| 摘要 |
FIELD: biochemical engineering; medicine. ^ SUBSTANCE: method involves producing immunoglobulin preparation by concentrating III Kohn spirit method fractions by means of ultrafiltration under 3.5-5.0 condition, washing from ethanol and carrying out final solution concentration process. The subsequent restoration hydrate immunoglobulin envelopes is carried out by means of molecular filtration method by creating concentration gradient by introducing low-molecular substance in concentration of 0.1-2.5% by weight into immunoglobulin solution, with water of 3.8-4.5 being used, cleared from dialyzing solution. Then stabilizing agent is added and value is fixed at 3.5-5.0. Sterilizing filtration is carried out and the produced preparation is dried by subliming when needed at the final stage of refinement process. The so produced immunoglobulin preparation for making intravenous injections has solution transparency index less than 0.01, and contains monomer immunoglobulin IgG more than 97% under full absence of polymeric forms, proteins 4.5-11% and sodium chloride no more than 0.3%. ^ EFFECT: reduced risk of side reactions when administering the immunoglobulin preparation; mechanically aided and automated process of preparation production; prolonged storage period. ^ 5 cl, 1 dwg, 2 tbl |
