RESUMO:Fitoterápico é uma classe de medicamento largamente utilizada no país e constitui um mercado em potencial expansão. Este artigo busca traçar um panorama sobre os medicamentos fi toterápicos registrados no país e as espécies vegetais que lhe deram origem, enfocando o papel regulador da Anvisa. Realizou-se uma pesquisa nas seguintes bases de dados: Visalegis e site da Anvisa para verifi car os medicamentos fi toterápicos registrados na Anvisa, obtendo-se os seguintes dados: há 432 fi toterápicos simples registrados e 80 compostos, as espécies vegetais com maior número de derivados registrados são o Ginkgo (Ginkgo biloba) e a Castanha da Índia (Aesculus hippocastanum), com 33 e 29 registros, respectivamente. O artigo traz ainda uma tabela com as espécies vegetais que possuem derivados registrados como fi toterápicos simples, sua classifi cação terapêutica, lista as espécies registradas em associação, as principais formas farmacêuticas registradas e os percentuais de registro e empresas por região do país, fornecendo assim um panorama da atuação da Anvisano setor de fi toterápicos.Unitermos: Medicamento, fi toterápico, regulação, registro, Anvisa.ABSTRACT: "Situation of herbal medicines register in Brazil". Herbal medicines are widely used in Brazil and constitute a market in potential expansion. This article explains the situation on herbal medicines registration in Brazil plant species, focusing on the regulatory role of Anvisa. The research was realized in the Visalegis and site of Anvisa databases to verify the herbal medicines registered in Anvisa, resulting in the following data: there are 432 simple herbal medicines (composed by one medicinal plant) registered and 80 compound herbal medicine (more than one plant), the plants species with the largest number of registered derivatives are the Ginkgo (Ginkgo biloba) and the Castanha da Índia (Aesculus hippocastanum), with 33 and 29 records, respectively. The article also brings a table with the plant species registered as simple herbal medicines, the main pharmaceutical forms registered and data about companies that produces herbal medicines.Keywords: Medicines, herbal medicines, regulation, register, Anvisa. INTRODUÇÃOFitoterápico, de acordo com a legislação sanitária brasileira, é o medicamento obtido empregandose exclusivamente matérias-primas ativas vegetais. É caracterizado pelo conhecimento da efi cácia e dos riscos de seu uso, assim como pela reprodutibilidade e constância de sua qualidade (Brasil, 2004a).Os fi toterápicos sempre apresentaram uma parcela signifi cativa no mercado de medicamentos. O setor movimenta globalmente US$ 21,7 bilhões por ano. No Brasil, não existem dados ofi ciais atualizados, porém, estima-se que esse mercado gira em torno de US$ 160 milhões por ano. E o fator de atração é o ritmo de crescimento das vendas internamente, mais de 15% anuais, contra 4% do que evoluem as vendas dos medicamentos sintéticos. Em toda a cadeia produtiva, o setor fi toterápico movimenta anualmente cerca de R$ 1 bilhão (Febrafarma, 2007).No Brasil, ...
Hexane, ethanol and aqueous extracts and fractions from leaves of Pouteria torta (Mart.) Radlk (Sapotaceae), a perennial tree, widespread in the Brazilian Cerrado, were tested for cytotoxicity with the Artemia salina toxicity model. Only the aqueous crude extract and the MeCN:CHCl3 fraction of the ethanol extract presented toxicity (0.28 mg/mL and 0.27mg/mL, respectively). Lupeol acetate was isolated from the hexane extract. It is the first report of lupeol acetate from the genus Pouteria
The National Policy of Integrative and Complementary Practices (PNPIC) in the Brazilian Unified Health System (SUS), and The National Policy of Medicinal Plants and Herbal Medicines (PNPMF) were launched in 2006. Based on these, the Brazilian Health Surveillance Agency (ANVISA) re-edited rules related to herbal medicines such as the Guideline to herbal medicine registration (RDC 14/10), the Good Manufacture Practices Guideline (RDC 17/10) and the List of references to assess the safety and efficacy of herbal medicines (IN 05/10). The requisites to prove herbal medicine's safety and efficacy were updated. Therefore, this review aims at presenting and commenting these new rules.
Pouteria caimito (Sapotaceae) is widely distributed throughout Latin America, including Brazil. The yellow fruits, known as abiu, caimito, or abiurana, are eaten in natura or used to prepare desserts. In addition to being a commercially available Brazilian fruit, P. caimito has also been used as a traditional medicine. Therefore, hexane, ethanol, and aqueous extracts from its leaves were evaluated for radical-scavenging activity. Free radical-scavenging activity was tested using the DPPH assay. Total phenolic and proanthocyanidin contents were also determined. The aqueous extract comprised the highest total phenol and proanthocyanidin contents (173.6 g/mL) and showed the highest radical-scavenging activity (ED50= 36.1 g/mL). Phytochemical analysis of the hexane extract allowed the isolation of spinasterol. We found a high correlation between total phenolic and proanthocyanidin contents and radical-scavenging activity. To our knowledge, this is the first time spinasterol has been isolated from P. caimito leaves.
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