DEVELOPMENT OF A PRODUCTION PROCESS AND EVALUATION OF QUALITATIVE CHARACTERISTICS OF A SPECIALIZED PLANT-BASED PREPARATION
The paper discusses key features of a production process of a new type of specialized product in the tablet form of a dietary supplement, which science-based formulation includes herbal raw stuffs (i.e. shoots of blueberry; leaves of birch, cowberry, nettle, peppermint; roots of artichoke, inula, ginger; stems and leaves of common St. John’s wort and knot-grass; extracts of burdock, raspberry, wormwood and Ginkgo biloba; sublimated garlic), as well as a complex of essential biologically active substances with synergistic effect on the correction of metabolic processes in Type 2 diabetes mellitus. Technological stages of production process are defined as follows: preparation of raw materials; dosing; sieving; mixing; wet granulation; drying of granulate; dry granulation; tableting, dedusting; film coating; separation of products that failed to meet the requirements of technical documents. The authors specify those controlled parameters that in addition to formulation composition form indicators of quality and nutritional value of the developed product: mixing is carried out at room temperature for 60 minutes; wet granulation is realized through a spinneret with holes of 1 mm, the amount of humidifier (purified water) is 50% by dry weight, the temperature of wet granules on exit from the granulation chamber is no higher than 40°C; drying of the granulates is carried out at a temperature not higher than 60°C for 1.5-2 hours, residual humidity is 8-9%; tableting is performed at an operating pressure not higher than 50 N; preparation of the film coating is implemented at the speed of rotation of the agitator blades of the reactor-homogenizer no more than 10 rpm for 15 minutes, then the solution is infiltrated using filters with hole diameter of 0.315-0,450 mm. The effectiveness and functional properties of dietary supplements are confirmed by the results of clinical studies, the developed product is included in the Register of Products That Have Passed State Registration in Rospotrebnadzor, and is recommended for patients suffering fromType 2 diabetes mellitus. The proposed production process of the specialized herbal preparation passed evaluation test at the enterprises of the Artlife Scientific and Production Association (Tomsk), received approval, and on completion of testing mass production was organized.