CAJ | 학술논문

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。
목적：채용장용재료병희산수지L100-55작위재체재료，제비α-상춘등조감병희산수지납미립（ SPD-L100-55-NPs）병진행체외평개。방법채용개량유화용제확산법제비SPD-L100-55-NPs，이립경、포봉솔（ EE）화다분산지수（ P. I.）위종합지표，통과단인소실험화정교설계실험우화납미립적처방공예，이홍외광보（ FT-IR）、X사선연사（ XRD）、차시소묘량열분석（ DSC）등대제비적납미립진행평개，병고찰기체외석방특성。결과제득적SPD-L100-55-NPs납미립외관원정、분포균균，평균립경위（63.5±3.6）nm，포봉솔위98.91%±0.18%，P. I.위0.198±0.014。약물재납미립중피재체재료유효포과，체외석방구유완석특성화PH의뢰성。결론소제득적납미립원정균균、포봉솔고，재체외구유량호적완석특성화PH민감성。
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 tech-nique. Taking Particle size,entraPment efficiency and PolydisPerse index as comPrehensive indexes,the orthogonal test de-sign 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.