球晶造粒技术制备可直压乙基纤维素及适应性研究  

Adaptability of ethylcellulose for direct compression by spherical crystallization technique

作　　者：高松[1,2] 胡容峰[1,2,3] 白中稳[1,2] 车富强[1,2] 

机构地区：[1]安徽中医学院药学院,安徽合肥230031 [2]安徽省中药研究与开发重点实验室,安徽合肥230038 [3]安徽省"115"现代中药研发创新团队,安徽合肥230038

出　　处：《安徽医药》2011年第7期809-811,共3页Anhui Medical and Pharmaceutical Journal

基　　金：2009年度安徽省高层次人才创新创业资金(No2009Z061);安徽高校省级自然科学研究重点项目(NoKJ2009A112)

摘　　要：目的评价进口、国产乙基纤维素（EC）及球晶技术自制EC聚集体对药物的适应性。方法分别以阿司匹林含量为10%~90%与进口、国产乙基纤维素（EC）及自制EC聚集体混合后直接压片,测定混合物粉体学性质如休止角,流出速度,卡氏指数及压片后的片重差异、脆碎度、硬度,以考察聚集体对药物的稀释潜力。结果与国产及进口乙基纤维素比较,自制聚集体与模型药物混合粉体休止角小、流出速度慢和卡氏指数较小,压片后片重差异及脆碎度小,硬度大。结论球晶造粒技术制备乙基纤维素聚集体具有将良好的流动性传递给高剂量药物的能力,直压性能优于进口辅料,稀释潜力约为50%。Aim To evaluate adaptability of imported,domestic ethylcellulose and self-made ethylcellulose agglomeration by spherical crystallization technique.Methods Different proportion of aspirin（10%~90%）were tableted with three kinds of EC which was made of Shanhe excipient Ltd.,Coloton Ltd.and our lab,respectively.The micromeritics properties of the mixture such as angle of repose,flow velocity,carr＇s index and standard deviation,friability,hardness were determined as to investigate the dilution potential.Results Self-made agglomeration mixed with ASP exhibited the smallest angle of repose,slowest flow velocity and smallest carr＇s index,the standard deviation and friability were smallest and hardness were big after direct compressioin,compared with the other two.Conclusion Compared with the other two,ethylcellulose agglomeration made by spherical crystallization has good flowability which could be transferred to the high doses of the drug,with a dilution potential of about 50%.

关 键 词：乙基纤维素 阿司匹林 球晶造粒 流动性 稀释潜力 

分 类 号：TQ460.4[化学工程—制药化工]