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采用 2(2)完全析因设计优化 SLN 和 NLC:均化技术的影响。

Optimizing SLN and NLC by 2(2) full factorial design: effect of homogenization technique.

机构信息

Biotechnological Processes Development Laboratory, School of Chemical Engineering, State University of Campinas-UNICAMP, Campinas, SP, Brazil; Faculty of Health Sciences, Fernando Pessoa University (FCS-UFP), Rua Carlos da Maia, 296, P-4200-150 Porto, Portugal.

Biotechnological Processes Development Laboratory, School of Chemical Engineering, State University of Campinas-UNICAMP, Campinas, SP, Brazil.

出版信息

Mater Sci Eng C Mater Biol Appl. 2012 Aug 1;32(6):1375-9. doi: 10.1016/j.msec.2012.04.017. Epub 2012 Apr 20.

Abstract

Solid lipid nanoparticles (SLN) and nanostructured lipid carrier (NLC) have been employed in pharmaceutics and biomedical formulations. The present study focuses on the optimization of the production process of SLN and NLC by High Shear Homogenization (HSH) and High Pressure Homogenization (HPH). To build up the surface response charts, a 2(2) full factorial design based on 2 independent variables was used to obtain an optimized formulation. The effects of the production process on the mean particle size, polydispersity index (PI) and zeta potential (ZP) were investigated. Optimized SLN were produced applying 20,000 rpm HSH and 500 bar HPH pressure and NLC process 15,000 rpm HSH and 700 bar HPH pressure, respectively. This factorial design study has proven to be a useful tool in optimizing SLN (100 nm) and NLC (300 nm) formulations. The present results highlight the benefit of applying statistical designs in the preparation of lipid nanoparticles.

摘要

固体脂质纳米粒(SLN)和纳米结构脂质载体(NLC)已被应用于药物制剂和生物医学配方中。本研究侧重于通过高剪切匀化(HSH)和高压匀化(HPH)优化 SLN 和 NLC 的生产工艺。为了构建表面响应图,使用基于 2 个独立变量的 2(2)完全因子设计来获得优化的配方。研究了生产工艺对平均粒径、多分散指数(PI)和 Zeta 电位(ZP)的影响。通过应用 20,000 rpm HSH 和 500 bar HPH 压力分别生产优化的 SLN 和 NLC 工艺 15,000 rpm HSH 和 700 bar HPH 压力。这项析因设计研究已被证明是优化 SLN(100nm)和 NLC(300nm)配方的有用工具。目前的结果强调了在制备脂质纳米粒时应用统计设计的益处。

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