METHOD FOR ASSESSING SUITABILITY OF SYNTHETIC POLYMERS BEING DEVELOPED FOR MEDICAL PURPOSES Russian patent published in 2021 - IPC G01N33/49 G01N33/68 G01N33/15 

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely biotechnology, immunology, implantology, and can be used to assess the suitability of synthetic polymers for medical purposes. A sample of peripheral venous blood is obtained from a volunteer, then it is centrifuged to obtain a population of mononuclear leukocytes. The resulting cell suspension is introduced into the wells of a round-bottom plate with samples of synthetic polymers placed in them in the form of a cylinder with a length of 3 mm and a diameter of 1 mm in the amount of 1 piece per well. The plate is incubated at 5% CO₂ for 72 hours at a temperature of 37°C. The number of mononuclear leukocytes and the concentration of anti-inflammatory cytokines IL-4 and IL-10 are determined, expressing the obtained indicators in the form of a stimulation index (SI), which is calculated by the formula: SI =SPP/SPG, having previously determined the specific production of each of the cytokines in the presence of a synthetic polymer (SPP, pg/k) and the specific production of each of the cytokines in the presence of glass (SPG, pg/kl) according to the formulas:

SPP = P/NL_s; SPG = G/NL_g, where

P is the cytokine concentration in a sample with a synthetic polymer, pg/ml;

NL_s the number of mononuclear leukocytes in a sample with a synthetic polymer, in 1 ml;

G is the concentration of cytokine in a sample with a glass sample, pg/ml;

NL_g is the number of mononuclear leukocytes in a sample with glass, in 1 ml. The suitability of the use of synthetic polymers for medical purposes is evaluated. An SI value equal to or greater than 1 indicates the suitability of their use for medical purposes.

EFFECT: method provides increased efficiency, reduced time and labor costs, the possibility of simultaneous verification of a significant number of samples, a comprehensive assessment of the proliferative and cytokine-producing activity of mononuclear cells in direct contact with the samples, making it possible to determine the direction of the immune response, justifying the choice of a promising material for medicine, by implementing a contact method for exposure of cells of the immune system, mononuclear leukocytes contained in human peripheral venous blood to synthetic polymer samples, with an assessment of their production of anti-inflammatory cytokines in vitro according to the index of stimulation, which in a comparative analysis of the test results makes it possible to select the most promising samples.

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