Quality consistency evaluation and intelligent visualization of performance parameters of carboxymethylcellulose sodium
10.16438/j.0513-4870.2019-0866
- VernacularTitle: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
- Author:
Xiao-na ZHANG
1
,
2
;
Hui-min SUN
3
;
Jue WANG
3
;
Rui YANG
3
;
Xue-mei ZHANG
4
;
Wan-hui LIU
4
;
Jia-xin DING
4
;
Chuan-yun DAI
5
;
Kao-xiang SUN
1
,
6
Author Information
1. 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
2. NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients, National Institutes for Food and Drug Control, Beijing 100050, China
3. NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients, National Institutes for Food and Drug Control, Beijing 100050, China
4. State Key Laboratory of Long-Acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co., Ltd., Yantai 264003, China
5. Institute of Biotechnology and Pharmaceutical Engineering Technology, Chongqing University of Science and Technology, Chongqing 401331, China
6. State Key Laboratory of Long-Acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co., Ltd., Yantai 264003, China
- Publication Type:Research Article
- Keywords:
carboxymethylcellulose sodium;
quality evaluation;
fingerprint;
multivariate analysis;
ata visualization
- From:
Acta Pharmaceutica Sinica
2020;55(8):1923-1931
- CountryChina
- Language:Chinese
-
Abstract:
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 is 30° - 40°, the appropriate design space was found as 5.092 2% < moisture content < 7.006 7%, 0.560 2 g·cm-3 < bulk density < 0.579 9 g·cm-3, and 0.646 3 g·cm-3 < tapped density < 0.816 5 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.
