盐酸阿扎司琼注射液与输液配伍的稳定性研究

目的考察盐酸阿扎司琼注射液在不同条件下与输液配伍的稳定性,为临床合理给药方法提供理论依据。方法盐酸阿扎司琼注射液与0.9%氯化钠注射液、5%葡萄糖注射液配伍,分别在室温（25℃）光照（自然光）、室温避光、水浴（35℃）避光、冷藏（4℃）避光条件下,于0,0.5,1.0,2.0,4.0,8.0,24.0 h时考察配伍液外观、pH及含量变化。结果盐酸阿扎司琼注射液与0.9%氯化钠注射液、5%葡萄糖注射液配伍,避光条件下较稳定;室温光照下,配伍液的外观、pH、含量均有变化,在0.9%氯化钠注射液、5%葡萄糖注射液中4h内含量分别下降为30.5%和34.0%,pH分别由4.93和4.40降至4.11和3.95,颜色由无色变成粉红色。结论盐酸阿扎司琼注射液与两种输液可以配伍使用,单从稳定性角度考虑,可以采用静脉滴注方式给药,但必须严格避光。

Study on Stability of Azasetron Hydrochloride Injection with Infusion Solutions under Different Conditions

Objective To investigate the stability of Azasetron Hydrochloride Injection after mixing with different conditions to provide the theoretical evidence for the administrating method of rational drug use.Methods Azasetron hydrochloride was mixed with 0.9%sodium chloride and 5%glucose,respectively.The concentration,pH values and external appearance were monitored at the following time points 0,0.5,1.0,2.0,4.0,8.0,24.0 h,under conditions of room temperature（25 ℃,light exposure or not）,thermostatic bath（35 ℃,protection from light） or refrigerating（4 ℃,protection from light） respectively.Results The contents,pH value and external appearance of the 2 mixtures were changed significantly under the condition of room temperature and light exposure.The concentration of azasetron was reduced by 30.5%in normal saline and by 34.0%in glucose injection after mixture for 4 h,respectively;pH value was decreased from 4.93 and 4.40 to 4.11 and 3.95,respectively;and the color was changed from colorless to pink.Conclusion Azasetron Hydrochloride Injection can be mixed with those two conditions,and administrated by intravenous drip only from the stability angle consideration,which should be strictly protected from light.