Department of Pharmacy, Hôpital du Sacré-Coeur de Montréal, Quebec, Canada.
Am J Health Syst Pharm. 2011 Sep 15;68(18):1723-8. doi: 10.2146/ajhp100599.
The 24-hour stability of a levothyroxine solution admixed and stored in three common infusion containers and infused through polyvinyl chloride (PVC) tubing was evaluated.
Levothyroxine sodium 1-μg/mL injection prepared in glass bottles and PVC and polyolefin bags were assayed using high-performance liquid chromatography at 0, 1, 3, 6, 12, and 24 hours; samples drawn directly from the containers, as well as from the distal end of attached PVC tubing, were assayed. The area under the time-versus-concentration curve (AUC) for predicted and delivered doses was calculated; analysis of variance was used for comparison of the percentages of predicted and actual AUC values.
The levothyroxine concentration was stable in glass bottles and polyolefin bags through 24 hours (mean ± S.D. percentage of initial concentration remaining, 103.5% ± 2.5% and 100.0% ± 2.9%, respectively). In the PVC infusion bags, the amount of drug decreased to 90% of the initial concentration within 1 hour and then rose and remained within acceptability limits. The levothyroxine concentration of the samples infused through PVC line from glass and polyolefin containers decreased after 1 hour by about 13%; the loss of the drug from the samples infused from PVC bags was higher (18%), presumably due to additive adsorptive effects. In all samples tested, the drug concentration rebounded and remained above 90% to the end of the study.
Levothyroxine sodium 1-μg/mL solution was stable for 24 hours in glass bottles and polyolefin bags but when stored in PVC bags, the concentration decreased by 10% after 1 hour.
评估三种常用输液容器中混合并储存的左甲状腺素溶液在 24 小时内的稳定性，并通过聚氯乙烯（PVC）管进行输注。
使用高效液相色谱法，在 0、1、3、6、12 和 24 小时时，对玻璃瓶和 PVC 及聚烯烃袋中制备的 1μg/mL 左甲状腺素钠注射液进行检测；直接从容器中以及从附接的 PVC 管的远端抽取样品进行检测。计算预测和输送剂量的时间-浓度曲线下面积（AUC）；方差分析用于比较预测和实际 AUC 值的百分比。
左甲状腺素浓度在玻璃瓶和聚烯烃袋中 24 小时内保持稳定（初始浓度剩余的平均值±标准差百分比分别为 103.5%±2.5%和 100.0%±2.9%）。在 PVC 输液袋中，药物量在 1 小时内降至初始浓度的 90%，然后上升并保持在可接受范围内。从玻璃和聚烯烃容器中通过 PVC 管输注的样品中的左甲状腺素浓度在 1 小时后下降了约 13%；从 PVC 袋中输注的样品中药物的损失更高（18%），推测是由于添加剂吸附作用。在所有测试的样品中，药物浓度反弹并在研究结束时保持在 90%以上。
1μg/mL 左甲状腺素钠溶液在玻璃瓶和聚烯烃袋中稳定 24 小时，但储存在 PVC 袋中时，1 小时后浓度下降 10%。
