STANDARDIZATION AND STABILITY EVALUATION OF DRY EXTRACTS OF MYRACRODRUON URUNDEUVA ALLEMÃO OBTAINED BY SPRAY DRIER

Objective: This study aimed to obtain standardised dry extracts of Miracrodruon urundeuva Allemão using spray-dryer and evaluate the stability of the extracts.Methods: It evaluated the drying parameters: Proportion of colloidal silicon dioxide (CSD) (10, 15 and 20%), inlet temperature (160, 170 and 180 °C) and feed rate (4, 6 and 8 ml/min). The study of the accelerated stability of dry extract occurred in temperature of 40 °C (±2 °C) and relative humidity of 75% (±5%) for 6 mo. The anti-inflammatory activity of the dry extract was evaluated in Swiss mice by the paw edema method.Results: Variations in drying conditions did not represent significant variations in yields of the process. The drying temperature and feed rate significantly influenced the concentration of quercetin (p≤0.05). The increase in inlet temperature and feed flow promoted the increase of quercetin concentration in the extracts. The stability study showed that the concentration of quercetin in dry extract was stable over a period of 6 mo. The dry extract showed anti-inflammatory activity in mice orally.Conclusion: A condition of 10% of colloidal silicon dioxide with an 180 °C inlet temperature and a feed rate of 8 ml/min was considered the most adequate for obtaining the extracts and the drying process resulted in stable dry extracts and the quercetin was a suitable biomarker for monitoring the process

Tecnologias de produção e controle de qualidade da matéria-prima vegetal, obtida a partir das folhas de Poincianella pyramidalis (TUL.) L. P. QUEIROZ

Poincianella pyramidalis (Tul.) L. P. QUEIROZ is an endemic species of the caatinga biome, popularly known as "catingueira". Used in traditional medicine for the treatment of gastritis, colic, diarrhea, asthma, bronchitis, diabetes, inflammation, besides presenting cicatrizant activity. Due to this variety of medicinal uses, the species has great potential for the development of a herbal medicine. The present work had as main objectives, to standardize dry extracts, obtained by the sprinkling process, to develop and validate analytical methodology by HPLC for quantification of canferol and quercetin and to carry out an accelerated stability study of binary mixtures of dry extract with different pharmaceutical excipients. Dry extracts were obtained by spraying in Mini Spray Dryer, LabPlant, SD-05, employing the following operating parameters: air inlet temperature (160, 170 and 180 ° C), feed flow rate (4, 6 and 8 mL / min) and drying adjuvant ratio colloidal silicon dioxide (10, 15 and 20%). A 23+1 factorial design associated with MSR was applied to evaluate the effects of the process parameters on canferol and quercetin contents and to define the best operating conditions (T = 160ºC, TF = 4mL / min and% of drying adjuvant = 10 %). The simultaneous quantification of the two flavonoids was performed by HPLC in the following chromatographic conditions: ? = 370 nm, methanol: 1% phosphoric acid (47:53 v / v), pH = 3.1, 1.2 mL flow / min and Phenomenex® C18 column (250 mm x 4.6 mm x 5µ). The accelerated stability study of the binary mixtures (1: 1) of the dry extract with microcrystalline cellulose, maltodextrin, starch and lactose was carried out in a B.O.D incubator under temperature control for 180 days at a temperature of 40 ± 2 ° C. The results obtained showed that the levels of canferol and quercetin were significantly affected by the process conditions. The analytical method was linear in the range of 0.4-7.6 µg / mL for both analytes, R2 = 0.9999 and 0.9996, for canferol and quercetin, respectively. The biomarkers presented better stability in the mixtures with starch and different degradation kinetics for each excipient studied.NenhumaPoincianella pyramidalis (Tul.) L. P. QUEIROZ é uma espécie endêmica do bioma caatinga, popularmente conhecida como ?catingueira?. Utilizada na medicina tradicional para o tratamento de gastrite, cólica, diarréia, asma, bronquite, diabetes, inflamação, além de apresentar atividade cicatrizante. Devido a esta variedade de usos medicinais, a espécie possui um grande potencial para o desenvolvimento de um medicamento fitoterápico. O presente trabalho teve como principais objetivos, padronizar extratos secos, obtidos por spray dryer, desenvolver e validar metodologia analítica por CLAE para quantificação do canferol e quercetina e realizar estudo de estabilidade acelerada de misturas binárias do extrato seco com diferentes excipientes farmacêuticos. A obtenção dos extratos secos foi realizada em Mini Spray Dryer, LabPlant, SD-05, com os seguintes parâmetros de operação: temperatura de entrada de ar (160, 170 e 180ºC), taxa de fluxo de alimentação (4, 6 e 8 mL/min) e proporção do adjuvante de secagem dióxido de silício coloidal (10, 15 e 20%). Um planejamento fatorial 23+1 associado a MSR foi aplicado para avaliar os efeitos dos parâmetros do processo sobre os teores de canferol e quercetina e definir as melhores condições operacionais (T= 160ºC, TF= 4mL/min e % do adjuvante de secagem=10%). A quantificação simultânea dos dois flavonoides, foi realizada por CLAE nas seguintes condições cromatográficas: ?= 370 nm, mistura de metanol: ácido fosfórico 1% (47:53 v/v), pH= 3,1, fluxo de 1,2 mL/min e coluna C18 Phenomenex® (250 mm x 4,6 mm x 5µm). O estudo de estabilidade acelerada das misturas binárias(1:1) do extrato seco com celulose microcristalina, maltodextrina, amido e lactose foi realizado em incubadora B.O.D, com controle de temperatura, durante 180 dias sob temperatura de 40 ± 2ºC. Os resultados obtidos demostraram que os teores de canferol e quercetina foram influenciados pelas condições do processo. O método analítico foi linear no intervalo de 0,4-7,6 µg/mL para ambos os analitos, R2= 0,9999 e 0,9996, para o canferol e a quercetina, respectivamente. Os biomarcadores apresentaram melhor estabilidade nas misturas com amido e cinética de degradação diferente para cada excipiente estudado