Accelerated stability study of a solution containing plant extract from Traditional Chinese Medicine

Detalhes bibliográficos
Autor(a) principal: Machado, Bianca Ishida
Data de Publicação: 2021
Outros Autores: Lima, Clara Beatriz de, Guidi, Ana Carolina, Teston, Ana Paula Margioto, Ferreira Romanichen, Francine Maery Dias, Mello, João Carlos Palazzo de, Araújo, Daniela Cristina de Medeiros
Tipo de documento: Artigo
Idioma: por
Título da fonte: Research, Society and Development
Texto Completo: https://rsdjournal.org/index.php/rsd/article/view/21624
Resumo: Traditional Chinese Medicine (TCM) is a science that has spent its thousands of years of existence aggregating knowledge of its practices, which are based on the principle of balancing yin and yang energies. Stability is the factor that determines the compatibility between the active principles with their excipients and packaging, when there is no such compatibility, the preservation of a formulation is directly affected. Therefore, the objective of this work was to carry out an accelerated stability study (0 to 6 months; 40 ºC, 25% UR) of a solution containing extract of six MTC plants, through physical-chemical (organoleptic characteristics, pH, density and viscosity) and microbiological (for fungi and bacteria) quality control tests, following the methodologies described in the Brazilian Pharmacopoeia 6th edition. The analysis of the chromatographic profile by HPLC was also performed. The results observed in the physicochemical evaluations carried out during the study period (6 months) demonstrated adequate stability in organoleptic parameters, pH and density. The observed viscosity was different from other works, but it is acceptable for solutions and remained stable during the analyzed times. In the evaluation by chromatography, there was evidence of degradation of the assets after time 1 month, not showing stability under the conditions of temperature and humidity used during the study. In the evaluation of microbiological quality, the growth of fungi or bacteria was not observed in the analyzed times.
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spelling Accelerated stability study of a solution containing plant extract from Traditional Chinese Medicine Estudio acelerado de estabilidade de solucíon que contiene extracto de planta de Medicina Tradicional China Estudo de estabilidade acelerada de solução contendo extrato de plantas da Medicina Tradicional ChinesaHerbal medicineHigh Performance Liquid Chromatography (HPLC)Quality control.Cromatografia líquida de alta resolución (HPLC)Medicina herbariaControl de calidad.FitoterápicoCromatografia líquida de alta eficiência (CLAE)Controle de qualidade.Traditional Chinese Medicine (TCM) is a science that has spent its thousands of years of existence aggregating knowledge of its practices, which are based on the principle of balancing yin and yang energies. Stability is the factor that determines the compatibility between the active principles with their excipients and packaging, when there is no such compatibility, the preservation of a formulation is directly affected. Therefore, the objective of this work was to carry out an accelerated stability study (0 to 6 months; 40 ºC, 25% UR) of a solution containing extract of six MTC plants, through physical-chemical (organoleptic characteristics, pH, density and viscosity) and microbiological (for fungi and bacteria) quality control tests, following the methodologies described in the Brazilian Pharmacopoeia 6th edition. The analysis of the chromatographic profile by HPLC was also performed. The results observed in the physicochemical evaluations carried out during the study period (6 months) demonstrated adequate stability in organoleptic parameters, pH and density. The observed viscosity was different from other works, but it is acceptable for solutions and remained stable during the analyzed times. In the evaluation by chromatography, there was evidence of degradation of the assets after time 1 month, not showing stability under the conditions of temperature and humidity used during the study. In the evaluation of microbiological quality, the growth of fungi or bacteria was not observed in the analyzed times.La Medicina Tradicional China (MTC) es una ciencia que ha pasado sus miles de años de existencia agregando el conocimiento de sus prácticas, que se basan en el principio de equilibrar las energías yin y yang. La estabilidad es el factor que determina la compatibilidad entre los principios activos con sus excipientes y el envase, cuando no existe tal compatibilidad, la conservación de una formulación se ve directamente afectada. Por tanto, el objetivo