Análise do comportamento do potencial hidrogeniônico de soluções de cloridrato de dobutamina segundo concentração e luminosidade
Data
2015-02-25
Autores
Lemos, Natalia Romana Ferreira 
Orientadores
Peterlini, Maria Angelica Sorgini
Tipo
Dissertação de mestrado
Título da Revista
ISSN da Revista
Título de Volume
Resumo
O sistema de medicação é complexo e deve ser realizado de maneira a oferecer assistência segura aos pacientes. As propriedades físicas e químicas de um medicamento podem ser alteradas pela ação da luz e temperatura. As consequências advindas poderão modificar as medidas do potencial hidrogeniônico (pH), resultando em produtos farmacêuticos impróprios para utilização. Assim, essa pesquisa experimental objetivou verificar o comportamento do potencial hidrogeniônico do cloridrato de dobutamina puro e diluído em cloreto de sódio a 0,9% em água (SF), mantidos em temperatura de 22ºC (+2ºC) e 37ºC (+2ºC) e sob influência da luminosidade, bem como comparar as determinações de pH dessas situações. Para a realização do estudo as soluções foram acondicionadas em Sistemas para Infusão de Terapia Intravenosa incolores, âmbares e protegidos da luminosidade. Realizou-se quatro situações de estudo, sendo Controle (totalmente protegido da luminosidade e em temperatura de 22ºC (+2ºC), Experimento Incolor (EI), Experimento Âmbar (EA) e Experimento Protegido (EP); todas executadas em triplicata. As soluções foram instaladas em bomba de infusão contínua, e as situações EI, EA e EP permaneceram sob exposição da luminosidade fluorescente e do equipamento de fototerapia, bem como sob temperatura de 22ºC (+2ºC) e 37ºC (+2ºC). Os controles de pH aconteceram após o preparo das soluções (T0), em 24 horas de simulação de infusão das soluções (T1), em 48 horas (T2), em 72 horas (T3) e em 96 horas (T4). A amostra ficou composta por 204 medidas de pH, sendo 35,3% referentes ao cloridrato de dobutamina e 5,9% ao SF, ambos empregados no preparo das soluções; 29,4% do medicamento puro e 29,4% do medicamento diluído. A análise dos resultados deu-se pela média aritmética, desvio-padrão e coeficiente de variação (CV). O cloridrato de dobutamina e o SF utilizados no preparo das soluções apresentaram média de pH de 3,28+0,10 (CV 3%) e 5,60+0,27 (CV 4,76%). A média das medidas das triplicatas resultou em 20 medidas referentes ao cloridrato de dobutamina puro e 20 do fármaco diluído. As maiores variações nas medidas de pH foram verificadas nos fármacos puros expostos à Situação EP (+0,34), Controle (+0,27) e EI (+0,27). A determinação de pH mais ácido ocorreu no fármaco puro na Situação EI e em T1 (2,78); e a medida mais elevada foi observada, também com o medicamento puro, porém na Situação EP e em T4 (4,19). As maiores variações nas medidas de pH do cloridrato de dobutamina puro aconteceram entre T0 e T1, exceto para o fármaco exposto na Situação Controle, em que a variação se manteve até T2. Quando essas soluções foram expostas ao EI e EA apresentaram diminuição nas determinações de pH; e a menor variação aconteceu com fármaco no EA (+0,15). Comportamento semelhante foi observado com o cloridrato de dobutamina diluído em SF, porém a solução exposta ao EA manteve a menor variação de todo o estudo (+0,02). As soluções puras em EP apresentaram as maiores elevações de pH da presente investigação, diferentemente do fármaco diluído. Portanto, o cloridrato de dobutamina quando diluído e em EA manteve-se mais estável, sugerindo a possibilidade de administrar o fármaco em Sistemas para Infusão de Terapia Intravenosa Âmbar. O mesmo podendo ser indicado para o medicamento puro.
