氟罗沙星注射液的稳定性研究

Study on the Stability of Fleroxacin Injection

目的 :考察氟罗沙星注射液的稳定性。方法 :采用高效液相色谱法测定氟罗沙星注射液中氟罗沙星及其降解产物的含量 ,并考察光照、加热、pH值及卤族元素离子对其稳定性的影响。结果 :氟罗沙星平均回收率为100.4 % (RSD=0. 87 % ) ;若pH值偏低、光照或加热时间较长 ,氟罗沙星注射液色泽则明显加深 ,降解产物含量增加 ;遇卤族元素离子则析出沉淀。结论 :氟罗沙星注射液对光、热不稳定 ,容易分解 ,对光尤为明显 ;pH值越低 ,越易降解 ;不宜与含卤族元素离子的药物配伍使用。

OBJECTIVE:To observe the stability of fleroxacin injection. METHODS: The contents of fleroxacin injection and its degradation product were determined by HPLC method,and the effects of light, heat, pH value and halogen ion on the stability of fleroxacin injection was also studied. RESULT: The average recovery rate of the fleroxacin was 100.4%(RSD=0.87%); the color of fleroxacin injection deepened and the content of the degradation product increased if its pH value was lower or if the illuminating or heating time became longer; the sediments were separated out if met with halogen ion. CONCLUSION: The fleroxacin injection was unstable and easy to decompose under light and heat, especially under the light; the content is more likely to be decomposed if the pH value is lower;fleroxacin injection can not to be applied together with the halogen ion.