Quality evaluation of angelica broken wall powder based on QbD concept of traditional Chinese medicine.
10.19540/j.cnki.cjcmm.20191221.310
- Author:
Zheng LUO
1
;
Wen DENG
2
;
Qian-Liang ZHANG
2
;
Bi-Yan FANG
1
;
Jin-le CHENG
2
Author Information
1. Research Center of Chinese Herbal Resource Science and Engineering, Guangzhou University of Chinese Medicine Guangzhou 510006, China Zhongshan Zhongzhi Pharmaceutical Group Zhongshan 528437, China Key Laboratory of Technologies and Applications of Ultrafine Granular Powder of Herbal Medicine, State Administration of Traditional Chinese Medicine Zhongshan 528437, China Key Laboratory of Chinese Medicinal Resource from Lingnan under Ministry of Education, Guangzhou University of Chinese Medicine Guangzhou 510006, China Joint Laboratory of National Engineering Research Center for Pharmaceutics of Traditional Chinese Medicines Guangzhou 510006, China.
2. Zhongshan Zhongzhi Pharmaceutical Group Zhongshan 528437, China Key Laboratory of Technologies and Applications of Ultrafine Granular Powder of Herbal Medicine, State Administration of Traditional Chinese Medicine Zhongshan 528437, China.
- Publication Type:Journal Article
- Keywords:
HPLC fingerprint;
angelica;
broken wall powder;
multivariate statistical analysis;
physical fingerprint;
quality by design;
quality evaluation
- MeSH:
Angelica/chemistry*;
Chromatography, High Pressure Liquid;
Drugs, Chinese Herbal/analysis*;
Medicine, Chinese Traditional;
Powders;
Quality Control
- From:
China Journal of Chinese Materia Medica
2020;45(5):1105-1113
- CountryChina
- Language:Chinese
-
Abstract:
In this paper, angelica broken wall powder(ABWP) was taken as the research object, HPLC fingerprint combined with multi-component determination(ferulic acid, senkyunolide I, coniferyl ferulate, ligustilide and 3-butylidenephthalide), physical fingerprint(D_(90), particle size distribution range, particle size distribution width, bulk density, tap density, inter-particle porosity, Carr index, specific surface area, pore volume, angle of repose, Hausner ratio, loss on drying and hygroscopicity)were used to characterize the quality attribute of ABWP; similarity analysis, cluster analysis, principal component analysis and orthogonal partial least squares discriminant analysis were conducted to construct the quality evaluation method of holographic analysis based on traditional Chinese medicine QbD "4 H mode", in order to evaluate the quality of ABWP from different sources and find out differentiated indicators. The quality evaluation method could be used for scientific, comprehensive evaluation of the quality attribute of ABWP, and the quality consistency evaluation of cell-wall-broken powder of different sources or different processes.It provides new ideas for quality control and research of ultrafine granular powders of traditional Chinese medicine.
