注射用凯西莱在不同输液中稳定性研究

Research on Stability of Tiopronin for Injection in Different Solvents,Temperatures and Time

目的考察注射用凯西莱在不同输液、温度和时间条件下的稳定性及其影响因素,供临床用药参考。方法将注射用凯西莱按说明书的使用方法分别溶解在5%葡萄糖注射液、10%葡萄糖注射液及氯化钠注射液中,按设计要求在不同的温度条件下放置,在各检测时间点观察其外观、不溶性微粒、pH的变化情况,并通过高效液相色谱(HPLC)法测定配伍液中凯西莱的含量。结果在不同温度条件下,各检测时间点的配伍液其外观及不溶性微粒数均无明显变化,pH均逐渐增大,主药含量则显著下降。结论注射用凯西莱与不同注射液配伍后放置时间越长,温度越高,稳定性越差。

Objective To investigate the stability and influencing factors of Tiopronin for Injection in different solvents, temperatures and time to provide reference for clinic. Methods Tiopronin for Injection was dissolved in 5%, 10% glucose injection and 10% sodium chloride injection according to the application method in the instructions and placed under different temperatures according to the design requirement. The changes of appearance, insoluble particles and pH value at different time points were observed and the tiopronin content was determined by the HPLC method. Results The appearance and insoluble particles of the compatible solution had no obvious change, the pH value was gradually increased and the content of tiopronin was significantly reduced in different temperatures and time. Conclusion The longer the placing time of the compatible solution of Tiopronin for Injection with different injections and the higher the temperature, the poor the stability of the compatible solution.