Standardization parameters of modified extracts from leonurus cardiaca herb

To date, in Ukraine there are 8 combined herbal medicines of Leonurus cardiaca registered in Ukraine, 10 national enterprises produce tincture of it and 3 national manufactures pack it herb. Tincture of Leonurus cardiaca has certain disadvantages: the instability of the chemical composition, and, accordingly, pharmacodynamics; contains ethyl alcohol, therefore it is contraindicated for children, pregnant women, persons whose activities require increased attention, etc. In this regard, the development of standardized drugs based on the tincture of herb of dog nettle, which would not contain ethanol in its composition, is an urgent task Aim. Determine the parameters of standardization of modified dry extract from tincture of Leonurus cardiaca and develop a draft quality control methodology for this substance. Methods of the research. The object of the study was dry extracts based on Leonurus cardiaca tinctures (Manufacturer: OAO "Lubnifarm", series 062021), which was modified with lysine. For analysis, three series of extracts were used. In determining the parameters of standardization of the obtained dry extract of Leonurus cardiaca herbs used standard pharmacopoeial techniques. The basis of development of quality control methods for dry extract of Leonurus cardiaca was taken SPHU monographs "Leonurus cardiaca grass", "Leonurus cardiaca tincture" and "Lysine hydrochloride". Results of the research. Parameters of standardization of modified dry extract of Leonurus cardiaca herbs are determined. It is proposed to control the quality of the obtained extract according to the following parameters: description, solubility, identification of the extract with TLC by the content of flavonoids, iridoids and lysine, mass loss during drying, residual organic solvents (ethanol), microbiological purity, heavy metal content, quantitative standardization conducted according to the content of flavonoids (not less than 2 %) and iridoids (not less than 0,5 %). Three series of extract were analyzed in accordance with the proposed MQC project, which fully met all the indicators. Conclusions. The parameters of standardization of modified dried extract of tincture of Leonurus cardiaca, which was obtained using lysine, were determined, and a draft quality control methodology was developed for this substance. Three series of extract were analyzed in accordance with the proposed MQC project, which fully met all the indicators