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目的:探讨功效函数法在透皮吸收促进剂促透效果综合评价中的应用。方法:在双室透皮扩散装置上进行离体动物皮肤透皮吸收实验,不同时间取样,测定薄荷醇与月桂氮卓芯酮单用及联用组接受液中双氯芬酸钠的浓度,计算稳态流量、渗透系数和滞后时间3个指标,采用功效函数法进行多指标的综合评价,依据指标的权重,计算各方案的综合权值并进行比较,其值最大的为最优方案。结果:不同组别的稳态流量和渗透系数相比较,其顺序依次为1%月桂氮芯卓酮>2%薄荷醇>1%薄荷醇>1%月桂氮芯卓酮+1%薄荷醇>1%月桂氮芯卓酮+2%薄荷醇>无促透剂组;而不同组别的时滞比较,其顺序依次为无促透剂组>1%月桂氮卓芯酮+1%薄荷醇>1%月桂氮芯卓酮+2%薄荷醇>1%月桂氮卓芯酮>2%薄荷醇>1%薄荷醇。功效函数法算得的最优组方为1%月桂氮卓芯酮。结论:功效函数法可作为促透剂综合评价的一种新方法。
Objective: To investigate the application of the efficacy function method in the comprehensive evaluation of the transdermal absorption enhancer penetration effect. Methods: Percutaneous transdermal absorption test of ex vivo animal skin was performed on a dual-chamber transdermal diffusion device. Samples were taken at different time intervals to determine the concentration of diclofenac sodium in the liquid of menthol and azithromycin alone and in combination. The steady-state Flow rate, permeability coefficient and lag time of the three indicators, the use of Efficacy Function method for multi-index comprehensive evaluation, based on the index weight, calculate the comprehensive weight of each program and compare the value of the maximum for the optimal program. Results: The steady state flow rate and permeability coefficient of different groups were compared as follows: 1% lauroxine> 2% menthol> 1% menthol> 1% lauroxadone + 1% menthol> 1% lauroxazolinone + 2% menthol> non-permeation enhancer group, while the order of delay in different groups was as follows: non-enhancing agent group> 1% azithromycin + 1% menthol > 1% Azithromycin + 2% Menthol> 1% Azithromycin> 2% Menthol> 1% Menthol. Efficacy function method of calculating the optimal formula is 1% azithromycin Zhuozhu ketone. Conclusion: The Efficacy Function Method can be used as a new method for the comprehensive evaluation of BTEs.