Analytical method for pancreatin and comparable compositions

G - Physics – 01 – N

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G01N 33/573 (2006.01)

Patent

CA 2528906

The present invention concerns a novel method to analyze identity, protein and/or peptide pattern and as well the stability of samples containing physiologically acceptable enzyme mixtures with lipolytic, proteolytic and amylolytic activity, but especially of mixtures of digestive enzymes such as pancreatin, in particular in the context of the manufacture of medicinal products comprising said enzyme mixtures, e.g. precipitated pancreatin or pancreatin mini-~microspheres.

L'invention concerne un nouveau procédé qui permet d'analyser l'identité, le motif protéique et/ou peptidique ainsi que la stabilité d'échantillons qui renferment des mélanges d'enzymes acceptables sur le plan physiologique, et qui possèdent une activité lipolytique, protéolytique et amylolytique. Et particulièrement, des mélanges d'enzymes digestives telles que la pancréatine, notamment dans le domaine de la fabrication de produits pharmaceutiques contenant ces mélanges d'enzymes, par exemple, la pancréatine précipitée ou des mini-microsphères de pancréatine.

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