Regulation of herbal medicines in Brazil: advances and perspectives

Carvalho, Ana Cecília Bezerra; Perfeito, João Paulo Silvério; Silva, Leandro Viana Costa e; Ramalho, Lívia Santos; Marques, Robelma France de Oliveira; Silveira, Dâmaris

doi:10.1590/s1984-82502011000300004

Cited by 29 publications

(13 citation statements)

References 3 publications

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“…The presence of foreign materials in the herbal medicines may compromise the quality of the drug and interfere in their effectiveness and ALSO endanger consumer´s health (Balbino, Dias, 2010;Carvalho et al, 2011;Freire, 2005;Melo et al, 2004;Tobias et al, 2007). The major concern for human health is the long-term exposure to chemicals nonessential TO humans, even at low concentrations (Fergusson, 1990;Remington, Genaro, 2000).…”

Section: Introductionmentioning

confidence: 99%

Determination of metals in medicinal plants highly consumed in Brazil

Leal

Prado

Gomes

et al. 2013

Braz. J. Pharm. Sci.

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In this work, samples of the medicinal plants: Boldo (Peumus boldus), Castanha da Índia (Aesculus hippocastanum), Chá Verde (Camelia sinensis), Erva Cidreira (Melissa officinalis), Espinheira Santa (Maytenus ilicifolia), Guaraná (Paullinia cupana), Maracujá (Passiflora sp.), Mulungu (Erythrina velutina), Sene (Cassia angustifolia) and Valeriana (Valeriana officinalis) were evaluated BY using the Neutron Activation Analysis technique (NAA-k 0 ) in order to determine the levels of metals and other chemical contaminants. The results showed the presence of non essential elements to the human body. The diversity of chemical impurities found even at low concentration levels, considering the potential for chronic toxicity of these elements, reinforces the need to improve the implementation of good practices by growers and traders, and the hypothesis of lack of quality control in plant products. (AAN-k 0 ), a fim de se determinar os teores de metais e outros elementos químicos contaminantes. Os resultados revelaram a presença de elementos não essenciais ao organismo humano. A diversidade de impurezas químicas encontradas, mesmo em níveis de baixa concentração, considerando o potencial de toxicidade crônica desses elementos, reforça a necessidade de melhorias na aplicação de boas práticas pelos produtores e comerciantes e a hipótese de falta de controle de qualidade nos produtos vegetais.Unitermos: Análise por ativação neutrônica/análise quantitativa. Plantas medicinais. Metais/determinação em plantas medicinais. Contaminantes químicos/determinação em plantas medicinais. Produtos vegetais/ controle de qualidade.

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Section: Introductionmentioning

confidence: 99%

Determination of metals in medicinal plants highly consumed in Brazil

Leal

Prado

Gomes

et al. 2013

Braz. J. Pharm. Sci.

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“…Se compararmos com o mercado dos fármacos sintéticos, os fitoterápicos apresentam vendas de 15% contra apenas 4% dos sintéticos, com taxas de crescimento duas vezes mais expressivas (1)(2)(3)(4)(5)(6).…”

Section: Introductionunclassified

Análise De Bulas Dos Medicamentos À Base De Ginkgo Biloba L. Comercializadas Em Patos De Minas, Minas Gerais, Brasil

Andrade

Ferreira

2017

Infarma

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Industrialized medicines prepared from the dry extract of Ginkgo biloba L. are found in community pharmacy mainly in the forms of capsules and tablets. In acquiring the industrialized medicine, users have the package insert as the main source of printed information and for this information fulfill their purpose, it must be presented in an objective, updated and complete way. Thus, the objective of the study was to analyze the medicine package inserts containing dry extract of Ginkgo biloba L. according to the standards required by Brazilian normative RDC n. 47/2009 of Brazilian Health Surveillance Agency. An observational study was conducted with analysis of phytomedicines package inserts containing dry extract of Ginkgo biloba L. as single drug in the pharmaceutical form of capsules or tablets, sold in communitarian pharmacies in the city of Patos de Minas in Brazil, considering the topics: Identification of the product, Information for the patient, Legal information and Mandatory statements. Of the total different pharmaceutical specialties found, two did not have their respective package insert. In 45% of package inserts, some of the Mandatory statements were absent. One package insert brought conflicting information about the actual physical aspect of medicine. About the topic Information to patients, 48% of the package inserts were incomplete, and among these, with indications not established by law. All package inserts had complete information relating to topics Legal information and Identification of the product. Even under specific legislation, there are still phytomedicines with their package insert out of the established standards. The package inserts may have their primary function diverted when they cease to be an educational and informational material and become a source of confusion and incentive to misuse. RESUMOOs medicamentos industrializados elaborados a partir do extrato padronizado de Ginkgo biloba L. são encontrados em farmácias comunitárias principalmente nas formas de cápsulas e comprimidos. Ao adquirirem o medicamento industrializado, os usuários têm a bula como principal fonte de informação impressa, e para que as informações contidas nesta cumpram sua finalidade, devem ser apresentadas de maneira objetiva, atualizada e completa. Assim, o objetivo do estudo foi analisar as bulas dos medicamentos à base de extrato seco de Ginkgo biloba L. frente às normas exigidas pela RDC nº 47/2009 da Anvisa. Foi realizado um estudo observacional com análise das bulas dos fitoterápicos contendo Ginkgo biloba L. como monofármaco, na forma farmacêutica de cápsulas ou comprimidos, comercializados nas farmácias comunitárias da cidade de Patos de Minas, em relação aos tópicos: Identificação do medicamento, Informações ao paciente, Dizeres legais e Frases obrigatórias. Do total de especialidades farmacêuticas, duas não possuíam bula. Em 45% das bulas, algumas das frases obrigatórias estavam ausentes. Uma bula trazia informação conflitante sobre o real aspecto físico do medicamento. Das informações ao...

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“…In Brazil, the dose rate of medicinal plants is not well defined [24]. These precautions are indispensable when larger amounts of fruits, leaves or others parts of the plant are consumed in long-term.…”

Section: Introductionmentioning

confidence: 99%

First comprehensive study on total determination of nutritional elements in the fruit of the Campomanesia adamantium (Cambess.): Brazilian cerrado plant

Lima¹,

Arakaki²,

Tschinkel³

et al. 2016

Int Arch Med

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Introduction: Fruits Objective: In the present study, evaluation of mineral contents (Na, K, Ca, Mg, P, Fe, Zn, Ni, Mn, Co, Cu, Mo, Cr, Si and Al) from peel, pulp and seeds of guavira was carried out. Method:The peel, pulp and seeds of guavira were studied by ICP-OES with microwave digestion. The contents of the elements in the parts of the guavira, were compared to the Recommended Dietary Allowance (RDA), values Adequate Intake (AI) and tolerable upper intake levels (ULs). Results:The results are considered in terms of the utility of the natural herbal medicaments as rich (Cu, P, Cr and Mo) or a source of minerals indispensable for proper functioning of the human organism. The concentration of elements in seeds, pulp and peel the guavira was compared with value of UL and does not cause toxicity. The concen-

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Regulation of herbal medicines in Brazil: advances and perspectives

Cited by 29 publications

References 3 publications

Determination of metals in medicinal plants highly consumed in Brazil

Determination of metals in medicinal plants highly consumed in Brazil

Análise De Bulas Dos Medicamentos À Base De Ginkgo Biloba L. Comercializadas Em Patos De Minas, Minas Gerais, Brasil

First comprehensive study on total determination of nutritional elements in the fruit of the Campomanesia adamantium (Cambess.): Brazilian cerrado plant

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