METHOD OF PRODUCING FINISHED DOSAGE FORM OF PROBIOTIC AGENT BASED ON STRAINS BIFIDOBACTERIUM LONGUM SUBSPECIES LONGUM AND LACTICASEIBACILLUS PARACASEI SUBSPECIESPARACASEI Russian patent published in 2024 - IPC C12N1/20 A61K35/745 A61K35/747 

FIELD: biotechnology.

SUBSTANCE: disclosed is a method for producing a finished dosage form of a probiotic agent based on bacterial strains Bifidobacterium longum subsp. longum VKM B-3717D and Lacticaseibacillus paracasei subsp. paracasei VKM B-3711D, including cultivation for 48 hours of bacteria at 37 °C in anaerobic conditions in an atmosphere of a three-component gas mixture 80% N₂, 10% CO₂, 10% H₂; then, under anaerobic conditions, preparing a protective medium consisting of 1 part of a stock solution prepared under anaerobic conditions at 0.05 mg of lacto-N-biose (C₁₄H₂₅NO₁₁) or N-acetylglucosamine per 100 ml in skim milk, and 1 part of sterile skim milk or sucrose-gelatinous medium; bottled in containers – penicillin bottles or ampoules; visible growth of bacteria is removed from the agar surface in each Petri dish with a sterile disposable viscose swab-probe into each container, containers are placed in aseptic sealed containers, then frozen and lyophilized in a given mode. After drying, the contents of each container are homogenised, 30 mg of chitosan, 50 mg of sucrose and 70 mg of lactose are added per 1 therapeutic dose of the preparation, including 7×10⁷ to 8×10⁷ CFU of each bacterial strain used, cotton plugs are replaced with rubber ones; then the bottles are sealed with a metal cap; if the finished dosage form of the probiotic agent is dried in ampoules, the ampoules are sealed or packed into enteric capsules at rate of 1 therapeutic dose per 1 capsule No. 3.

EFFECT: invention provides stability of the titre of bacterial strains in the composition of the medicinal agent for at least three years of storage in the lyophilised form.

1 cl, 4 tbl, 4 ex