FIELD: chemistry; pharmaceutics.
SUBSTANCE: group of inventions relates to chemical-pharmaceutical industry, namely to a pharmaceutical composition having neuroprotective activity, as well as to a method for preparing and using it. Method for preparing a pharmaceutical composition having neuroprotective activity in chronic cerebral ischemia, in the form of a tablet, is characterized by the fact that citicoline, ethylmethylhydroxypyridine succinate substances are mixed for 10–15 minutes with microcrystalline cellulose at a mixer rotation frequency of 55–65 rpm, then the mixture is stirred for 1–2 minutes, at a rotation frequency of 1,400–1,600 rpm, 10% aqueous solution of povidone K-25 is added as a granulating liquid, stirring for 2–4 minutes at a mixer rotation frequency of 25–35 rpm, obtained mass is granulated using a sieve with a hole diameter of 2 mm, the granulate is dried in a fluidised bed dryer to temperature of 35–40 °C, controlling moisture content in granulate from 0.8 to 1.5% during drying, granulate is calibrated using a sieve with a hole diameter of 2.0 mm, sieved granulate is powdered with highly dispersed silicon dioxide, croscarmellose sodium and stearic acid salt, selected from magnesium stearate and/or calcium stearate, to a homogeneous state and pressed, wherein the obtained tablet contains the following components, wt.%: citicoline 45–55, ethylmethylhydroxypyridine succinate 22.5–27.5, microcrystalline cellulose 9–11, povidone K-25 4.5–5.5, croscarmellose sodium 4.5–5.5, highly dispersed silicon dioxide 3.6–4.4, magnesium stearate and/or calcium stearate 0.9–1.1. A pharmaceutical composition having neuroprotective activity in chronic cerebral ischemia, in the form of a tablet, obtained using the above method, is characterized by the fact that it contains the above components in the above ratio. Use of said pharmaceutical composition having neuroprotective activity in the form of a tablet prepared using said method for treating chronic cerebral ischemia.
EFFECT: use of the group of inventions provides the preparation of oral forms with a combined fixed active principle, which is highly effective in treating chronic cerebral ischemia and is stable.
6 cl, 1 tbl, 4 ex
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Authors
Dates
2024-03-28—Published
2023-07-24—Filed