灯盏花素前体脂质体胶囊突释的评价方法

The study on initial burst release of Scutellarin Proliposome Capsules

目的:建立灯盏花素前体脂质体胶囊的突释考察方法。方法:采用透析-高效液相色谱法(HPLC),水化前体脂质体后,用透析袋分析游离药物和脂质体,并用HPLC法测定含量。采用Diamonsil ODS C18色谱柱(4.6mm×250mm,5μm),流动相为甲醇-乙腈-40mmol/L KH2PO4(磷酸调pH至2.5)(18∶12∶70);检测波长335nm;流速1.0ml/min;柱温35℃。结果:游离药物在透析膜两侧均匀分布,而脂质体被截留于透析袋中。含量测定方法平均加样回收率为103.32%,RSD为1.12%(n=9)。结论:本法操作简便、准确,可用于灯盏花素前体脂质体胶囊突释的评价。

Objective： To establish a method for determining the initial burst release of Sculellarin Proliposome Capsules. Methods：A dialysis-HPLC method was applied.After the hydration of proliposome, bag filter was used to separate free drug and liposonle, then determined the content by HPLC with Diamonsil ODS C18（4.6 minx250 mm,5 μm）, using the mobile phase of methanol-aeetonitrile-40 mmol/L KH2PO4（adjusted pH to 2.5 by phosphoric acid） （18：12：70） with a flow rate at 1.0 ml/min, and the detective wavelength was 335 nm and the column temperature was 35℃. Results： The distribution of free dntgs was equivalent on two sides of bag filter, but liposomes were kept in the bag. The average recovery and RSD of the enntent determination nlethod were 103.32% and 1.12% （n=9） respectively. Conclusion： The nlethod is convenient and accurate. It can be used to evaluate the initial burst release of Seutellarin Proliposome Capsules.