátano; 1997.
34. Ghorbani A, Saeedi Y, de Boer HJ. Unidentifiable by morphology: DNA barcoding of plant material in local markets in Iran. PLOS ONE. 2017; 12(4):e0175722.
35. Valmorbida J, Fernandes Boaro CS. Growth and Development of Mentha piperita L. in Nutrient Solution as Affected by Rates of Potassium. Braz Arch Biol Technol. 2007; 50(3):379-384.
36. Tamargo J, Le Heuzey J, Mabo P. Narrow therapeutic index drugs: a clinical pharmacological consideration to flecainide. Eur J Clin Pharmacol. 2015; 71(5):549-567.
37. European Medicines Agency. Assessement report on Mentha x piperita L., folium. Londres; European Medicines Agency: 2008.
38. Cholayudth P. Establishing Acceptance Limits for Uniformity of Dosage Units. Pharm Technol. 2016; 40(12):34-43.
39. World Health Organization. Quality control methods for herbal materials. Geneva: WHO; 2011
40. Mahapatra A, Nguyen CN. Drying of medicinal plants. Acta Hortic. 2007; 756(756): 47-54.
41. Kunle OF, Egharevba HO, Ahmadu PO. Standarization of herbal medicines - A review. Int J Biodivers Conserv. 2012; 4(3):101-112.
42. Kripanand S, Guruguntla S, Korra S. Effect of Various Drying on Quality and Flavor Characteristics of Mint Leaves (Mentha spicata L.). J Food Pharm Sci. 2015; 3:38-45
43. Vidaurre Martínez MF, Querevalú García LM, de los Ríos Martínez E, Ruiz Reyes SG. Caacterísticas farmacognósticas de las hojas de Capparis Avicennifolia. Rev Med Vallejiana. 2007; 4(2):122-131.
44. Miranda M. Farmacognosia y Productos naturales. 2001. Cuba: Editorial Félix Varela; 2001.
45. Rao Y, Xiang B. Determination of Total Ash and Acid-insoluble Ash of Chinese Herbal Medicine Prunellae Spica by Near Infrared Spectroscopy. Yakugaku Zasshi. 2009; 129(7):881-886.
46. Chandel HS, Pathak, AK, Tailang M. Standardization of some herbal antidiabetic drugs in polyherbal formulation. Pharmacogn Res. 2011; 3(1):49-56.
47. Genuis SJ, Schwalfenberg G, Siy AJ, Rodushkin I. Toxic Element Contamination of Natural Health Products and Pharmaceutical Preparations. PLOS ONE. 2012; 7(11):e49676.
48. Shaban NS, Abdou KA, Hassan NEY. Impact of toxic heavy metals and pesticide residues in herbal products. Beni-Seuf Univ J Appl Sci. 2016; 5:102-106.
49. Gunturu KS, Nagarajan P, McPhedran P, Goodman TR, Hodsdon ME, Strout MP. Ayurvedic herbal medicine and lead poisoning. J Hematol Oncol. 2011; 4(51).
50. Khalid M, Karim T. Lead Poisoning due to Herbal Remedies for Infertility. Gulf Med J. 2015; 4(1):46-48.
51. Franco L, Castillo N, González MJ, Santillán JM, Vázquez M, Botto I. Arsénico y Medio Ambiente: Efectos del Riego con Aguas Conteniendo As sobre Cultivos Hortícolas. La Plata: Actas Sétimo Congreso de Medio Ambiente AUGM; 2012.
52. Chung J, Yu S, Hong Y. Enviromental Source of Arsenic Exposure. J Prev Med Public Health. 2014; 47:253-257.
53. Shankar S, Shanker U, Shikha. Arsenic Contamination of Groundwater: A Review of Sources, Prevalence, Health Risks, and Strategies for Mitigation. Sci World J. 2014; 2014.
54. Steinmaus CM, Ferreccio C, Acevedo Romo J, Yuan Y, Cortes S, Marshall G et al. Drinking Water Arsenic in Northern Chile: High Cancer Risks 40 Years after Exposure Cessation. Cancer Epidemiol Biomarkers Prev. 2013; 22(4):623-630.
55. Tournas VH, Katsoudas E, Miracco EJ. Moulds, yeasts and aerobic plate counts in ginseg supplements. Int J Food Microbiol. 2006; 108:178-181.
56. Ratajczak M, Kubicka MM, Kamińska D, Sawicka P, Długaszewska J. Microbiological quality of non-sterile pharmaceutical products. Saudi Pharm J. 2015; 23:303-307.
57. Hebbelstrup Jensen B, Olsen KE, Struve C, Krogfelt KA, Petersen AM. Epidemiology and Clinical Manifestations of Enteroaggregative Escherichia coli. Clin Microbiol Rev. 2014; 27(3):614-630.
58. E. coli, Compilation prepared by the World Health Organization, http://www.who.int/mediacentre/factsheets/fs125/en/
59. Andino A, Hanning I. Salmonella enterica: Survivial, Colonization, and Virulence Differences among Serovars. Sci World J. 2015; 2015.
60. Eng S, Pusparajah P, Ab Mutalib N, Ser H, Chan K, Lee L. Salmonella: A review on pathogenesis, epidemiology and antibiotic resistance. Front Life Sci. 2015; 8(3):284-293.
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Mora Román JJ, Agüero Brenes N, Angulo Morales C, Castro Solís J, Hidalgo Carrillo G, van Hoof Gómez M, Loría Gutiérrez A, Blanco Barrantes J. Physicochemical and Microbiological Assays for Quality Evaluation of a Brand of Mentha piperita Tisanes in Costa Rica Market: Employment of the Central American Technical Regulation. JDDT [Internet]. 10Sep.2018 [cited 12May2024];8(5):329-37. Available from: https://jddtonline.info/index.php/jddt/article/view/1878
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