高效液相色谱法测定骨形成蛋白长效微球的含量

Determination the Content of Bone Morphogenetic Protein-loaded Long-acting Microspheres by HPLC

目的:建立测定骨形成蛋白长效微球中药物含量的方法。方法:以乳酸-羟基乙酸共聚物为材料制备微球,用HPLC法测定制剂的含量。结果:骨形成蛋白在1.5—75.0μg·ml^(-1)的浓度范围内,峰面积与浓度呈良好的线性关系,方法的平均回收率为98.5%,RSD为0.5%。结论:该方法操作简单、可靠,可用于测定乳酸.羟基乙酸共聚物微球中的药物的含量。

Objective： To establish a method for determination the content of bone morphogenetic protein -loaded microspheres. Method： Poly （lactic-co-glycolic acid） （PLGA） was used to fabricate the microspheres. HPLC was used to determine drug content in microspheres. Result： The linear range of BMP was 1.5 - 75 μg· ml ^-1, the average recovery was 98.8% , RSD was 0.9%. Conclusion： The method is simple, accurate, It can be used to determine the BMP in PLGA microspheres.