Lebitasy M, Hecq J-D, Athanassopoulos A, Vanbeckbergen D, Jamart J, Galanti L
Medical Laboratory, Cliniques UCL Mont-Godinne, Yvoir, Belgium.
J Clin Pharm Ther. 2009 Aug;34(4):423-8. doi: 10.1111/j.1365-2710.2009.01043.x.
Calcium levofolinate infusions could be prepared in advance by a centralized intravenous additive service (CIVAS) to improve safety and time management.
To investigate the effect of freezing, microwave thawing and long-term storage at 5 +/- 3 degrees C on the stability of calcium levofolinate in 5% dextrose solution.
Solutions of 250 mL of 5% dextrose in polyolefin bags (n = 5) containing approximately 400 mg of calcium levofolinate were prepared under aseptic conditions and frozen for 95 days at -20 degrees C. The solutions were then thawed using microwaves and stored at 5 +/- 3 degrees C for 1 month. The calcium levofolinate concentrations were measured by high performance liquid chromatography (HPLC). Visual inspection was performed and pH was measured periodically during the storage at 5 +/- 3 degrees C. Stability of the solution was defined as a concentration remaining superior to 90% of the initial concentration by regression analysis as recommended by the Food and Drug Administration (FDA).
No colour change or precipitation in the solutions was observed. Calcium levofolinate infusions were stable when stored at 5 +/- 3 degrees C during 1 month after freeze-thaw treatment. Throughout this period, the lower confidence limit of the estimated regression line of concentration-time profile remained above 90% of the initial concentration. Slight change in pH values from 6.52 +/- 0.01 to 6.50 +/- 0.01 during storage time did not affect retention time on HPLC and has no clinical consequence, the solutions remaining in the acceptable range for perfusion (4 <or= pH <or= 10).
Under the conditions of this study, calcium levofolinate in 5% dextrose infusion may be prepared, frozen in advance by CIVAS, and then microwave thawed before use. Such treatment extends long-term stability and releases pharmacist's time for major activities such as checking medication order errors.
亚叶酸钙输注液可由集中式静脉药物配置中心（CIVAS）提前配制，以提高安全性和时间管理效率。
研究冷冻、微波解冻以及在5±3℃长期储存对5%葡萄糖溶液中亚叶酸钙稳定性的影响。
在无菌条件下，制备250 mL装于聚烯烃袋中的含约400 mg亚叶酸钙的5%葡萄糖溶液（n = 5），并在-20℃冷冻95天。然后用微波解冻这些溶液，并在5±3℃储存1个月。通过高效液相色谱法（HPLC）测定亚叶酸钙浓度。在5±3℃储存期间定期进行外观检查并测量pH值。按照美国食品药品监督管理局（FDA）的建议，通过回归分析将溶液稳定性定义为浓度保持高于初始浓度的90%。
溶液未观察到颜色变化或沉淀。冻融处理后，亚叶酸钙输注液在5±3℃储存1个月期间保持稳定。在此期间，浓度 - 时间曲线估计回归线的置信下限始终高于初始浓度的90%。储存期间pH值从6.52±0.01轻微变化至6.50±0.01，这并未影响HPLC的保留时间，也无临床意义，溶液pH值仍在可接受的灌注范围内（4≤pH≤10）。
在本研究条件下，5%葡萄糖输注液中的亚叶酸钙可由CIVAS提前配制、冷冻，然后在使用前进行微波解冻。这种处理方式可延长长期稳定性，并使药剂师有时间进行主要工作，如检查医嘱错误。
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