medigraphic.com
ISSN 1561-2988 (Print)

2011, Number 4

<< Back Next >>

Rev Cubana Farm 2011; 45 (4)

Accelerated stability of a Rhizophora mangle L. (red mangrove) gel for wounds and burns

Soler RDM, Rodríguez PY, Pérez BT, Riverón AY, Morales LIG

Language: Spanish
References: 37
Page: 563-574
PDF size: 93.60 Kb.


ABSTRACT

The objective of the present paper was to evaluate the accelerated stability of a Rhizophora mangle L. (red mangrove) gel under 2 storage conditions. The three pilot batches (GM01, GM02 and GM03) were stored at two temperature settings: 40 ± 2 °C for three months and 25 ± 2 °C for 6 months. One physical-chemical and microbiological evaluation was performed in two periods of time: at the months 0, 1, 2 and 3 for the first and at the months 0, 1, 2, 3 y 6 for the second tested storage condition. All the batches stored at both temperatures showed stable organoleptic characteristics and extensibility, the pH ranged from 6 to 7 and rheology confirmed a non-Newtonian fluid of Herschel Bulkley-type in the evaluated periods of time. The minimum inhibitory concentration remained 8 to 10 mg/mL whereas the tannin concentration ranged 13 to 30 mg/g. All the batches were within the allowable microbial limits. The red mangrove gel showed good stability under accelerated temperatures, but this is an aspect that requires to be confirmed in a future on-shelf stability study.


REFERENCES

  1. Principales ecosistemas frágiles cubanos: manglares. [Internet] 2008 [citado Feb 2010]. Disponible en: http://www.medioambiente.cu/ecosistemas_manglares.asp

  2. Suman D. Situación de los manglares en América Latina y la Cuenca del Caribe. El ecosistema de manglar en América Latina y en la Cuenca del Caribe: su manejo y conservación. Miami: Rosenstiel School of Marine and Atmospheric Science; 1994. p. 1-10.

  3. Melchor G, Fernández O, Alvarez E, Fragas I, Lobo E. Evaluación del efecto antiséptico in vivo del CIKRON-H. Rev Mex Cien Farm. 2001;32(2):25-32.

  4. Fernández O, Capdevila JZ, Dalla G, Melchor G. Efficacy of Rhizophora mangle aqueous bark extract in the healing of open surgical wounds. Fitoter. 2002;73(7/8):564-8.

  5. Bulnes C, Fernandez O, Navarro D, Marrero E, Rueda D, Figueroa O, Melchor G, Proenza T. Healing effect of a red mangrove extract on open aseptic wounds in rats. Rev Salud Anim. 2001;23(2):102-8.

  6. Sánchez LM, Escobar A, Valcárcel L. Caracterización preliminar de la materia prima de Rhizophora mangle L. en la obtención de productos farmacéuticos procedentes de tres zonas geográficas de Cuba. Rev Salud Anim. 2005;27(2):115-23.

  7. Sánchez LM, Valcárcel L, Escobar A, Noa M. Polyphenol and phytosterols composition in an antibacterial extract from Rhizophora mangle L´s bark. J Herbal Pharmacother. 2006;6:5.

  8. Marrero E. Phytopharmaceuticals as therapeutic tools for veterinary and human therapy: Research on natural health products developed at CENSA, Havana, Cuba. In: Capasso A (ed). Recent Developments in Medicinal Plant Research. 2007. Available from: http://www.censa.edu.cu/blog/emf/wp-content/uploads/2009/10/115-marreroe-capitulo14-libro-capasso-2007.pdf

  9. Rashmi MS. Topical Gel: A Review. Latest reviews. 2008;6(3):244-9. Available from: http://www.pharmainfo.net/reviews/topical-gel-review

  10. Shivhare UD, Jain KB, Mathur VB, Bhusari KP, Roy AA. Formulation development and evaluation of Diclofenac sodium gel using water soluble polyacrylamide polymer. Digest J Nanomat Biostruct. 2009;4(2):285-90.

  11. Gupta A, Mishra AK, Singh AK, Gupta V, Bansal P. Formulation and evaluation of topical gel of diclofenac sodium using different polymers. [Internet]. Drug Invention Today 2010 [cited 2010 Jun].;2(5):250-3. Available from: http://ditonline.info/article/view/2378

  12. Alves MP, Funck, JAB, Bittencourt CF, Silva MAS. Desenvolvimento e avaliação da estabilidade de bases dermatológicas não iônicas para incorporação de fármacos. Rev Pharm Tech (Ed. port.). 1999;3(2):40-5.

  13. Zanin SMW, Miguel MD, Chimelli M, Dalmaz AC. Parâmetros físicos no estudo da estabilidade das emulsões. Vis Acad. 2001;2(2):47-58.

