| 刘玉明,钱甜甜,蒋定文,等.海洋星虫多糖胶囊的制备及其质量控制△[J].中国海洋药物,2014,33(5):71-76. |
| 海洋星虫多糖胶囊的制备及其质量控制△ |
| Preparation and quality control of Sipunculus nudus polysaccharide capsules |
| 投稿时间：2014-04-08 修订日期：2014-06-04 |
| DOI： |
| 中文关键词: 方格星虫多糖 制备工艺 胶囊剂 质量控制 处方筛选 |
| English Keywords:polysaccharide from Sipunculus nudus preparation technology capsules quality control prescription screening |
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| 中文摘要: |
| 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％乙醇作润湿剂可克服制粒粘性大,难过筛等情况。所制的胶囊流动性能满足生产需要,其多糖含量为标示量的102.2%。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。 |
| English Summary: |
| Objective To study the preparation technique of Sipunculus nudus polysaccharide capsules and to assess the quality of the prepared capsules．Methods Through formulation of capsules including microcrystalline cellulose,magnesium stearate and ethanol．The percentage of qualified granule、angle of repose and hygroscopicity can 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 pelletizations high glutinosity and hard sifting, etc. The content of polysaccharide was labeled amount of 102.2%. Conclusion The granules of capsules prepared in this study have satisfactory moldability and fluidity．The preparation technique 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. |
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