Shi Gaofeng, Guo Yun, Yang Minlie
Burn and Trauma Treatment Center, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.
Front Cell Infect Microbiol. 2025 Jul 22;15:1640799. doi: 10.3389/fcimb.2025.1640799. eCollection 2025.
This study aimed to develop and evaluate SabiWhite-loaded ethosomes (SW-ETH) for topical application, focusing on improving stability, biocompatibility, and therapeutic efficacy. Ethosomal formulations are known for their enhanced drug delivery properties, making them suitable for skin inflammation.
The SW-ETH formulations were developed utilizing an adapted cold preparation technique. A 3² factorial design was used to optimize phospholipid concentration and ethanol content, and their impact on vesicle size and entrapment efficiency (EE%) was assessed. Structural characterization of SabiWhite was performed using melting point determination, Fourier-Transform Infrared Spectroscopy (FTIR), and X-ray Diffraction (XRD). drug release was assessed using a Franz diffusion cell, and anti-inflammatory and skin irritation studies were performed on Wistar rats.
SabiWhite exhibited a melting point of 96°C and characteristic FTIR peaks, confirming its identity and purity. XRD analysis revealed its crystalline nature, while ethosomal formulations showed a shift to an amorphous state. The optimized SW-ETH formulation (SW-ETH 6) had a vesicle size of 184.4 nm, an EE% of 92.5%, and a zeta potential of -13.50 mV, indicating stable and uniform vesicles. drug release from SW-ETH 6 showed a sustained release profile with 93.12% drug release over 24 hours. , SW-ETH demonstrated significant anti-inflammatory effects with 36.17% edema inhibition at 150 minutes, comparable to Diclofenac gel (41.92%). No skin irritation was observed, and the formulation was classified as non-irritant. Stability tests confirmed minimal changes in appearance, viscosity, and drug content over 120 days at different storage conditions.
SW-ETH demonstrated effective drug encapsulation, enhanced anti-inflammatory activity, and excellent biocompatibility, making it a promising candidate for topical therapy. Further clinical validation is warranted to confirm its therapeutic potential.
本研究旨在开发并评估用于局部应用的载有萨比怀特（SabiWhite）的乙醇脂质体（SW-ETH），重点在于提高其稳定性、生物相容性和治疗效果。乙醇脂质体制剂以其增强的药物递送特性而闻名，使其适用于皮肤炎症。
采用改良的冷制备技术开发SW-ETH制剂。使用3²析因设计优化磷脂浓度和乙醇含量，并评估它们对囊泡大小和包封率（EE%）的影响。通过熔点测定、傅里叶变换红外光谱（FTIR）和X射线衍射（XRD）对萨比怀特进行结构表征。使用Franz扩散池评估药物释放，并在Wistar大鼠上进行抗炎和皮肤刺激性研究。
萨比怀特的熔点为96°C，并具有特征性的FTIR峰，证实了其身份和纯度。XRD分析揭示了其晶体性质，而乙醇脂质体制剂显示出向无定形状态的转变。优化后的SW-ETH制剂（SW-ETH 6）的囊泡大小为184.4 nm，EE%为92.5%，ζ电位为-13.50 mV，表明囊泡稳定且均匀。SW-ETH 6的药物释放显示出持续释放曲线，24小时内药物释放率为93.12%。此外，SW-ETH在150分钟时表现出显著的抗炎作用，水肿抑制率为36.17%，与双氯芬酸凝胶（41.92%）相当。未观察到皮肤刺激，该制剂被归类为无刺激性。稳定性测试证实，在不同储存条件下120天内，外观、粘度和药物含量的变化极小。
SW-ETH显示出有效的药物包封、增强的抗炎活性和优异的生物相容性，使其成为局部治疗的有前景的候选者。需要进一步的临床验证来确认其治疗潜力。
