Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON M5S 3M2, Canada.
Department of Pharmacy, Sunnybrook Health Sciences Centre, Toronto, ON M4N 3M5, Canada.
Nutrients. 2019 Aug 23;11(9):1994. doi: 10.3390/nu11091994.
Emerging data suggest that intravenous ascorbic acid (AA) may be beneficial in patients with sepsis. Clinicians require data on stability of diluted AA for safe administration. We evaluated the stability of AA diluted in normal saline (NS) or 5% dextrose in water (D5W) solutions over 14 days at 25 °C and at 4 °C, protected from light, using concentrations of 37 mg/mL and 77 mg/mL (Sandoz) and 40 mg/mL and 92 mg/mL (Mylan). We also assessed stability of a 40 mg/mL solution (Mylan) at 25 °C exposed to light for 75 h. Concentrations were measured using liquid chromatographic separation with ultraviolet light detection on days 0, 0.33, 1, 1.33, 2, 3, 4, 7, 10 and 14. By day 14, solutions at 4 °C retained >97.72% of the initial concentration; at 25 °C, solutions retained >88.02% of the initial concentration, but visual changes were evident after day 2. Multiple linear regression demonstrated that study day and temperature ( < 0.001) but not solution type ( = 0.519), concentration ( = 0.677) or manufacturer ( = 0.808) were associated with the percentage remaining. At 75 h, degradation rates were similar in solutions protected from vs. exposed to light. In conclusion, AA solutions are stable for at least 14 days at 4 °C, with protection from light.
新出现的数据表明,静脉内给予抗坏血酸(AA)可能对脓毒症患者有益。临床医生需要了解 AA 稀释液的稳定性数据,以确保安全给药。我们在 25°C 和 4°C 条件下,分别在生理盐水(NS)或 5%葡萄糖水中(D5W)中评估了浓度为 37 mg/mL 和 77 mg/mL(山德士)及 40 mg/mL 和 92 mg/mL(迈兰)的 AA 稀释液在避光条件下 14 天内的稳定性,同时还评估了在 25°C 下暴露于光线下 75 h 的 40 mg/mL(迈兰)溶液的稳定性。在第 0、0.33、1、1.33、2、3、4、7、10 和 14 天,使用液相色谱分离法,用紫外光检测法测量浓度。在第 14 天,4°C 下的溶液保留了初始浓度的 >97.72%;在 25°C 下,溶液保留了初始浓度的 >88.02%,但在第 2 天后可见明显的外观变化。多元线性回归显示,研究天数和温度(<0.001),而非溶液类型(=0.519)、浓度(=0.677)或制造商(=0.808)与剩余百分比有关。在 75 h 时,避光和暴露于光线下的溶液的降解速度相似。总之,AA 溶液在 4°C 下避光保存至少 14 天是稳定的。