William S. Middleton Memorial Veterans Hospital, Madison, WI, USA.
Am J Health Syst Pharm. 2010 Jun 15;67(12):1026-9. doi: 10.2146/ajhp090301.
The stability of sodium bicarbonate solutions in sterile water for injection or 5% dextrose injection stored at 21-24 degrees C or 2-4 degrees C was evaluated.
Sodium bicarbonate injection was obtained in 50-mL vials of 8.4% (1 meq/mL). A total of 50, 100, or 150 meq of sodium bicarbonate was added to each 1-L polyolefin bag of either sterile water for injection or 5% dextrose injection. All solutions were prepared in a laminar-airflow hood using aseptic technique. Bags were punctured once to remove headspace air and once for the addition of each 50 meq of sodium bicarbonate. Six replicates of each test solution were prepared. The solutions were stored at 21-24 degrees C and 2-4 degrees C. Control solutions (50 and 150 meq) were similarly prepared in triplicate. Control solutions were sparged with either nitrogen gas or oxygen gas before storage. Sodium bicarbonate stability was assessed by measuring solution pH. Bicarbonate content was measured utilizing titration. Both pH and bicarbonate concentrations were measured immediately upon preparation and on days 3, 5, and 7 for both test and control solutions.
All 95% confidence interval values for sample solution pH remained within 7.0-8.5 for seven days at 2-4 degrees C.
Sodium bicarbonate solutions of 50, 100, and 150 meq in sterile water for injection or 5% dextrose injection were stable for up to seven days when refrigerated. The 50-meq solution was stable for up to 48 hours when stored at room temperature, and the 100- and 150-meq solutions were stable for up to 30 hours when stored at room temperature.
评估在 21-24°C 或 2-4°C 下，注射用无菌水或 5%葡萄糖注射液中储存的碳酸氢钠溶液的稳定性。
获得 50-mL 小瓶的 8.4%（1 meq/mL）碳酸氢钠注射液。将总共 50、100 或 150 meq 的碳酸氢钠加入到每个 1-L 聚烯烃袋的注射用无菌水或 5%葡萄糖注射液中。所有溶液均在层流空气罩中使用无菌技术制备。通过穿刺袋子一次以去除顶空空气，然后再穿刺一次以加入每 50 meq 的碳酸氢钠。每种测试溶液制备 6 个重复。将溶液储存在 21-24°C 和 2-4°C。类似地制备 50 和 150 meq 的对照溶液一式三份。在储存前，对照溶液用氮气或氧气进行吹扫。通过测量溶液 pH 来评估碳酸氢钠的稳定性。使用滴定法测量碳酸氢盐含量。在制备后立即以及在第 3、5 和 7 天，对测试和对照溶液的 pH 和碳酸氢盐浓度进行测量。
在 2-4°C 下，所有样品溶液 pH 的 95%置信区间值在七天内均保持在 7.0-8.5 之间。
当冷藏时，注射用无菌水或 5%葡萄糖注射液中的 50、100 和 150 meq 的碳酸氢钠溶液在长达七天内稳定。在室温下储存时，50-meq 溶液在长达 48 小时内稳定，而 100-和 150-meq 溶液在室温下储存时稳定长达 30 小时。
