盐酸二氟沙星注射液稳定性研究

本文以紫外—可见分光光度仪测定盐酸二氟沙星注射液中二氟沙星的含量 ,采用经典恒温加速实验和强光照射实验研究该制剂的热稳定性和光稳定性。结果表明 ,该制剂盐酸二氟沙星的热降解反应为一级动力学过程。在40℃ ,5 0℃ ,6 0℃和 70℃时的降解速度常数分别为 :3 92 4× 10 -4 ,8 0 70× 10 -4 ,1 5 91× 10 -3 ,3 0 17× 10 -3 其热降解速度常数R2 98为 :1 2 13× 10 4 贮存有效期t0 9为 2 38年 ,半衰期为 15 6 6年 ,该制剂光稳定性尚属良好。

Study of stability on difloxacin hydrochloride injection

The content of difloxacin in difloxacin hydrochloride injection was assayed by UV-vis.The heating stability and light stability of the preparation were studied by the experiment methods of classical constant temperature acceleration and strong light irradiation.The results shown that the heating degradation reaction of difloxacin hydrochloride injection is one grade dynamics process.The degradation rate parameters in the additions of 40℃、50℃、60℃ and 70℃ are 3\^924×10\+\{-4\}、8 070×10\+\{-4\}、1 591×10\+\{-3\}、3 017×10\+\{-3\} respectively. Its degradation activation energy E is 6 072×10kJ/mol. The degradation rate parameter R\-\{298\} in the condition of room temperature is 1 213×10\+\{-4\}. Storage validity duration t\-\{0 9\} is 2 38 year. Half-life is 15 66years. The Heating stability of the preparation is well.