METHOD OF DETERMINATION OF HYALURONIDASE ACTIVITY OF MEDICINES WITH USE OF LYDAZUM LYOPHILISATE AS A STANDARD WORKING SAMPLE Russian patent published in 2018 - IPC G01N33/15 

FIELD: biotechnology.

SUBSTANCE: invention relates to biotechnology and quality control. Method for determining the hyaluronidase activity of drugs involves mixing a test solution of known concentration with an acetate buffer solution with a pH of 5.6, incubating, adding a hyaluronic acid solution, incubation for 15 minutes, cooling in ice, adding a titrated amount of 0.8 M potassium tetraborate, placing in a boiling water bath, interaction with Ehrlich's reagent, determination of optical density by spectrophotometric method at a wavelength of 586 nm, layer thickness of 10 mm, determination of hyaluronidase activity by comparison with a standard sample, as a working standard sample, Lydazum drug with hyaluronidase activity of at least 300 IU/ml and a protein concentration of no more than 4 mg/ml is used, the hyaluronidase activity is determined in International units.

EFFECT: invention may be used in the pharmaceutical industry and research activities to quantify the hyaluronidase activity of drugs.

3 cl, 1 dwg, 2 tbl, 2 ex