T.Y. Mandjigoladze, T.Y. Archinova, V. I. Pogorelov

The aim of the present researching is the development of combined ointment with the drug of natural origin - thick extract of licorice root (GESK) and antiseptic chlorhexidin bigluconate (CGD) possessing anti-inflammatory, antiallergenic and antimicrobial action, as well as methods of qualitative subjective and quantitative analysis. To select the best ointment base, biopharmaceutical study of different formulations of ointments by dialysis was held. It was found that the maximal release (56 % of GC and 84.96 % CGD) in in vitro model experiments is provided by a basis of polyethilenglicol (PEG). Further study of osmotic and structural and mechanical properties, which indicated the presence of high adsorption capacity for PEG-based ointment (420 %), pronounced antibacterial activity against gram-positive cocci, spore of microorganisms, salmonell at 1 % concentration of active ingredients. On the basis of rheological studies it was found that the ointment is a disperse system with coagulation (thixotropic) type of structure characterized by the elastic-viscous properties. For qualitative and quantitative analysis of ointments we used the HPLC method allowing separation of biologically active substances. As a standard for the GC in the ointment, we selected a standard sample (CO) of glycyram. This choic was guided by the fact that the clay-ammonium salt is a glycyram of GC. Our preliminary study showed that using the method of TLC, Rf glycyram coincided with Rf GC (Rf = 0.1). Furthermore, as the salt of GC it is more stable and has close to GC physico-chemical and chemical properties. Analysis of the study ointment was performed on microcolumn liquid chromatograph «Milichrome A-02». In order to develop a methodology for identification of the GC and CGD in the ointment, we first subjected to chromatography CGD CO, CO glycyram's and a 50 % solution of ethyl alcohol (solvent). CGD in the chromatogram of CO peak is detected with a retention time of 7.8 min. Chromatogram contained four peaks glycyram's CO, one of which corresponds to the peak of the GC (retention time 9.6 min.). Chromatogram of 50 % solution of ethyl alcohol contained no peaks. Then we have subjected to chromatography an alcoholic solution under study of the ointment. In the chromatogram of the solution of ointment four peaks were found, two of which are consistent with CGD (retention time 7.8 min.) and GC (retention time 9.6 min.). In order to establish the suitability of the analytical method, estimation of the parameters «Openability», «Correctness of», «Linearity», «Precision» was carried out. The results illustrate the fact that the developed method of quantitative determination of the substances studied is suitable for analytical purposes. The results show a fairly high accuracy of the technique, as the relative error does not exceed ± 3 %. Thus, the optimal composition and technology of an ointment, with-holding GESK and CGD are established. Biopharmaceutical research allows us to determine the maximum degree of release of GC (56 %) and GESK and CGD (84.96 %). The high adsorption capacity of PEG-based ointment (420 %) is revealed and its rheological properties are determined. The best practices for identification and quantification of BAS ointments are developed with using the HPLC.