喃氟啶脂质体稳定性的研究

STUDIES ON THE STABILITY OF FTORAFUR LIPOSOME

用经典恒温加速试验法对自制的Ft-207脂质体的稳定性进行了研究。应用库尔特计数器测定粒度分布及粒径变化规律。结果表明粒径的变化符合一级反应过程,并求得脂质体的凝集速度方程、凝聚活化能(E凝)及室温凝聚速度常数(κ_(25)凝)。室温放置及冷藏(5℃)各30个月后,不论粒径大小、外观色泽及均匀度等均无明显变化;37±0.1℃贮存3个月后的漏渗率为3％,根据以上结果证明本品的稳定性良好。

The stability of the authors' self-formulated Ftorafur liposome was studied by the classical isothermal method at 60, 70 & 80℃. The particle size distribution of the particulates and the rate of their coalescence were determined by using the Coulter counter. It was shown that the change of particle size of Ftorafur liposome was a first-order reaction. The rate equation and the activation energy of coalescence and the kinetic constant of coalescence at room temperature were derived. The particle size distribution, appearance and homogeneity changed just slightly after storage at room temperature and in refrigerator (5℃) for 30 months, respectively. Drug enclosed within liposome leaked out about 3.8 % after storage for 3 months at 37℃ (±0.1℃). The above results indicate that the Ftorafur liposome is rather stable.