【摘要】 目的以较难压缩成型且压缩后表观密度较大的三七粉为模型药物,研究影响中药胃漂浮片漂浮能力的关键因素。方法利用粉体压缩特性分析仪,建立常用辅料应力缓和曲线数据库,比较三七粉的应力缓和曲线与常用辅料曲线的相似度;将质量比不同的十六醇与三七粉混合制粒,比较在相同条件下的压缩功和对应压块的表观密度,筛选出十六醇的最佳用量;通过正交实验设计,比较各种辅料因素对漂浮能力的影响。结果三七粉应力缓和曲线与玉米淀粉最相似;十六醇与三七粉的质量比为1∶20时为最优制粒比例;胃漂浮片中羟丙甲基纤维素(HPMC)用量占总质量的30%以上时,较易形成凝胶骨架;低黏度HPMC、起泡剂中含有NaHCO3有利于漂浮片的溶蚀;制备了5 min内起漂、续漂时间在8~24 h间的胃漂浮片。结论选择合适的凝胶骨架剂、起泡剂,平衡片剂的硬度与密度的矛盾,是成功制备胃漂浮片的关键因素;本研究对中药胃漂浮片制备中辅料的筛选具有一定的借鉴意义。更多还原

【Abstract】 Objective To investigate the key factors influencing floating ability for the gastric-floating tablets of traditional Chinese medicine(TCM).Panax notoginseng(PN) powder was used as a model drug,which is difficult to compress and has heavy compact density.Methods The stress-relaxation curve of PN powder was measured using Micro Powder Characterizer(MPC-100),and compared with that of frequent-using excipients to find out the most similar curve.PN powder was granulated with cetyl alcohol in different concentrations,and the granules were compressed under the same conditions.The optimal ratio of cetyl alcohol to PN powder was determined through the comparison of plastic work during compression and apparent density of the resultant tablets.The effects of different excipients on the gastric-floating ability were investigated by orthogonal experimental design and ocular observation.Results Stress-relaxation curve of PN powder was relatively similar to that of corn starch.The optimal weight ratio of cetyl alcohol to PN was 1 to 20.When the weight of HPMC to all ingredients was over 30%,the tablets were inclined to form gel matrix.HPMC with lower viscosity grade,CaCO3 and NaHCO3 as foaming agent and hydrophobic aiding floating agent redound to the erosion of the floating tablets.PN gastric-floating tablets,which can float within five minutes and maintain floating state in simulated gastric fluids for 8 to 24 h,were successfully prepared.Conclusions The key factor in the preparation of gastric-floating tablets is to balance the contradiction between tablet density and tablet hardness,under the precondition that gel matrix agents and foaming agents are rightly chosen.This study will provide a good reference to design gastric-floating tablets of TCM.更多还原