注射用丙帕他莫单药及与β-内酰胺类药、质子泵抑制剂的配伍稳定性考察

Stability of Propacetamol for Injection Single-Agent and Compatible with β-lactam Drugs or Proton Pump Inhibitors

目的:考察注射用丙帕他莫与β-内酰胺类药、质子泵抑制剂(PPI)的配伍稳定性。方法:采用高效液相色谱(HPLC)法测定丙帕他莫48 h内的含量变化,考察其p H值变化,并观察与β-内酰胺类药及PPI配伍后各溶液的外观变化。结果:丙帕他莫的水溶液不稳定,药物含量在7 h内可降解至90%以下,p H值在3 h内从5.37降至3.52,48 h后p H值降至1.87。丙帕他莫与β-内酰胺类药配伍3 h时肉眼可观察到液体乳光,配伍12 h时可观察到白色沉淀;与PPI配伍立即发生颜色的变化并逐渐形成深色沉淀。结论:丙帕他莫的水溶液稳定性差,与β-内酰胺类药物及PPI存在配伍禁忌。丙帕他莫临床上应现配现用,尽量在配伍1 h内用完且不与其他药物进行配伍,输液前后应冲管。

OBJECTIVE： To investigate the compatible stability of Propacetamol for injection with β-lactam drugs or proton pump inhibitors （PPI）. METHODS： The contents of propacetamol were detected by HPLC within 48 h. The appearance of the solu- tions that propacetamol compatible with β-lactam drugs or PPIs was observed. RESULTS： Propacetamol solution was not stable, and the content of propacetamol was less than 90% within 7 h. The pH of propacetamol solution decreased from 5.37 to 3.52 within 3 h, and to 1.87 after 48 h. The opalescent solution could be observed 3 h after propacetamol compatible with β-lactam drugs, and white precipitation was found 8 h later. The color of propacetamol changed immediately after being compatible with PPI, and gradu- ally formed dark precipitation. CONCLUSIONS： Propacetamol solution is unstable. There is incompatibility for Propacetamol injec- tion with β-lactam drugs or PPI. Propaeetamol should be used immediately after configured and used up in one hour, moreover, can not compatible with other drug. The infusion tube should be washed before and after using propacetamol.