The objects – sapropel, dry sapropel, sapropasta, oil sapropel extract (OSE), aqueous sapropel extract (AqSE), alcohol sapropel extract (AES), soap with sapropasta, cream with OSE and AqSE, gel with AqSE; excipients and comparator products; the purpose - the aim of the dissertation is to create a scientific and methodological approach to the complex use of sapropel, development and standardization of promising medical, veterinary and cosmetic remedies with sapropel processing products; methods - general scientific (analysis and generalization), organoleptic (color, odor, homogeneity, etc.), chemical (Kjeldahl’s titrimetric method, intermediate filtration method), physical, physico-chemical (gravimetry, potentiometry, photocolorimetry, chromatography mass spectroscopy, capillary electrophoresis, gas-liquid chromatography); as well as methods for assessing the structural and mechanical properties of semi-solid dosage forms (structural viscosity, spreadability, extrusion capacity of semi-solid medical and cosmetic remedies based on native sapropel and sapropasta); pharmaco-technological methods of researching quality indicators of the developed drugs (description, identification, homogeneity, weight of container contents, etc.); microbiological (antimicrobial activity, effectiveness of preservatives, microbiological purity); pharmacological (determination of pharmacological activity and toxicity of sapropel and preparations based on it); research methods of quality indicators of the developed preparations; statistical; results - the complex use concept of sapropel is substantiated, the general research methodology is developed; technology is worked out, researched and standardized sapropasta; the composition and technology of antibacterial soap with sapropasta are confirmed; substantiated the technology of aqueous sapropel extract using the dispersion method, which increases the yield of humic acids, compared with the classical method, more than 9%; substantiated and developed the technology of oil sapropel extract using step two-phase extraction by 90% ethanol and corn oil, which provides an increase in chlorophyll yield by 24% compared to single-phase extraction; the composition is proved, the technology is developed and the quality indicators of semi-solid dosage forms under the conditional names: "Saprogel" and "Saprocream" are investigated; methods of identification and content quantitative determination of the total mass fraction of humic acids in the aqueous sapropel extract, gels and creams with sapropel extracts are developed; quantitative determination methods of the amount of natural pigments and chlorophylls in oil sapropel extract, cream with sapropel extracts; validation of the developed methods is carried out; the anti-inflammatory and wound-healing effect of “Saprogel” in the second phase of the wound process, as well as its antioxidant properties were established on the model of full-thickness wounds in rats; on the model of UV erythema in rats is showed a pronounced anti-inflammatory activity of soft dosage forms with sapropel extracts, which is most pronounced in "Saprogel"; with skin application of aqueous, alcohol and oil extracts of sapropel; sapropasta, preparations: "Saprogel" and "Saprocream" detected no toxic effect, sensitizing and local irritant properties; clinical trials of Saprocream have proven its effectiveness and safety in the treatment of microtraumas, erosions and cracks (wounds) of teats on cow’s udders; implemented - TSU 20.1-2870305538 - 004: 2016 "Natural cosmetic sapropels and their products" for sapropel, sapropasta and AqSE is developed and approved; the projects of the technical specifications(TS) and quality control methods (QCM) on the production of "Sapropasta", AqSE, OSE, preparations "Saprogel", "Saprocream" and foaming antibacterial agent with sapropasta are developed; the technology of pharmaceutical developments has been implemented in the industrial condition on the pharmaceutical factory "Chervona zirka", Ukraine (Kharkiv), LLC "Zender-Ukraine" (Ukraine, Lutsk), RPPhC "AIM" (Ukraine, Kharkiv), AS "Pharmaco" JSC (Republic of Moldova, Chisinau); in the scientific and educational process of pharmaceutical (medical) institutions of higher education and research institutes of Ukraine and foreign countries ; branch - pharmacy.
