Разработка и регистрация лекарственных средств (Jun 2024)
Technology of dry extract from the <i>Filipendula ulmaria</i> (L.) Maxim. and preliminary assessment of its safety profile
Abstract
Introduction. Medicines of natural origin have advantages over synthetic drugs and occupy a significant share in the assortment of pharmacies. Filipendula ulmaria (L.) Maxim., characterized by a chemical composition rich in phenolic compounds and various types of biological activity has the potential in terms of the development of new herbal medicines. In an in vivo experiment, F. ulmaria extract showed immunomodulatory, anti-inflammatory, osteogenic activity and effectively stimulated myelopoiesis in conditions of microbial damage of bone tissue.Aim. Development of an optimal technology for obtaining dry extract of F. ulmaria by remaceration and investigation of its аcute toxicity.Materials and methods. The technology of extract was developed in a laboratory reactor equipped with a water heater jacket and a stirrer. The content of flavonoids was determined by differential spectrometry. Flowability was determined on a flowability tester for powders and granules, bulk density was determined on a bulk density tester for powders and granules, moisture content was developed on a moisture content analyzer. Acute toxicity was determined on Wistar rats.Results and discussion. The dry extract of F. ulmaria, obtained using 70 % ethanol by remaceration, is effective in conditions of microbial damage of bone tissue and bone marrow, which determined the choice of extragent and the type of extract. The optimal parameters for obtaining the extract were determined (three-fold maceration at a water jacket temperature of 80 °C, the ratio of raw materials to extragent 1 : 14, time 30 min), its main technological characteristics were determined and a wet granulation method for improving them was proposed. In the study of acute toxicity of the extract, according to the results of toxicometry for 14 days after administration and necropsy data, the studied extract was classified as low-toxic substance.Conclusion. The dry extract of F. ulmaria, obtained by remaceration using 70 % ethanol, has specific activity in conditions of microbial damage to bone tissue. Optimal extraction parameters allow to increase the yield of target components, it is advisable to improve the technological parameters of the extract by wet granulation. The assessment of the safety profile of the dry extract from F. ulmaria, along with its high biological activity, provides a perspective for its further study and implementation into medical practice.
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