Mori K F, Wood R J
J Biol Stand. 1984 Oct;12(4):427-34. doi: 10.1016/s0092-1157(84)80066-9.
A sensitive and practical radioreceptor assay method for pharmaceutical insulin products has been developed with partially purified rat liver plasma membranes and the optimal conditions under which the best overall assay performance is obtainable have been defined. Intra- and inter-assay variations of the method averaged 7.3 and 12.2% of the man, respectively, when expressed as the coefficient of variation. Potency estimates of an insulin product obtained with the proposed method correlated well with those determined by the mouse convulsion bioassay method. Liver membranes prepared according to the method could be stored for up to ten weeks at 4 degrees C and for 6 months or more at - 18 degrees C without losing insulin-binding ability.
利用部分纯化的大鼠肝细胞膜，已开发出一种灵敏且实用的用于检测药用胰岛素产品的放射受体分析方法，并确定了能获得最佳总体分析性能的最佳条件。以变异系数表示时，该方法的批内和批间变异平均分别为人均值的7.3%和12.2%。用所提出的方法获得的胰岛素产品效价估计值与通过小鼠惊厥生物测定法确定的值相关性良好。按照该方法制备的肝细胞膜在4℃下可保存长达十周，在-18℃下可保存6个月或更长时间而不会丧失胰岛素结合能力。
