【摘要】 目的:采用白砂多孔玻璃膜(SPG膜)乳化法结合W/O/W复乳-溶剂挥发法,研究制备载蛋白类药物聚乳酸羟基乙酸共聚物(PLGA)微球的一种新工艺。方法:以溶菌酶为模型药物,制备微球,比较制备过程中处方因素对微球性质的影响,并对所制得的微球进行理化性质、微球的体内相容性和降解特性进行研究。结果:制得溶菌酶微球载药量为11.84%,包封率为72.43%,平均粒径为63.89μm,径距为0.675。通过差示扫描量热法(DSC)及傅立叶变换红外光谱(FTIR)表征表明药物溶菌酶被包裹在微球内。微球的体内相容性良好,体内降解缓慢。结论:本研究获得了较为满意的制备蛋白类药物-PLGA微球的新工艺,微球的体外体内性质良好。更多还原

【Abstract】 Objective: To develop a new preparation process of PLGA microparticles for protein drugs by SPG membrane emulsification combined with W / O / W double emulsion-solvent technique. Methods: Lysozyme was used as the model drug to prepare the microparticles. The influence of formula factors on the properties of the microparticles was studied,and the physicochemical properties,in vivo compatibility and degradation of the microparticles were investigated as well. Results: The drug loading of lysozyme-loaded microparticles was 35%,the entrapment efficiency was 72. 43% and the average size was 63. 89 μm with PDI of 0. 675. DSC and FTIR showed that lysozyme was entrapped in the microparticles. The microspheres had promising biocompatibility and sustained degradation in vivo. Conclusion: The paper describes a new satisfactory preparation process of PLGA microparticles for protein drugs with good in vitro and in vivo properties.更多还原