甲磺酸非诺多泮的化学降解动力学及其制剂的有效期预测  

Studies on the chemical degradation kinetics and expiry date of fenoldopam mesylate

作　　者：刘放[1] 周芝芳[1] 孙洁胤[1] 

机构地区：[1]浙江省医学科学院,杭州310013

出　　处：《中国新药杂志》2007年第12期961-964,共4页Chinese Journal of New Drugs

摘　　要：目的:研究甲磺酸非诺多泮的化学降解动力学,来预测制剂的有效期。方法:采用经典恒温法对甲磺酸非诺多泮溶液和甲磺酸非诺多泮注射剂在不同温度不同时间的含量和有关物质进行考察,采用反相高效液相色谱法进行定量分析,通过数学拟合,确定反应动力学方程,求出反应速率常数K。并运用Arrhenius公式,预测甲磺酸非诺多泮溶液和注射剂在常温下的有效期。结果:甲磺酸非诺多泮溶液和注射剂的含量下降符合一级动力学模型,有关物质增加符合零级动力学模型。甲磺酸非诺多泮溶液在25℃时的t_(0．9)为1．09年,其注射剂在25℃时的t_(0．9)为5．12年。结论:通过制剂学手段,显著提高了甲磺酸非诺多泮注射剂的稳定性。Objective： To investigate the chemical degradation kinetics of fenoldopam mesylate in the solution and predict the shelf life of the injection. Methods：The constant temperature acceleration test was used according to the principles of chemical kinetics. The content and the related substances of fenoldopam mesylate were determined by a RP-HPLC method. The reaction rate constant（K）and shelf life at room temperature were calculated in accordance with Arrhenius equation. Results： The data showed that the degradation kinetics of fenoldopam mesylate in solution and injection met the first order process, and that of the related substances the zero order one. T^25℃ 0.9 values of fenoldopam mesylate in solution and in injection were 1.09 years and 5. 12 years, respectively. Conclusion ： The stability of fenoldopam mesylate in solution is significantly improved by the injection formulation.

关 键 词：甲磺酸非诺多泮 化学动力学 稳定性 有效期 高效液相色谱 

分 类 号：R972.4[医药卫生—药品] R943.3[医药卫生—药学]