海洋星虫多糖胶囊的制备及质量控制  

Preparation and quality control of Sipunculus nudus polysaccharide capsules

作　　者：刘玉明[1] 钱甜甜[1] 蒋定文[1] 何颖[1] 沈先荣[1] 江叔奇[2] 

机构地区：[1]海军医学研究所,上海200433 [2]浙江中医药大学,浙江杭州310053

出　　处：《中国海洋药物》2014年第5期71-76,共6页Chinese Journal of Marine Drugs

基　　金：国家科技重大专项新药创制项目(2008ZXJ09004-027)资助

摘　　要：目的探讨海洋星虫多糖胶囊的制备工艺条件,并对其理化性质和质量控制进行研究。方法通过筛选合适的辅料,采用湿法制粒,以颗粒得率、休止角、吸湿性为主要评价指标,以多糖含量作为其质量控制指标。结果采用微晶纤维素作为填充辅料,具有良好的流动性和崩解性,采用80%乙醇作为润湿剂可克服制粒粘性大,难过筛等情况,所制备颗粒流动性能满足生产需要,其多糖含量为标示量的104.7%。结论本研究所制备的胶囊颗粒成型性和流动性好,制备工艺稳定,质量可控,适合于工业化生产,可为海洋星虫多糖胶囊的新药申报提供依据。Objective To study the preparation technology of Sipunculus nudus polysaccharide capsules and to assess the quality of the prepared capsules.Methods Through formulation of capsules including microcry stallin cellulos,magnesium stearate and ethanol,the percentage of qualified granule,angle of repose and hygroscopicity could be considered as screening indexes for the best prescription.Results Microcrystalline cellulose was used as padding accessories for its satisfactory flowability and disintegrability.80%ethanol was used as wetter to overcome pelletization high glutinosity and hard sifting,etc.The content of polysaccharide was labeled amount of 104.7%.Conclusion The granules of capsules prepared in this study have satisfactory moldability and fluidity.The preparation technology is stable and the quality can be controlled,making it suitable for industrial production.Also this study laid the foundation for the new drug application.

关 键 词：海洋星虫多糖 制备工艺 胶囊剂 质量控制 处方筛选 

分 类 号：R285.6[医药卫生—中药学]