Kasama T, Iwata Y, Okubo T, Sakaguchi Y, Sugiura M
Jpn J Pharmacol. 1980 Jun;30(3):293-300. doi: 10.1254/jjp.30.293.
Prolonged administration of insulin leads to the formation of insulin-binding antibodies due to contaminant peptides and the animal source of the insulin. It follows that quantitation and identification of these factors are of significant importance in pharmaceutical insulin preparations. The assay and test procedures stipulated in the current pharmacopoeia of various countries, nevertheless, cannot determine either of these effects. In the present study, the content of impurities in insulin preparations was measured by polyacrylamide gel disc electrophoresis and the animal source of insulin identified by amino acid analysis. Assays of 17 commercial insulin preparations by these techniques revealed diversity in purity and animal sources of insulin. The present results suggest potential usefulness of these assay methods and advisability of their adoption not only by the manufacturers but also by the official pharmacopoeia as well.
由于胰岛素中的污染物肽以及胰岛素的动物来源，长期使用胰岛素会导致胰岛素结合抗体的形成。因此，对这些因素进行定量和鉴定在药用胰岛素制剂中具有重要意义。然而，各国现行药典规定的检测和试验方法均无法确定上述任何一种影响。在本研究中，通过聚丙烯酰胺凝胶圆盘电泳测定胰岛素制剂中的杂质含量，并通过氨基酸分析鉴定胰岛素的动物来源。采用这些技术对17种市售胰岛素制剂进行检测，结果显示胰岛素的纯度和动物来源存在差异。目前的结果表明这些检测方法具有潜在的实用性，不仅制造商而且官方药典也宜采用这些方法。
