两种型号微晶纤维素对微丸成型的比较研究  

Comparative studies on characteristics of microcrystalline cellulose in pelletization

作　　者：郭金秀[1] 程娟 谢俊 黄春玉 周建平[1] 

机构地区：[1]中国药科大学药剂学教研室,南京210009 [2]南京金陵药业股份有限公司技术中心,南京210009

出　　处：《中国药科大学学报》2014年第5期551-556,共6页Journal of China Pharmaceutical University

摘　　要：以微晶纤维素(MCC)为主要研究对象,探讨适合以挤出滚圆法制备微丸的物料性质以及建立微丸成型性预测指标。选择两种型号的MCC,考察其微观结构;采用液塑限测定仪和物性测试仪分别测试湿软材的液塑限、硬度、黏性、弹性、黏聚性、回弹性等物理性质,考察和比较MCC101与MCC102微观结构、吸水性能、质构特性等。结合挤出滚圆法制丸最优处方,优选出可以表征制剂软材特征物理性质的方法。结果表明二者都具有较好的可塑性与吸水性,而MCC102的多孔性与大孔体积特性,使其具有较强的储水性能。二者的液塑限与质构分析测试参数在各自最优处方含水量下具一致性,其液塑限值都在20%以上,锥入深度、硬度、黏性、黏聚性、弹性和回弹性都分别在3.0~5.0 mm、20 000~30 000 g、-100^-200 g/s、0.3~0.4、0.30~0.35和0.2~0.3之间。因此可以通过液塑限、TPA测试等评价方法对样品的物理性质进行数据化的准确表达,预测是否适合挤出滚圆制丸,从而为微丸制备提供量化指标。To discuss the relativity between properties of microcrystalline cellulose （MCC） and pelletization bythe process of extrusion-spheronization. First, the microstructure of MCC 101 and MCC 102 was observed, then,the liquid-plastic limit of wetting mass by adding water into MCC was tested using measuring apparatus for liquid-plastic limit, and its physical properties, including hardness, adhesiveness, springness, cohesiveness, resilience andso on was tested using texture analyser, to find out the differences between MCC101 and MCC102. The resultsshowed that both MCC have suitable plasticity and water absorbence. MCC102 has stronger water absorption ability,due to its porosity and large pore volume. The statistics of liquid-plastic limits and TPA properties are common inoptimal prescription. Its liquid-plastic limits were above 20 %, and its penetration depth, hardness, adhesiveness,cohesiveness, elasticity, and resilience were in the rage of 3.0-5.0 mm, 20 000-30 000 g, （ - 100） -（ - 200） g/s,0.3-0.55 and 0.2-0.3 . 4, 0.30-0. 35, respectively The physical properties of wet mass can be determined byliquid-plastic limit and TPA, which provide a quantitative index for the pellet preparation.

关 键 词：微晶纤维素 软材 液塑限 质构分析 量化指标 

分 类 号：R944[医药卫生—药剂学]