目的:制备粒径均一的水飞蓟宾PLGA微球,并优选其制备工艺。方法:采用快速膜乳化-溶剂萃取/挥发法制备水飞蓟宾PLGA微球,以平均粒径和径距为指标,通过单因素试验考察油相溶剂、膜孔径、过膜压力、油水相体积比4个影响因素,正交试验考察药辅比、PVA质量分数及油水相体积比对制备工艺的影响;考察水飞蓟宾PLGA微球的平均粒径、粒径分布、载药量、包封率及形貌等理化性质。结果:SPG膜孔径2.8μm,过膜压力1.0 MPa,离心20 min,固化液为生理盐水;水飞蓟宾PLGA微球的最佳制备工艺为药辅比1∶4,PVA质量分数3%,油水相体积比1∶19。制备的微球圆整度好、表面光滑,平均粒径(2.634±0.35)μm,径距(13.326±3.06),载药量(14.84±0.76)%,包封率(56.16±3.77)%。结论:快速膜乳化法可用于制备中药难溶性成分水飞蓟宾PLGA微球,且制备的微球粒径均一可控。 Objective: To prepare silybin PLGA microspheres with uniform particle size and to optimize its preparation process. Methods: The silybin PLGA microspheres were prepared by rapid membrane emulsification-solvent extraction / volatilization method. The average particle size and radial distance were used as indexes to study the effects of solvent, membrane pore size, membrane pressure, Compared with four influencing factors, orthogonal experiment was conducted to investigate the effect of drug-assisted ratio, PVA mass fraction and oil-water volume ratio on the preparation process. The average particle size, particle size distribution, drug loading, Gathering rate and morphology and other physical and chemical properties. RESULTS: SPG membrane pore size 2.8 μm, membrane pressure 1.0 MPa, centrifugation 20 min, and saline solution. The optimal preparation process of silybin PLGA microspheres was as follows: the ratio of drug to drug was 1: 4, the mass fraction of PVA was 3% Oil-water volume ratio of 1:19. The prepared microspheres had good roundness, smooth surface, average particle diameter (2.634 ± 0.35) μm, radial distance (13.326 ± 3.06), drug loading (14.84 ± 0.76)% and entrapment efficiency (56.16 ± 3.77)%. CONCLUSION: Rapid membrane emulsification can be used to prepare silybin PLGA microspheres with poor solubility. The prepared microspheres have uniform particle size.