姜黄素微乳凝胶皮肤刺激性及质量评价  

Evaluation of skin irritation and quality of curcumin microemulsion gel

作　　者：高杏翠 韩笑 高旭辉 杜艳[1] 李建宽[1] GAO Xingcui;HAN Xiao;GAO Xuhui;DU Yan;LI Jiankuan(Department of Traditional Chinese Medicine,Shanxi Medical University,Taiyuan 030001,China)

机构地区：[1]山西医科大学药学院中药教研室,太原030001

出　　处：《山西医科大学学报》2025年第3期294-298,共5页Journal of Shanxi Medical University

基　　金：山西省研究生教育教学改革项目(2024JG089);山西省研究生实践创新项目(2024SJ184)。

摘　　要：目的通过考察姜黄素微乳凝胶的皮肤刺激性及质量,探讨其局部外用给药的可行性。方法制备姜黄素微乳凝胶,采用高效液相色谱仪测定姜黄素微乳凝胶中姜黄素的含量。家兔皮肤刺激性实验考察姜黄素微乳凝胶对正常皮肤和破损皮肤的影响。考察姜黄素微乳凝胶体外释放特性、黏度、稳定性、稳定性影响因素进行质量评价。结果姜黄素微乳凝胶中姜黄素的含量为(4.96±0.10)mg/g。姜黄素微乳凝胶对兔子正常皮肤和破损皮肤均无明显的刺激性。所得姜黄素微乳凝胶的稳态渗透速率为(8.40±0.58)μg/(cm^(2)·h),24 h单位面积累积透皮渗透量为(139.28±6.93)μg/cm^(2)。姜黄素微乳凝胶黏度为(7209±94.87)mPa·s,其稳定性良好。稳定性影响因素试验表明,与第0天相比,第5天和第10天姜黄素微乳凝胶在高温、高光、高湿条件下的含量显著降低。结论姜黄素微乳凝胶无皮肤刺激性,透皮性能良好,质量符合要求,有望成为姜黄素新型给药制剂。该制剂需要常温、避光、密封保存。Objective To explore the possibility of curcumin microemulsion gel for topically external administration based on skin irritation and quality evaluation.Methods The curcumin microemulsion gel was prepared and the content of curcumin in curcumin microemulsion gel was determined by high performance liquid chromatography.The effects of curcumin microemulsion gel on normal skin and damaged skin were investigated in rabbit skin irritation experiment.The in vitro release characteristics,viscosity,stability and stability-influencing factors of curcumin microemulsion gel were investigated for quality evaluation.Results The content of curcumin in curcumin microemulsion gel was(4.96±0.10)mg/g.Curcumin microemulsion gel had no obvious irritation to rabbit normal skin and damaged skin.The steady penetration rate of curcumin microemulsion gel was(8.40±0.58)μg/(cm^(2)·h),and the cumulative transdermal penetration per unit area in 24 h was(139.28±6.93)μg/cm^(2).The viscosity of curcumin microemulsion was(7209±94.87)mPa·s,and the stability was good.The stability-influencing factor test showed that compared with day 0,the contents of curcumin microemulsion gel at day 5 and day 10 were significantly reduced under the conditions of high temperature,high light and high humidity.Conclusion Curcumin microemulsion gel has no skin irritation,and the transdermal performance is good.Curcumin microemulsion gel meets the quality requirements and is promising as a new drug delivery formulation.The preparation should be stored at room temperature,away from light and sealed.

关 键 词：姜黄素 微乳凝胶 皮肤刺激性 质量评价 稳定性 

分 类 号：R94[医药卫生—药剂学]