Deng JiaHua, Cai WeiHui, Jin Fang
Shanghai Institute of Pharmaceutical Industry, Shanghai Engineering Research Center of Lipid Emulsions, Shanghai 200437, PR China.
Shanghai Institute of Pharmaceutical Industry, Shanghai Engineering Research Center of Lipid Emulsions, Shanghai 200437, PR China.
Int J Pharm. 2014 Jul 1;468(1-2):187-95. doi: 10.1016/j.ijpharm.2014.04.003. Epub 2014 Apr 4.
Oil-in-water emulsions consisting of squalene, tween and/or span have shown significant benefits for the prevention and control of influenza, with their adjuvant efficacy enhancing the immunogenicities of influenza vaccines in high-risk groups. However, concerns have been raised following reports that post-immunization reactions associated with these adjuvanted vaccines are more frequent. In this work, a stable and biocompatible oil-in-water emulsion adjuvant containing squalene, egg lecithin and sodium oleate has been developed. Animal studies demonstrated that this adjuvant could induce strong immune responses in BALB/c mice, as measured by hemagglutinin inhibition titers, influenza-specific serum antibody titers and cytokine levels (IFN-γ and IL-4). Different oil compositions, including squalene, medium chain triglyceride and long chain triglyceride, were also evaluated. Furthermore, in contrast to MF59(®) which can only be sterilized by aseptic filtration, this adjuvant remained stable during autoclaving, showing minimal changes in pH, particle size and lysolecithin concentration.
由角鲨烯、吐温及/或司盘组成的水包油乳剂已显示出对预防和控制流感具有显著益处，其佐剂功效可增强高危人群中流感疫苗的免疫原性。然而，有报道称这些佐剂疫苗相关的免疫后反应更为频繁，这引发了人们的担忧。在这项研究中，已开发出一种含有角鲨烯、蛋黄卵磷脂和油酸钠的稳定且生物相容性良好的水包油乳剂佐剂。动物研究表明，通过血凝抑制效价、流感特异性血清抗体效价和细胞因子水平（IFN-γ和IL-4）测定，这种佐剂可在BALB/c小鼠中诱导强烈的免疫反应。还评估了不同的油成分，包括角鲨烯、中链甘油三酯和长链甘油三酯。此外，与只能通过无菌过滤进行灭菌的MF59(®)不同，这种佐剂在高压灭菌过程中保持稳定，pH值、粒径和溶血卵磷脂浓度变化极小。
