Experimental research on the development of composition of complex action ointment based on phytocomplex

Abstract

The aim of the work is to develop the composition of a complex action ointment based on active pharmaceutical ingredients of natural origin for the treatment of cheilitis of various etiologies. Materials and methods. The development of the ointment base by selecting active pharmaceutical ingredients and auxiliary substances determined by organoleptic, physicochemical, rheological and microbiological research methods. Results. Studies of the antimicrobial activity of experimental samples have established that the optimal ointment base is a water/oil emulsion, which provides better API release rates than absorption bases. According to the results of structural and mechanical studies, the introduction of the API complex reduces the structural viscosity of the ointment base. Furthermore, the ability of the ointment to thin out with an increase in the gradient of the shear rate is shown, which will contribute to the uniform distribution of the API during the technological process and the easy application of the ointment to the skin. The study of textural properties of the experimental ointment samples (cohesion, adhesion, and elasticity) also confirmed the satisfactory spreadability of the sample. The optimal container for its consistent properties was chosen according to the results of the ointment's structural, mechanical and textural properties. A test of the effectiveness of antimicrobial preservatives was conducted, resulting in the minimum effective concentration of sodium benzoate in the amount of 1 % was substantiated. Furthermore, based on the results of a complex of studies, the composition of the emulsion ointment was developed, which includes vaseline (liquid paraffin) 20 %, emulsifiers glycerol monostearate 5.5 %, polysorbate-80 3.5 %, viscosity regulator of the aqueous phase hydroxyethyl cellulose 3 %, phytocomplex API "Phytol" (concentrated aqueous extract of burdock root: oak bark: pot calendula in the ratio 5:1:1.5, respectively) and essential oils of tea tree 1 % and geranium 1.5 %, purified water. Conclusions. Based on organoleptic, physicochemical, rheological and microbiological studies, the composition of the ointment of complex action was developed based on active pharmaceutical ingredients of natural origin for the treatment of cheilitis of various etiologies.