艾迪注射液在0.9%氯化钠注射液中的稳定性研究

目的 考察艾迪注射液在0.9%氯化钠注射液中的稳定性.方法 观察高温、常温、低温3种环境下艾迪注射液在0.9%氯化钠注射液中的外观、pH、微粒及紫外吸收变化.结果 艾迪注射液在0.9%氯化钠注射液中外观、pH、紫外吸收变化不明显,10μm以上微粒数略高于药典规定.结论 艾迪注射液在0.9%氯化钠注射液中总体稳定性良好,高温时相对稳定,建议使用配备精密过滤装置的输液器,相对高温进行配液、输液,以减少微粒产生的不良反应.

A Study of Stability of Aidi Injection in 0.9%Sodium Chloride Injection

Objective To study the stability of Aidi Injection in 0.9%sodium chloride injection.Methods To observe the number of particles,pH value and UV absorbance changes of Aidi Injection in 0.9%sodium chloride injection at high,normal and low temperatures at different times.Results No apparent changes were shown in the outward appearance,pH value,the value of UV absorbance changes of Aidi Injection in 0.9%sodium chloride injection,the number of ≥10 μm particles was a little more than the requirement formulated by the pharmacopoeia.Conclusion Aidi Injection in 0.9%sodium chloride injection is stable,especially relatively stable at high temperature.It is suggested that the infusion apparatus equipped precision filter should be used and dispensing solution and transfusion should be performed at relative high temperature in order to reduce the microparticle-causing adverse reactions and their injury to patients.