Sutcliffe N, Bristow A F
J Pharm Pharmacol. 1984 Mar;36(3):163-6. doi: 10.1111/j.2042-7158.1984.tb06931.x.
The proinsulin-like immunoreactivity (PLI) content of traditional and highly purified bovine insulin preparations sold by three insulin manufacturers in the UK has been estimated by radioimmunoassay. We report the PLI content of 22 batches of traditional insulin products and 32 of highly purified insulin, marketed between March 1980 and March 1983. Estimates of the PLI content of traditional insulins ranged from 2290 to 48400 parts per million (ppm). In contrast the estimated PLI content of the highly purified insulins varied between less than 1 ppm and 1160 ppm, although more recent batches prepared by current methodology contained less than 10 ppm of PLI. We conclude that highly purified bovine insulin on sale in the UK may now be expected to contain less than 10 ppm of proinsulin-like immunoreactivity.
已通过放射免疫分析法估算了英国三家胰岛素制造商出售的传统和高纯度牛胰岛素制剂中的胰岛素原样免疫反应性(PLI)含量。我们报告了1980年3月至1983年3月间上市的22批传统胰岛素产品和32批高纯度胰岛素的PLI含量。传统胰岛素的PLI含量估计范围为百万分之2290至48400(ppm)。相比之下,高纯度胰岛素的估计PLI含量在小于1 ppm至1160 ppm之间变化,尽管采用当前方法制备的最新批次含有的PLI小于10 ppm。我们得出结论,目前在英国销售的高纯度牛胰岛素可能预期含有小于10 ppm的胰岛素原样免疫反应性。