FIELD: pharmaceutical industry.
SUBSTANCE: invention relates to the pharmaceutical industry, namely to a method for producing insulin crystals or insulin analogues. The method for producing insulin crystals or insulin analogues includes the following stages, in which: a suspension of insulin crystals and insulin analogues is obtained using ZnCl2 and the pH is brought to a value in the range from 4.5 to 8.5; b) the suspension obtained at stage (a) is poured onto a filter material placed on an area in the range from 80 to 100 cm2 in a pressure filtration cell; c) nitrogen gas is purged through the inlet of the pressure filtration cell; d) collect filtrate through the outlet of the pressure filtration cell; e) stages (b) and (c) are repeated for multiple washing of sediments on the filter using acetonitrile in a volume of 5-10% of the volume of the crystal suspension; f) drying by passing nitrogen gas under pressure in the range from 1 to 2.5 bar; g) extracting the filter-dried sediment in the form of dried powder.
EFFECT: above method reduces the time spent and describes a new scheme for using multiple organic solvent washings and purging with nitrogen gas to remove absorbed water and obtain a final medicinal substance that meets the quality requirements.
7 cl, 7 dwg, 7 tbl
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Authors
Dates
2023-03-14—Published
2018-09-19—Filed