The thesis paper is devoted to the development of technology and methods of analysis of new ophthalmic drugs based on 1,2,4-triazole. In the course of the study, the selection of excipients in order to create eye Angiolin drops was performed. The following excipients were used to create Angiolin eye drops: sodium choride, methylcellulose and purified water. Subsequently, we carried out the experimental part of determining the osmolality of the solution of Angiolin eye drops, selected the optimal concentration of excipients for these drops. As a result, the composition of Angiolin eye drops was developed: angiolin 1.0 g, sodium chloride 0.7 g, methylcellulose 0.5 g, purified water 100.00 ml. Subsequently, a microbiological study of Angiolin eye drops was carried out. According to the results of the study, it was found that the growth of colonies of microorganisms was not detected. In the future, a method of standardization of Angiolin eye drops by spectrophotometry was developed. A modified spectrophotometric method of angioline substance analysis was taken as a basis. Six batches of 1% Angiolin eye drops were made in the laboratory, which included such excipients as sodium chloride, methylcellulose and purified water. To confirm the reliability of the method of spectroscopic examination, an analysis of 6 series of Angiolin eye drops (S) -2,6-diaminohexanoic acid 3-methyl-1,2,4-triazolyl- 5-thioacetate was carried out. For each solution, absorption spectra in the range of 200- BOO nm were taken. The absorption spectra of the test solution and the solution of the work standard were taken alternately. Since Angiolin eye drops contain the excipient sodium chloride, a quantitative determination was proposed and carried out by the method of argentometry, namely by the Folgard method (inverse titration method). According to the results obtained by quantitative determination during argentometry the content of sodium chloride in Angiolin eye drops varies in the range of 0.7012-0.7188 g/ml. The Department of Pharmaceutical Chemistry of ZSMU produced six series of Angiolin eye drops, using the angioline substance and work standard; methylcellulose, sodium chloride and purified water were used as excipients. Subsequently, the following method was developed for the quantitative determination of the active substance angioline ((S) -2,6-diaminohexanoic acid 3- methyl-1,2,4-triazolyl-5-thioacetate) in Angiolin eye drops by HPLC. The following solutions were prepared for the study: test solution, comparison solution (a), comparison solution (b). It was found that the content of angioline in 1% eye drops in the series N1 is in the range from 0.9850 to 1.01 g, i.e. the content of the active substance in the test series meets the requirements of SPU. Further we analyzed other 5 series of Angiolin eye drops, which also met the pharmacopoeial requirements for the content of the active substance, and the amount of active substance is in the range from 0.988 to 1.06. A method for quantitative determination of 1% of Angiolin eye drops by HPLC has been developed, which is reproducible, accurate and can be further used in quality control of the created eye dosage form. After validation of the developed methods for determining the quantitative content of the active ingredient and excipient in these eye drops, all indicators met the requirements of the SPU. In the process, the specification for Angiolin eye drops was developed, as well as the method of qualitative and quantitative determination of active and auxiliary substances in eye drops by HPLC. The ICJ project for Angiolin eye drops has been developed. A method for quantitative determination of the active substance in eye drops by HPLC has been developed, which has been tested and implemented in the quality system of JSC "Lekhim-Kharkiv". A study of the stability of Angiolin eye drops was also carried out to determine the shelf life and storage conditions. The results proved the stability of eye drops and determined the shelf life of 1 year in a dry, dark place at a temperature not exceeding 25°C. On the basis of a complex of biological studies, the pharmacological characteristics of eye drops are defined. An experimental evaluation of the specific activity of a new dosage form of angioline in cataract modeling has been studied. The effectiveness of 1% Angiolin eye drops in cataract modeling was studied. The pharmacological activity of Angiolin eye drops in chemical modeling of eye burns was studied. It was found that Angiolin eye drops in concentrations: 1%, 1.5%, 2%, 2.5% show almost the same pharmacological activity, and the most effective were 1% Angiolin eye drops, which gives us the opportunity to further study them. According to the results of the study, it was found that Angiolin eye drops show high anti-inflammatory, wound-healing, reparative activity in the treatment of cataracts and eye burns.
