Characterization and principal component analysis of functionality-related characteristics of hydroxypropyl methylcellulose type 2208
10.16438/j.0513-4870.2020-1163
- VernacularTitle:2208型羟丙甲纤维素功能性相关指标的考察与主成分分析
- Author:
Wen-bin DENG
1
;
Hao PAN
2
;
Yun-jian LI
1
;
Sen QIAO
1
;
Xiao-tong ZHOU
1
;
Wei-san PAN
1
Author Information
1. School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China
2. School of Pharmacy, Liaoning University, Shenyang 110036, China
- Publication Type:Research Article
- Keywords:
hydroxypropyl methylcellulose type 2208;
pharmaceutical excipient;
functionality-related characteristics;
principal component analysis;
comprehensive evaluation
- From:
Acta Pharmaceutica Sinica
2021;56(1):314-318
- CountryChina
- Language:Chinese
-
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.
