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2208型羟丙甲纤维素功能性相关指标的考察与主成分分析
引用本文:邓文斌,潘昊,李云建,乔森,周晓彤,潘卫三. 2208型羟丙甲纤维素功能性相关指标的考察与主成分分析[J]. 药学学报, 2021, 0(1): 314-318
作者姓名:邓文斌  潘昊  李云建  乔森  周晓彤  潘卫三
作者单位:沈阳药科大学药学院;辽宁大学药学院
摘    要:
本文以《中国药典》(2020年版)为指导,对来自进口A厂、国产S厂和国产T厂的2208型羟丙甲纤维素以及同一厂家不同批次的羟丙甲纤维素的功能性相关指标进行了表征,并通过主成分分析对羟丙甲纤维素的功能性相关指标进行全面综合评价.实验结果表明:不同厂家的羟丙甲纤维素黏度和多分散系数(D)未见显著性差异,而样品累积粒度分布百...

关 键 词:2208型羟丙甲纤维素  药用辅料  功能性相关指标  主成分分析  综合评价

Characterization and principal component analysis of functionalityrelated characteristics of hydroxypropyl methylcellulose type 2208
DENG Wen-bin,PAN Hao,LI Yun-jian,QIAO Sen,ZHOU Xiao-tong,PAN Wei-san. Characterization and principal component analysis of functionalityrelated characteristics of hydroxypropyl methylcellulose type 2208[J]. Acta pharmaceutica Sinica, 2021, 0(1): 314-318
Authors:DENG Wen-bin  PAN Hao  LI Yun-jian  QIAO Sen  ZHOU Xiao-tong  PAN Wei-san
Affiliation:(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China;School of Pharmacy,Liaoning University,Shenyang 110036,China)
Abstract:
Under the guidance of Chinese Pharmacopoeia(2020 edition),the functionality-related characteristics of hydroxypropyl methylcellulose(HPMC)type 2208 from imported A manufacturer,domestic S manufacturer,domestic T manufacturer and different batches of the same manufacturer were characterized.The principal component analysis was used to comprehensively evaluate the functionality-related characteristics.The results were as follows:hydroxypropyl methylcellulose had no significant difference in viscosity and molecular weight distribution between different manufacturers,and there were significant differences in the cumulative particle size distribution of the sample reaches 50%(d50)and 90%(d90),bulk density,tap density and Carr's index.The HPMC from A manufacturer have the biggest inter-batch difference of particle size and their inter-batch difference of polydispersion coefficientis smaller than S manufacturer.Domestic manufactures have the largest inter-batch difference in other functionalityrelated characteristics.The three principal components were extracted by principal component analysis,and the variance contribution rate reached 89.44%,indicating that the extracted principal components can explain all the data well.By constructing a comprehensive evaluation model,the comprehensive score ranking of all HPMC samples is obtained:S manufacturer>A manufacturer>T manufacturer.
Keywords:hydroxypropyl methylcellulose type 2208  pharmaceutical excipient  functionality-related char‐acteristics  principal component analysis  comprehensive evaluation
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