[The preparation of highly purified insulin and its clinical use. Insulin Cooperative Study Group]

Antigenicity of insulin preparations is obviously related to their purity. The average contents of proinsulin, glucagon and pancreatic polypeptide in highly purified insulin (HP-I) produced by us are 76.0, 2.11 and 0.11 ppm respectively. These results are superior to those for domestic conventional crystalline insulin and single peak insulin (SP-I). The antibodies to insulin, proinsulin and pancreatic polypeptide in serum were examined in 24 diabetic patients treated with HP-I for more than 6 months. The positive rates for the above three antibodies were 37.5%, 0% and 0% respectively. The results showed that the antigenicity of HP-I was much lower than that of domestic conventional crystalline insulin and almost the same as that of MC-I from Nordisk, Denmark.