依托泊苷输液在不同储存条件下的稳定性考察

Study on the Stability of Etoposide Infusion Under Different Storage Conditions

目的考察依托泊苷输液在不同储存条件下的稳定性,为临床合理用药提供依据。方法分别设置依托泊苷输液的配伍浓度为0.04、0.1、0.2、0.25、0.4 mg·mL^(-1),在室温遮光、室温不遮光和2~8℃冷藏条件下,于各时间点分别观察外观、使用pH计和高效液相色谱(HPLC)法测定pH值和含量。结果当配伍浓度≤0.25 mg·mL^(-1)时,依托泊苷输液在3种储存条件下24 h内外观、pH值和含量均未发生明显变化。当配伍浓度为0.40 mg·mL^(-1)时,依托泊苷输液在在室温遮光、室温不遮光和2~8℃冷藏条件下均会产生沉淀,且24 h时含量分别下降至67.07%、61.00%和38.29%。结论当配伍浓度≤0.25 mg·mL^(-1)时,依托泊苷输液在室温遮光、室温不遮光和2~8℃冷藏条件下24 h内稳定;当依托泊苷输液的配伍浓度为0.40 mg·mL^(-1)时,依托泊苷输液在3种储存条件下的稳定性不佳,因此非必要不建议最终浓度超过0.25 mg·mL^(-1)。

Objective To investigate the stability of etoposide infusion under different storage conditions,and to provide a basis for clinical rational drug use.Methods The compatible concentrations of etoposide infusion were set as 0.04,0.1,0.2,0.25,and 0.4 mg·mL^(-1),respectively.Under the conditions of room temperature without light,room temperature with light,and 2-8℃,the appearance of etoposide infusion was observed at each time point,and the pH value and content were determined by pH meter and high-performance liquid chromatography(HPLC),respectively.Results When the compatible concentration was not more than 0.25 mg·mL^(-1),etoposide infusion's appearance,pH value and content had no significant changes in 24 h under three storage conditions.When the compatible concentration of etoposide infusion was 0.4 mg·mL^(-1),precipitation all occurred,and the content decreased to 67.07%,61.00%,and 38.29%at 24 h under the conditions of room temperature without light,room temperature with light,and 2-8℃,respectively.Conclusion When the compatible concentration does not exceed 0.25 mg·mL^(-1),etoposide infusion can stabilize in 24 h under the conditions of room temperature without light,room temperature with light,and 2-8℃.When the compatible concentration is 0.4 mg·mL^(-1),considering the poor stability of the etoposide infusion under three storage conditions,the compatibility concentration of etoposide infusion exceeds 0.25 mg·mL^(-1) is not recommended unnecessarily.