Dunbar J C, Simon F A
Pancreas. 1986;1(4):317-9. doi: 10.1097/00006676-198607000-00004.
Insulin potency during storage in plastic disposable syringes for short periods of time is a concern of diabetics as well as syringe manufacturers. Previous studies have indicated that leaching of organic materials from rubber gaskets may have cytotoxic effects. The purpose of this study was to evaluate the immunologic and radioreceptor degradation of insulin storage in commercial plastic syringes. Insulin syringes were filled with insulin and stored at 4 degrees C for 2 weeks. Immunologic potency was assessed by radioimmunoassay while biologic potency was evaluated by binding to hepatic insulin receptors. Recoverable insulin was measured on days 1, 3, 7, and 14 and compared with highly purified porcine insulin. Insulin content of samples stored in all three plastic syringes showed no statistically significant (p less than 0.05) loss of immunologic or biologic potency for 2 weeks compared with stock controls. Lente insulin gave more variability in storage in the radioimmunoassay, possibly due to settling, and was less effective in displacing labeled insulin in the radioreceptor assay. We conclude that premeasured insulin may safely be stored in plastic disposable syringes under selected conditions, especially in blind and handicapped diabetic patients, for 2 weeks.
胰岛素在一次性塑料注射器中短期储存期间的效价是糖尿病患者以及注射器制造商所关注的问题。先前的研究表明,橡胶垫圈中有机材料的浸出可能具有细胞毒性作用。本研究的目的是评估市售塑料注射器中胰岛素储存时的免疫学和放射受体降解情况。胰岛素注射器装满胰岛素后在4℃下储存2周。通过放射免疫测定评估免疫学效价,同时通过与肝胰岛素受体结合评估生物学效价。在第1、3、7和14天测量可回收的胰岛素,并与高度纯化的猪胰岛素进行比较。与库存对照相比,储存在所有三种塑料注射器中的样品胰岛素含量在2周内免疫学或生物学效价均未显示出统计学上的显著损失(p<0.05)。在放射免疫测定中,低精蛋白锌胰岛素储存时变异性更大,可能是由于沉淀所致,并且在放射受体测定中置换标记胰岛素的效果较差。我们得出结论,在选定条件下,预测量的胰岛素可安全地储存在一次性塑料注射器中2周,尤其是对于视力障碍和残疾糖尿病患者。