| 摘要: |
| 目的：研究广泛pH范围内来氟米特的化学稳定性。方法：建立来氟米特的HPLC测定方法，测定不同温度下不同pH值时来氟米特分解的速度常数，得到不同pH值时的分解活化能及不同温度下的最稳定pH值。结果：常温（20-40℃）下来氟米特最稳定的pH范围是2.85-4.56，活化能数值恰在此范围内出现极大值。最稳定的pH范围随温度升高而向低pH值方向移动，当温度大于60℃时，最稳定pH值为1.80以下。结论：适当调整溶液的pH值可以显著改善来氟米特的化学稳定性,为其制剂学研究提供了部分依据。 |
| 关键词: 来氟米特、药物稳定性、经典恒温法、高效液相色谱，反相 |
| DOI： |
|
| 基金项目: |
|
| Study on chemical stability of leflunomide in aqueous solution |
| 孙华君,胡晋红,朱全刚 |
| () |
| Abstract: |
| Objective：To study the chemical stability of leflunomide in a wide pH value range. Methods：A method to determine leflunomide by high performance liquid chromatography (HPLC) was established. The rate constants at different temperature and different pH values were determined. The pH values of maximum stability at different temperatures and the decomposed activation energy values for different pH values were obtained. Results：The pH values of maximum stability were pH2.85-4.56 at 20-40℃, the activation energy also showed maximum values within pH2.85-4.56. The most stable pH values of leflunomide aqueous solution moved to lower pH values with a rise in temperature. When temperatures were over 60℃, the pH values of maximum stability were below 1.80. Conclusion：The chemical stability of leflunomide in aqueous solution can be improved by modifying pH values. |
| Key words: leflunomide drug stability classical isothermal kinetic method HPLC |
