NMR技术测定PVPP交联度及其粉体可压缩性研究  

Study on the cross-linking degree of PVPP by NMR technology and its powder compressibility

作　　者：王珏[1,2] 胡丽 武美芹 杨锐[1] 孙会敏[1] 涂家生[2] WANG Jue;HU Li;WU Mei-qin;YANG Rui;SUN Hui-min;TU Jia-sheng(NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients,National Institutes for Food and Drug Control,Beijing 100050,China;NMPA Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients,China Pharmaceutical University,Nanjing 210009,China;Chengdu Suncadia Medicine Co.,Ltd.,Chengdu 610000,China)

机构地区：[1]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 [2]中国药科大学,国家药品监督管理局药物制剂及辅料研究与评价重点实验室,江苏南京210009 [3]成都盛迪医药有限公司,四川成都610000

出　　处：《药学学报》2022年第2期474-479,共6页Acta Pharmaceutica Sinica

基　　金：国家科技重大新药创制专项(2017ZX09101001006)。

摘　　要：本文采用低场核磁共振技术Carr-Purcell-Meiboom-Gill(CPMG)回波法测定了不同厂家交联聚维酮(crospovidone,PVPP)的交联度和交联密度,在交联聚维酮7个物理属性基础上建立了20个二级质量指标的物理指纹图谱,通过指纹图谱计算得到3个可压性评价指标:参数指数(index of parameter,IP)、参数轮廓指数(index of parametric profile,IPP)、良好可压性指数(index of good compression,IGC)。相关性分析发现交联聚维酮的交联度与可压性指标IP的相关性系数为0.816,呈现强相关性,表明交联聚维酮的交联度是影响其可压性的重要质量指标之一。In this paper,the low-field nuclear magnetic resonance technology CPMG(Carr-Purcell-MeiboomGill)echo method was used to determine the cross-linking degree and cross-linking density of crospovidone(PVPP)from different manufacturers.Based on the seven physical properties of PVPP,a fingerprint spectrum(radar chart)of twenty secondary quality indicators were obtained,and three compressibility evaluation indicators,index of the parameter(IP),index of parametric profile(IPP),index of good compression(IGC)were calculated by the fingerprint spectrum.It was found that the cross-linking degree and compressibility index IP of PVPP showed a strong correlation(r=0.816)by the correlation analysis,indicating that the cross-linking degree is one of the key quality attributes for evaluating the compressibility of PVPP.

关 键 词：交联聚维酮 交联度 交联密度 核磁共振 可压性 物理指纹图谱 

分 类 号：R917[医药卫生—药物分析学]