胰岛素生物检定的快速测定方法的建立  

Establishment of a rapid method for determination of insulin bioassay

作　　者：王莉芳 贾首前 冯润东 胡萌萌 李晓春 呼延婷婷 WANG Lifang;JIA Shouqian;FENG Rundong;HU Mengmeng;LI Xiaochun;HU YANtingting(Shaanxi Institute for Food and Drug Control,Xi′an 710065,China)

机构地区：[1]陕西省食品药品监督检验研究院

出　　处：《中国药品标准》2020年第1期9-12,共4页Drug Standards of China

摘　　要：目的:建立胰岛素生物测定的快速检测方法。方法:血糖试纸上的葡萄糖脱氢酶将血液中的葡萄糖转化为葡萄糖酸内脂。这种作用会产生直流电,血糖仪以此判读血糖值。使用血糖仪快速测定小鼠血糖。结果:血糖仪能够快速测定小鼠血糖值,与全自动生化分析仪测定结果高度相关,效价偏差率<5%,结果无显著性差异(P>0.05)。结论:经方法学验证,本法可用于胰岛素生物活性的快速测定。Objective:To establish arapid detection of bioassay method for insulin.Method:The glucose dehydrogenase on the test strip converts the glucose in the blood sample togluconolactone this reaction creates electrical current that the meter interpres for the blood glucose result.Results:The blood glucose levels in mice could be rapidly measured by blood glucose meter it is highly correlated with the results of automatic biochemical.The titer deviation rate was less than 5%,and there was no significant difference in the results(P>0.05)Conclusion:The method can be used for the rapid determination of insulin bioactivity.

关 键 词：中国药典 胰岛素 生物检定的快速测定 血糖仪 

分 类 号：R921.2[医药卫生—药学]