Quality of phytotherapeutic drugs registered in Brazil containing Aesculus hippocastanum extract

Detalhes bibliográficos
Autor(a) principal: Balbino, Evelin Elfriede
Data de Publicação: 2014
Outros Autores: Cunha, Luzia Helena, Duarte, Maria Gorette Resende, Valenzuela, Virginia Del Carmen T., Rodrigues, Juliana Elizabeth da Silva, Oliveira, Adriana Passos
Tipo de documento: Artigo
Idioma: por
Título da fonte: Vigilância Sanitária em Debate
Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/191
Resumo: The seeds of Aesculus hippocastanum L. (Hippocastanaceae), known as horsechestnut, have been used in several parts of the world to treat chronic venous insufficiency. The present study aimed to evaluate the quality of commercial samples of herbal medicines containing extract of A. hippocastanum seeds. In total, 16 commercial samples from Brazilian market with a valid registration in March 2013 were analyzed for the concor-dance with the specifications contained in each application file approved by ANVISA. The fingerprint, the content of aescin, the mean weight and macro and microscopic analysis of these medicines were carried out in an official laboratory. Furthermore, the evalua-tion of the package leaflet and the packaging was achieved by an ANVISA specialist. The results showed that 13 of the 16 commercial samples analyzed were outside of the approved specifications. Therefore, it is imperative that the focus of health activities turn over to the monitoring and evaluation of the herbal medicines throughout its marketing.
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spelling Quality of phytotherapeutic drugs registered in Brazil containing Aesculus hippocastanum extractQualidade de medicamentos fitoterápicos contendo extrato de Aesculus hippocastanum registrados no BrasilAesculus HippocastanumHorse-ChestnutQuality ControlHerbal MedicineANVISAAesculus HippocastanumCastanha-da-ÍndiaControle de QualidadeFitoterápicosANVISAThe seeds of Aesculus hippocastanum L. (Hippocastanaceae), known as horsechestnut, have been used in several parts of the world to treat chronic venous insufficiency. The present study aimed to evaluate the quality of commercial samples of herbal medicines containing extract of A. hippocastanum seeds. In total, 16 commercial samples from Brazilian market with a valid registration in March 2013 were analyzed for the concor-dance with the specifications contained in each application file approved by ANVISA. The fingerprint, the content of aescin, the mean weight and macro and microscopic analysis of these medicines were carried out in an official laboratory. Furthermore, the evalua-tion of the package leaflet and the packaging was achieved by an ANVISA specialist. The results showed that 13 of the 16 commercial samples analyzed were outside of the approved specifications. Therefore, it is imperative that the focus of health activities turn over to the monitoring and evaluation of the herbal medicines throughout its marketing.As sementes de Aesculus hippocastanum L. (Hippocastanaceae), conhecida como castanha-da-Índia, são utilizadas em várias partes do mundo no tratamento da insuficiência venosa crônica. O objetivo do presente estudo foi avaliar a qualidade de amostras comerciais de medicamentos fitoterápicos contendo extrato de sementes de A. hippocastanum. O total de 16 amostras comercializadas no Brasil com registro válido em março de 2013 foram avaliadas quanto à correspondência com as especificações do dossiê de registro aprovado pela ANVISA. As amostras foram analisadas em Laboratório Oficial, quanto ao perfil cromatográfico, teor de escina, características macroscópicas e microscópicas e peso médio. A bula e a rotulagem foram avaliadas por especialista da ANVISA. Os resultados apontaram que 13 dos 16 medicamentos avaliados apresentavam ao menos uma não-conformidade. Portanto, é imprescindível a implementação de ações de vigilância sanitária efetivas, com foco no monitoramento e avaliação de medicamentos fitoterápicos ao longo de sua comercialização.Instituto Nacional de Controle de Qualidade em Saúde2014-08-28info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfimage/jpeghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/19110.3395/vd.v2n3.191Health Surveillance under Debate: Society, Science & Technology ; Vol. 2 No. 3 (2014): August; 71-79Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 2 Núm. 3 (2014): Agosto; 71-79Vigil Sanit Debate, Rio de Janeiro; v. 2 n. 3 (2014): Agosto; 71-792317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/191/138https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/191/633Copyright (c) 2014 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessBalbino, Evelin ElfriedeCunha, Luzia HelenaDuarte, Maria Gorette ResendeValenzuela, Virginia Del Carmen T.Rodrigues, Juliana Elizabeth da SilvaOliveira, Adriana Passos2023-06-27T14:57:33Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/191Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T14:57:33Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Quality of phytotherapeutic drugs registered in Brazil containing Aesculus hippocastanum extract
