摘要
目的:预测注射用赖氨匹林的稳定性,为临床提供贮存期依据。方法:采用恒温加速法对注射用赖氨匹林不同时间不同温度的含量和有关物质(水杨酸)进行考察,采用HPLC方法定量分析。通过数学拟合,确定动力学方程,求出各个温度下的速度常数K值。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,预测注射用赖氨匹林在常温下的稳定性。结果:注射用赖氨匹林的含量下降符合一级动力学模型,有关物质(水杨酸)增加符合一级动力学模型。注射用赖氨匹林在25℃时的t0.9为4.59年。结论:运用经典恒温加速法,通过HPLC法同时测定注射用赖氨匹林中阿司匹林和有关物质(水杨酸)含量,预测注射用赖氨匹林的稳定性。方法简便、快速、准确、专属性强。
Objective： To estimate the stability of the lysinipirine for injection, this will provide a basis of storage life in clinic. Methods： The constant temperature accelerated test was used according to the principles of chemical dynamics. The content and related substances of lysinipirine for injection were determined in different temperatures and times 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 lysinipirine for injection at room temperature. Results： The kinetics of the degradation of lysinipirine for injection followed the first order reaction, and the kinetics of the related substances followed the zero order reaction. If lysinipirine for injection is at 25℃, the t0.9 would be 4.59 years. Conclusion： Using constant temperature accelerated test to determine the content and related substances of lysinipirine for injection can forecast the stability of the drug. The method is simple, rapid, accurate and exclusive.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2009年第10期958-961,968,共5页
Chinese Journal of New Drugs
关键词
注射用赖氨匹林
化学动力学
稳定性
高效液相色谱法
lysinipirine for injection
chemical dynamics
stability
high performance liquid chromatography （HPLC）
