药学学报, 2021, 56(1): 314-318
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, 56(1): 314-318.
DENG Wen-bin, PAN Hao, LI Yun-jian, QIAO Sen, ZHOU Xiao-tong, PAN Wei-san. Characterization and principal component analysis of functionality-related characteristics of hydroxypropyl methylcellulose type 2208[J]. Acta Pharmaceutica Sinica, 2021, 56(1): 314-318.

2208型羟丙甲纤维素功能性相关指标的考察与主成分分析
邓文斌1, 潘昊2, 李云建1, 乔森1, 周晓彤1, 潘卫三1
1. 沈阳药科大学药学院, 辽宁 沈阳 110016;
2. 辽宁大学药学院, 辽宁 沈阳 110036
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分数达50%时所对应的粒径(d50)、样品累积粒度分布数达90%时所对应的粒径(d90)、松密度(ρb)、振实密度(ρbt)和卡尔指数等均存在显著性差异。同一厂家不同批次产品各功能性相关指标均存在批间差异,A厂羟丙甲纤维素粒径的批间差异最大,多分散系数批间差异次于S厂,其他指标的批间差异均小于国产厂家。通过主成分分析提取出方差贡献率达89.44%的3个主成分。再通过构建综合评价模型,得到羟丙甲纤维素的综合得分排序:S厂 > A厂 > T厂。
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 functionality-related characteristics of hydroxypropyl methylcellulose type 2208
DENG Wen-bin1, PAN Hao2, LI Yun-jian1, QIAO Sen1, ZHOU Xiao-tong1, PAN Wei-san1
1. School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China;
2. 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 functionality-related 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.
Key words:    hydroxypropyl methylcellulose type 2208    pharmaceutical excipient    functionality-related characteristics    principal component analysis    comprehensive evaluation   
收稿日期: 2020-07-13
DOI: 10.16438/j.0513-4870.2020-1163
通讯作者: 潘卫三,Tel:86-24-43520533,E-mail:ppwwss@163.com
Email: ppwwss@163.com
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