非诺贝特纳米脂质载体的制备及包封率测定

Preparation of fenofibrate-loaded nanostructured lipid carriers and their determination of entrapment efficiency

目的制备非诺贝特纳米脂质载体并测定其包封率。方法采用热熔超声分散法制备非诺贝特纳米脂质载体,以葡聚糖凝胶(Sephadex G-50)微柱离心法分离纳米结构脂质载体和游离药物;采用高效液相色谱(HPLC)法测定非诺贝特含量,计算包封率。结果与结论所制备的非诺贝特纳米脂质载体平均粒径为119.2 nm;在建立的色谱条件下,脂质等辅料不干扰测定,非诺贝特在10.41~124.92μg/ml范围内线性关系良好,低、中、高浓度方法回收率分别为100.97%、99.19%和99.01%(n=3);所建立的微柱离心条件可有效分离载非诺贝特纳米脂质载体和游离药物,测得3批次纳米脂质载体包封率分别为96.81%、96.04%和96.74%。该微柱法简单方便,可用于测定制备的载非诺贝特纳米脂质载体包封率。

Objective To prepare fenofibrate-loaded nanostructured lipid carriers and determine their entrapment efficiency. Methods Fenofibrate-loaded nanostructured lipid carriers were prepared by hot homogenization,followed by an ultrasonication method. A dextran gel（ Sephadex G-50） mini-column centrifugation was employed to separate the free drug from nanostructured lipid carriers. The content and encapsulation efficiency of fenofibrate was qualified and calculated by the HPLC method. Results and Conclusion The average particle size of the prepared fenofibrate nanostructured lipid carriers was 119. 2 nm. Under the applied chromatographic conditions, the excipients did not interfere with the determination of fenofibrate. A calibrated linearity of fenofibrate concentration was within 10. 41-124. 92 μg/ml. The recoveries of low,medium and high concentrations of fenofibrate were 100. 97%,99. 19% and 99. 01%,respectively. The free fenofibrate was well separated from nanostructured lipid carriers by using mini-column centrifugation. The entrapment efficiency of three batches of fenofibrate-loaded nanostructured lipid carriers was 96. 81%,96. 04% and 96. 74%,respectively. This method is simple and easy,which can be used for the determination of entrapment efficiency of fenofibrate-loaded nanostructured lipid carriers.