Radomska-Soukharev A, Müller R H
Dept. of Pharmaceutical Technology, K. Marcinkowski University of Medical Sciences, Poznari, Poland.
Pharmazie. 2006 May;61(5):425-30.
The study investigates the chemical stability of lipids used as excipients in the production of solid lipid nanoparticles (SLN). A total of 17 SLN formulations was produced using different lipids. Most of the formulations were produced using identical binary surfactant mixtures and concentrations to study the effect of the chemical nature of the lipid on its stability in SLN. In some formulations surfactants were exchanged to study the contribution of the surfactant. The particles were characterised by photon correlation spectroscopy, laser diffractometry, zeta potential determination and differential scanning calorimetry, the latter to assess potential effects of lipid crystallinity and modifications on lipid stability. Lipid analysis was performed by gas chromatography using a sampling preparation and analysis procedure especially developed for SLN. This short-term study provides primarily information about the stability of the lipid under production conditions, that means high pressure homogenisation (cavitation) at high temperature. No degradation products couldbe detected for all lipids, the production process itself did not impair excipient stability.
该研究调查了用作固体脂质纳米粒（SLN）生产辅料的脂质的化学稳定性。使用不同脂质共制备了17种SLN制剂。大多数制剂使用相同的二元表面活性剂混合物和浓度，以研究脂质化学性质对其在SLN中稳定性的影响。在一些制剂中更换了表面活性剂以研究表面活性剂的作用。通过光子相关光谱法、激光衍射法、ζ电位测定和差示扫描量热法对颗粒进行表征，后者用于评估脂质结晶度和修饰对脂质稳定性的潜在影响。脂质分析通过气相色谱法进行，使用专门为SLN开发的采样制备和分析程序。这项短期研究主要提供了关于脂质在生产条件下（即高温高压均质化（空化））稳定性的信息。所有脂质均未检测到降解产物，生产过程本身并未损害辅料的稳定性。
