Os estudos toxicológicos não-clínicos funcionam com um alicerce no processo de desenvolvimento de novos fármacos, visto que antecipam riscos e, portanto, reduzem a probabilidade de um novo fármaco interferir no metabolismo celular prejudicando a saúde do indivíduo além de não cumprir sua função farmacológica no organismo. Assim, considerando o potencial terapêutico das plantas medicinais, o presente trabalho tem como objetivo descrever a importância dos ensaios toxicológicos e os aspectos atuais concernentes ao registro de medicamentos fitoterápicos no Brasil. Para realização deste trabalho foram pesquisadas bases de dados científicas, tais como: Periódicos CAPES e Scielo, tendo o banco de dados sido complementado com artigos da legislação brasileira. Não houve restrição de busca quanto ao idioma ao ano de publicação dos materiais científicos, mas sim, quanto à relevância do seu conteúdo para o presente artigo. Dessa forma, observou-se que o papel regulador da ANVISA é fundamental para evitar que medicamentos ineficazes, tóxicos e de má qualidade alcancem o mercado e ocasionem problemas como intoxicações, interações com outros medicamentos, danos terapêuticos, ou até mesmo óbitos. Assim, por ser uma prática tradicional de saúde e já revelada em diversos estudos como de utilidade terapêutica por uma parcela significativa da população, torna-se interessante discutir a situação atual dos fitoterápicos e a seriedade que se deve ter no seu desenvolvimento principalmente diante dos ensaios toxicológicos não-clínicos uma vez que eles podem evitar problemas de saúde pública a curto e longo prazo.
Lippia origanoides is a honey shrub which has showed hypotensive potential assessed by in vivo studies. The aim of this work is the development of a pharmaceutical formulation composed by an optimized extract obtained from aerial parts of L. origanoides. The quantification of the naringenin marker in the dry extract and tablets developed was performed, as well as the assessment of the oral acute toxicity in rats. The hydroalcoholic extract of L. origanoides was spray-dried with the addition of colloidal silicon dioxide (Lo-HAE/CSD), and then applied in the preparation of eight different lots of tablets. The influence of the diluent (cellulose or babassu mesocarp), the presence of binder, and the percentage of lubricant, as well as organoleptic and physicochemical characteristics were screened. For the quantification of the marker content both in Lo-HAE/CSD and in the tablets, an analytical curve of the naringenin standard was fitted, and the samples were then analyzed in UFLC. The toxicological assessment was performed in female Wistar rats according to the Acute Toxic Class Method from OECD. The developed tablets produced meet acceptable macroscopic characteristics, and the presence of babassu as diluent provided improved physicochemical properties. The best content of Lo-HAE/CSD in the tablet (100.27%) was identified for the lot containing babassu, composed by 1.0% magnesium stearate, without PVP binder in its formulation. Moreover, Lo-HAE/CSD showed no signs of toxicity. Therefore, the babassu mesocarp powder is a promising pharmaceutical excipient for the development of herbal tablets containing the Lippia origanoides extract.
Background:
Pharmaceutical nanotechnology represents an efficient alternative for the delivery of pharmacologically active plantderived compounds, considering their protective capacity, oral bioavailability and drug vectorization capacity. In this context, butters obtained
from plant seeds have emerged as promising products for development of pharmacologically active nanostructures. They possess a complex
lipid composition, allowing the formation of different emulsion systems with solid cores, since this mixture of the different triglycerides is
solid at room temperature and body temperature. Therefore, the systematic mapping around the technological development of nanostructures
produced from plant-derived butters is potentially valuable for researchers interested in novel alternative formulations for pharmacological
therapy, with potential industrial, economic, health and societal impacts.
Methods:
Systematic review was carried out by the search of scientific papers and patents deposited in official databases concerning the
development of nanostructured pharmaceutical products using plant-derived butters as starting material. The publications obtained were
subjected to sorting and analysis by applying the following inclusion/exclusion criteria.
Results:
The Solid Lipid Nanoparticle (SLN) was the type of nanostructure produced in all the analyzed scientific papers, due to the
physicochemical characteristics of the lipid constituents of plant-derived butters. In this sense, 54% of the articles have reported the use of
Cocoa Butter for the production of nanostructures; 28% for Shea Butter; 6% for Cupuacu Butter, 6% for Murumuru Butter and 6% for Bacuri
Butter. In the technological prospection, only two patents exhibited SLN as an invention based on cocoa butter and on shea butter,
respectively. The production methods employed have included: phase inversion temperature, microemulsion, hot high pressure
homogenization, high shear homogenization and ultrasonication.
Conclusion:
In light of this prospective review, the encouragement of novel studies in lipids-based nanotechnology is evident, considering the
small number of findings so far, in order to stimulate new research involving plant-derived butters from easily cultivated fruits in tropical
regions, then stimulating the pharmaceutical development of new therapeutic alternatives using biocompatible and sustainable raw materials.
O presente estudo tem como objetivo descrever o perfil epidemiológico referente aos casos notificados de tentativas de suicídio por intoxicação exógena no estado do Piauí nos últimos 5 anos (2015-2020). Trata -se de um delineamento transversal quantitativo e descritivo. Os dados foram extraídos da plataforma DATASUS, tendo como variáveis inclusas: sexo, faixa etária, raça, agente tóxico e município de notificação. Os dados foram organizados e analisados por estatística descritiva. Foram detectados 3.400 casos de tentativas de suicídio com o uso de agentes tóxicos no estado do Piauí; e, através desse total, verificou-se que 76,18% era do sexo feminino, 53,35% estavam na faixa de jovens adultos, 54,15% possuía pele parda, 77,74% utilizou medicamentos na lesão autoinflingida e 53,59% foram notificações da cidade de Teresina. A identificação do perfil epidemiológico da população estudada indicou aspectos essenciais para melhoria das abordagens em saúde pública. Com isso, constatou-se que, para os casos avaliados, a prevalência foi de pessoas do sexo feminino, com idade entre 20-39 anos, pardas, que usaram medicamentos como agentes tóxicos e residentes na capital do estado.
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