de este trabajo fue realizar un estudio de estabilidad acelerada (0 a 6 meses; 40 ºC, 25% UR) de una solución que contiene extracto de seis plantas de MTC, mediante pruebas físico-químicas (características organolépticas, pH, densidad y viscosidad) y de control de calidad microbiológico, siguiendo las metodologías descritas en la 6ª edición de la Farmacopea Brasileña. También se realizó el análisis del perfil cromatográfico por HPLC. Los resultados observados en las evaluaciones fisicoquímicas realizadas durante el período de estudio (6 meses) demostraron una adecuada estabilidad en los parámetros organolépticos, pH y densidad. La viscosidad observada fue diferente a otros trabajos, pero es aceptable para soluciones y se mantuvo estable durante los tiempos analizados. En la evaluación por cromatografía, se evidenció degradación de los activos después del tiempo 1 mes, no mostrando estabilidad en las condiciones de temperatura y humedad utilizadas durante el estudio. En la evaluación de la calidad microbiológica, no se observó crecimiento de hongos o bacterias en los tiempos analizados.A Medicina Tradicional Chinesa (MTC) é uma ciência que passou seus milhares de anos de existência agregando conhecimentos de suas práticas, que se baseiam no princípio do equilíbrio das energias yin e yang. A estabilidade é o fator que determina a compatibilidade entre os princípios ativos com seus excipientes e embalagens, quando não há essa compatibilidade, a conservação de uma formulação é diretamente afetada. Sendo assim, o objetivo deste trabalho foi realizar um estudo de estabilidade acelerado (0 a 6 meses; 40 ºC, 25% UR) de solução contendo extrato de seis plantas da MTC, por meio de testes de controle de qualidade físico-químicos (características organolépticas, pH, densidade e viscosidade) e microbiológicos (para fungos e bactérias), seguindo as metodologias descritas na Farmacopeia Brasileira 6ª edição. Foi realizada também a análise do perfil cromatográfico por CLAE. Os resultados observados nas avaliações físico-químicas realizadas durante o período de estudo (6 meses) demonstraram estabilidade adequada nos parâmetros organolépticos, pH e densidade. A viscosidade observada foi diferente de outros trabalhos, mas é aceitável para soluções e manteve-se estável durante os tempos analisados. Já na avaliação por cromatografia, observou-se indícios de degradação dos ativos após o tempo 1 mês, não apresentando estabilidade diante das condições de temperatura e umidade utilizadas durante o estudo. Na avaliação da qualidade microbiológica, não foi constatado o crescimento de fungos ou bactérias nos tempos analisados.Research, Society and Development2021-10-24info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://rsdjournal.org/index.php/rsd/article/view/2162410.33448/rsd-v10i14.21624Research, Society and Development; Vol. 10 No. 14; e31101421624Research, Society and Development; Vol. 10 Núm. 14; e31101421624Research, Society and Development; v. 10 n. 14; e311014216242525-3409reponame:Research, Society and Developmentinstname:Universidade Federal de Itajubá (UNIFEI)instacron:UNIFEIporhttps://rsdjournal.org/index.php/rsd/article/view/21624/19303Copyright (c) 2021 Bianca Ishida Machado; Clara Beatriz de Lima; Ana Carolina Guidi; Ana Paula Margioto Teston; Francine Maery Dias Ferreira Romanichen; João Carlos Palazzo de Mello; Daniela Cristina de Medeiros Araújohttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessMachado, Bianca Ishida Lima, Clara Beatriz deGuidi, Ana CarolinaTeston, Ana Paula Margioto Ferreira Romanichen, Francine Maery DiasMello, João Carlos Palazzo deAraújo, Daniela Cristina de Medeiros 2021-12-04T11:48:39Zoai:ojs.pkp.sfu.ca:article/21624Revistahttps://rsdjournal.org/index.php/rsd/indexPUBhttps://rsdjournal.org/index.php/rsd/oairsd.articles@gmail.com2525-34092525-3409opendoar:2024-01-17T09:41:00.305946Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)false
dc.title.none.fl_str_mv Accelerated stability study of a solution containing plant extract from Traditional Chinese Medicine
Estudio acelerado de estabilidade de solucíon que contiene extracto de planta de Medicina Tradicional China
Estudo de estabilidade acelerada de solução contendo extrato de plantas da Medicina Tradicional Chinesa
title Accelerated stability study of a solution containing plant extract from Traditional Chinese Medicine
spellingShingle Accelerated stability study of a solution containing plant extract from Traditional Chinese Medicine
Machado, Bianca Ishida
Herbal medicine
High Performance Liquid Chromatography (HPLC)
Quality control.
Cromatografia líquida de alta resolución (HPLC)
Medicina herbaria
Control de calidad.
