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目的:制备聚乳酸载药微球,研究制备工艺参数对载药微球的药物包封率和粒径的影响。方法:以线形聚D,L-乳酸为聚合物基材,以亮蓝(EDS)作为水溶性模型药物,采用复乳-溶剂挥发法制备亮蓝聚乳酸微球(PLA/EDS),用均匀试验设计的方法安排试验。结果:采用逐步回归分析的方法建立PLA/EDS的药物包封率、微球平均粒径与制备工艺参数之间的定量数学关系。在此基础上采用模拟循环筛选法遴选出较优工艺,并加以实验验证。结论:采用均匀试验设计所建立的多元二次模型可以很好地预测载药微球的基本特性,可为聚乳酸载药微球的制备提供指导。
OBJECTIVE: To prepare polylactic acid drug-loaded microspheres and study the influence of preparation parameters on drug entrapment efficiency and particle size of drug-loaded microspheres. Methods: Linear poly D, L-lactic acid was used as the polymer matrix and bright blue (EDS) as the water-soluble model drug. PLA / EDS microspheres were prepared by double emulsion- Test design methods to arrange the test. Results: The relationship between the entrapment efficiency of PLA / EDS and the average particle size of PLA / EDS was established by stepwise regression analysis. On this basis, the simulation cycle screening method was used to select the better technology and verified by experiment. CONCLUSION: The multivariate quadratic model established by the uniform experimental design can predict the basic properties of drug-loaded microspheres and provide guidance for the preparation of PLA-loaded microspheres.