Research of quality indicators and stability of herbal species for mastopathy therapy

Abstract

Topicality. Given the high incidence of breast pathologies and the limited pharmacological treatment, it is urgent to consider the possibility of using medicinal herbs in complex mastopathy therapy.Aim. To study the quality indicators and stability during storage of the developed medicinal herbal species for complex mastopathy therapy.Materials and methods. The study of the species samples named “Mastonorm” in different types of packaging was carried out using the methods of organoleptic, physicochemical, pharmacotechnological and biological research, which results in an objective assessment of the quality and stability of the developed species.Results and discussion. In the course of the studies the weight loss in drying process was found , depending on the type of packaging from 9.7 to 10,86 %, total ash is in the range of 8.0-10.5 %, ash insoluble in hydrochloric acid, – in the range of 2.2-2.8 %, the weight loss in drying of the samples during the shelf life is in the range of 9.7-10.9 %. The content of extractive substances extracted with water from species, laid in four types of packaging, is 26.7-28.7 %. The amount of biologically active substances (flavonoids) in terms of the routine during the shelf life is 0.4-0.5 %. The results obtained meet the requirements for this dosage form and during storage remains almost unchanged. Tests for microbiological purity proved the compliance of the developed drug with the requirements of SPhU 2 ed., Item 2.6.12, 2.6.13.Conclusions. The criteria for the specifications of the “Mastonorm” species under the sections “Description”, “Moisture content”, “Ash content”, “Ash insoluble in hydrochloric acid”, “Weight of packaging content”, “Quantitative content”, “Microbiological purity” are substantiated and investigated. The stability of the developed species for two years at the temperature 5 ± 3 °C and 25 ± 2 °C in different types of packaging was experimentally proved. Microbiological studies have established that the developed species “Mastonorm” in terms of microbiological purity meets the requirements of SPhU throughout the shelf life.