氟罗沙星注射液光稳定性研究

目的: 研究不同规格氟罗沙星注射液的光稳定性。 方法: 用差示光照扫描量热法和液相色谱法测定不同规格的氟罗沙星注射液,分析氟罗沙星注射液的光稳定性及影响因素。 结果: 注射液的浓度是影响该品种光稳定性的主要原因。高、低浓度的注射液发生的光解反应不同,光解产物也不相同。 结论: 小针剂比大输液对光的稳定性更好,因此该品种更适合制成小针剂,而大输液在贮藏和使用过程中更应注意避光。

Objective: To study the photostability of fleroxacin injections with different specification. Methods: Different fleroxacin injections were determined with DPC (differential photocalorimeter) and high-performance liquid chromatography(HPLC).Photostability of fleroxacin injections and influential factors were analyzed. Results: Concentration level was the main reason that affects photostability of fleroxacin injection.Different degradation types were found in different concentration level of fleroxacin,and degradation products were different too. Conclusion: Fleroxacin injections with high concentration level were more stable than those with low concentration and prevention of light should be concerned during storage and application.