羧甲基纤维素钠质量一致性评价及性能参数智能可视化研究  

Quality consistency evaluation and intelligent visualization of performance parameters of carboxymethylcellulose sodium

作　　者：张孝娜 孙会敏[2] 王珏[2] 杨锐[2] 张雪梅 刘万卉 丁嘉信 戴传云[4] 孙考祥[1,3] ZHANG Xiao-na;SUN Hui-min;WANG Jue;YANG Rui;ZHANG Xue-mei;LIU Wan-hui;DING Jia-xin;DAI Chuan-yun;SUN Kao-xiang(Key Laboratory of Molecular Pharmacology and Drug Evaluation(Yantai University),Ministry of Education,Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong,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 Targeting Drug Delivery System,Shandong Luye Pharmaceutical Co.,Ltd.,Yantai 264003,China;Institute of Biotechnology and Pharmaceutical Engineering Technology,Chongqing University of Science and Technology,Chongqing 401331,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),山东烟台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,山东烟台264003 [4]重庆科技学院生物与制药工程技术研究院,重庆401331

出　　处：《药学学报》2020年第8期1923-1931,共9页Acta Pharmaceutica Sinica

基　　金：国家科技重大新药创制专项(2017ZX09101-001-006)。

摘　　要：本文通过物理指纹图谱、多元分析方法评价不同来源羧甲基纤维素钠质量一致性,用R语言可视化功能探索了其性能参数之间的内在联系,并绘制自变量与粉体流动性的等高线图,求得设计空间。通过物理指纹图谱及多元分析方法,发现不同来源的羧甲基纤维素钠粉体学性质存在差异,其含水量、松密度及振实密度对流动性影响较大。运用R智能可视化分析得出样品流动性与填充性呈正相关,与可压性呈负相关,且具有统计学意义(P<0.01)。在休止角为30°~40°时,确定了合适的设计空间,即5.0922%<含水量<7.0067%、0.5602 g·cm^-3<松密度<0.5799 g·cm^-3、0.6463 g·cm^-3<振实密度<0.8165 g·cm^-3。结果表明,运用物理指纹图谱、多元分析及可视化方法对药用辅料质量一致性进行评价是科学可行的,为辅料生产、质量评价及仿制药处方开发提供了新的思路。In this study,physical fingerprint and multivariate statistical analysis was applied to characterize the quality consistency of different sources of carboxymethylcellulose sodium,and the visualization of R language was used to explore the intrinsic correlation on its performances,and we drew contour maps between independent variables and flowability of powder to find the design space.Through the physical fingerprint and multivariate statistical analysis,it was found that there were differences in the powder properties of carboxymethylcellulose sodium from different sources,and its moisture content,bulk density and tapped density have a great influence on the fluidity.The fillibility was positively correlated with flowability,both negatively correlated with compressibility by R intelligent visualization analysis,which was statistically significant(P<0.01).When the angle of repose is30°^-40°,the appropriate design space was found as 5.0922%<moisture content<7.0067%,0.5602 g·cm^-3<bulk density<0.5799 g·cm^-3,and 0.6463 g·cm^-3<tapped density<0.8165 g·cm^-3.The results show that it is scientific and feasible to evaluate the quality consistency of pharmaceutical excipients by using the physical fingerprint,multivariate statistical analysis and visualization methods,which provides new ideas for the production and quality evaluation of excipients and the development of generic prescriptions.

关 键 词：羧甲基纤维素钠 质量评价 指纹图谱 多元分析法 数据可视化 

分 类 号：R943[医药卫生—药剂学]