Wegmans School of Pharmacy, St. John Fisher College, 3690 East Ave., Rochester, NY 14618, USA.
J Am Pharm Assoc (2003). 2013 May-Jun;53(3):304-6. doi: 10.1331/JAPhA.2013.12164.
To evaluate the stability of U-500 regular insulin in prefilled syringes stored under refrigeration for up to 28 days.
U-500 regular insulin was drawn up in 1 mL insulin syringes in a clean, nonsterile environment to emulate conditions of a patient's home. Samples were assayed using a stability-indicating reverse-phase high-performance liquid chromatography method immediately after preparation (day 0) and after 7, 14, 21, and 28 days under refrigeration. Before evaluation, all samples were diluted to a concentration of 40 units/mL in the starting mobile phase. Stability was determined by evaluating the percentage of the initial concentration remaining at each time point.
At least 93.3% of the initial U-500 insulin concentration remained throughout the 28-day study period, with no statistically significant changes in the amount remaining. The percent of initial concentration remained above 97% for the first 21 days of the study.
A prefilled syringe with U-500 regular insulin is stable for at least 28 days when stored under refrigeration. These data are similar to those reported for U-100 regular insulin, indicating that prefilling syringes with U-500 insulin is a safe and effective practice for patients who are unable to accurately draw up their own point-of-care doses.
评估冷藏条件下预装 U-500 常规胰岛素在 28 天内的稳定性。
在清洁、非无菌的环境中，将 U-500 常规胰岛素吸入 1 毫升胰岛素注射器中，模拟患者家庭的条件。使用稳定性指示反相高效液相色谱法，在制备后立即（第 0 天）以及冷藏 7、14、21 和 28 天后，对样品进行检测。在评估之前，所有样品均在起始流动相中稀释至 40 单位/毫升的浓度。通过评估每个时间点初始浓度的剩余百分比来确定稳定性。
在整个 28 天的研究期间，至少有 93.3%的初始 U-500 胰岛素浓度保持不变，剩余量没有统计学意义上的变化。在研究的前 21 天，初始浓度的保留率超过 97%。
冷藏条件下，预装 U-500 常规胰岛素的注射器至少稳定 28 天。这些数据与 U-100 常规胰岛素的报告相似，表明为无法准确抽取自身即时剂量的患者预填充 U-500 胰岛素注射器是一种安全有效的做法。
