METHOD OF OBTAINING MICROENCAPSULATED FORMS OF LIVE CULTURE VACCINE AGAINST SEASONAL AND PANDEMIC INFLUENZA FOR INTRANASAL USE Russian patent published in 2017 - IPC A61K39/165 A61K9/00 C12N7/00 

FIELD: biotechnology.

SUBSTANCE: method includes obtaining a substance of influenza virus, a simultaneous introduction of a hardener and charged water-soluble polyeloctrolyte in the virus-containing substance to reach the final concentration of the polyelectrolyte and hardener which does not cause a phase separation in the medication solution. Further, the microcapsules are produced resulting from a composite coacervation of the charged polyelectrolyte and the hardener with a formation of a complex by freezing the solution at a speed of 0.1-3.0°C per minute to the temperature which is lower than the glass transition temperature of amorphous phase remaining after the ice crystallization and freeze-drying of the final microcapsules. The substance of the influenza virus is produced with a specific activity of not less than 7.0 lg EID₅₀/0.5 ml in a serum-free medium containing a proteolytic enzyme in the amount of 0.25-50.0 mcg/ml and soy peptone stabiliser in a concentration of (0.5-4.0) wt %. Stabilizing soy peptone additives and sucrose are added to the purified substance together with the polyelectrolyte and hardener. Carbopol is used as a polyelectrolyte and gelatose is used as a hardener at the following quantitative component content in the resulting liquid substance prior to microencapsulation: soy peptone - (0.007-0.015) g/0.5 ml; sucrose - (0.007-0.015) g/0.5 ml; gelatose - (0.007-0.015) g/0.5 ml; carbopol - (0.00005-0.0001) g/0.5 ml; liquid nutritional medium containing influenza virus with a titre of not less than 10^7.0 EID₅₀. The rest is up to 0.5 ml.

EFFECT: use of this method for producing live-culture influenza vaccine in microcapsules provides for a higher immunogenicity in intranasal application due to increasing the adhesion of microcapsules to nasal mucosa.

3 cl, 6 ex, 1 tbl, 1 dwg