文章摘要
药用辅料羧甲基纤维素钠物理表征参数研究
Study on physical characterization parameters of sodium carboxymethyl cellulose as pharmaceutical excipient
投稿时间:2019-11-18  修订日期:2020-07-22
DOI:
中文关键词: 羧甲基纤维素钠  物理指纹图谱  粉体性质  质量一致性
英文关键词: sodium carboxymethyl cellulose  physical fingerprints  powder properties  quality consistency
基金项目:国家科技重大新药创制专项
作者单位邮编
张孝娜 中国食品药品检定研究院 100050
孙会敏 中国食品药品检定研究院 
杨锐 中国食品药品检定研究院 
王珏 中国食品药品检定研究院 
丁嘉信 山东绿叶制药有限公司长效和靶向制剂国家重点实验室 
张雪梅 山东绿叶制药有限公司长效和靶向制剂国家重点实验室 
刘万卉 山东绿叶制药有限公司长效和靶向制剂国家重点实验室 
孙考祥* 山东绿叶制药有限公司长效和靶向制剂国家重点实验室 264005
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中文摘要:
      目的:对不同来源的羧甲基纤维素钠物理质量属性进行评价。方法:借鉴中药化学指纹图谱的概念,由松密度、振实密度、粒径<50μm百分比、粉体粒度分布宽度、粉体粒度分布范围、豪斯纳比、休止角、颗粒间空隙率、卡尔指数、干燥失重、吸湿性11个指标作为羧甲基纤维素钠的物理表征参数,并对其进行评价;构建了可压性参数(参数指数、参数轮廓指数和良好可压性指数),预测辅料的压缩特性。结果:不同来源或同一型号不同批次的羧甲基纤维素钠粉体学性质存在明显差异,可压性差异不大。结论:建立的羧甲基纤维素钠物理参数表征方法,可以帮助评价不同来源粉体质量一致性,为辅料质量评价和口服固体制剂处方开发及工艺控制提供新的思路。
英文摘要:
      Abstract Objective: To evaluate the physical quality properties of sodium carboxymethyl cellulose from different sources. Methods: Based on the concept of the chemical fingerprint for quality control of traditional Chinese medicine products, the physical characterization parameters of sodium carboxymethyl cellulose were constructed by 11 indexes including bulk density, tapped density, particles < 50 μm, size distribution width, size distribution range, Hausner ratio, angle of repose, inter-particle porosity, Carr index, loss on drying, hygroscopicity, and evaluate it. Furthermore, compressibility parameters (i.e. index of parameter, index of parametric profile and index of good compression) were constructed to predict the compressibility characteristics of the excipients. Results: There were significant differences in the powder properties of sodium carboxymethyl cellulose from different sources or different batches of the same product and litter differences in compressibility. Conclusion: The established physical parameter characterization method of sodium carboxymethylcellulose is of great importance to evaluate the quality consistency of powder from different sources, and provides new ideas for the quality evaluation of excipients and the development and process control of oral solid preparations.
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