甲磺酸培氟沙星注射液稳定性及有效期预测

Prediction of the stability and expiry term of Pefloxacin Mesylate Citrate Injection

目的:考察甲磺酸培氟沙星注射液的稳定性,并预测其室温贮存有效期。方法:用分光光度法测定甲磺酸培氟沙星注射液的含量;用初均速法预测其有效期。结果:本品在室温、高温条件下稳定;在光照下色泽变深,含量及pH值有较明显的变化。结论:甲磺酸培氟沙星注射液应避光贮藏。

Objective： To study the stability of Pefloxaein Mesylate Injection at room temperature in order to predict its expiry term. Methods： The content of Pefloxaein Mesylate Injection was determined by speetrophotometry, the expiry term was predicted by initial average rate method. Results： Pefloxacin Mesylate Injection was stable at room or high tempera- ture. The content and pH value of Pefloxacin Mesylate Injection changed markedly and its color darkened when it was ex- posed to sunlight at room temperature. Conclusion： The Pefloxaein Mesylate Injection should be kept in a dark place.