THROMBIN SOLUTION AND METHODS FOR USE THEREOF Russian patent published in 2018 - IPC A61K9/19 A61K38/48 A61K47/02 A61K47/10 A61K47/12 A61P7/04 F26B5/06 A61J3/00 

FIELD: medicine; pharmaceuticals.

SUBSTANCE: group of inventions relates to pharmaceutical solutions, in particular to methods for lyophilising an aqueous solution of thrombin, solutions for use in such lyophilisation processes and to solid thrombin compositions. Method for lyophilising an aqueous solution of thrombin comprises the preparation of an aqueous solution of thrombin, containing from 1 to less than 4.6 % (w/v) saccharide or sugar alcohol; from at least 0.7 to less than 1.75 % (w/v) sodium chloride; from 0.2 to 3 % (w/v) albumin; 0.3 to 1.5 % (w/v) calcium chloride; and from 0.14 to 1 % (w/v) sodium acetate; and free of polyethylene glycol, and lyophilisation of the aqueous solution of thrombin, wherein the level of the aqueous solution of thrombin in the lyophilisation vessel is in the range of 6 mm to 10 mm, and the total lyophilisation time is not more than 35 hours. Solid composition for stopping bleeding obtained by this method is also disclosed.

EFFECT: group of inventions provides stable solid compositions with a low water content and high thrombin activity upon reconstitution.

30 cl, 1 dwg, 9 tbl, 5 ex