FIELD: pharmaceutics.
SUBSTANCE: group of inventions relates to the pharmaceutical industry, namely to a composition for the treatment of metabolic syndrome. A composition based on medicinal materials of traditional Chinese medicine for the treatment of metabolic syndrome is proposed, where the composition based on medicinal materials of traditional Chinese medicine contains Coptidis Rhizoma, Aurantii Fructus Immaturus, Pinelliae Rhizoma, Trichosanthis Fructus, Cinnamomi Cortex, and red yeast rice in the form of raw materials. At the same time, the composition contains 19.57 wt. % of Coptidis Rhizoma, 19.56 wt. % of Aurantii Fructus Immaturus, 19.57 wt. % of Pinelliae Rhizoma, 26.09 wt. % of Trichosanthis Fructus, 2.17 wt. % of Cinnamomi Cortex, and 13.04 wt. % of red yeast rice. The composition based on medicinal materials of traditional Chinese medicine for the treatment of metabolic syndrome is described, where the composition contains Coptidis Rhizoma, Aurantii Fructus Immaturus, red yeast rice, and optionally one or more components selected from a group consisting of Pinelliae Rhizoma, Trichosanthis Fructus, and Cinnamomi Cortex in the form of raw materials. In this case, the composition contains: 7.9-45 wt. % of Coptidis Rhizoma, 8.5-32.1 wt. % of Aurantii Fructus Immaturus, 0-33.8 wt. % of Pinelliae Rhizoma, 0-26.09 wt. % of Trichosanthis Fructus, 0-13.1 wt. % of Cinnamomi Cortex, and 13.04-57.2 wt. % of red yeast rice. A pharmaceutical composition for the treatment of metabolic syndrome contains the composition based on medicinal materials of traditional Chinese medicine and a pharmaceutically acceptable carrier. A method for the production of a composition for the treatment of metabolic syndrome from the above-described composition is proposed, where (a-1) Coptidis Rhizoma is extracted using an aqueous acid solution and filtered, concentrated, subjected to alkaline precipitation, salted, filtered, dried, and crushed to obtain an extract of the sum of alkaloids from Coptidis Rhizoma; (a-2) four medicinal materials, including red yeast rice, which makes up 90% of the amount required by the recipe, Aurantii Fructus Immaturus, Pinelliae Rhizoma, and Cinnamomi Cortex, are extracted using 70% ethanol and filtered; (a-3) Trichosanthis Fructus is extracted using 85% ethanol, the solution of Trichosanthis Fructus extract is combined with a solution of the extract of four medicinal materials of traditional Chinese medicine, ethanol is removed at reduced pressure, concentrated, dried, and crushed to obtain a mixed extract of five medicinal materials of traditional Chinese medicine, consisting of Aurantii Fructus Immaturus, Pinelliae Rhizoma, red yeast rice, Cinnamomi Cortex, and Trichosanthis Fructus; and (a-4) the extract of the sum of alkaloids from Coptidis Rhizoma, the mixed extract of five medicinal materials of traditional Chinese medicine, and fine powder of red yeast rice, which makes up 10% of the amount required by the recipe, are mixed to a homogeneous state to obtain a composition based on medicinal materials of traditional Chinese medicine. A pharmaceutical drug for the treatment of metabolic syndrome containing a composition based on medicinal materials of traditional Chinese medicine is proposed, where the pharmaceutical drug provides injectable solutions, tablets, capsules, granules, and solutions for oral administration. The use of a composition based on medicinal materials of traditional Chinese medicine is proposed for the treatment of a disease selected from: a. metabolic syndrome; b. disorder of a blood glucose level and lipid metabolism at an early stage of the metabolic syndrome. The use of a composition based on medicinal materials of traditional Chinese medicine is proposed to provide one or more of following effects: lowering a blood glucose level, lowering a blood insulin level, improving glucose tolerance according to the result of an oral test, lowering a level of glycated hemoglobin (HbAlc), increasing an index of insulin sensitivity, improving a condition in insulin resistance, lowering a level of triglycerides in blood, lowering total cholesterol, and lowering blood pressure. The use of a pharmaceutical drug is proposed for the treatment of a disease selected from: a. metabolic syndrome; b. disorder of blood glucose level and lipid metabolism at an early stage of the metabolic syndrome. The use of a pharmaceutical drug is proposed to provide one or more of following effects: lowering a blood glucose level, lowering a blood insulin level, improving glucose tolerance according to the result of an oral test, lowering a level of glycated hemoglobin (HbAlc), increasing an index of insulin sensitivity, improving a condition in insulin resistance, lowering a level of blood triglycerides, lowering total cholesterol, and lowering blood pressure.
EFFECT: above -described compositions are effective for the treatment of metabolic syndromes, namely relatively to lowering a blood glucose level, lowering a blood insulin level, improving glucose tolerance according to the result of an oral test, lowering a level of glycated hemoglobin (HbAlc), increasing an index of insulin sensitivity, improving a condition in insulin resistance, lowering a level of blood triglycerides, lowering total cholesterol, and lowering blood pressure.
10 cl, 24 tbl, 12 ex
Authors
Dates
2022-09-23—Published
2019-09-17—Filed