PHARMACEUTICAL COMPOSITION CONTAINING COMPLEX MARKING SITE - FAB-FRAGMENT OF ANTI-HUMAN ANTIBODY Russian patent published in 2023 - IPC A61K39/395 A61K51/10 A61K47/02 A61K47/10 A61K47/12 A61K47/18 A61K47/20 A61K47/26 A61K9/08 A61K9/19 A61P35/00 

FIELD: pharmaceuticals.

SUBSTANCE: group of inventions relates to a stable pharmaceutical composition containing a conjugate of a marking fragment with a Fab fragment of an anti-human antibody. The pharmaceutical composition contains a conjugate of the marking fragment of formula I with a Fab fragment of an anti-human antibody against CEACAM5 or MUC1, from 10 to 30 mmol/l of citric acid, from 5 to 30% w/v of sucrose or glycerol, from 0.02 to 0.2% w/v of polysorbate 80, a pH is up to 6.5–7.5. Also methods of preparing a pharmaceutical composition and stable preservation of a marking fragment conjugate, using the pharmaceutical composition in the diagnosis of colorectal or breast cancer, or cancer resulting from metastasis of colorectal cancer or breast cancer are provided.

EFFECT: inventions make it possible to suppress the formation of multimers and insoluble invisible particles during conservation of the conjugate of the marking fragment with the Fab fragment of an anti-human antibody, to suppress the decrease in the coordination efficiency of the metal in relation to the marking fragment and the weakening of the color of the marking fluorescent dye.

13 cl, 39 tbl, 3 ex