穿琥宁注射液降解动力学研究

Degradation kinetics of Chuanhuning injection

目的:研究穿琥宁注射液在不同pH值、不同温度、不同光照条件下降解反应的动力学参数。方法:用高效液相色谱法测定含量,并运用经典恒温法、多元线性模型探讨其稳定性,用阿累尼乌斯公式预测其有效期和活化能。结果:穿琥宁注射液的降解反应为假一级动力学。结论:穿琥宁注射液在pH值6．0时最稳定,有效期为24个月。为进一步探讨其降解机制提供必要的实验结果和数据。

Objective： To evaluate the degradation kinetic profile of Chuanhuning injection （ CHN Inj. ） under the changeable pH, temperature and light environments. Methods：The active components in the injection were quantified by HPLC. The stability of the injection was evaluated using classic isothermal method and multivariate linear model. The activation energy and shelf life in different pH settings were predicted with Arrhenius equation. Results：The degradation reaction of the active components of CHN Inj. obeyed pseudo-first-order kinetics. At the most optimal pH 6.0, the CHN Inj. was stable for 24 months. Conclusion：The kinetic profile was warranted for the investigation of the degradation mechanism.