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目的:建立醋酸泼尼松龙醇质体含量及包封率的测定方法。方法:采用注入法制备醇质体,以超滤法分离醇质体和游离药物,建立HPLC测定醋酸泼尼松龙含量的方法。结果:醋酸泼尼松龙浓度在1.0～50.0 mg·L-1范围内与峰面积呈良好的线性关系(r=0.9996),回收率为99.8%～100.8%,日内及日间精密度均小于2%,样品24 h内稳定性良好。超滤法能将醇质体与游离药物良好地分离,超滤回收率为97.2%～97.8%,加样回收率为96.6%～97.5%,平均包封率为(76.79±0.29)%。结论:该方法准确可靠、方便快捷,可用于醋酸泼尼松龙醇质体中药物含量及包封率的测定。
Objective: To establish a method for the determination of the content and entrapment efficiency of prednisolone acetate. Methods: Ethosomes were prepared by injection method. The ethosomes and free drugs were separated by ultrafiltration. The method for the determination of prednisolone acetate content by HPLC was established. RESULTS: Prednisolone acetate had a good linear relationship with the peak area in the range of 1.0-50.0 mg · L-1 (r = 0.9996) and the recovery rate was 99.8% -100.8%. The intra- and inter-day precision was less than 2%, good stability of the sample within 24 h. The ultrafiltration method could well separate the ethosomes from the free drugs. The recoveries of ultrafiltration were 97.2% ~ 97.8%. The recoveries were 96.6% ~ 97.5%. The average entrapment efficiency was 76.79 ± 0.29%. Conclusion: The method is accurate, reliable, convenient and fast, and can be used for the determination of drug content and entrapment efficiency of prednisolone acetate.