Study on the cross-linking degree of PVPP by NMR technology and its powder compressibility
10.16438/j.0513-4870.2021-0937
- VernacularTitle:NMR技术测定PVPP交联度及其粉体可压缩性研究
- Author:
Jue WANG
1
,
2
;
Li HU
3
;
Mei-qin WU
4
;
Rui YANG
1
;
Hui-min SUN
1
;
Jia-sheng TU
4
Author Information
1. NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients, National Institutes for Food and Drug Control, Beijing 100050, China
2. NMPA Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients, China Pharmaceutical University, Nanjing 210009, China
3. Chengdu Suncadia Medicine Co., Ltd., Chengdu 610000, China
4. NMPA Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients, China Pharmaceutical University, Nanjing 210009, China
- Publication Type:Research Article
- Keywords:
crospovidone;
crosslinking degree;
crosslinking density;
NMR;
compressibility;
physical fingerprint
- From:
Acta Pharmaceutica Sinica
2022;57(2):474-479
- CountryChina
- Language:Chinese
-
Abstract:
In this paper, the low-field nuclear magnetic resonance technology CPMG (Carr-Purcell-Meiboom-Gill) 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.
