药用辅料羧甲基纤维素钠物理表征参数研究  

Study on the Physical Characterization Parameters of Sodium Carboxymethyl Cellulose as Pharmaceutical Excipient

作　　者：张孝娜 孙会敏[2] 杨锐[2] 王珏[2] 丁嘉信 张雪梅 刘万卉[1,3] 孙考祥 Zhang Xiaona;Sun Huimin;Yang Rui;Wang Jue;Ding Jiaxin;Zhang Xuemei;Liu Wanhui;Sun Kaoxiang(Key Laboratory of Molecular Pharmacology and Drug Evaluation,Ministry of Education,Collaborative Innovation Center of Shandong Universities for the Research of New Preparations and Biotech Drugs(Yantai University),Yantai 264005,China;NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients,National Institutes for Food and Drug Control,Beijing 100050,China;State Key Laboratory of Long-Acting and Targeted Preparations,Shandong Luye Pharmaceutical Co.,Ltd,Yantai 264005,China)

机构地区：[1]烟台大学新型制剂与生物技术药物研究山东省高校协同创新中心、分子药理和药物评价教育部重点实验室(烟台大学),烟台264005 [2]中国食品药品检定研究院国家药品监督管理局药用辅料质量研究与评价重点实验室,北京100050 [3]山东绿叶制药有限公司长效和靶向制剂国家重点实验室,烟台264005

出　　处：《中国药事》2020年第8期925-933,共9页Chinese Pharmaceutical Affairs

基　　金：国家科技重大新药创制专项“药物一致性关键技术与标准研究”子课题六《药用辅料关键质量属性的评价技术与功能性指标数据库的建立》(编号2017ZX09101-001-006)。

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,可以用于评价不同来源粉体的质量一致性,为药用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。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,percentage of particles<50μm,width and range of particle size distribution,Hausner ratio,angle of repose,inter-particle porosity,Carr index,loss on drying and hygroscopicity.After the parameters had been evaluated,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 in different sources or different batches of the same product,and there was little difference 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 the method provides new ideas for the quality evaluation of pharmaceutical excipients and the development and processing control of oral solid preparations.

关 键 词：羧甲基纤维素钠 物理表征参数 粉体性质 质量一致性 

分 类 号：R94[医药卫生—药剂学] R95[医药卫生—药学]