兰索拉唑片的稳定性预测  

Estimation of the chemical dynamics and stability of Lansoprazole tablets

作　　者：吴宏富[1] 黄卫平[2] 刘放[3] 

机构地区：[1]浙江省庆元县中医院,浙江庆元323800 [2]浙江医学高等专科学校,浙江杭州310053 [3]浙江省医学科学院药物研究所,浙江杭州310013

出　　处：《华西药学杂志》2014年第3期331-333,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的预测兰索拉唑肠溶片的稳定性,为临床提供贮存期的依据。方法采用经典恒温法考察兰索拉唑片在不同温度下、不同时间的含量和有关物质,采用HPLC法定量分析,通过数学拟合,确定动力学方程,求出各温度下的速度常数K。再根据Arrhenius指数规律,得到速度常数K随温度变化的规律,由此规律向低温外推得到室温下的K值,预测兰索拉唑片在常温下的有效期。结果兰索拉唑肠溶片的含量下降符合一级动力学模型,有关物质的增加符合零级动力学模型。兰索拉唑片在25℃时的t0.9=2.91年。结论运用经典恒温加速法,采用HPLC法同时测定兰索拉唑片的含量和有关物质,预测兰索拉唑片的稳定性,方法简便、快速、准确、专属性强。OBJECTIVE To estimate the stability of Lansoprazole tablets, and provide a basis of storage life in clinic. METHODS The constant temperature acceleration test was used according to the priniciples of ehemial dynamics. The content and the related substances of Lansoprazole tablets were determined in different temperatures and time by HPLC method. Mathematical modeling was used to determine the kinetic equation. The rate constant K under the temperatures was calculated, which could forecast the stability of Lansoprazole tablets at room temperature. RESULTS The kinetics of the degradation of Lansoprazole tablets followed the first order process, and the kinetics of the related substances followed the zero order reaction. If lansoprazole tablets was at 25℃, the t0.9 would be 2.91 years. CONCLUSION Using constant temperature accelerated test to determine the content and related substances of Lansoprazole tablets can forecast the srability of the drug, The method is simple, rapid, accurate and exclusive.

关 键 词：兰索拉唑片 化学动力学 稳定性 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]