尼古丁缓释贴剂的制备及体外透皮释药评价  

Study on preparation and in vitro release characteristics of nicotine sustained-release patch

作　　者：刘文静[1] 魏玉辉[1] 宋玉琴[1,2] 武新安[1] 

机构地区：[1]兰州大学第一医院药剂科,兰州730000 [2]淄博市药品检验所,淄博255000

出　　处：《中国新药杂志》2009年第8期755-758,768,共5页Chinese Journal of New Drugs

摘　　要：目的:制备尼古丁缓释贴剂并研究其体外释药性能及透皮吸收行为。方法:采用饱和水溶液法制备尼古丁-β-环糊精包合物,以水溶性高分子材料为基质制备尼古丁缓释贴剂,采用高效液相色谱法测定制剂中尼古丁的含量。利用Franz扩散池研究贴剂的透皮释药行为。结果:尼古丁经β-环糊精包合后,采用聚丙烯酸树脂EUDRAGIT E100为控释骨架和压敏胶材料,制备的尼古丁缓释贴剂体外释药行为符合Higuchi方程,且释药速率可通过改变促透剂的用量来进行调控。结论:所制备的尼古丁贴剂具有缓释作用。Objective：To prepare nicotine patch and study its in vitro release characteristics. Methods： The inclusion complex was prepared by solution stirring method and nicotine patch was prepared with high polymer hydrophilic material as matrix. The determination method of nicotine was established by HPLC. The percutaneous absorption of nicotine patch was evaluated with the Franz diffusion cell. Results： The optimal combination of the formulation included EUDRAGIT E100 as the pressure sensitive adhesive and propylene glycol acted as the enhancer. The release mechanism of nicotine patch in vitro coincided with Higuchi Equation and the release rate was controlled by the dose of penetration. Conelusion： Nicotine patch is a sustained-release TDDS whose permeation speed is limited by skin.

关 键 词：尼古丁 缓释贴剂 Β-环糊精 HPLC 

分 类 号：R943.41[医药卫生—药剂学]