罗替戈汀压敏胶分散型贴剂的制备及质量评价
发布时间:2018-01-23 20:30
本文关键词: 罗替戈汀 压敏胶分散型贴剂 体外透皮 促透剂 制备 质量评价 出处:《中国医药工业杂志》2015年06期 论文类型:期刊论文
【摘要】:制备了含不同促透剂[月桂氮酮、油酸、N-甲基吡咯烷酮(NMP)、薄荷醇、萜品醇、庚酸薄荷醇酯(M-HEP)或油酸薄荷醇酯(M-OA)]的罗替戈汀压敏胶分散型贴剂。采用双室扩散池,以离体大鼠皮肤为屏障进行体外渗透试验,考察了压敏胶和促透剂的种类及浓度对贴剂中药物渗透行为的影响。结果表明,以丙烯酸树脂压敏胶Duro-Tak 87-2677为基质,3%M-OA与10%NMP联用时贴剂中罗替戈汀的累积透过量较高且无释放时滞。初步稳定性考察结果表明,该制品在30℃、相对湿度60%环境放置6个月,黏附性和透皮性能无显著改变。市售制剂Neupro(规格2.4 mg/10 cm2)和自制品(规格5 mg/10 cm2)的24 h累积透过量为(254.34±46.16)和(499.36±53.27)?g/cm2。
[Abstract]:Different penetration enhancers were prepared. [Cinnamon azone, oleic acid N-methylpyrrolidone, menthol, terpene alcohol. Rotigotin pressure-sensitive adhesive dispersible patch of menthol heptanate (M-HEP) or oleic acid menthol ester (M-OA)]. In vitro osmotic test was carried out by using a double-chamber diffusion cell and isolated rat skin as barrier. The effects of the types and concentrations of pressure sensitive adhesive and permeability enhancer on the drug permeation behavior in the patch were investigated. The results showed that the acrylic resin pressure sensitive adhesive Duro-Tak 87-2677 was used as the matrix. (3) the cumulative transmittance of rotigotin in the patch was higher and there was no release delay when M-OA and 10NMP were used. The preliminary stability test showed that the product was at 30 鈩,
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