Standardization of dry extracts from large cranberry leaves

Abstract

Aim. To determine the parameters of standardization of a dry extract from large cranberry (Oxycoccus macrocarpus (Ait.)) leaves and a dry extract modified with arginine and develop projects of Drug Quality Control Methods (DQCM) for these substances.Materials and methods. The study object was dry extracts from large cranberry leaves. Leaves were harvested in October 2021 in the Zhytomyr region (Kostivtsi village, 50.326862437345945, 29.54310845594284). The extracts were obtained with a 50 % solution of ethyl alcohol in the ratio of 1:30 by double maceration. Half of the combined extract was dried to a dry extract (Extract 1), and the other half was modified with arginine in the threefold equimolar amount relative to the total amount of phenolic compounds and evaporated to a dry extract (Extract 2). Standard pharmacopoeial methods were used to determine standardization parameters. The quantitative determination was carried out using the spectrophotometric method by the content of flavonoids calculated with reference to hyperoside and hydroxycinnamic acids calculated with reference to chlorogenic acid on an Evolution 60S spectrophotometer (Thermo Scientific Spectronic, USA).Results and discussion. The parameters of standardization of dry extracts from large cranberry leaves were determined. The project of DQCM was proposed according to the following indicators: description, solubility, identification using the thin-layer chromatography method (by the content of flavonoids, hydroxycinnic acids and arginine), loss on drying, the residual amount of organic solvents (ethanol), microbiological purity, and the content of heavy metals. The assay was carried out using spectrophotometry by the content of flavonoids and derivatives of hydroxycinnic acids. Three batches of the extracts obtained, which fully corresponded to the projects of DQCM developed, were analyzed.Conclusions. The parameters of standardization of dry extracts from large cranberry leaves have been determined, and projects of DQCM for the substances obtained have been developed. It is the basis for creating new medicines for the correction of insulin-resistant conditions in Type 2 diabetes mellitus.