盐酸多巴酚丁胺注射液配伍稳定性的分析

Analysis of Compatibility Stability of Dobutamine Hydrochloride Injection

目的考察盐酸多巴酚丁胺注射液与0.9%氯化钠注射液或10%葡萄糖注射液在两种不同材质(聚氯乙烯/热塑性弹性体)的输液器下配伍后的稳定性,为临床科学用药提供合理依据。方法模拟临床上的应用方法,使用0.9%氯化钠或10%葡萄糖注射液作为配伍溶剂,将其稀释成含多巴酚丁胺浓度为0.25~5.0 mg/mL的溶液,建立盐酸多巴酚丁胺注射液有关物质测定的高效液相色谱法并进行验证,对盐酸多巴酚丁胺注射液的两种不同材质的给药器具进行配伍稳定性考察,同时对关键质量属性进行研究。结果盐酸多巴酚丁胺注射液和不同配伍溶剂及不同材质输液器配伍后35 h内稳定,可用于临床应用,且配伍稳定性结果均符合本品质量标准。结论本文开发的高效液相色谱方法适用于配伍稳定性检测,且本品与0.9%氯化钠溶液配伍更加稳定,TPE材质的输液器安全性优于PVC材质。

Objective To investigate the stability of dobutamine hydrochloride injection,0.9% sodium chloride injection or 10% glucose injection after mixing with two different materials(PVC/TPE)infusion sets,so as to provide reasonable basis for clinical scientific drug use.Methods To simulate the clinical application method,0.9% sodium chloride iniection or 10% glucose was used as the compatible solvent,which was diluted into a solution containing dobutamine with a concentration of 0.25~5.0 mg/mL,and a HPLC method for the determination of related substances in dobutamine hydrochloride injection was established and verified.The compatibility stability of two different materials of dobutamine hydrochloride injection was investigated,and the key quality attributes were also studied.Results Dobutamine hydrochloride injection was stable within 35 hours after being mixed with different compatible solvents and infusion sets made of different materials,and it could be used for clinical application,and the results of compatibility stability met the quality standards of this product.Conclusion The HPLC method developed in this paper is suitable for testing the compatibility stability,and the compatibility of this product with 0.9% sodium chloride solution is more stable,and the safety of infusion set made of TPE is better than that of PVC.