摘要
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 content and entrapment efficiency of predniso- lone acetate ethosome. Method： Prednisolone acetate ethosome was prepared with injection method. Uhrafiltration method was employed to separate the free drug from the ethosome. The content of prednisolone acetate was deter- mined by an HPLC method. Results：A good linear relationship was found between the peak area and the concentra- tion of prednisolone acetate ranging from 1.0 mg ·L-1 to 50 mg · L-1 （r = 0. 9996 ）. The recovery of prednisolone acetate was in a range of 99.8% - 100. 8%. Intra - day and inter - day RSDs were less than 2%. Prednisolone ace- tate was stable in the prepared samples after placing in the auto - sampler for 24 h at ambient temperature. The free drug was well separated from the ethosome by uhrafihration method. The drug recovery by uhrafiltration was in a range of 97.2% -97.8% ,the sample recovery was in a range of 96.6% -97.5%. The average entrapment effi- ciency of prednisolone acetate in ethosome was （76. 79 ± 0. 29） %. Conclusion： The method is simple, accurate and suitable for determination of content and entrapment efficiency of prednisolone acetate ethosome.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2013年第3期498-502,共5页
Chinese Journal of Pharmaceutical Analysis
基金
山东省自然科学基金(ZR2010HL065)
