| 摘要 |
FIELD: medicine, pharmaceutics.SUBSTANCE: invention relates to biotechnology. Described is lyophylised drug form of glycoprotein of human deoxyribonuclease I for preparation of inhalation solution for reduction of sputum viscosity, characterised by the fact that said glycoprotein represents recombinant human deoxyribonuclease with amino acid sequence, given in description, obtained in microorganism E. coli and covalently bound with polysaccharide, containing from 65 to 80 units of alpha-2,8-sialic acid in polysaccharide chain, by its N-end. Glycoprotein is used as active substance in amount 45.0±5.0 wt %, with magnesium chloride 3.5±0.5 wt %, calcium chloride 4.0±0.5 wt % and lactose 45.0±5.0 wt % being used as auxiliary substances. Method of obtaining claimed drug form, characterised by the fact that water solution, containing magnesium chloride, calcium chloride, lactose with the following component ratio, wt %: glycoprotein of formula I (45.0±5.0), magnesium chloride (3.5±0.5), calcium chloride (4.0±0.5), lactose (45.0±5.0) is added to water solution of synthetic glycoprotein of formula I; mixed, then poured into borosilicate vials in sterile way, lyophilised, vials are filled with sterile nitrogen, sealed with plugs in sterile way, and squeezed with caps.EFFECT: invention makes it possible to obtain preparation of polysialylated recombinant human DNase I, suitable for preparation of inhalation solution for reduction of sputum viscosity.2 cl, 3 tbl, 4 ex |