The medication system is complex and must be performed in order to provide safe patient care. The physical and chemical properties of a drug can be altered by light and temperature. The resulting effects may modify the action hydrogen potential (pH), resulting in unsuitable for pharmaceutical use. Thus, this experimental study aimed to investigate the hydrogen potential performance of pure dobutamine hydrochloride and diluted in sodium chloride 0.9% in water (SF), kept in 22°C (+2ºC) temperature and 37°C (+2ºC)and under the influence of light and compare the values of pH of these situations. To accomplish the work, solutions were placed in systems for Infusion Intravenous Therapy colorless, amber and protect from luminosity. Held in four study situations, and Control (fully protected from luminosity and temperature 22°C (+2ºC) Tinted Experiment (EI), Experiment Amber (EA) and Experiment Protected (EP); all performed in triplicate, and situations EI, EA and EP, remained under fluorescent luminosity exposure and phototherapy equipment, as well as at a temperature of 22°C (+2ºC) and 37°C (+2ºC). PH of the controls occurred after preparation of solutions (T0), 24 hours of infusion solutions simulation (T1), 48 hours (T2) within 72 hours (T3) and in 96 hours (T4). The sample was composed of 204 pH being 35.3% with respect to dobutamine hydrochloride and 5.9% in the SF, both used for preparing the solutions; 29.4% of the pure drug and 29.4% of the diluted product. The analysis of the results was determined by the arithmetic mean, standard deviation and coefficient of variation (CV). The hydrochloride salt of dobutamine and SF used in the preparation of the solutions had an average pH of 3.28 + 0.10 (3% CV) and 5.60 + 0.27 (4.76% CV). The mean of triplicate values resulted in 20 points for the pure dobutamine hydrochloride and 20 of the diluted drug. The largest variations in pH values were observed in pure drugs exposed to Situation EP (+0.34), Control (+0.27) and EI (+0.27). The more acidic pH occurred in the pure drug in the EI situation and T1 (2.78); and the highest value was also observed with the pure drug, but in Situation EP and T4 (4.19). The largest variations in pH of pure dobutamine hydrochloride occurred between T0 and T1, except for the above drug in the control situation, wherein the variation is maintained until T2. When these solutions were exposed to EI and EA showed a decrease in pH; and the smallest change happened to the drug in the EA (+0.15). Similar performance was observed with dobutamine hydrochloride diluted in SF, but the exposed solution to EA kept the smaller variation of the entire study (+0.02). The pure solutions in EP had the highest pH elevations of this research, unlike the diluted drug. Therefore, dobutamine hydrochloride when diluted in EA, and remained stable, suggesting the possibility of administering the drug in systems for Intravenous Infusion Therapy amber. The same can be stated for the pure drug.
The medication system is complex and must be performed in order to provide safe patient care. The physical and chemical properties of a drug can be altered by light and temperature. The resulting effects may modify the action hydrogen potential (pH), resulting in unsuitable for pharmaceutical use. Thus, this experimental study aimed to investigate the hydrogen potential performance of pure dobutamine hydrochloride and diluted in sodium chloride 0.9% in water (SF), kept in 22°C (+2ºC) temperature and 37°C (+2ºC)and under the influence of light and compare the values of pH of these situations. To accomplish the work, solutions were placed in systems for Infusion Intravenous Therapy colorless, amber and protect from luminosity. Held in four study situations, and Control (fully protected from luminosity and temperature 22°C (+2ºC) Tinted Experiment (EI), Experiment Amber (EA) and Experiment Protected (EP); all performed in triplicate, and situations EI, EA and EP, remained under fluorescent luminosity exposure and phototherapy equipment, as well as at a temperature of 22°C (+2ºC) and 37°C (+2ºC). PH of the controls occurred after preparation of solutions (T0), 24 hours of infusion solutions simulation (T1), 48 hours (T2) within 72 hours (T3) and in 96 hours (T4). The sample was composed of 204 pH being 35.3% with respect to dobutamine hydrochloride and 5.9% in the SF, both used for preparing the solutions; 29.4% of the pure drug and 29.4% of the diluted product. The analysis of the results was determined by the arithmetic mean, standard deviation and coefficient of variation (CV). The hydrochloride salt of dobutamine and SF used in the preparation of the solutions had an average pH of 3.28 + 0.10 (3% CV) and 5.60 + 0.27 (4.76% CV). The mean of triplicate values resulted in 20 points for the pure dobutamine hydrochloride and 20 of the diluted drug. The largest variations in pH values were observed in pure drugs exposed to Situation EP (+0.34), Control (+0.27) and EI (+0.27). The more acidic pH occurred in the pure drug in the EI situation and T1 (2.78); and the highest value was also observed with the pure drug, but in Situation EP and T4 (4.19). The largest variations in pH of pure dobutamine hydrochloride occurred between T0 and T1, except for the above drug in the control situation, wherein the variation is maintained until T2. When these solutions were exposed to EI and EA showed a decrease in pH; and the smallest change happened to the drug in the EA (+0.15). Similar performance was observed with dobutamine hydrochloride diluted in SF, but the exposed solution to EA kept the smaller variation of the entire study (+0.02). The pure solutions in EP had the highest pH elevations of this research, unlike the diluted drug. Therefore, dobutamine hydrochloride when diluted in EA, and remained stable, suggesting the possibility of administering the drug in systems for Intravenous Infusion Therapy amber. The same can be stated for the pure drug.
Descrição
Citação
LEMOS, Natalia Romana Ferreira. Análise do comportamento do potencial hidrogeniônico de soluções de cloridrato de dobutamina segundo concentração e luminosidade. 2015. 85 f. Dissertação (Mestrado) - Escola Paulista de Enfermagem, Universidade Federal de São Paulo (UNIFESP), São Paulo, 2015.