METHOD FOR EVALUATING HEMOLYTIC ACTION OF POLYMERS, POLYMER MATERIALS AND ARTICLES MADE FROM THEM IN VITRO IN STATIC CONDITIONS Russian patent published in 2024 - IPC G01N33/44 G01N33/48 

FIELD: chemistry.

SUBSTANCE: invention is intended for evaluation of haemolytic action of polymers, polymer materials and articles made from them, which are in solid state of aggregation, in vitro and can be used in research laboratories and laboratories of enterprises when assessing the haemolytic action of new polymers and polymer materials or when changing the scope of application of a known polymer or polymer material. Evaluation method involves incubation in static conditions of at least three parallel samples of 4 types: samples of the analysed material of the first type, which are the analysed polymer in the erythrocyte suspension with the ratio of their surface area to the volume of the erythrocyte suspension, equal to 0.25, with a haematocrit of the erythrocyte suspension in range of 0.8 to 1%, prepared using a phosphate buffered saline with a pH value of 7.4; positive control samples, which are a suspension of human erythrocytes with a haematocrit in range of 0.8 to 1%, prepared in distilled water; negative control samples, which are a suspension of human erythrocytes with a haematocrit in range of 0.8 to 1%, prepared using a phosphate buffered saline with a pH value of 7.4; and samples of the analysed material of the second type, which are samples of the analysed polymer in a phosphate-buffered saline solution with a pH value of 7.4, at ratio of their surface area to volume of phosphate-salt buffer solution equal to 0.25. After incubation, all samples are subjected to centrifugation, and optical density of supernatants is measured photometrically at wavelength 540 nm. Haemolysis in percentage is calculated by formula. Value of haemolysis is the average maximum percentage of haemolysis of human erythrocytes in the presence of a sample of material obtained from parallel experiments and not changing with increase in incubation time of samples by 1 hour or calculated by dependence of haemolysis on incubation time, if the obtained haemolysis value after 24 hours of incubation of the samples is greater than the value of haemolysis obtained after 23 hours of incubation of the samples.

EFFECT: method is simple and provides higher reliability of results of determining haemolytic activity of polymers.

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