Analysis of the pharmacokinetic properties of a native drug on the basis of a complex of sorbents

Abstract

Absolutely all preclinical studies involve three groups of experiments: preclinical studies of the pharmacokinetics of the substance, including toxicokinetics, preclinical studies of the pharmacokinetics of the drug and the clinical study of pharmacokinetics on target animals. Pharmacokinetic studies of native drugs are complex because they usually involve the administration of complex components. Thus, only the use of the whole complex of pharmacognostic, chemical, spectral, physicochemical and biological methods can provide an objective assessment of the authenticity and quality of medicinal herbal raw materials and medicinal herbal preparations. The study used Wistar white rats, weight 150-160g according to the Guidelines for Evaluation of Medicinal Products (3).The purpose of the study was to evaluate the pharmacokinetic properties of a new feed additive in the form of a premix of sorbents and phytocompositions: milk thistle (DV-silibinin, Pharmcenter VILAR CJSC), thyme (DV-timol, Akhma100). Supplements in the form of finished dosage forms were standardized for the active substance, and have a constant composition. Thus, it allowed to create a study design for a new substance in one animal species. Since the composition of the sorption component was studied earlier, the introduced substances were considered separately and in combination with sorbents.After a single injection, the linearity of the pharmacokinetics was assessed, based on the administered different doses, the analysis of the main biochemical parameters of the blood was carried out, and the bioavailability was also calculated. Thus, the new premix based on sorbents and plant substances in the form of milk thistle and thyme does not have a negative effect on the body of laboratory animals. As a result of the studies, LD50 and LD100 were not established for the drug, the drug is classified as low-toxic, belongs to the fourth hazard class according to GOST 12.1.007-76 "Harmful substances", which allows further toxico-therapeutic tests.