【摘要】 胰岛素制剂的免疫原性与其纯度密切相关。作者研制的高纯度胰岛素(HP-I)其主要大分子杂质胰岛素原、胰高血糖素和胰多肽的含量分别为76.00、2.11和0.11ppm。产品的纯度显著优于国产普通结晶胰岛素,并超过国外单峰胰岛素(SP-I)的质量标准。临床试用结果,病人血清中胰岛素、胰岛素原和胰多肽等三种特异抗体的阳性率分别为37.5％、0％和0％。其免疫原性也明显低于国产普通结晶胰岛素、接近丹麦单组分胰岛素(MC-I,Nordisk)的水平。更多还原

【Abstract】 Antigenicity of insulinpreparations is obviously related to theirpurity. The average contents of proinsu-lin. glucagon and pancreatic polypeptidein highly purified insulin (HP-I) producedby us are 76.0, 2.11 and 0.11 ppm respec-tively. These results are superior to thosefor domestic conventional crystalline insu-lin and single peak insulin (SP-I). The antibodies to insulin, proinsulinand pancreatic polypeptide in erum wereexamined in 24 diabetic patients treatedwith HP-I for more than 6 months. Thepositive rates for the above three antibod-ies were 37.5%, 0% and 0% respectively.the results showed that the antigenicityof HP-I was much lower than that of do-mestic conventional crystalline insulin andalmost the same as that of MC-I fromNordisk, Denmark.更多还原