【摘要】 制备了褐藻多糖硫酸酯(FPS)的缓释片,并对其释放特性进行考察。以羟丙基甲基纤维素(HPMC)、羧甲基纤维素钠(CMC-Na)和十八醇为骨架材料,采用湿法制粒制备FPS缓释片,并用响应面法优化其处方,通过测定SO2-4的含量来评价FPS缓释片的体外释放度。响应面优化结合实际,FPS缓释片的最优处方为FPS占片重的41%,HPMC-K4M、CMC-Na、十八醇、乳糖、硬脂酸镁分别占片重的20%、20%、13%、5%和1%;此处方下制备的缓释片2,6,12h可分别释放药物32%、64%和92%,体外药物释放行为符合一级模型,并以Fick扩散和骨架溶蚀2种机制协同作用释放药物。通过响应面优化得到了最优处方,最优处方下制备的FPS缓释片体外缓释效果良好。更多还原

【Abstract】 To prepare FPS sustained-release tables and evaluate its release characteristics in vitro.FPS sustained-release tables were prepared by wet granulation,using HPMC,CMC-Na and octadecanol as matrix materials and prescription was optimized by the response surface design;the release of FPS sustained-release tables was determined by determining the amount of SO2-4.Under the response surface optimization combined with practice,the optimum prescription was determined as follows:The weight percents of FPS,HPMC,CMC-Na,octadecanol,lactose and magnesium stearate were 41%,20%,20%,13%,5% and 1% respectively.The cumulative release value of the active drug was 32%,64% and 92% respectively in the 2,6 and 12 h.Our data illustrated that the drug release behavior of the tablets is line with the first-order release pattern and the drug is released driven by a combination of Fick diffusion and skeletal dissolution effects.Under the best prescription,the release characteristics of FPS in vitro are satisfactory.更多还原