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Determina??o de par?metros de qualidade para formas farmac?uticas homeop?ticasCabe, Carolina Moraes 10 February 2012 (has links)
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Previous issue date: 2012-02-10 / All medicine, whether allopathic or homeopathic, must go through strict quality
control, which must ratify their characteristics throughout the period of validity. During
the time of preparation and storage, solutions of the drugs are in permanent contact
with packaging materials that can release undesirable substances to the solution.
Several factors may influence the release of packing materials, and factorial design
(FD) is a useful tool for analyzing the phenomenon. The aim of this study was the
determination of quality parameters for Homeopathic solid (globules) and liquid
(drops) dosage forms. It was carried out analysis in homeopathic globules for weight
variation, mechanical strength, and moisture content uniformity. For liquid
preparations, standard solutions were prepared from natural rubber bulbs, which
were subjected to exhaustive extraction with two ethanol solutions (30 and 70%) in
the ultrasonic bath for 20 minutes at 25?C and 50?C in three successive cycles.
Studies of transfer have been made within five days, by spectrophotometric analysis
in the UV region at 312 nm with λm?x and 323 nm for samples in 70% ethanol and
30% respectively. PH values were analyzed. We also conducted two FD studies,
where the first, the three-level variables were solvent (chloroform, ethanol and nhexane),
sample mass (30, 60 and 90mg), particle size (large disk, small disk and
powder sample). In the second study, the solvent level variables were different
ethanolic degrees (EtOH 30%, 70% and pure). The percentage of lending in the
solutions was 5.5%, 12.4%, 24.2% and 41% of the total estimated in the reference
solution. The values of rate constants of transfer were determined in the order of
0.0134 days-1 and 0.0232 days-1 in absorbance values, the solutions in ethanol at
30% and 70% respectively. These results suggest that the speed of transfer of
materials from rubber is affected both by the nature of the vehicle as by the
temperature / Todo medicamento, quer seja alop?tico ou homeop?tico, deve passar por
rigoroso controle de qualidade, o qual deve ratificar as suas caracter?sticas ao longo
de todo o per?odo de validade. Durante o tempo de preparo e armazenamento, as
solu??es dos medicamentos est?o em contato permanente com os materiais de
embalagem que podem liberar subst?ncias indesej?veis para a solu??o. V?rios
fatores podem influenciar a libera??o de materiais da embalagem, e planejamento
fatorial (PF) ? uma ferramenta ?til para analisar o fen?meno. O objetivo deste
trabalho foi a determina??o de par?metros de qualidade para Formas Farmac?uticas
Homeop?ticas s?lidas (gl?bulos) e liquidas (gotas). Foi efetuada a avalia??o dos
gl?obulos homeop?ticos no que diz respeito ? sua varia??o de peso, testes de
resist?ncia mec?nica, uniformidade de conte?do e umidade. Para as prepara??es
liquidas, preparamos solu??es de refer?ncia a partir de bulbos de borracha natural,
os quais foram submetidos ? extra??o exaustiva com duas solu??es de etanol (30 e
70%), em banho de ultrassom durante 20 minutos a 25?C e 50?C, em tr?s ciclos
sucessivos de 24 horas. Os estudos de ced?ncia foram efetuados num tempo de
cinco dias, atrav?s de an?lise espectrofotom?trica na regi?o UV com λm?x em 312 nm
e 323 nm para as amostras em etanol a 70% e 30%, respectivamente. Foram
verificados valores de pH. Foram tamb?m realizados dois estudos de PF, onde no
primeiro, as tr?s vari?veis de n?vel foram solvente (clorof?rmio, etanol e n-hexano),
massa de amostra (30, 60 e 90mg), a forma de amostra (grande disco, disco
pequeno, a amostra em p?). No segundo estudo, as vari?veis de n?vel solvente
foram gradua??es etan?licas diferentes (EtOH 30%, 70% e puro). O percentual de
ced?ncia nas solu??es foi de 5,5%, 12,4%, 24,2% e 41% do total estimado na
solu??o de refer?ncia. Os valores das constantes de velocidade de ced?ncia foram
determinados na ordem de 0,0134 dia-1 e 0,0232 dia-1, em valores de absorb?ncia,
nas solu??es em etanol a 30% e 70%, respectivamente. Esses resultados sugerem
que a velocidade de ced?ncia de materiais a partir da borracha ? afetada tanto pela
natureza do ve?culo como pela temperatura
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