替加氟注射液配伍0.9%氯化钠注射液的稳定性研究

Stability of Tegafur Injection combined with 0.9% Sodium Chloride Injection

目的考察替加氟注射液在0.9%氯化钠溶液中配伍的稳定性。方法观察室温、避光、冷藏,24 h内替加氟注射液0.9%氯化钠溶液的外观、pH值变化,观察配伍液中不溶性微粒的变化,并采用高效液相色谱法考察配伍液中替加氟的变化。结果配伍液在24 h内无浑浊、沉淀、气体产生,颜色、pH值、不溶性微粒数无明显变化;24 h内替加氟注射液在0.9%氯化钠注射液中无明显变化。结论在实验条件下,24 h内替加氟注射液在0.9%氯化钠注射液中稳定。

Objectives To observe the stablility of Tegafur Injection combined with 0.9% Sodium Chloride Injection. Methods The changes in appearance, insoluble particle, and pH value of the mixture of Tegafur Injection combined with 0.9% Sodium Chloride Injection within 24 h under the conditions of room temperature, protection from light, and refrigeration were observed. The concentration oftegafur was determined by HPLC. Results There was no turbidity, sedimentation, and gas production, and the color, pH value, and insoluble particles had no obvious change. Also the content of tegafur had no obvious change within 24 h. Conclusion Tegafur Injection in 0.9% Sodium Chloride Injection is stable within 24 h.