盐酸多塞平乳膏的经皮渗透性比较研究  

Comparison of transdermal release of doxepin hydrochloride creams

作　　者：张肖玲[1] 张蜀[1] 邓红[1] 林华庆[1] 侯悦翰[1] 

机构地区：[1]广东药学院药物研究所广东省药物新剂型重点实验室,广州510006

出　　处：《中国新药杂志》2013年第4期477-481,共5页Chinese Journal of New Drugs

基　　金：广州市科技局药物制剂关键技术研发及产业化示范项目(2008A1-E4101)

摘　　要：目的:对比两种盐酸多塞平乳膏的体外透皮特性。方法:建立反相高效液相色谱法测定盐酸多塞平含量;以小型猪皮肤为屏障,改良Franz单室扩散池为体外模型,进行体外经皮渗透实验,求算累积透过量,并测定药物在皮肤的贮留量和剩余量。结果:盐酸多塞平检测浓度的线性范围为0.010 01～0.800 8μg(r=0.999 8),方法准确简单,重复性好;两种乳膏24 h内的皮肤透过量接近(尤其是4 h内几乎重合),在皮肤中的贮留量也相近,药物透皮后均未发生构型的转化。结论:预测两种药品的药效和安全性基本一致。Objective： To compare transdermal release cream in vitro. Methods： The penetration experiment in vitro characteristics of two kinds of doxepin hydrochloride with the skin of pig was performed on modified Franz diffusion cells. The amount of penetrated doxepin hydrochloride and the storage capacity in the skin were determined by HPLC, and the steady penetration rate was calculated. Results： The linear range of detection limit for doxepin hydrochloride was 0. 010 01 - 0. 800 8μg （ r = 0. 999 8）. The cumulative permeation amounts as well as dermal loading quantities of the samples were similar within 24 h. The configuration of doxepin hydrochloride did not change after penetration. Conclusion： Two kinds of doxepin hydrochloride creams have same efficacy and safety.

关 键 词：盐酸多塞平乳膏 高效液相色谱法 体外透皮 累积渗透量 安全性 

分 类 号：R971.43[医药卫生—药品] R976[医药卫生—药学]