Bornstein M, Kao S H, Mercorelli M, Verma S
Pharmaceutical Development, R. W. Johnson Pharmaceutical Research Institute, Raritan, NJ 08869.
Am J Hosp Pharm. 1992 Nov;49(11):2756-60.
The stability of ofloxacin was evaluated in 10 different infusion fluids under various storage conditions. Solutions of ofloxacin (0.4 mg/mL and 4.0 mg/mL) were prepared in (1) 0.9% sodium chloride injection; (2) 5% dextrose injection; (3) 5% dextrose and 0.9% sodium chloride injection; (4) 5% dextrose and lactated Ringer's injection; (5) 5% sodium bicarbonate injection; (6) Plasma-Lyte 56 and 5% dextrose injection; (7) 5% dextrose, 0.45% sodium chloride, and 0.15% potassium chloride injection; (8) 1/6 M sodium lactate injection; (9) water for injection; and (10) 20% mannitol injection. Each solution was injected into polyvinyl chloride bags and stored at (1) 24 degrees C for 3 days, (2) 5 degrees C for 7 days, (3) 5 degrees C for 14 days, (4) -20 degrees C for 13 weeks and then 5 degrees C for 14 days, or (5) -20 degrees C for 26 weeks and then 5 degrees C, for 14 days. Samples were assayed initially and after storage by high-performance liquid chromatography and examined for visual clarity, pH, turbidity, and particulates. Ofloxacin was stable in all solutions and under all storage conditions. All of the solutions were clear, pH was stable, and particulate-matter counts were acceptable under all storage conditions (except for the 20% mannitol solution, which formed crystals at 5 degrees C and -20 degrees C). An injectable formulation of ofloxacin was stable for at least 3 days at 24 degrees C, 14 days at 5 degrees C, and 26 weeks at -20 degrees C in all tested infusion fluids. Crystals formed in refrigerated or frozen solutions prepared with 20% mannitol injection.
在不同储存条件下，对10种不同输液中的氧氟沙星稳定性进行了评估。将氧氟沙星溶液（0.4mg/mL和4.0mg/mL）分别配制于：（1）0.9%氯化钠注射液；（2）5%葡萄糖注射液；（3）5%葡萄糖和0.9%氯化钠注射液；（4）5%葡萄糖和乳酸林格氏注射液；（5）5%碳酸氢钠注射液；（6）平衡液56和5%葡萄糖注射液；（7）5%葡萄糖、0.45%氯化钠和0.15%氯化钾注射液；（8）1/6M乳酸钠注射液；（9）注射用水；（10）20%甘露醇注射液。每种溶液注入聚氯乙烯袋中，并分别在以下条件下储存：（1）24℃保存3天；（2）5℃保存7天；（3）5℃保存14天；（4）-20℃保存13周，然后5℃保存14天；或（5）-20℃保存26周，然后5℃保存14天。储存前后的样品通过高效液相色谱法进行分析，并检查其外观澄明度、pH值、浊度和微粒。在所有溶液和所有储存条件下，氧氟沙星均稳定。所有溶液均澄清，pH值稳定，在所有储存条件下微粒计数均合格（20%甘露醇溶液除外——该溶液在5℃和-20℃时形成晶体）。在所有测试的输液中，氧氟沙星注射剂在24℃至少稳定3天，5℃至少稳定14天，-20℃至少稳定26周。用20%甘露醇注射液配制的冷藏或冷冻溶液中会形成晶体。
