注射用雷替曲塞在输液中的稳定性考察

Evaluation on stability of raltitrexed for injection in infusions

目的:考察注射用雷替曲塞用0.9%氯化钠注射液或5%葡萄糖注射液溶解稀释后输液的稳定性。方法:模拟临床实际情况,分别考察雷替曲塞输液在不同温度下(4℃冰箱内、25℃室内不避光和37℃室内不避光)24 h内的外观、不溶性微粒、pH值和含量的变化。结果:雷替曲塞输液在不同温度下24 h内的外观和pH值均无明显改变,不溶性微粒符合药典相关规定,雷替曲塞相对初始含量的变化范围在93.9%~100.7%之间。结论:在临床常见情况下,雷替曲塞输液在24 h内的稳定性良好,不必现配现用。

OBJECTIVE To investigate the stability of raltitrexed for injection in infusions after dissolved and diluted with0.9% sodium chloride or 5% glucose injection.METHODS Under simulated clinical practical conditions,the appearance,particulate matter pH values and contents of raltitrexed infusion were evaluated within24 h under different temperatures（4 ℃in a refrigerator,25℃ under indoor light and 37℃ under indoor light）.RESULTS There were no significount changes in the appearance and pH value of the infusion within 24 under different temperatures.The particulate matter met the relevant reguirements of the pharmacopoeia.The relative initial contents of raltitrexed varied between 93.9% and 100.7%.CONCLUSION Raltitrexed for injection in infusions is stable under clinical common conditions within 24 h.