The dissertation is dedicated to the solution of an important scientific task aimed at the solution of today's urgent problems - the pharmaceutical development of a complex phytoextract with a sedative effect and a dosage form based on it.
The possibility of long-term safe use of herbal preparations due to their mild therapeutic effect and high efficiency justifies their wide use in the treatment of various diseases. However, despite the undeniable advantages, the demand for domestic herbal preparations exceeds their availability, which explains the urgency of developing new drugs based on medicinal plant raw materials.
One of the possible compositions is a complex phytoextract, which includes medicinal plants approved for medical use and included in the DFU (valerian rhizome roots, hawthorn fruits, St. John's wort, peppermint leaves, hop cones, viburnum fruits). Liquid phytoextract contains up to 40% ethyl alcohol.
The given composition of the mixture of medicinal plant raw materials includes various anatomical and morphological organs, which significantly affects the kinetics of extraction. Thus, under the conditions of simultaneous extraction of the given types of raw materials at a certain point in time, for raw materials that are easily extracted, equilibrium is reached faster, while in order to achieve equilibrium of another type of raw materials in a mixture that is difficult to extract, it is necessary to spend some additional time. This, in turn, negatively affects the quality of the final extraction product (complex phytoextract), as it is contaminated with ballast substances. In order to rationally carry out the extraction process, conditions are created for simultaneously achieving equilibrium of different types of plant raw materials in the mixture. This is achieved by selecting the particle size of medicinal plant raw materials. The work presents the methodology of analytical calculation of the particle size, to which medicinal plant raw materials of various species and morphological organs should be crushed, with the aim of simultaneously achieving equilibrium under the condition of simultaneous extraction. The methodology is based on the derivation and solution of a system of analytical equations that describe the kinetics of extraction of the same raw material of different sizes of the corresponding morphological organs.
Based on the chemical composition of the active substances that are part of the complex phytoextract, the type of selected extractant, as well as the conducted research, the main biologically active compounds extracted with 40% ethyl alcohol are polyphenolic compounds (flavonoids, hydroxocinnamic acids), which are characteristic of fruits hawthorn and viburnum, St. John's wort, peppermint leaves, hop cones; organic acids, including isovaleric, contained in rhizomes with valerian roots, viburnum fruits, as well as partially in peppermint leaves; amino acids contained in rhizomes with valerian roots; hyperoside and hypericin in St. John's wort herb identification methods are proposed. According to the requirements for analytical documentation, quantitative determination methods have been developed and validated in the work in accordance with the requirements of the State Federal Office for Analytical and Regulatory Documentation.
The pharmacological action of the complex phytoextract is due to the properties of biologically active compounds contained in the plant raw materials included in its composition. In this regard, the experimental evaluation of the pharmacological activity of the complex phytoextract was performed on intact animals, as well as on animals with models close to the pathogenesis with the corresponding clinical pathology. As a comparison drug, a well-known drug was chosen - Novo-Pasyt solution, which includes medicinal plant raw materials with a similar pharmacological effect, and the complex phytoextract itself has a similar pharmacological effect.
According to pharmacological studies, the complex phytoextract has a sedative effect and belongs to non-toxic substances. The obtained result indicates the presence of a pronounced sedative, anxiolytic effect. In the course of experimental studies, no signs of chronic toxicity were found for two months. The obtained results allow us to assert the feasibility of using a complex phytoextract for the development of other drugs with a pronounced sedative and anxiolytic effect, as well as a means that increases the body's ability to tolerate physical and emotional stress.
