FIELD: medicine and biotechnology.
SUBSTANCE: invention relates to a method for producing a medicinal product with antihypoxic, regenerative activity, namely, to a method for producing a component of the respiratory chain - cytochrome C. The medicinal product is obtained from biological raw materials, namely, the hearts of farm animals and equine-hoofed animals. The proposed method provides for grinding the prepared raw materials, extraction with a 2.0-3.0% solution of trichloroacetic acid at a temperature of 10-20°C and a pH of 3.0-4.5. The extract is clarified and sequentially carried out the precipitation of ballast impurities at pH 9.0-11.0 and pH 3.5-5.0, followed by separation and microfiltration. Next, the extract is sorbed on the cation exchanger. After the completion of sorption, the cation exchanger is washed with water for injection and an ammonia-ammonium buffer solution. Then cytochrome C is eluted from the cation exchanger with a solution of ammonium sulfate, followed by its purification by extra addition of ammonium sulfate, diafiltration and concentration of cytochrome C by ultrafiltration. The solution of the intermediate product after ultrafiltration is subjected to sterilizing filtration and freeze-drying.
EFFECT: invention makes it possible to obtain a cytochrome C drug that fully meets the requirements of the State Pharmacopoeia of the Russian Federation.
1 cl, 1 tbl, 7 ex, 1 dwg
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Authors
Dates
2021-03-25—Published
2020-06-10—Filed