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目的构建载葛根素(Pur)聚乙烯亚胺/海藻酸钠(PEI/ALG)自组装纳米粒(Pur-PEI/ALG-NPs),并考察其制备工艺与性能。方法采用自组装法制备Pur-PEI/ALG-NPs;采用UV法定量,采用马尔文粒度仪对Pur-PEI/ALG-NPs进行表征;并考察其体外释放行为;以包封率和载药量为评价指标,采用中心组合设计-效应面法(CCD-RSM)优化Pur-PEI/ALG-NPs处方。结果优化后的处方:PEI质量浓度为3.2 mg/m L,ALG质量浓度为1.3 mg/m L,PEI-ALG质量比为3.75∶1,平均粒径为(118.0±0.4)nm,Zeta电位为(35.2±0.7)m V,包封率为(24.13±1.78)%,载药量为(11.17±0.71)%;体外释放结果表明Pur-PEI/ALG-NPs加快了Pur的释放速率。结论成功制备了Pur-PEI/ALG-NPs,粒径小且分布集中,表面具有丰富的正电荷,为葛根素在临床眼部治疗奠定了基础。
OBJECTIVE To construct Pur PEI / ALG self-assembled nanoparticles (Pur-PEI / ALG-NPs) and investigate the preparation process and properties. Methods Pur-PEI / ALG-NPs were prepared by self-assembly method. The purity of Pur-PEI / ALG-NPs was characterized by UV spectrophotometry and Malvern particle size analyzer. The encapsulation efficiency and drug loading For the evaluation of the indicators, Central Composite Design-Response Surface Methodology (CCD-RSM) was used to optimize the formulation of Pur-PEI / ALG-NPs. Results The optimized formulation showed that the mass concentration of PEI was 3.2 mg / m L, the concentration of ALG was 1.3 mg / m L, the mass ratio of PEI-ALG was 3.75:1, the average particle size was (118.0 ± 0.4) nm and the Zeta potential was (35.2 ± 0.7) mV. The entrapment efficiency was (24.13 ± 1.78)% and the drug loading was (11.17 ± 0.71)%. The in vitro release showed that Pur-PEI / ALG-NPs accelerated the release rate of Pur. Conclusions Pur-PEI / ALG-NPs were successfully prepared with small particle size and concentrated distribution and abundant positive charges on the surface, which laid the foundation for the treatment of puerarin in clinical ophthalmology.