Estudos tecnológicos para padronização do extrato seco de Ocotea duckei Vattimo (Lauraceae)

• Ano de defesa: 2023
• Autor(a) principal: Peixoto, Laisla Rangel
• Tipo de documento: Tese
• Tipo de acesso: Acesso aberto
• Idioma: por
• Instituição de defesa: Universidade Federal da Paraíba; Brasil; Farmacologia; Programa de Pós-Graduação em Produtos Naturais e Sintéticos Bioativos; UFPB
• Palavras-chave em Português: Plantas medicinais; Família Lauraceae; Gênero Ocotea; Ocotea duckie Vattimo; Extrato secos; Validation; Dry extract; CNPQ::CIENCIAS BIOLOGICAS::FARMACOLOGIA
• Link de acesso: https://repositorio.ufpb.br/jspui/handle/123456789/32132

Ocotea duckei Vattimo, popularly known as “Louro-de-cheiro”, “Louro-pimenta” and “Louro-canela” is a member of the Lauraceae family found in Northeastern Brazil. Popularly, it is used in the treatment of neuralgia, dyspepsia, anorexia and pain. With regard to its constituents, it presents the lignoids Yangambina (YAN) and EPI-Yangambina (EPI-YAN) as the main plant markers. Aiming to contribute to the advancement of the pharmacological potential of Brazilian plant species, the present work aimed to develop analytical methodologies and technological processes to obtain standardized dry extracts (DE) of O. duckei. After collection, the aerial parts of the botanical material underwent a drying and crushing process to obtain the plant drug (PD). With this, its physical-chemical characterization was carried out, being carried out the granulometry tests, determination of the density, moisture content, determination of the hydrogenionic potential (pH), spectroscopy in the infrared region with Fourier transform (FTIR), analysis thermogravimetry (TGA) and differential thermal analysis (DTA). A liquid-liquid extractive process was carried out to obtain extracts and phases and chromatographic techniques were performed to obtain the major substances and other chemical compounds. In addition, through the chloroform and hexane phase, the toxicity test for Artemia salina of O. duckei was performed. For the development of analytical methods for quantification of markers, sample and standard preparation, HPLC and evaluation of selectivity parameters, linearity, limits of detection and quantification, precision, matrix effect, accuracy and robustness followed. To carry out the technological studies, obtaining the dry extract (DE) was carried out through planning for extraction by maceration, comparing the gradient ratio of the EtOH solvent at 30, 50, 70 and 96% and the drug/solvent ratio at 10, 20 and 30% and a 3² factorial design for drying by rotary evaporation, in which cellulose and aerosil were used as drying aids. The DE obtained were characterized by density test, angle of repose, granulometry, TG and DTA. The best DE obtained was used to develop a solid pharmaceutical formulation (capsule). The DV was classified as a coarse powder, had acceptable flow properties, as confirmed by the compressibility index (25%). In addition, it was classified as easy drainage, low moisture content (5.8%) and average pH value of 6.01. The presence of bands in the FTIR suggested the presence of functional groups such as amines, alcohols, esters, ketones, carboxylic acids and indicates a variety of secondary metabolites such as flavonoids, alkaloids, steroids, lignoids and polyphenols. The TG analysis of the PD showed the occurrence of three stages of mass loss and the DTA analysis showed three endothermic peaks. Toxicity testing revealed a low toxicity LC50 value. Through chromatographic techniques, it was possible to isolate six substances, with YAN and EPI-YAN being the major compounds and markers of O.duckei. The Crude Ethanol Extract (CEE) and the standards (YAN and EPI-YAN) obtained were used in the validation of the analytical method according to the criteria of the International Conference on Harmonization (ICH) and RDC 166, proving to be selective for both epimers, linear in the concentration range of 5-25 μg/mL, precise (CV ≤ 11%), exact (80-100%) and robust, in which the present analytical methodology can be applied in the quality control of raw materials and BSE-based products from O. duckei. As for the extraction planning, the analyzes of the extracts by HPLC showed increasing concentrations of the two markers with an increase in the drug/solvent ratio (v/m) and the Ethanol/water ratio (v:v). The system containing 96% ethanol and 30% PD showed the best concentration of IAN and EPI-IAN equivalent to 61.39 and 124.24 μg/mL, respectively. The Dry Waste (DW) presented an average result of 2.85%. Nine DE were obtained by rotary evaporation. According to the physical-chemical characteristics, the DE obtained showed unsatisfactory flow and compressibility properties. As for the angle of repose, they were classified as good and fair. The thermal characterization study with DE showed similar profiles regarding the change in ratio, where the TG analysis showed the occurrence of four stages of mass loss and the DTA analysis showed three exothermic peaks. The thermal degradation kinetics was determined by the Ozawa method, presenting degradation order equal to one. The best ES being classified as thin and with low hygroscopicity. Analytical characterization of PD and obtaining DE through technological studies are useful in the development of new drugs, so that the results obtained in this study can be used in scale transposition and quality control of products originating from the aerial parts of O. duckei.