Galanti Laurence, Lebitasy Massin P, Hecq Jean-Daniel, Cadrobbi Julie, Vanbeckbergen Danielle, Jamart Jacques
, MD, PhD, is with the Medical Laboratory, UCL Mont-Godinne, Yvoir, Belgium.
Can J Hosp Pharm. 2009 Jan;62(1):34-8. doi: 10.4212/cjhp.v62i1.115.
To investigate the stability of 5-fluorouracil diluted in 0.9% sodium chloride (normal saline [NS]) after freezing, microwave thawing, and storage for 28 days at 5°C ± 3°C.
Polyvinylchloride (PVC) infusion bags (n = 5) containing 5-fluorouracil 800 mg/100 mL were frozen for 79 days at -20°C. The bags were then thawed in a microwave oven and stored at 5°C ± 3°C for 28 days. The concentration of 5-fluorouracil was measured by high-performance liquid chromatography. Visual and microscopic inspections were performed and pH was measured periodically during storage. Solutions were considered stable if the lower limit of the 95% confidence interval of the concentration versus time profile remained greater than 90% of the initial concentration.
No colour change or precipitation was observed in any of the solutions. Slight changes in pH were observed during refrigeration. 5-Fluorouracil solutions were stable during storage at 5°C ± 3°C for 28 days, as indicated by the results of high-performance liquid chromatography.
5-Fluorouracil 8 mg/mL in NS may be prepared in advance, frozen and stored in PVC bags, and thawed before use. The solutions remained stable after freezing at -20°C for 79 days followed by storage at 5°C ± 3°C for up to 28 days.
研究5-氟尿嘧啶在0.9%氯化钠（生理盐水[NS]）中稀释后经冷冻、微波解冻并在5°C±3°C下储存28天的稳定性。
将含有800mg/100mL 5-氟尿嘧啶的聚氯乙烯（PVC）输液袋（n = 5）在-20°C下冷冻79天。然后将袋子在微波炉中解冻，并在5°C±3°C下储存28天。通过高效液相色谱法测定5-氟尿嘧啶的浓度。在储存期间定期进行外观和显微镜检查并测量pH值。如果浓度-时间曲线的95%置信区间下限保持大于初始浓度的90%，则认为溶液稳定。
在任何溶液中均未观察到颜色变化或沉淀。在冷藏期间观察到pH值有轻微变化。高效液相色谱法结果表明，5-氟尿嘧啶溶液在5°C±3°C下储存28天期间稳定。
可以预先配制NS中8mg/mL的5-氟尿嘧啶，冷冻并储存在PVC袋中，使用前解冻。在-20°C下冷冻79天，然后在5°C±3°C下储存长达28天后，溶液仍保持稳定。
