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目的 :研究地高辛在不同温度、不同浓度β 环糊精水溶液中的溶解度、热力学参数以及包合物制剂的稳定性。方法 :采用溶解度法和经典恒温法 ;含量测定用UV和HPLC。结果 :相溶解度曲线呈AN型。温度升高 ,包合物的稳定常数减小 ,包合物的生成能增大 ,反应热为 - 9.10 4(kJ/mol)。 4℃时DIGτ0 .9=2 .73年。结论 :包合过程为放热过程 ,包合物在制剂中稳定。
OBJECTIVE: To study the solubility and thermodynamic parameters of digoxin in β-cyclodextrin solution at different temperatures and different concentrations, and the stability of the preparation. Methods: The solubility method and the classical thermostat method were used. The content was determined by UV and HPLC. Results: Phase solubility curve was AN type. When the temperature is increased, the stability constant of the inclusion complex decreases, and the formation of the inclusion complex can be increased, with a heat of reaction of - 9.10 4 (kJ / mol). 4 ℃ DIGτ0 .9 = 2.73 years. Conclusion: The inclusion process is an exothermic process and the inclusion complex is stable in the preparation.