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医薬製剤の製造方法及び医薬製剤キット
专利权人:
YASUI Kiyotada
发明人:
YASUI Kiyotada,安井清忠
申请号:
JPJP2013/081190
公开号:
WO2014/207956A1
申请日:
2013.11.19
申请国别(地区):
WO
年份:
2014
代理人:
摘要:
Provided is a production method for a medicinal preparation comprising a first preparation component and a second preparation component, wherein the method includes: a step of preparing a first preparation component that is an active pharmaceutical ingredient previously demonstrated in non-clinical studies to be stable, effective, and safe, and that comprises an effective component and a solvent only, the effective component being either a protein preparation component, a nucleic acid preparation component, or a vaccine preparation component a step of preparing a second preparation component which, in the event that the effective component is a protein preparation component or a nucleic acid preparation component, contains at least one type of preparation additive, or in the event that the effective component is a vaccine preparation component, contains at least one type of adjuvant and/or preparation additive a step in which an adsorption preventive agent is filtered through a filtration sterilization filter to effect adsorption preventive treatment of the filtration sterilization filter a step of filtration sterilization of the first preparation component through the filtration -sterilization filter and a step of formulation through mixing the filtration-sterilized first preparation component and the second preparation component in any proportion, making possible administration without the need to evaluate stability in clinical studies.La présente invention concerne un procédé de production pour une préparation médicinale comprenant un premier composant de préparation et un deuxième composant de préparation, le procédé comprenant : une étape de préparation dun premier composant de préparation qui est une substance pharmaceutique active dont la stabilité, lefficacité et la sécurité ont été démontrées précédemment dans des études cliniques, et qui comprend un composant efficace et un solvant uniquement, le composant efficace étant un composant de préparation de prot
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