Stable Transglutaminase Formulation and Manufacturing Method Thereof

摘要

The present invention relates to a pharmaceutical composition comprising a purified transglutaminase and a D- and / or L-amino acid, which is easily dissolved without lyophilization after lyophilization, and which comprises glycine and arginine, salts, derivatives and analogues thereof, Or their oligomers or mixtures thereof, and / or from sugar or sugar alcohols, if appropriate mixed with a surfactant and / or a reducing agent, for example, Factor XIII. The invention also relates to a process for the preparation of stable protein preparations and to the use of the stable formulations described above for the manufacture of a medicament suitable for the treatment of diseases characterized by, for example, F XIII deficiency.