School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Rue Michel-Servet 1, 1211 Geneva 4, Switzerland.
School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Rue Michel-Servet 1, 1211 Geneva 4, Switzerland.
J Pharm Biomed Anal. 2018 Apr 15;152:89-93. doi: 10.1016/j.jpba.2018.01.029. Epub 2018 Jan 31.
Iron sucrose (IS), a nanocolloidal solution used in the treatment of iron deficiency anemia, is currently under investigation for the elucidation of its critical quality attributes. Assessment of IS's size and size distribution has been recently attempted using dynamic light scattering (DLS). However, due to heterogeneous interpretation of DLS data, variable results were retrieved. The aim of this work was to establish a simple and reproducible DLS protocol to unequivocally define the size and size distribution of IS by using size distribution approximation in Number. Underlining the limitations of the commonly used DLS approximations, we identified the drug as being composed of a population of monodisperse nanoparticles of about 7 nm in diameter. The method here described might therefore be useful for the evaluation of quality, safety and efficacy of IS and its follow-on versions.
铁蔗糖（IS）是一种纳米胶体溶液，用于治疗缺铁性贫血，目前正在研究其关键质量属性。最近使用动态光散射（DLS）尝试评估 IS 的大小和大小分布。然而，由于 DLS 数据的解释存在差异，因此得到了不同的结果。本工作的目的是建立一个简单且可重现的 DLS 方案，通过使用数量的粒径分布逼近，明确地定义 IS 的大小和大小分布。强调了常用 DLS 逼近的局限性，我们发现该药物由直径约 7nm 的单分散纳米颗粒组成。因此，所描述的方法可能对评估 IS 及其后续版本的质量、安全性和疗效有用。
