Topical questions of assessing the quality of a polycomponent reparative gel

Nikiforova E.B.,Melkonyan K.I., Veselova D.V., Nechaeva A.G., Kozmai Y.A.,Rusinova T.V.

"Medical & pharmaceutical journal "Pulse"(2023)

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摘要
The domestic pharmaceutical market still lacks reparative drugs, which determines research on their creation as an urgent theoretical and applied task. In this regard, the expediency of developing the composition and technology for obtaining a polycomponent gel with a predictable positive effect on wound healing processes based on dermal biopolymers and a complex of biologically active substances of corn columns with stigmas is substantiated. The complex of technological studies carried out made it possible to establish the optimal composition and technology for obtaining a polycomponent gel. At the next necessary stage of pharmaceutical development, it was necessary to solve the issues of assessing the quality of the proposed composition of the polycomponent gel. The purpose of this study was to determine the criteria and methods for monitoring the quality indicators of a multicomponent reparative gel. The object of the study was experimental samples of a multicomponent gel obtained by introducing a thick extract of corn columns with stigmas into a collagen base. The quality of the polycomponent gel was assessed in accordance with the requirements of GPM.1.4.1.0008.15 "Ointments" of the State Pharmacopoeia IV edition according to the following criteria: "Description", pH, "Microbiological purity", authenticity and quantitative content of active substances. The indicator "Description" was evaluated organoleptically. The determination of the pH of the gel was carried out potentiometrically using a pH meter (Mettler Toledo, USA) according to GPM.1.2.1.0004.15 "Ionometry" directly in the gel sample. Microbiological purity was studied by the agar plate method in accordance with GPM.1.2.4.0002.15. The presence and quantitative determination of flavonoids in the developed gel was determined spectrophotometrically on a UV-1800 SHIMADZU spectrophotometer, Japan. As a result of the studies carried out, the criteria for the quality of a multicomponent gel of reparative action were studied and proposed. According to the "Description" indicator, the polycomponent gel is a homogeneous mass of light brown color with a pleasant fruity odor without impurities. It has been established that the polycomponent gel is characterized by a slightly alkaline pH value, which creates optimal conditions for the healing phase of the wound process. It is shown that the use of the method of differential spectrophotometry makes it possible to carry out a statistically significant qualitative and quantitative assessment of the content of flavonoids in the composition of a polycomponent gel.
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