摘要
目的研究重酒石酸去甲肾上腺素注射液的热降解动力学过程,评估其在室温(25℃)条件下的热稳定性,为临床使用及保存重酒石酸去甲肾上腺素注射液提供参考。方法采用高效液相色谱法测定去甲肾上腺素注射液在30℃、40℃、60℃放置0、120、240、360、480 h的含量;采用经典恒温法预测在室温的有效期。结果经典恒温法5次拟合后,得Arrhenieus方程lgK=-3 591.89/T+7.066(r=0.936 7),K_(25℃)=1.036 001×10^(-5)/h,t_(0.9)=10 173.735 h=14.13个月,活化能Ea=68.774 KJ/mol。结论重酒石酸去甲肾上腺素注射液的热降解符合一级动力学方程,在室温(25℃)约可放置14个月左右,比在规定贮存条件缩短了10个月。
Objective To study the thermal degradation kinetic process of norepinephrine bitartrate injection,evaluate its thermal stability at room temperature（25℃）,and provide the reference for clinical application and storaging norepinephrine bitartrate injection. Methods HPLC was used to determine the Norepinephrine Bitartrate Injection content storage at constant temperature of 30℃,40℃ and 60℃ for 0,120,240,360 and 480 h. Classical constant temperature acceleration was used to calculate the expiration data at room temperature（25℃）. Results The regression equation was obtained through5 tested by classical constant temperature acceleration;lgK=-3 591.89/T＋7.060 6（r=0.936 7）,K25℃ was 1.036 001×10^-5/h and the activation energy was 68.774 KJ/mol. Conclusions The degradation of norepinephrine bitartrate injection was in line with the first-class kinetics reaction. The expiration data at room temperature（25℃）of norepinephrine bitartrate injection was about 14 months,10 months shorter than the recommended storage conditions.
出处
《热带医学杂志》
CAS
2017年第4期472-475,共4页
Journal of Tropical Medicine
关键词
重酒石酸去甲肾上腺素注射液
室温
热稳定性
Norepinephrine bitartrate injection
Room temperature
Thermal stability
