不同孔体积微丸的制备及其物理特性与压缩特性的研究  

Preparation of Pellets with Different Porosity and Characterization of Physical Properties and Compressibility

作　　者：陈盛君[1] 朱家壁[2] 祁小乐[2] 

机构地区：[1]江阴天江药业有限公司,江苏江阴214434 [2]中国药科大学药物制剂研究所,南京210009

出　　处：《中国药学杂志》2009年第2期124-127,共4页Chinese Pharmaceutical Journal

基　　金：国家自然科学基金资助项目(30672549)

摘　　要：目的制备不同孔体积微丸,并考察其物理特性和压缩特性。方法不同体积比的乙醇-水作黏合剂,采用挤出-滚圆工艺制备具有不同孔体积的微丸,并测定微丸的物理性质,采用压缩度和抗张强度-压力曲线表征微丸的压缩特性。结果以3种比例乙醇-水溶液做黏合剂,采用挤出-滚圆法制备不同孔体积微丸,且微丸流动性良好,随着黏合剂中乙醇用量增加,微丸内孔体积增加,抗张强度减小;高孔体积微晶纤维素微丸可压缩性较低孔体积微丸好,3种孔体积的磷酸二氢钙-微晶纤维素(4∶1)微丸可压缩性均较好,且三者没有明显差异,3种孔体积的乳糖-微晶纤维素(4∶1)微丸可压缩性也较好,且差异也不明显。结论所制备的高孔体积微晶纤维素、3种孔体积磷酸二氢钙-微晶纤维素(4∶1)微丸、3种孔体积乳糖-微晶纤维素(4∶1)微丸可压性较好,为多单元片剂的制备提供科学参考。OBJECTIVE To prepare pellets with different porosity and study its physical properties and compressibility. METHODS Three volume ratios of ethanol to water were used as binder agent to prepare different types of pellets in an extrusion- spheronizator. The flowability of pellets was characterized by Hausner ratio and the internal pore volume of pellets was determined by a specific surface area analyzer. The mechanical properties of different porosity pellets were determined on a stress force determinator. And the tensile strength of tablets vs. compression force plots and the compression degree were employed to characterize the compressibility of different pellets. RESULTS Different porosity of pellets was obtained and the flowability of pellets was good. With increasing ratios of ethanol to water, the internal pore volume of pellets made up of microcrystalline cellulose was increased and the compressibility was improved. The mechanical properties of microcrystalline cellulose pellets decreased when the content of ethanol increased, The compressibility of different porosity ofpeUets made up of calcium phosphate ： microcrystalline cellulose （4：1,w/w） or lactose： microerystalline cellulose （4：1, w/w） was good, however, they were not significantly different. CONCLUSION Several types of pellets with good compressibility were prepared.

关 键 词：挤出-滚圆工艺 微丸内孔体积 微丸抗张强度 压缩特性 压缩度 抗张强度-压力曲线 

分 类 号：R944[医药卫生—药剂学]