注射用乌司他丁与2种常用溶剂在输液泵中的配伍稳定性考察

摘要

目的:考察注射用乌司他丁与2种常用溶剂在输液泵中的配伍稳定性.方法:将注射用乌司他丁500 000单位分别与0.9％氯化钠注射液和5％葡萄糖注射液各50 mL配伍后,分别在25℃和37℃下于0、1、2、4、8、12、24h时观察配伍液的外观变化,测定其pH值和不溶性微粒数,采用高效液相凝胶过滤色谱法测定配伍液中乌司他丁的相对百分含量.结果:在上述条件下,配伍液在24h内外观和pH值均无明显变化;≥10μm的微粒数＜25粒/mL,≥25 μm的微粒数＜3粒/mL,均符合药典标准;乌司他丁在24h内各时间点的相对百分含量为99.45％～i02.55％.结论:注射用乌司他丁与0.9％氯化钠注射液、5％葡萄糖注射液配伍后,在25 ℃和37℃条件下,24 h内保持稳定,可在输液泵中持续给药.%OBJECTIVE:To investigate the compatibility stability of Ulinastatin for injection with 2 commonly used solvents in the infusion pump.METHODS:After Ulinastatin for injection 500 000 U was respectively added into 0.9％ Sodium chloride injection and 5％ Glucose injection 50 mL,the appearance of the mixture at 25 ℃,37 ℃ were observed at 0,1,2,4,8,12,24 h,re spctively,pH value and the number of insoluble particles were measured.The relative percentage of ulinastatin in the mixture was determined by HPGFC.RESULTS:Under this condition,the appearance and pH value of the mixture had no significant change within 24 h;the number of particles ≥10 μm was lower than 25 particle/mL,and that ≥25 μm was lower than 3 particle/mL,which was in line with the pharmacopeia standard.The relative percentage of ulinastatin within 24 h ranged 99.45％-102.55％.CONCLUSIONS:After mixed with 0.9％ Sodium chloride injection and 5％ Glucose injection,Ulinastatin for injection keep stable within 24 h at 25 ℃,37 ℃ and can be used for continuous administration in the infusion pump.