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目的:制备右旋酮洛芬氨丁三醇水凝胶贴剂,优化其处方并评价其体外透皮性能。方法:选择NP-800为水凝胶骨架材料,甘羟铝为交联剂,EDTA为交联剂调节剂,甘油为保湿剂,制备右旋酮洛芬氨丁三醇水凝胶贴剂,以初黏力、持黏力、剥离强度和12 h累积透皮量为评价指标,进行正交优化试验,筛选出最佳处方。用改良的Franz扩散池进行透皮吸收试验,比较氮酮、油酸及薄荷脑对贴剂中右旋酮洛芬氨丁三醇的促渗作用。结果:优选的最佳处方为:NP-800、甘羟铝、甘油、EDTA的质量百分含量分别为5%、0.3%、25%、0.15%。透皮促进剂对右旋酮洛芬氨丁三醇有透皮作用,其中以3%氮酮的作用最显著,其促渗倍数达3.26倍。结论:制备的右旋酮洛芬氨丁三醇水凝胶贴剂处方工艺稳定,合理可行。
OBJECTIVE: To prepare dexketoprofen tromethamine hydrogel patch, optimize its formulation and evaluate its in vitro transdermal performance. Methods: NP-800 was selected as the hydrogel matrix material, glycidyl aluminum as crosslinking agent, EDTA as crosslinking agent regulator, glycerol as humectant, dexketoprofen trometamol hydrogel patch preparation, The initial viscosity, the holding capacity, the peel strength and the cumulative transdermal volume for 12 h were used as evaluation indexes to conduct the orthogonal optimization test, and the best prescription was screened out. Transdermal absorption test was performed with a modified Franz diffusion cell to compare the effects of Azone, oleic acid and menthol on the dexketoprofen tromethamine in the patch. Results: The optimal prescription was NP-800, Ca (OH) 3, glycerol and EDTA with the mass percentages of 5%, 0.3%, 25% and 0.15%, respectively. Transdermal enhancers have a transdermal effect on dexketoprofen trometamol, among which the effect of 3% Azone is the most significant, and the multiplication factor is 3.26 times. Conclusion: The formulation of dexketoprofen trometamol hydrogel patch preparation is stable, reasonable and feasible.