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METHOD FOR CARRYING OUT A TEST FOR DISSOLVING SOLID COMPOSITIONS CONTAINING DIGESTIVE ENZYMES
专利权人:
Апталис Фарма Лтд. (IE)
发明人:
ЛАТИНО Массимо (IE),ГИДОРСИ Луиджи (IE),ОРТЕНЦИ Джованни (IE)
申请号:
RU2014104591/15
公开号:
RU2014104591A
申请日:
2012.08.08
申请国别(地区):
RU
年份:
2015
代理人:
摘要:
1. A method for measuring the amount of digestive enzymes released from a composition in a dissolution medium, including the use of fluorescence spectroscopy to measure the amount of digestive enzymes released from a composition in a dissolution medium. A method according to claim 1, characterized in that the composition is a solid pancrelipase composition. A method according to claim 2, characterized in that the solid pancrelipase composition is an enteric-coated pancrelipase composition. A method according to claim 1, characterized in that the dissolution medium is water, an HCl solution, a reproducible gastric juice, a buffer solution, a reproducible intestinal juice, an aqueous or buffer solution containing at least one surfactant. The method of claim 2, comprising the steps of: (a) securing the release of digestive enzymes from a solid pancrelipase composition in a dissolution medium, (b) taking a fluorescence reading to measure the amount of digestive enzymes in the medium. A method according to claim 4 or 5, characterized in that the dissolution medium consists of at least two media that are used sequentially. The method of claim 6, comprising the steps of a) adding a solid pancrelipase composition to the first dissolution medium, b) transferring the suspension to the second dissolution medium, c) securing the release of digestive enzymes, d) taking aliquots of the dissolution medium, e) taking the fluorescence reading at 346 nm , f) calculating the amount of digestive enzymes released. 8. The method according to claim 7, characterized in that the first dissolution medium is an aqueous medium having a pH of from about 1 to about 4.5, and the second medium1. Способ измерения количества пищеварительных ферментов, высвобождаемых из композиции в среде растворения, включающий применение флуоресцентной спектроскопии для измерения количества пищеварительных ферментов, высвобождаемых из композиции в среде растворения.2. Способ по п. 1, отличающийся тем, что композици
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