  14. Brasil. Guia de Estabilidade de Produtos Cosméticos. Anvisa. 2004;1:52.

  15. Zunino GPA. Farmácia Magistral no contexto da saúde. Pharm Bras. 2007; 10(59-60):44-8.

  16. Escobar A, Pérez T, Riverón Y, Sánchez LM, Fernández O, Marrero E. Estabilidad en condiciones drásticas del CIKRON-H. Rev Salud Anim [Internet]. 2008 Abr [citado 14 Mar 2010]; 30(1):25-31. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0253-570X2008000100004&lng=es

  17. PN/L/CP/003/00 Determinación del índice de extensibilidad. [Internet] 2008 [citado Sept 2009]. Disponible en: http://www.rentasoft.es/Compufarma/Formulacion/PN_L_CP_003_00.pdf

  18. Travieso MC, Betancourt A, Escobar A, Linares A, Rodríguez Y, Pérez T. Validación del método de cuantificación de taninos totales en formulaciones semisólidas de Rhizophora mangle L. (mangle rojo). Rev Cubana Plant Med [Internel]. 2011[citado Mar 2011]; 16(1). Disponible en: http://bvs.sld.cu/revistas/pla/vol16_1_11/pla09111.htm

  19. Daguet GL, Chabbert VA. Técnicas en Bacteriología. Barcelona: Editorial Jims, 1977. p. 135-53.

  20. United States Pharmacopeia Convention USP XXIX. United States Pharmacopeial Convention. 29 ed. Rockville: Mack Printing; 2006. p. 2503-8.

  21. Regulación 23-2000. Requerimientos de los estudios de estabilidad para el registro de productos farmacéuticos nuevos y conocidos. CECMED. Cuba. 2000. Disponible en: http://www.cecmed.sld.cu/Docs/RegFarm/DRA/LicProd/1992-2000/Reg/Reg_23-00.pdf

  22. Soriano MC, Sánchez-Lafuente C, Alvarez-Fuentes J, Holgado MA. Acondicionamiento de medicamentos: funciones y tipos de envasado. Industria Farmacéutica. 2000;15(3):95-101.

  23. Ratna V. Stability of drugs: Packaging and stability. [en línea] 2005 [cited 2010 marzo]. Available from: http://www.pharmainfo.net/free-books/stabilitydrugs? page=4961

  24. Shabir GA. Review of Pharmaceutical Product Stability, Packaging and the ICH Guidelines. Am Pharm Rev. 2008;11(1):139-41.

  25. World Health Organization. WHO Technical Report Series, No. 902, Annex 9. Guidelines on packaging for pharmaceutical products. 2002: 119-146. Available from: http://whqlibdoc.who.int/trs/WHO_TRS_902.pdf#page=129

  26. Rodríguez Leyes EA, Sierra Pérez RC, González Canavaciolo VL, Marrero Delange D, Vicente Murillo R. Estudio de estabilidad acelerada del ingrediente activo D-004 en diferentes envases. Rev Cubana Plant Med [Internet]. 2009 Sep [citado 17 Ene 2010]; 14(3):54-60. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1028-47962009000300008&lng=es

  27. Suárez Pérez Y, García Pulpeiro O, Cueto León M. Estabilidad acelerada del ungüento QL. Rev Cubana Farm [Internet]. 2008 Abr [citado 17 Ene 2010]; 42(1). Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75152008000100010&lng=es

  28. Muñoz M. Síntesis y caracterización de geles como vehículos de meloxicam y acetato de vitamina E de aplicación tópica terapéutica y cosmética. Tesis doctoral. [Internet] 2005 [citado Feb de 2009]. Disponible en: http://digibug.ugr.es/bitstream/10481 /560/1/15381870.pdf

  29. Welin BK, Neelissen JAM, Bergenstah B. The effects of the rheological behavior of the topical anesthesic formulation on the release permeation rates of the active compound. Eur J Pharm Sci. 2001;13(3):309-18.

  30. Marquele-Oliveira F, Fonseca YM, de Freitas O, Fonseca MJV. Development of topical functionalized formulations added with propolis extract: Stability, cutaneous absorption and in vivo studies. Int J Pharm. 2007;342:40-8.

  31. Hagerman AE, Butler LG. Protein precipitation method for the quantitative determination of tannins. J Agricult Food Chem. 1978;26(4):809-12.

  32. Travieso MC, Hechavarría OL, Betancourt AB, Frontera M, Miranda I. Validación del método de determinación de taninos totales en productos naturales vegetales. Rev Protección Veg. 1998;13(3):189-94.

  33. Escobar A, Pérez T, Riverón Y, Melchor G, Sánchez LM, Fernández O, et al. Estabilidad en vida de estante del CIKRON-H. Rev Salud Anim. [Internet]. 2008 Abr [citado 14 Mar 2010]; 30(1):32-38. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0253-570X2008000100005&lng=es

  34. Andrews JM. Determination of minimum inhibitory concentrations. J Antimicrob Chemother. 2001;4(Suppl 1):5-16.

  35. Sánchez LM, Melchor G, Alvarez S, Bulnes C. Caracterización química y toxicológica de una formulación cicatrizante de Rhizophora mangle L. Rev Salud Anim. 1998;20(2):69-72.

  36. Sánchez LM, Armenteros M, Varcárcel L. Actividad antimicrobiana de los principales grupos químicos presentes en Rhizophora mangle L. Rev Salud Anim. 2000;22(3):174-9.

  37. Armenteros M, Ginorio MC. Determination of the minimum inhibitory concentration of Rizophora mangle L. (Red mangrove) against different microorganisms. Rev Salud Anim. 1999;1(2):135.




2020     |     www.medigraphic.com