目的:采用肠溶材料丙烯酸树脂L100-55作为载体材料,制备α-常春藤皂苷丙烯酸树脂纳米粒( SPD-L100-55-NPs)并进行体外评价。方法采用改良乳化溶剂扩散法制备SPD-L100-55-NPs,以粒径、包封率( EE)和多分散指数( P. I.)为综合指标,通过单因素实验和正交设计实验优化纳米粒的处方工艺,以红外光谱( FT-IR)、X射线衍射( XRD)、差示扫描量热分析( DSC)等对制备的纳米粒进行评价,并考察其体外释放特性。结果制得的SPD-L100-55-NPs纳米粒外观圆整、分布均匀,平均粒径为(63.5±3.6)nm,包封率为98.91%±0.18%,P. I.为0.198±0.014。药物在纳米粒中被载体材料有效包裹,体外释放具有缓释特性和PH依赖性。结论所制得的纳米粒圆整均匀、包封率高,在体外具有良好的缓释特性和PH敏感性。
Objective To PrePare and in vitro evaluate SaPonins PD loaded Eudragit L100-55 NanoParticles( SPD-L100-55-NPs). Methods The SPD-L100-55-NPs were PrePared by modified quasiemulsion solvent diffusion technique. Taking Particle size,entraPment efficiency and PolydisPerse index as comPrehensive indexes,the orthogonal test design was used to oPtimize the PreParation Process. The characteristics of nanoParticles were determined by FT-IR,X-ray diffraction,DSC,etc.;In vitro release was investigated. Results Novel nanoParticles were sPherical,average Particle size of nanoParticles was(63. 5 ± 3. 6)nm,EE 98. 91% ± 0. 18%,P. I. 0. 198 ± 0. 014. The release of SPD significantly dePended on the PH conditions. Conclusion SPD-L100-55-NPs had high EE and homogeneous size distribution. The effect of drug sustained release of nanoParticles was significant.