【作者】 张雪； 洪燕龙； 鲜洁晨； 冯怡； 徐德生； 阮克锋；

【Author】 ZHANG Xue;HONG Yan-long;XIAN Jie-chen;FENG Yi;XU De-sheng;RUAN Ke-feng;Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine;Engineering Research Center of Modern Preparation Technology of Zhangjiang;Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine;

【机构】 上海张江中药现代制剂技术工程研究中心； 上海中医药大学 中药现代制剂技术教育部工程研究中心； 上海中医药大学附属曙光医院；

【摘要】 目的对挤出滚圆法制备微丸中软材物理性质的表征及其对微丸成型性影响的研究进行文献综述,以期为深入研究软材的物理性质及其对微丸成型性的影响,制备高载药量、高质量的微丸提供参考。方法通过查阅近年来国内外关于软材性质的表征及其影响作用的相关文献,进行详细的归纳分析和总结。结果与结论以保水性、表面粗糙程度、粒径、饱和度特征及混合转矩流变性等对软材性质进行表征,参数较单一,缺乏对软材整体系统的评价。而物性测试仪不仅可以多指标测定软材的特征物理性质包括硬度、黏附性、弹性、内聚性、咀嚼性及回复性参数,综合评价软材的性质,而且能够将适宜软材所具备的塑性及内聚性等性质特点进行量化,进而可以预测微丸的成型性,为制备高质量微丸特别是高载药量中药微丸打下基础。更多还原

【Abstract】 OBJECTIVE To investigate the physical properties of wet mass in pellets by extrusioin-spheronization and the effects on formability of pellets,so that a reference can be given for in-depth study with the effects of wet mass on pellet formability,and production of pellets with high drug loading and high quality.METHODS Literatures at home and abroad on the characterization of wet mass and the factors on pellets were summarized and analysized in detials.RESULTS AND CONCLUSIONS Different methods for characterizing wet mass such as water content,surface rounghness,size,hydro-textural characterisation and mixer torque properties only have single parameter without systematic evaluation.While TA texture as a tool for studying wet mass in extrusion spheronization can evaluate wet mass with multi-parameters including hardness,adhesiveness,springiness,cohesiveness,chewiness and resilience.The more we learn about wet mass,the more easily we can do to control the quality of pellets and the effective methods can be found for pellets with high drug loading.更多还原