METHOD FOR PRODUCING TULAREMIC LIVE VACCINE LYOPHILIZATE Russian patent published in 2020 - IPC A61K39/02 A61K47/26 A61K47/36 

FIELD: medicine.

SUBSTANCE: invention relates to the technology of producing medical immunobiological preparations and a method of producing a lyophilizate of a live tularemic vaccine. That is ensured by mixing prepared in required concentration of F. tularensis 15 NIIEG strain and excipients at the following ratio of components (composition is given per 1 ml): F. tularensis cells of 15 NIIEG strain – 10±5 billion cells; trehalose – 0.034 g; reopolyglukine (dextran with average molecular weight 30,000–40,000) – 0.0075 g; chitosan – 0.0075 g, the produced mixture is poured 2 ml into bottles, frozen on the shelves of the sublimation drying plant to the temperature of full freezing minus 35–45 °C, holding it for 2–3 hours, performing sublimation drying at vacuum depth (0.1±0.01) mbar with a rate of shelf temperature increase of not more than 5 °C per hour to preparation temperature of 24–26 °C, holding it 1–2 hours, after which it is sealed under vacuum conditions.

EFFECT: invention provides a lyophilizate of a live tularemic vaccine providing the required quality of the vaccine.

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