血必净注射液中洋川穹内酯I的降解动力学研究

Degradation kinetics of Senkyunolide I in Xuebijing injection

关键词:  洋川芎内酯I  血必净注射液  pH  温度  降解动力学

Key words:  Senkyunolide I  Xuebijing injection  pH  temperature  degradation kinetics

摘要:

[目的] 研究洋川芎内酯I(Sen I)在血必净注射液及水溶液中, 不同pH缓冲液、不同温度下降解的动力学规律, 为血必净注射液及洋川芎内酯I的提取、贮藏及使用条件提供依据。[方法] 建立高效液相色谱分析方法, 考察不同pH(1～13)和温度(65、75、85、95 ℃)对Sen I稳定性的影响, 利用速率方程、化学反应动力学模型及Arrhenius公式分析Sen I 在不同条件下的降解规律并计算相关降解反应动力学参数。[结果] Sen I在碱性条件下降解较快, 符合一级动力学规律, 并随碱性增强, 降解速度明显加快。温度对降解速度影响较大, 温度升高, 降解明显加快。经计算得, Sen I在水溶液和血必净注射液中降解活化能分别为177.94 kJ/mol和194.86 kJ/mol.[结论] 在碱性和高温条件下, 洋川芎内酯I更易降解。同样条件下, Sen I在血必净注射液中的稳定性都要高于其水溶液。

Abstract:

[Objective] To study the degradation kinetic characteristics of Senkyunolide I (Sen I) in Xuebijing injection and aqueous solution under different pH buffer and temperatures.[Methods] HPLC method was established to study the effect on the Senkyunolide I under different pHs and temperatures(65,75,85,95℃). Based on the chemical reaction kinetics and Arrhenius equation, the model of degradation of Sen I and the parameters of degradation kinetics were confirmed.[Results] The results indicated that the degradation of Sen I in aqueous solution and Xuebijing injection conforms to the first-order degradation kinetic. In the injection and aqueous solution, respectively, the energy of activation (Ea) was 177.94 kJ/mol and 194.86 kJ/mol. [Conclusion] Sen I is unstable in alkaline solution and high temperature in both aqueous and Xuebijing injection. Under the same condition, Sen I in Xuebijing injection was more stable than that in aqueous solution.