process for the production of a mixture of isomalto - oligosacchariden containing a high proportion of isomaltopentaose and isomaltohexaose and the obtained mixture containing sterile aqueous solution for parenteral administration

摘要

1. A process for preparing a mixture of isomaltooligosaccharides containing a high proportion of isomaltopentose and isomaltohexose by the partial hydrolysis of dextran having an average molecular weight Mw of from 12,000 to 22,000, which is dissolved in a quantity of from 25 to 45 g in 100 g of water, by means of hydrochloric acid and by separating part of the resulting glucose, isomaltose and the other low molecular weight sugars as well as the inorganic constituents, characterised in that, a) for hydrolysis, hydrogen chloride is used in a quantity of from 0.9 g to 1.3 g of HCl per 100 g of water, b) the hydrolysis is carried out at 95 degrees C up to reflux temperature for a duration of from 40 to 250 minutes, c) the separation of part of the resulting glucose, isomaltose, and the other low molecular weight sugars, as well as of the inorganic constituents, is effected by precipitation with ethanol and recovering the precipitate, the solution to be precipitated having a carbohydrate concentration of less than 30 g/100 ml of solution and at least 80 wt/wt % ethanol being added in a quantity such that 100 g of mixture contain from 57 to 70 g of ethanol, or the separation of part of the resulting glucose, isomaltose, and the other low molecular weight sugars, as well as of the organic constituents, is effected by mixtures of strongly acidic and strongly basic ion exchange resins and a mixture containing a high proportion of isomaltopentose and isomaltohexose is recovered from the first eluate fractions obtained with water.