盐酸多塞平乳膏人体透皮吸收试验

Experiment of Percutaneous Absorption of Doxepin Cream in Human Body

目的 :比较进口与国产5 %盐酸多塞平乳膏的人体透皮吸收效果。方法 :采用高效液相色谱法测定血药浓度 ,8位健康男性受试者按交叉试验设计 ,以进口的5 %盐酸多塞平乳膏为对照品 ,对比研究国产5 %盐酸多塞平乳膏的人体透皮吸收效果。结果 :连续8d于受试者前臂皮肤涂抹相同剂量的盐酸多塞平乳膏试验品和对照品后进行测定 ,两组血药浓度均较低 ,无显著性差异。结论 :国产5 %盐酸多塞平乳膏的人体透皮吸收效果可达国外同类品种水平 ,且安全。

OBJECTIVE:To compare the percutaneous absorbency between imported and domestic5%doxepin cream.METHODS:In a cross design,8health male volunteers were enrolled in the study.Determination was performed by HPLC with chlorimipramine as internal standard.RESULTS:The same dose of domestic and imported doxepin cream was topically applied to the forearm skin of the volunteers for8consecutive days.The blood drug levels were very low in both groups without significant difference.CONCLUSION:The percutaneous absorbency of domestic5%doxepin cream can reach that of imported ones and the domestic cream is safe and effective.