Fischer J H, Cwik M J, Luer M S, Sibley C B, Deyo K L
Department of Pharmacy Practice, College of Pharmacy, University of Illinois at Chicago 60612, USA.
Ann Pharmacother. 1997 May;31(5):553-9. doi: 10.1177/106002809703100505.
To determine the stability of fosphenytoin sodium admixtures with NaCl 0.9% injection and dextrose 5% (D5W) injection when stored in glass or polyvinyl chloride (PVC) containers, to evaluate the compatibility of fosphenytoin with 11 other intravenous solutions, and to determine the stability of fosphenytoin repackaged in polypropylene syringes.
Dilutions of fosphenytoin sodium 1, 8, and 20 mg phenytoin sodium equivalents (PE)/mL were prepared in NaCl 0.9%, D5W, and 11 other intravenous fluids. Aliquots of each solution in NaCL 0.9% or D5W were transferred to three glass bottles for storage at 25 degrees C and 21 PVC bags for storage at 25, 4, or -20 degrees C. Aliquots of each admixture with the other intravenous fluids were transferred to three PVC bags and stored at 25 degrees C for 7 days. In addition, 63 syringes were filled with fosphenytoin sodium 50 mg PE/mL (undiluted) and stored at 25, 4, or -20 degrees C. Samples of each solution from the three containers were analyzed for visual compatibility, pH, and fosphenytoin concentration initially and at 0.5, 1, 2, 3, 7, 14, and 30 days during storage at 25 and 4 degrees C and at 1, 7, 14, and 30 days during storage at -20 degrees C. Following removal of containers from the freezer, additional samples were obtained after 7 days at 4 or 25 degrees C, and 7 days at 25 degrees C, and then 7 days at -20 degrees C.
No visible precipitation or change in color or clarity was observed in any of the fosphenytoin solutions during the study. The concentration of fosphenytoin at each sampling time remained within 97-104% of initial concentration, regardless of container, concentration, intravenous admixture, or storage temperature.
Fosphenytoin sodium, either undiluted in polypropylene syringes or diluted with NaCl 0.9% or D5W in PVC bags, remains stable for at least 30 days at room temperature, under refrigeration, or frozen. After removal from the freezer, fosphenytoin can be thawed, kept at 4 or 25 degrees C for 7 days, and then returned to the freezer for another 7 days. Admixtures of fosphenytoin sodium in various other intravenous fluids are stable for at least 7 days at room temperature.
确定磷苯妥英钠与0.9%氯化钠注射液和5%葡萄糖（D5W）注射液混合后，储存在玻璃或聚氯乙烯（PVC）容器中的稳定性；评估磷苯妥英与其他11种静脉输液的相容性；并确定重新包装在聚丙烯注射器中的磷苯妥英的稳定性。
制备浓度为1、8和20mg苯妥英钠等效物（PE）/mL的磷苯妥英钠稀释液，分别加入0.9%氯化钠注射液、D5W注射液以及其他11种静脉输液中。将0.9%氯化钠注射液或D5W注射液中的每种溶液等分转移至三个玻璃瓶中，于25℃储存；转移至21个PVC袋中，分别于25℃、4℃或-20℃储存。将每种与其他静脉输液混合的溶液等分转移至三个PVC袋中，于25℃储存7天。此外，63支注射器中装入50mg PE/mL（未稀释）的磷苯妥英钠，分别于25℃、4℃或-20℃储存。在25℃和4℃储存期间，分别于初始时刻以及储存0.5、1、2、3、7、14和30天时，从三个容器中取出每种溶液的样品，分析其外观相容性、pH值和磷苯妥英浓度；在-20℃储存期间，分别于1、7、14和30天时进行分析。从冰箱中取出容器后，在4℃或25℃放置7天，再在25℃放置7天，然后在-20℃放置7天后，获取额外的样品。
在研究期间，任何磷苯妥英溶液均未观察到明显沉淀、颜色或澄清度变化。无论容器类型、浓度、静脉混合液或储存温度如何，每个采样时间的磷苯妥英浓度均保持在初始浓度的97%-104%范围内。
未稀释于聚丙烯注射器中的磷苯妥英钠，或在PVC袋中用0.9%氯化钠注射液或D5W稀释后的磷苯妥英钠，在室温、冷藏或冷冻条件下至少30天保持稳定。从冰箱中取出后，磷苯妥英可解冻，在4℃或25℃保存7天，然后再放回冰箱保存7天。磷苯妥英钠与各种其他静脉输液的混合液在室温下至少7天保持稳定。
