| 摘要 |
A method for preparing a lyophilisate, comprising: (a) preparing of a solution comprising; factor VIII in a concentration ranging from 50 to 10,000 international units/ml, a surfactant in a concentration ranging from above critical micellar concentration to 1% v/v, calcium chloride in a concentration ranging from 0.5 to 10 mM, sucrose in a concentration ranging from 5 to 50 mM, sodium chloride in a concentration ranging from 0.15 to 0.5 M, trisodium citrate in a concentration ranging from 1 to 50 mM, and a buffer in a concentration ranging from 1 to 50 mM, and (b) lyophilising the solution. The invention also relates to the lyophilisate obtainable by said method and a liquid pharmaceutical composition prepared therefrom. |
