中文摘要：

目的制备胰岛素单克隆抗体，用此抗体检测2型糖尿病患者血清胰岛素水平。方法以交联胰岛素-牛血清清蛋白为免疫原，免疫Balb／c小鼠，用杂交瘤技术制备得到4株稳定分泌胰岛素抗体的单克隆细胞株，对单抗效价、亚类、亲和常数进行了分析。利用所得单抗，通过竞争性抑制酶联免疫吸附法（ELISA）随机检测90例2型糖尿病患者血清和90例正常人血清中胰岛素的含量。结果制备的单抗亲和常数达10^11，除1株属IgGzh（k）外，其余3株为IgG1（k），检测发现2型糖尿病患者血清胰岛素含量低于正常人水平。结论2型糖尿病患者血清胰岛素平均低于正常人水平，可能由于胰腺功能衰竭所致，仍可用补充胰岛素缓解病情。约10％患者血清胰岛素含量高于正常人平均水平，可能由于体内胰岛素拮抗所致，不宜用胰岛素治疗。

英文摘要：

Objective The monoclone antibody against insulin was prepared and used to measure plasma level of insulin in patients with type 2 diabetes mellitus. Methods Balb/e mice were immuned with cross-linking insulin-BSA as immunogen. Four monoclone cell strains stably secreting insulin monoclone antibody were prepared by applying hybridoma technique. The valence, subclass and affinity constant of the monoclone antibody were analyzed. The serum insulin content was measured with competitive inhibition ELISA in 90 patients with type 2 diabetes mellitus and 90 healthy controls. Resuits The affinity constant of the established monoclone antibody reached to 10^11. The subclass of 1 strain was IgG2b（k）, and the other 3 strains were IgG1（k） subclass. The mean level of insulin was significantly lower in patients with type 2 diabetes mellitus than that of healthy controls. Conclusion These results implicated that the insulin insufficient might be due to the depletion of the pancreatic beta cell function of patients with type 2 diabetes mellitus, and the pathogenetic condition might be alleviated by supplying insulin. About 10% patients are with higher insulin level than healthy controls, which may be due to insulin resistance. It is inadvisable to treat these patients with insulin therapy.