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目的:制备新鱼腥草素钠乳酸-羟基乙酸共聚物微球(SNH-PLGA-MS)并考察其理化性质和体外释药特性。方法:采用乳化-溶剂挥发法制备SNH-PLGA-MS,通过正交实验设计优化、筛选处方与制备工艺,并对微球的外观形态、粒径及粒度分布、载药量和包封率、体外释放等进行考察。结果:工艺优化后所制备SNH-PLGA-MS为圆球形,平均粒径为10.736μm,粒度分布集中,平均载药量为8.31%,平均包封率为89.297%,微球体外释药特性符合双相动力学方程。结论:通过工艺优化所制备微球,粒径符合肺靶向要求,包封率达到药典要求。
OBJECTIVE: To prepare new houttuyfonate sodium-lactic-co-glycolide microspheres (SNH-PLGA-MS) and study its physicochemical properties and in vitro release characteristics. Methods: SNH-PLGA-MS was prepared by emulsion-solvent evaporation method. The orthogonal design was used to optimize the formulation and preparation process. The morphology, particle size and particle size distribution, drug loading and encapsulation efficiency, In vitro release and other inspection. Results: The SNH-PLGA-MS prepared after the process optimization was spherical with an average particle size of 10.736μm. The average particle size distribution was 8.31% and the average encapsulation efficiency was 89.297%. The in vitro release characteristics of microspheres were in accordance with Two-phase kinetic equation. Conclusion: Microspheres prepared by the process optimization, particle size in line with lung targeting requirements, entrapment efficiency to Pharmacopoeia requirements.