环索奈德固体脂质纳米粒包封率的测定方法研究

目的建立环索奈德固体脂质纳米粒中药物包封率的测定方法。方法采用葡聚糖凝胶柱层析和高速冷冻离心的方法分离环索奈德纳米粒胶体溶液,再用高效液相色谱法测定溶液中环索奈德的含量,计算包封率。色谱柱为C18柱(150 mm×4.6 mm,5μm),流动相为甲醇-水(92∶8),流速为1 mL/min,检测波长为243 nm,柱温为30℃,进样量为20μL。结果在该色谱条件下,辅料对药物检测无干扰,环索奈德质量浓度在10～200μg/mL范围内与峰面积线性关系良好(r=0.999 9),平均回收率为98.33%,RSD=0.64%。包封率测定的两种方法所测药物包封率均在85%以上。结论所建立方法简便、准确、灵敏度高,能用于环索奈德固体脂质纳米粒包封率的测定。

Research on Determination Method for Encapsulation Efficiency of Ciclesonide Nanoparticles

Objective To establish the determination methods for the drug content and the encapsulation efficiency of ciclesonide solid lipid nanoparticles. Methods The sephadex gel filtration chromatography and the high speed refrigerated centrifuge were used to sepa- rate the ciclesonide nanoparticle colloidal solution. The ciclesonide content in the colloidal solution was encapsulation efficiency determined by the HPLC method and the encapsulation efficiency was calculated. The chromatographic column was C18 column（150 mm ×4. 6 mm, 5 μm）with methanol-water（92：8）as the mobile phase at a flow rate of 1 mL/min. The detection wavelength was 243 nm,the column temperature was 30 ℃ ,and the sample size was 20 ILL. Results Under this chromatographic condition,the auxiliary material had no inter- ference on the drug determination. The mass concentration of ciclesonide in the range of 10-200 μg/mL demonstrated the good linear relationshlp（r=0. 999 9）,and the average recovery rate was 98.33% （RSD=O. 64% ）,The encapsulation efficiencies detenninied by the two methods all were more than 85%. Conclusion The established method is proved to be simple,accurate and highly sensitive,and can be applied for the determination of the encapsulation efficiency of the ciclesonide solid lipid nanoparticles.