Formulation development and establishment of quality standards of sedative drug “Flegmen”

Abstract

Background: Sedatives have long been widely used in all sectors of traditional and folk medicine (stress - sensitive patients with neurasthenia, neurosis, anxiety - depressive states, irritability, sleep disorders, emotional disorders, etc.). The objectives of this study were to determine the quantitative content of flavonoids in the collection of “Flegmen”.Methods: As raw materials use the herb of Jerusalem sage Regel (Herba phlomis Regelii) - 30 pieces; Turkestan motherwort grass (Herba Leonuri turkestanicae) - 30 pieces; licorice root (Radix Glycyrrhizae) - 20 parts; peppermint leaves (Folia Mentha piperite) - 20 pieces. All components of sedative collection are grown in Uzbekistan and have sufficient natural stock. The loss in weight upon drying were made in the range of 8.41 to 9.67%; ash shared from 7.9 to 8.73%; ash insoluble in 10%, HCl from 2.0 to 2.32; Particles not passing through a sieve with hole diameter of 7 mm from 5.1 to 7.5. Particles passing through a sieve with a hole diameter of 0.5 mm, from 2.8 to 3.2 percent. Particles of raw materials, loss of natural color from 1.7 to 2.4 percent. Organic impurity ranged from 1.1 to 1.32%; mineral admixture is 0.4 to 0.9%.Results: The content of flavonoids sedative collection “Flegmen” in the range of 0.88-0.9 percent. Based on these data, the rate of content of flavonoids in the collection set at least 0.4%. In order to determine the period of validity of sedative collection “Flegmen”, the storage stability and optimum expiration date were studied. New sedative collection “Flegmen” consists exclusively of local official medicinal plants with sufficient natural reserves. The expiration date of the licorice roots is 4 years, for herb of Jerusalem sage Regel and motherwort is 3 years, and for peppermint leaves, it is 2 years. For establishing expiry date of studied collection, five batches of laboratory sample of the drug were prepared, packed according to project temporary pharmacopeia article (TPA).Conclusions: According to the results of commodity and chemical study of the collection, the characteristics of its authenticity and quality. To determine the expiry date, the stability during storage of the studied collection and the optimum shelf life for 2 years. Vegetable collection “Flegmen” is recommended for use in medical practice as a sedative for central nervous system diseases (neurosis, migraine, neurasthenia, insomnia, etc.).