注射用亚胺培南西司他丁钠不同输液配比溶液稳定性评价

Evaluation of the Stability of Imipenem/Cilastatin Sodium for Injection in Different Infusion Proportions

目的考察注射用亚胺培南西司他丁钠与3种常用输液的配伍稳定性。方法采用高效液相色谱法(HPLC)测定注射用亚胺培南西司他丁钠与3种输液配伍,不同浓度药物溶液在不同条件下放置24h内的含量变化,同时考察溶液的外观和p H值变化。结果注射用亚胺培南西司他丁钠与3种输液不同比例配伍后,4h内药物溶液稳定性良好;8h亚胺培南含量明显下降,溶液颜色变黄;与含有葡萄糖的输液配伍后,亚胺培南含量下降速度明显快于0.9%氯化钠注射液。0.9%氯化钠注射液的输液对注射用亚胺培南西司他丁钠粉末具有更好的溶解度,而5%葡萄糖注射液的溶解性能相对较弱。结论注射用亚胺培南西司他丁钠与常用输液配伍的稳定性不一,临床上尽量少与p H值较低(p H5.0以下)或含葡萄糖输液配伍使用,且应现配现用。

Objective To study the compatible stability of imipenem/cilastatin for injection with 3 common infusions. Methods The contents of imipenem/cilastatin in 3 infusions were determined by HPLC. The content changes of the drug solutions of different concentrations were observed in different conditions during 24 h, and the changes of the appearance and pH value of the solutions were also investigated. Results After the imipenem cilastatin sodium for injection was compatible with the 3 infusions in different proportions, the drug solution was stable within 4 hours;the content of imipenem decreases significantly after 8 hours, and the color of the solution turns yellow;after compatibility with the infusion containing glucose, the content of imipenem decreased significantly faster than 0.9% sodium chloride solution. The 0.9% sodium chloride infusion had better solubility for imipenem cilastatin sodium powder for injection, while the solubility of 5% glucose injection was relatively weak. Conclusion Clinically, Imipenem/cilastatin for injection is not compatible with commonly used infusion, and should not be used with low pH value(pH5.0) or infusion containing glucose,and should be prepared for immediate use.