Slipchenko H. Scientific and experimental substantiation of creation of medicinal products based on vegetable raw materials and extract of Scutellaria baicalensis

The dissertation is devoted to the substantiation of a scientific and methodological approach to the creation of pharmaceutical preparations based on biologically active substances (BAS) of medicinal plant raw materials (PRM) and the development of composition and technology of new original phytopreparations in the form of tablets, capsules, and emulgel from Scutellaria baicalensis. According to the literature, the prospects of creating solid dosage forms based on Scutellaria baicalensis to expand the range of plant-origin nootropic drugs with a sedative effect and the creation of an emulgel for wound healing have been established. The analysis of the current state of production of solid dosage forms - tablets and capsules has been performed. Excipients used in the production of tablets and capsules based on plant raw materials, extracts, and the prospects of using the technological process of production - granulation have been reviewed. The course of the wound process has been considered and the expediency of creating an effective plant-based emulgel for the treatment of phases II and III of the wound process has been proven. For the first time based on physicochemical, biopharmaceutical, pharmacotechnological, and pharmacological researches with the use of methods of mathematical planning of experiment the composition and technology of tablets with nootropic and sedative action based on Scutellaria baicalensis roots dry extract (SBDE) have been justified. Critical parameters for qualitative validation of the drug have been determined. The composition and technology of capsules with nootropic and sedative action have been developed based on crushed PRM - Scutellaria baicalensis roots (SBCR). To confirm the bioavailability of the developed drug, a study of the release of BAS (the amount of flavonoids) has been performed using biorelevant media. Using SBDE as API, the composition and technology of emulsion with antimicrobial, anti-inflammatory and reparative action were developed. The dependence of the pharmacological activity of the developed drugs on the dosage form. The properties of the developed drugs are investigated, the methods of their quality control are offered, the conditions and terms of storage are determined. Necessary reference documentation and drafts of quality control methods (QCM) were developed, which were tested in industrial conditions of PJSC SPC "Borshchahiv Chemical-Pharmaceutical Plant", Kyiv (tablets and capsules); LLC "Leda", Kharkiv (emulgel).