Fitoterápico
Cromatografia líquida de alta eficiência (CLAE)
Controle de qualidade.
title_short Accelerated stability study of a solution containing plant extract from Traditional Chinese Medicine
title_full Accelerated stability study of a solution containing plant extract from Traditional Chinese Medicine
title_fullStr Accelerated stability study of a solution containing plant extract from Traditional Chinese Medicine
title_full_unstemmed Accelerated stability study of a solution containing plant extract from Traditional Chinese Medicine
title_sort Accelerated stability study of a solution containing plant extract from Traditional Chinese Medicine
author Machado, Bianca Ishida
author_facet Machado, Bianca Ishida
Lima, Clara Beatriz de
Guidi, Ana Carolina
Teston, Ana Paula Margioto
Ferreira Romanichen, Francine Maery Dias
Mello, João Carlos Palazzo de
Araújo, Daniela Cristina de Medeiros
author_role author
author2 Lima, Clara Beatriz de
Guidi, Ana Carolina
Teston, Ana Paula Margioto
Ferreira Romanichen, Francine Maery Dias
Mello, João Carlos Palazzo de
Araújo, Daniela Cristina de Medeiros
author2_role author
author
author
author
author
author
dc.contributor.author.fl_str_mv Machado, Bianca Ishida
Lima, Clara Beatriz de
Guidi, Ana Carolina
Teston, Ana Paula Margioto
Ferreira Romanichen, Francine Maery Dias
Mello, João Carlos Palazzo de
Araújo, Daniela Cristina de Medeiros
dc.subject.por.fl_str_mv Herbal medicine
High Performance Liquid Chromatography (HPLC)
Quality control.
Cromatografia líquida de alta resolución (HPLC)
Medicina herbaria
Control de calidad.
Fitoterápico
Cromatografia líquida de alta eficiência (CLAE)
Controle de qualidade.
topic Herbal medicine
High Performance Liquid Chromatography (HPLC)
Quality control.
Cromatografia líquida de alta resolución (HPLC)
Medicina herbaria
Control de calidad.
Fitoterápico
Cromatografia líquida de alta eficiência (CLAE)
Controle de qualidade.
description Traditional Chinese Medicine (TCM) is a science that has spent its thousands of years of existence aggregating knowledge of its practices, which are based on the principle of balancing yin and yang energies. Stability is the factor that determines the compatibility between the active principles with their excipients and packaging, when there is no such compatibility, the preservation of a formulation is directly affected. Therefore, the objective of this work was to carry out an accelerated stability study (0 to 6 months; 40 ºC, 25% UR) of a solution containing extract of six MTC plants, through physical-chemical (organoleptic characteristics, pH, density and viscosity) and microbiological (for fungi and bacteria) quality control tests, following the methodologies described in the Brazilian Pharmacopoeia 6th edition. The analysis of the chromatographic profile by HPLC was also performed. The results observed in the physicochemical evaluations carried out during the study period (6 months) demonstrated adequate stability in organoleptic parameters, pH and density. The observed viscosity was different from other works, but it is acceptable for solutions and remained stable during the analyzed times. In the evaluation by chromatography, there was evidence of degradation of the assets after time 1 month, not showing stability under the conditions of temperature and humidity used during the study. In the evaluation of microbiological quality, the growth of fungi or bacteria was not observed in the analyzed times.
publishDate 2021
dc.date.none.fl_str_mv 2021-10-24
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/21624
10.33448/rsd-v10i14.21624
url https://rsdjournal.org/index.php/rsd/article/view/21624
identifier_str_mv 10.33448/rsd-v10i14.21624
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/21624/19303
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Research, Society and Development
publisher.none.fl_str_mv Research, Society and Development
dc.source.none.fl_str_mv Research, Society and Development; Vol. 10 No. 14; e31101421624
Research, Society and Development; Vol. 10 Núm. 14; e31101421624
Research, Society and Development; v. 10 n. 14; e31101421624
2525-3409
reponame:Research, Society and Development
instname:Universidade Federal de Itajubá (UNIFEI)
instacron:UNIFEI
instname_str Universidade Federal de Itajubá (UNIFEI)
instacron_str UNIFEI
institution UNIFEI
reponame_str Research, Society and Development
collection Research, Society and Development
repository.name.fl_str_mv Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)
repository.mail.fl_str_mv rsd.articles@gmail.com
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