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目的:建立胰岛素脂质体含量及包封率的测定方法。方法:采用葡聚糖凝胶柱色谱法分离胰岛素脂质体及游离胰岛素,RP-HPLC法测定胰岛素含量,色谱柱:Hypersil ODS_2柱(250 mm×4.6 mm,5μm),流动相:0.05 mol·L~(-1)硫酸盐缓冲液-乙腈(72:28);流速:1.0 ml·min~(-1)。结果:辅料及溶剂不干扰胰岛素的含量测定,可准确求得胰岛素脂质体的药物含量及包封率。结论:所用方法简便准确,可用于胰岛素脂质体的含量及包封率测定。
Objective: To establish a method for the determination of the content of liposomes and encapsulation efficiency of insulin. METHODS: Insulin liposomes and free insulin were separated by Sephadex LH-20 column chromatography. The contents of insulin were determined by RP-HPLC. The column was Hypersil ODS_2 (250 mm × 4.6 mm, 5 μm) with a mobile phase of 0.05 mol · L ~ (-1) sulfate buffer - acetonitrile (72:28); flow rate: 1.0 ml · min ~ (-1). Results: Excipients and solvents did not interfere with the determination of insulin content, can be accurately determined insulin liposome drug content and encapsulation efficiency. Conclusion: The method is simple and accurate, which can be used to determine the content of liposomes and encapsulation efficiency.