酮咯酸氨丁三醇注射液中可见微粒的分析及控制

Control and Analysis of Visible Particles in Ketorolac Tromethamine Injection

收集酮咯酸氨丁三醇注射液中的可见微粒,采用核磁共振、液相色谱-质谱联用、紫外-可见分光光度法、傅里叶变换红外光谱、扫描电镜-能谱分析,对可见微粒进行定性分析。确定酮咯酸氨丁三醇注射液中的可见微粒为酮咯酸钙,推测其形成的原因为玻璃瓶中迁移出来的钙与注射液中的酮咯酸相结合。基于此,提出了有效的控制措施,如包材应选择钙含量低的PP安瓿,希望为酮咯酸氨丁三醇注射液的用药安全提供参考。

The visible particles in ketorolac tromethamine injection were collected.It was determined that chemical composition of the visible particles in ketorolac tromethamine injection was calcium-ketorolac by NMR,LC-MS,UV-Vis,FT-IR and scanning electron microscope-energy spectrum.And it was speculated that the reason for its formation was the combination of calcium migrated from glass bottles and ketorolac in the injection.Based on the above conclusion,effective control measures were proposed.For example,PP ampoules with low calcium content should be selected as the packaging material,which provides a reference for the medication safety of ketorolac tromethamine injection.