FIELD: medicine, pharmaceutics.
SUBSTANCE: invention relates to chemistry and deals with a pharmaceutical substance based on hydroxiethylated starch, its production method and a pharmaceutical composition for production of a medication with volemic action. The invention may find application in chemistry and medicine. The pharmaceutical substance represents a water-soluble powder of amylopectin hydroxiethylated starch with ratio of substituted hydroxiethylated C2/C6 atom groups is equal to 2 - 20, average molecular weight (Mw) remaining within the range of 100-450 kDa and the substitution degree amounting to 0.25-0.75. For production of the pharmaceutical substance of hydroxiethylated starch one uses starch with amylopectin content equal to 60-98% that is hydrolysed in suspension with an acid until an inherent viscosity value [η]=0.10-0.2. The hydrolysed starch is dissolved in water at T=70-105°C, hydroxiethylated in an inert gas atmosphere an alkylating agent and a catalyst until substitution degree is 0,25-0.75. The reaction mixture is neutralised; the produced solution is cleared of low-molecular fractions of hydroxiethylated starch and impurities by ultrafiltration method, filtered in a sterile way and dried. Additionally, the invention deals with a pharmaceutical composition for production of a medication with volemic action using the above method.
EFFECT: development of a pharmaceutical substance volemic action as well as optimisation of the pharmaceutical substance production method enabling regulation of substitution degree within the interval required, obtaining a favourable ratio of substituted hydroxiethyl groups.
21 cl, 5 ex
