经典恒温法预测格列美脲水溶液有效期

Study on expiration date of glimepiride solution by classical constant-temperature experiment

目的:研究格列美脲水溶液在加入稳定剂前后稳定性比较,预测其在室温下的有效期。方法:采用HPLC法测定溶液中格列美脲的含量,用经典恒温法预测其有效期。结果:格列美脲水溶液中格列美脲的含量随时间变化属一级降解反应,经典恒温法测得未加及加入稳定剂的格列美脲水溶液在25℃的分解速度常数K及有效期分别为:K25℃=8.7382×10-6h-1,t0.925℃=1.37年和K25℃=1.03688×10-6h-1,t0.925℃=11.6年。结论:格列美脲水溶液中加入稳定剂对提高其稳定性效果显著,格列美脲水溶液的有效期暂定为11年。

Objective： To investigate the stability of glimepiride solution which contained stabilizers or not, and forecast its expiration date. Methods： The contents of glimepiride were determined by HPLC. The expiration date were tested by classical constant-temperature experiment. Results： The contents of glimepiride changed with time which belong to first class degradation reaction. The disintegration rate constant K and expiration date of glimepiride solution with and without stabilizers at 25 ℃ were K25℃ = 8.738 2 ×10^-6h^-1, t0.9^25 ℃= 1.37 years and K25℃ = 1.036 88 ×10^-6h^-1, t0.9^25℃ = 11.6 years, respectively. Conclusion： The glimepiride solution containing stabilizers have significant stability, and its expiration date tentatively set on 11 years.