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目的制备盐酸布替萘芬微乳温敏凝胶,并对其质量进行评价。方法以油酸乙酯为油相,聚山梨酯80为乳化剂,无水乙醇为助乳化剂,泊洛沙姆188和407为温敏材料,制备对体表温度敏感的微乳凝胶,并对其形态、粒径、稳定性进行考察,和市售乳膏进行透皮吸收速度和皮内滞留量的对比。结果微乳凝胶最终处方为:油酸乙酯-聚山梨酯80-无水乙醇-P407-P188-纯化水=4∶15∶10∶16.33∶5.68∶71。所得的微乳为水包油型,透射电镜下乳滴呈圆球形,平均粒径91.03 nm,PDI为0.246,自制微乳凝胶透皮速度较市售乳膏快,皮肤内药物滞留量为市售乳膏的5倍。结论该实验制备得到的温敏微乳凝胶具有良好的温度敏感性和透皮滞留效果,能够以较快速度进入皮肤内层形成药物贮库,提高局部药物浓度,增强抗菌效果。
OBJECTIVE To prepare butenafine hydrochloride microemulsion temperature-sensitive gel and evaluate its quality. Methods Ethyl oleate as the oil phase, polysorbate 80 as emulsifier, ethanol as co-emulsifier, poloxamer 188 and 407 as temperature-sensitive materials to prepare surface temperature-sensitive microemulsion gel, The morphology, particle size and stability of the creams were compared with those of the commercially available creams. Results The final formulation of microemulsion was: ethyl oleate-polysorbate 80-absolute ethanol-P407-P188-purified water = 4:15:10:16.33:5.68:71. The obtained microemulsion was oil-in-water, and the droplet was spherical under the transmission electron microscope. The mean particle diameter was 91.03 nm and the PDI was 0.246. The self-made microemulsion gel transdermally faster than the commercially available cream. The drug retention in the skin was Five times the cream on the market. CONCLUSION The temperature-sensitive microemulsion gel prepared in this experiment has good temperature sensitivity and transdermal retention effect. It can enter into the inner layer of the skin to form a drug reservoir at a faster speed, increase the local drug concentration and enhance the antibacterial effect.