БЫСТРОРАСТВОРИМЫЕ ГРАНУЛЫ - РАЦИОНАЛЬНАЯ И СОВРЕМЕННАЯ ЛЕКАРСТВЕННАЯ ФОРМА

Разработан комбинированный препарат - быстрорастворимые гранулы, содержащие полисахариды мальвы лесной и глицирризиновую кислоту солодки голой. Исследованы технологические характеристики сухих экстрактов мальвы лесной и солодки голой, вспомогательных веществ, их смеси, с также готовых гранул. Выбран оптимальный состав гранул. Представлена технологическая схема изготовления гранул. Наработаны серии образцов гранул для определения стабильности.

EFFERVESCENT GRANULES - RATIONAL AND MODERN DOSAGE FORM

Research conducted in the all-Russian research Institute of medicinal and aromatic plants (VILAR) showed the need to develop of complex preparation - effervescent granules with Malva sylvestris dry extract and Glycyrrhiza glabra L. dry extract for the treatment of cold-related respiratory diseases. Malva sylvestris L., containing polysaccharides, has anti-inflammatory action and is a promising raw plant materials for the treatment of colds, bronchitis. Active component of Glycyrrhiza glabra is glycyrrhizic acid (has expectorant and emollient for the diseases of the upper respiratory tract). In the laboratory were carried out experiments on animals to select an effective concentration of active substances in the granules. With regard to the therapeutic effect pharmacology VILAR recommended to enter at one dose granuless (pack weight of 1.4 g) 100.0 mg of Malva sylvestris dry extract and 200.0 mg of Glycyrrhiza glabra L. extract. It is established that the values of the technological characteristics of dry extracts correspond to the reference values. At development of composition of granules were used the following excipients citric acid, sodium bicarbonate, microcrystalline cellulose (MCC-90), polyvinylpyrrolidone. Along with the technological characteristics of dry extracts was determined the technological characteristics of the mixture for granulation. Found that the bulk density of the mixture for granulation is 0.48 g/cm³; flowability - 1.2 g/sec; the angle of repose - 34°. As a result of the research was selected the following composition of the granules: Malva sylvestris dry extract (0,100 g); Glycyrrhiza glabra L. dry extract (0,200 g); sodium bicarbonate (0,230 g); citric acid (0,280 g); MCC-90 (0.518 g); polyvinylpyrrolidone (0,072 g). The mass of granules per dose is 1,400 g. The technology of preparation of granules included of stage weighing of active ingredients (dry extract of Malva sylvestris and dry extract of Glycyrrhiza glabra L.) and excipientes, sifting, mixing, wetting, granulation and drying. Order to obtain granules used a method of non-aqueous granulation with 10 % solution of polyvinylpyrrolidone. Was carried out the experimental time series of granules. Was defined the technological characteristics of effervescent granules: the bulk density - 0.44 g/cm³; the flowability - 4,24 g/sec; the angle of repose - 32°. The solubility of the granules is not more than 5 minutes. The obtained granules were Packed up to 1.4 g in a single dose packets. At present, are developed the methods for quantitative determination of active substances to study the stability of the granules.