State Key Laboratory of Fine Chemicals, Dalian University of Technology, 2 Linggong Road, 116024 Dalian, China; Frontiers Science Center for Smart Materials Oriented Chemical Engineering, School of Chemical Engineering, Dalian University of Technology, 2 Linggong Road, 116024 Dalian, China.
School of Chemistry, Dalian University of Technology, 2 Linggong Road, 116024 Dalian, China.
J Pharm Sci. 2024 Feb;113(2):455-462. doi: 10.1016/j.xphs.2023.10.009. Epub 2023 Oct 8.
Aluminum hydroxide adjuvants are widely used in human vaccines, such as diphtheria, tetanus, hepatitis A and hepatitis B vaccines. The adsorption of antigens on aluminum hydroxide adjuvants determines the immune boosting effect of vaccines, but it is not clear how changes in physicochemical properties resulting from the production and formulation processes affect the adsorption of aluminum hydroxide adjuvants with antigens. In this study, the commercial aluminum hydroxide adjuvant Alhydrogel® was pretreated by commonly used processes such as autoclaving and calcination, and the changes of aluminum hydroxide adjuvant in physicochemical properties during the treatment were then comprehensively characterized. The adsorption of ovalbumin (OVA) with treated Alhydrogel®, was also investigated, it was found that the decrease in specific surface area caused by the autoclaving process reduced the adsorptive capacity of the antigen, and the adsorptive strength of antigen was decreased only when the surface hydroxyl groups and chemically bound water of adjuvant were reduced by calcination. These findings help to optimize the production and formulation process of adjuvants for the rational regulation of antigen adsorption in vaccines.
氢氧化铝佐剂被广泛应用于人类疫苗,如白喉、破伤风、甲型肝炎和乙型肝炎疫苗。抗原在氢氧化铝佐剂上的吸附决定了疫苗的免疫增强效果,但目前尚不清楚生产和配方过程中理化性质的变化如何影响氢氧化铝佐剂与抗原的吸附。在这项研究中,对商业氢氧化铝佐剂 Alhydrogel®进行了高压灭菌和煅烧等常用处理,然后全面表征了处理过程中氢氧化铝佐剂理化性质的变化。还研究了经处理的 Alhydrogel®对卵清蛋白(OVA)的吸附,发现高压灭菌过程中比表面积的降低降低了抗原的吸附能力,只有当佐剂表面羟基和化学结合水被煅烧减少时,抗原的吸附强度才会降低。这些发现有助于优化佐剂的生产和配方工艺,从而实现对疫苗中抗原吸附的合理调控。