Qualidade de medicamentos fitoterápicos contendo extrato de Aesculus hippocastanum registrados no Brasil
title Quality of phytotherapeutic drugs registered in Brazil containing Aesculus hippocastanum extract
spellingShingle Quality of phytotherapeutic drugs registered in Brazil containing Aesculus hippocastanum extract
Balbino, Evelin Elfriede
Aesculus Hippocastanum
Horse-Chestnut
Quality Control
Herbal Medicine
ANVISA
Aesculus Hippocastanum
Castanha-da-Índia
Controle de Qualidade
Fitoterápicos
ANVISA
title_short Quality of phytotherapeutic drugs registered in Brazil containing Aesculus hippocastanum extract
title_full Quality of phytotherapeutic drugs registered in Brazil containing Aesculus hippocastanum extract
title_fullStr Quality of phytotherapeutic drugs registered in Brazil containing Aesculus hippocastanum extract
title_full_unstemmed Quality of phytotherapeutic drugs registered in Brazil containing Aesculus hippocastanum extract
title_sort Quality of phytotherapeutic drugs registered in Brazil containing Aesculus hippocastanum extract
author Balbino, Evelin Elfriede
author_facet Balbino, Evelin Elfriede
Cunha, Luzia Helena
Duarte, Maria Gorette Resende
Valenzuela, Virginia Del Carmen T.
Rodrigues, Juliana Elizabeth da Silva
Oliveira, Adriana Passos
author_role author
author2 Cunha, Luzia Helena
Duarte, Maria Gorette Resende
Valenzuela, Virginia Del Carmen T.
Rodrigues, Juliana Elizabeth da Silva
Oliveira, Adriana Passos
author2_role author
author
author
author
author
dc.contributor.author.fl_str_mv Balbino, Evelin Elfriede
Cunha, Luzia Helena
Duarte, Maria Gorette Resende
Valenzuela, Virginia Del Carmen T.
Rodrigues, Juliana Elizabeth da Silva
Oliveira, Adriana Passos
dc.subject.por.fl_str_mv Aesculus Hippocastanum
Horse-Chestnut
Quality Control
Herbal Medicine
ANVISA
Aesculus Hippocastanum
Castanha-da-Índia
Controle de Qualidade
Fitoterápicos
ANVISA
topic Aesculus Hippocastanum
Horse-Chestnut
Quality Control
Herbal Medicine
ANVISA
Aesculus Hippocastanum
Castanha-da-Índia
Controle de Qualidade
Fitoterápicos
ANVISA
description The seeds of Aesculus hippocastanum L. (Hippocastanaceae), known as horsechestnut, have been used in several parts of the world to treat chronic venous insufficiency. The present study aimed to evaluate the quality of commercial samples of herbal medicines containing extract of A. hippocastanum seeds. In total, 16 commercial samples from Brazilian market with a valid registration in March 2013 were analyzed for the concor-dance with the specifications contained in each application file approved by ANVISA. The fingerprint, the content of aescin, the mean weight and macro and microscopic analysis of these medicines were carried out in an official laboratory. Furthermore, the evalua-tion of the package leaflet and the packaging was achieved by an ANVISA specialist. The results showed that 13 of the 16 commercial samples analyzed were outside of the approved specifications. Therefore, it is imperative that the focus of health activities turn over to the monitoring and evaluation of the herbal medicines throughout its marketing.
publishDate 2014
dc.date.none.fl_str_mv 2014-08-28
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
"Peer-reviewed article"
"Artículo revisado por pares"
"Artigo avaliado pelos pares"
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/191
10.3395/vd.v2n3.191
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/191
identifier_str_mv 10.3395/vd.v2n3.191
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/191/138
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/191/633
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
image/jpeg
dc.publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
dc.source.none.fl_str_mv Health Surveillance under Debate: Society, Science & Technology ; Vol. 2 No. 3 (2014): August; 71-79
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 2 Núm. 3 (2014): Agosto; 71-79
Vigil Sanit Debate, Rio de Janeiro; v. 2 n. 3 (2014): Agosto; 71-79
2317-269X
reponame:Vigilância Sanitária em Debate
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Vigilância Sanitária em Debate
collection Vigilância Sanitária em Debate
repository.name.fl_str_mv Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br
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