Kowarski C R, Kowarski D, Bick B D, Stein H, Rudzavich D, Kowarski A A
J Clin Endocrinol Metab. 1981 Dec;53(6):1145-7. doi: 10.1210/jcem-53-6-1145.
The USP bioassay for insulin currently used by industry and government requires a sc injection of insulin to rabbits and multiple assays of blood glucose. One hundred and forty-four rabbits are usually assayed, each assay taking at least 2 weeks. A bioassay for insulin is described. The new assay is based on a continuous monitoring of blood glucose and repeated iv injection of insulin to dogs. The test is completed in 1 day and is carried out on one dog. The interassay variability of seven repeated tests of an off the shelf soluble insulin was +/- 8%.
目前行业和政府使用的胰岛素美国药典生物测定法要求给兔子皮下注射胰岛素,并对血糖进行多次测定。通常要对144只兔子进行测定,每次测定至少需要2周时间。本文描述了一种胰岛素生物测定法。新的测定法基于对血糖的持续监测以及对狗重复静脉注射胰岛素。该测试在1天内完成,且只对一只狗进行。对一种市售可溶性胰岛素进行的七次重复测试的测定间变异性为±8%。