目的 设计一种更适宜皮肤局部给药系统的体外研究的质量守恒方法.方法 对甲硝唑(MTZ)凝胶剂进行体外透皮渗透试验,分别用无毛小鼠离体皮肤、猪离体皮肤作为透皮模型,在不同时间点(1,2,4,8,12,16,20,24 h)检测甲硝唑在皮肤表面残留、角质层、活性表皮/真皮层、接受液4层中的药物含量,并计算其回收率.结果 用无毛小鼠离体皮肤作为透皮模型,给予不同处方量时甲硝唑的回收率均在80％以上,每组试验数据的RSD均在15％以下.用猪皮作为透皮模型,给予不同处方量时甲硝唑的回收率均高于85％,每组试验数据的RSD均在15％以下.结论 此质量守恒方法回收率高,重现性好,适宜不同皮肤模型,可应用于局部给药系统.%Objective To design a mass conservation method suitable for the in vitro research of topical drug delivery system. Methods Metronidazole (MTZ) gel was performed on the in vitro transdermal penetration test in hairless detached mouse skin and pig skin models respectively. The metronidazole contents on the skin surface residual, stratum corneum, active epidermis/dermis, receptor medium at the different time points (1, 2, 4, 8, 12, 16, 20, 24 h) were detected and the recovery rate was calculated at each time point. Results Using the hairless mouse skin as the transdermal model, the recoveries at different doses were more than 80%, RSD of the experimental data in each group were lower than 15%. Using the pig skin as the transdermal model, recoveries at different doses were more than 85% , RSD of the experimental data in each group were lower than 15%. Conclusion The mass conservation method has the high recovery rate and good reproducibility and is suitable for different skin models, which can be used in the topical drug delivery systems.
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