尤特奇 RLPO 基促愈合液体创口贴制备及处方优化

Development and Prescription Optimization of Wound Healing Liquid Band Aid

摘要

为制备兼具快速成膜、良好生物相容性、抑菌与促愈合功能的液体创口贴,以尤特奇 RLPO 为成膜基材,通过单因素试验考察成膜剂、增塑剂及辅料种类与用量,结合响应面法优化处方;对优化后制剂的成膜性能、水蒸气透过率、阻水性、机械强度、抑菌活性、细胞相容性及动物促愈合效果进行系统评价.结果表明:最优处方(质量分数)为 RLPO 40%、柠檬酸三乙酯3%、利多卡因2%、尿囊素0.2%、聚六亚甲基双胍盐酸盐0.3%、苯甲地那铵0.0005%、乙醇54.5%;该液体创口贴可快速成膜(≤60 s),兼具透气防水、柔韧舒适特性,对大肠杆菌与金黄色葡萄球菌具有显著抑制作用,细胞存活率>90%;动物实验显示其刺激性低,可显著加速小鼠皮肤创面愈合,含尿囊素制剂促愈合效果更优.所制备 RLPO 基液体创口贴成膜性好、安全无毒、兼具抑菌与促愈合功能,适用于浅层皮肤损伤护理,具有良好应用前景.但该制剂水蒸气透过率为98 g/(m²·24 h),未达理想范围[100~3300 g/(m²·24 h)],后续可将水蒸气透过率作为关键指标进一步优化处方.

Abstract

This study aims to develop a novel liquid bandage that rapidly forms a protective film, exhibits excellent biocompatibility, and promotes wound healing. Through single-factor experiments, the types and contents of film-forming agents, plasticizers, and other excipients in the liquid bandage were screened. Further optimization of the formulation was conducted using response surface methodology. To validate the performance of the optimized liquid bandage, comprehensive tests were conducted on its water vapor transmission rate, water resistance, mechanical properties, antibacterial activity, biocompatibility, and effect on wound healing in mice. Results show that the optimal formulation for the liquid bandage, derived from the screening process, consisted of EUDRAGIT RLPO 40%, triethyl citrate (TEC) 3%, lidocaine 2%, allantoin 0.2%, polyhexamethylene biguanide hydrochloride (PHMB) 0.3%, and denatonium benzoate 0.0005%. When applied to wounds, it forms a breathable, waterproof, comfortable, and bacteriostatic film. However, during the actual experimental process, the water vapor transmission rate (WVTR) did not reach the desired target. Therefore, WVTR may need to be adopted as an evaluation index for further optimization of the liquid bandage performance.

关键词

液体创口贴 / 尤特奇 RLPO / 聚丙烯酸树脂 / 柠檬酸三乙酯 / 抑菌活性 / 创面愈合

Key words

liquid wound dressing / eudragit / polyacrylic resin / triethyl citrate / antibacterial / wound healing

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