A comparative analysis of compounding aqueous extracts from the medicinal plant raw material in accordance with the requirements of the regulatory legal acts of Ukraine and the European Union

Abstract

In the world pharmaceutical practice, there are significant differences regarding the requirements for the technological parameters of aqueous extracts from medicinal plant raw materials.

Aim. To conduct a comparative analysis of the requirements of regulatory documents of Ukraine, the European Union and Poland regarding the compounding of water extracts from medicinal plant raw materials.

Materials and methods. Comparative analysis was carried out using systemic and structural-logical analysis. The object of research was normative legal acts regulating medicines compounding in Ukraine, European Pharmacopoeia (EP) XI ed., European Medicines Agency (EMA), Pharmacopoeia of Poland (PP) VI and IX ed., textbook "Farmacja stosowana, Technologia formaci leku; podręcznik dla studentów farmacji" and others.

Results and discussion. As a result of the analysis, a few distinctive features in the technology of water extracts from medicinal plant raw materials were revealed compared to the requirements of the EU and Poland. According to the requirements of European Pharmacopoeia and the European Medicines Agency, aqueous extracts from medicinal plant raw materials, so-called herbal teas, are prepared with the methods of maceration, infusion and decoction. Macerates are prepared from mucilaginous medicinal plant raw materials with the method of cold infusion at room temperature for 30 minutes. Infusions are usually prepared from delicate parts of the plant, while medicinal plant raw materials are poured with hot water with an initial temperature of 90-100 ºС and infused by gradually cooling the extract at room temperature for 5-15 minutes. Decoctions are usually prepared from roots, rhizomes and bark by boiling medicinal plant raw materials in a boiling water bath for 15-30 minutes, while the raw materials are initially poured with an extractant at room temperature, and after boiling, the extract is immediately filtered.

The compounding peculiarities of water extracts from medicinal plant raw materials in Poland are as follows: the ratio of medicinal plant raw materials to the extractant with weak biologically active substances is 1:10, with mucus-containing medicinal plant raw materials – 1:20; for medicinal plant raw materials with cardiac glycosides and alkaloids – 1:100; water extracts are prepared by mass, while water absorption coefficients or consumption coefficients are not taken into account; for acidification, 0.5 g of citric acid per 100 g of extractant is added to extracts from alkaloid-containing raw materials; macerates are prepared from mucilage-containing raw materials only by the cold infusion method (for example, flax seed macerate); infusions are prepared only from medicinal plant raw materials containing cardiac glycosides (Lily of the Valley herb, Adonis vernalis herb), where raw materials are poured with boiling water, infused in a water bath for 15 minutes and cooled at room temperature for 15 minutes; decoctions are always prepared from other types of medicinal plant raw materials, where the raw materials are poured with an extractant at room temperature, heated and boiled in a boiling water bath for 30 minutes, filtered without cooling.

Conclusions. A comparative analysis of the technological parameters of water extracts compounding from medicinal plant raw materials in accordance with the requirements of regulatory documents of Ukraine, the European Union and the Republic of Poland was carried out. A number of differences have been established, particularly in the methods of recipes prescribing, features of calculations, in the ratio of medicinal plant raw materials to the extractant, temperature regimes, extraction time, medium pH, the concepts of the processes of maceration, infusion and decoction. It was found that compared to domestic regulations, the technological process in the EU and Poland is optimized in terms of time, energy and in some cases, raw material expenditure. The obtained results have a practical importance, as they are the basis for further scientific research on the substantiation of the influence of technological factors on the quantitative content of the main groups of biological active substances in the compounded water extracts.