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目的 :制备环吡酮胺涂膜剂 ,研究其透皮吸收性能。方法 :用加速试验法研究环吡酮胺涂膜剂的热稳定性动力学 ,以双室渗透扩散装置进行环吡酮胺体外渗透试验。结果 :试验结果表明 ,环吡酮胺涂膜剂降解反应为一级动力学过程 ,预测其有效期为 2年。其体外透皮释药方程为Q =6 3 .15 41t- 6 0 .72 99(r =0 .9940 ) ,8h累积渗透量为 5 0 5 .2 3μg·cm-2 。结论 :环吡酮胺涂膜剂为一种新颖的控释型外用制剂。涂膜剂中的环吡酮胺以零级动力学经皮渗透。
OBJECTIVE: To prepare ciclopirox olamine coated film and study its transdermal absorption properties. Methods: The kinetics of thermostability of ciclopirox olamine coated film was studied by accelerated test. The in vitro permeation test of ciclopirox olamine was carried out with dual chamber osmotic diffusion device. Results: The results showed that the degradation reaction of ciclopirox olamine film was a first-order kinetic process and its expiration date was predicted to be 2 years. The in vitro transdermal drug delivery equation was Q = 6 3 .15 41t-6 0 .72 99 (r = 0.9940). The cumulative permeation volume was 8 0 5 .2 3 μg · cm-2 in 8h. Conclusion: Ciclopirox olamine is a novel controlled release topical preparation. Ciclopirox olamine in the film coating transdermally penetrates with zero-order kinetics.