METHOD OF STUDYING THE PHARMACOKINETIC PROPERTIES OF A MEDICINAL PRODUCT WITH ENISAMIA IODIDE ACTIVE SUBSTANCE Russian patent published in 2023 - IPC C07D213/81 A61K31/4425 G16H70/40 G01N33/48 

FIELD: pharmacology and clinical pharmacology.

SUBSTANCE: group of inventions discloses a method of studying the pharmacokinetic properties of a medicinal product with the active ingredient enisamia iodide, including intragastric single or multiple administration in the same dose to a mammal, subsequent sampling of blood and organs from mammals, with a single injection before medicinal product administration, and then after 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h and 24 h after the administration of the medicinal product, and with repeated administration before the last administration of the medicinal product and then after 0.5 h, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 24 hours after the last administration of the medicinal product, determination of the concentration of enisamia iodide in blood plasma and in the tissues of mammalian organs using high performance liquid chromatography (HPLC) with ultraviolet (UV) detection and determination of parameters characterizing the distribution of enisamium iodide in the tissues of organs and in the blood of mammals: maximum concentration is C_max µg/ml; the time to reach the maximum concentration is T_max h; area under the concentration-time curve is AUC µg h/g; half-life is T1/2 h; the average retention time of the medicinal product in the body is MRT h; tissue availability of enisamium iodide in tissues and organs of rats is ft (options).

EFFECT: determination of the quantitative characteristics of the processes of absorption, distribution and elimination of a medicinal product with the active substance enisamia iodide after its single and multiple use for 5 days on mammals; substantiation of the choice of ways and methods of medicinal product administration with the active substance enisamia iodide after its single and multiple use for 5 days on mammals; identification of tissues into which the medicinal product with the active substance enisamia iodide penetrates most intensively and/or in which it is retained for the longest time after its single and repeated use for 5 days in mammals; establishment of the main routes of elimination of the medicinal product with the active substance enisamia iodide after its single and multiple use for 5 days in mammals; establishing the "concentration-effect" relationship for a medicinal product with the active substance enisamia iodide after its single and multiple use for 5 days on mammals; study of the pharmacokinetics and distribution of the medicinal product with the active substance enisamia iodide in the internal organs of mammals after its single and multiple use for 5 days on mammals; study of the distribution of a medicinal product with the active substance enisamia iodide into the internal organs of mammals after its single and multiple use for 5 days on mammals; study of the tissue availability of the medicinal product with the active substance enisamia iodide, to control the transport of the medicinal product to the area of its action, in order to determine the effect of the medicinal product; predicting the action of a medicinal product with the active substance enisamia iodide in humans.

15 cl, 19 dwg, 11 tbl