基于富勒醇-氧化铈复合体系的长效光防护纳米凝胶的制备与评价-中国药房

基于富勒醇-氧化铈复合体系的长效光防护纳米凝胶的制备与评价

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篇名：	基于富勒醇-氧化铈复合体系的长效光防护纳米凝胶的制备与评价
TITLE：	Preparation and evaluation of long-acting light-protective nanogel based on fullerenol-cerium oxide composite system
摘要：	目的开发一种兼具物理屏障和化学清除功能的长效光防护纳米凝胶，并评价其性能。方法基于富勒醇-氧化铈纳米复合体系构建由贻贝黏蛋白和透明质酸钠组成的富勒醇-氧化铈纳米凝胶（FCN），并进行表征。采用体外自由基清除实验评价FCN的抗氧化能力；采用防晒指数（SPF）检测仪评价其紫外线屏蔽能力；根据《药品安全性评价指南》要求评价其生物安全性；采用小动物三维活体成像技术评价其皮肤黏附性；采用皮肤防晒伤观察和组织病理学观察评价其防晒伤能力。结果FCN中的氧化铈纳米颗粒和富勒醇纳米颗粒的平均粒径分别约20、10nm，FCN表现出良好的紫外线吸收能力和自由基清除能力。FCN在临界波长370nm处的SPF值为58.95±0.82，紫外线防护等级为6.21±0.15。纳米凝胶中未检出金黄色葡萄球菌等致病菌，铅、砷、汞、镉含量均符合药用辅料标准；FCN组小鼠未出现红斑、水肿、脱屑等刺激性反应，血生化指标均在正常参考范围内。人工汗液冲刷组小鼠的材料清除率不到30%，干态清洁组小鼠的材料清除率约为92%。防护组小鼠在整个实验过程中均未出现明显红斑或形成溃疡；组织病理学观察可见皮肤组织纤维排列有序，胶原纤维数量接近对照组。结论本研究制备的FCN符合《中国药典》相关要求，其安全性和皮肤相容性良好，且实现了紫外线屏蔽、自由基清除双重协同防护。
ABSTRACT：	OBJECTIVE To develop a long-acting light-protective nanogel with both physical barrier and chemical clearance functions， and evaluate its performance. METHODS The photoprotective nanogel composed of mussel mucin and sodium hyaluronate was constructed based on a fullerenol-cerium oxide composite nano system， namely fullerenol-cerium oxide nanogel （FCN）， and was characterized. The antioxidant capacity of FCN was evaluated using in vitro free radical scavenging experiments； its UV shielding ability was assessed by using an SPF value detector； its biosafety was assessed according to the requirements of the Guidelines for Drug Safety Evaluation； skin adhesion was assessed using small animal 3D live imaging technology； its sun protection ability was assessed through skin sunscreen detection and histopathological observation. RESULTS The average particle sizes of cerium oxide and fullerenol nanoparticles in FCN were about 20 and 10 nm， respectively， and FCN exhibited good UV absorption and free radical scavenging abilities. SPF value of FCN was 58.95±0.82， and the ultraviolet A protection level value was 6.21±0.15. No pathogenic colonies such as Staphylococcus aureus， were detected in the nanogel， and the contents of lead， arsenic， mercury and cadmium all met the standards for pharmaceutical excipients； FCN group did not show any irritating reactions such as erythema， edema， or desquamation； blood biochemical indicators of the FCN group were within the normal reference range. The material clearance rate of mice in the artificial sweat flushing group was less than 30%， while the material clearance rate of mice in the dry cleaning group reached about 92%. The mice in the protective group did not show obvious erythema or ulcer formation throughout the experiment. Histopathology showed that the fibers were arranged in an orderly manner， and the number of collagen fibers was close to that of the control group. CONCLUSIONS The FCN formulation constructed in this study meets the relevant requirements of the Chinese Pharmacopoeia， has good safety and skin compatibility， and achieves dual synergistic protection of UV shielding and free radical scavenging.
期刊：	2025年第36卷第17期
作者：	张天龙；刘佳；赵庆；周玥；杨明；罗倩钰
AUTHORS：	ZHANG Tianlong，LIU Jia，ZHAO Qing，ZHOU Yue，YANG Ming，LUO Qianyu
关键字：	纳米凝胶；富勒醇；氧化铈；高原紫外线损伤；抗氧化；光防护
KEYWORDS：	nanogel； fullerenol； cerium oxide； high altitude ultraviolet damage； antioxidant； light protection
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