Critical quality attribute assessment of big brand traditional Chinese medicine: quality control method of ginkgo leaves extract material based on powder physical properties.
10.19540/j.cnki.cjcmm.20210205.306
- Author:
Jing ZHANG
1
;
Ming-Li ZHU
2
;
Ling LIN
2
;
Jing-Qi ZENG
2
;
Xiao PENG
2
;
Zhong-Qing YAO
3
;
Min LI
3
;
Yong-Xia GUAN
4
;
Zhi-Sheng WU
5
Author Information
1. College of Pharmacy, Fujian University of Traditional Chinese Medicine Fuzhou 350122, China.
2. School of Chinese Materia Medica, Beijing University of Chinese Medicine Beijing 102488, China Engineering Research Center of Chinese Medicine Production and New Drug Development, Ministry of Education Beijing 102488, China.
3. Traditional Chinese Medicine Manufacturing Technology National Engineering Research Center, Yangtze River Pharmaceutics Group Co., Ltd. Taizhou 225321, China.
4. State Key Laboratory of Generic Manufacture Technology of Chinese Traditional Medicine, Lunan Pharmaceutical Group Co., Ltd. Linyi 276006, China.
5. College of Pharmacy, Fujian University of Traditional Chinese Medicine Fuzhou 350122, China School of Chinese Materia Medica, Beijing University of Chinese Medicine Beijing 102488, China Engineering Research Center of Chinese Medicine Production and New Drug Development, Ministry of Education Beijing 102488, China.
- Publication Type:Journal Article
- Keywords:
big brand traditional Chinese medicine;
critical quality attribute;
ginkgo leaves extract;
multivariate statistical process control;
powder physical properties;
production in real world
- MeSH:
Drugs, Chinese Herbal;
Ginkgo biloba;
Medicine, Chinese Traditional;
Plant Extracts;
Plant Leaves;
Powders;
Quality Control
- From:
China Journal of Chinese Materia Medica
2021;46(7):1622-1628
- CountryChina
- Language:Chinese
-
Abstract:
The physical properties of ginkgo leaves extract(GLE) are the critical quality attributes for the control of the manufacturing process of ginkgo leaves preparations. In this study, 53 batches of GLE with different sources from the real world were used as the objects to carry out the research from 3 levels. First, based on micromeritics evaluation method, a total of 29 physical attribute quality parameters in five dimensions were comprehensively characterized, with a total of 1 537 data points. Further, with use of physical fingerprinting technology combined with similarity evaluation, the powder physical properties of 53 batches of GLE showed obvious differences from an overall perspective, and the similarity of the physical fingerprints was 0.876 to 1.000. Secondly, hierarchical clustering analysis(HCA) and principal component analysis(PCA) models were constructed to realize the reliable identification and differentiation of real-world materials produced by GLE from different sources. Multivariate statistical process control(MSPC) model was used to create GLE material Hotelling T~2 and squared prediction error(SPE) control charts. It was found that the SPE score of B_(21) powder exceeded the 99% confidence control limit by 22.495 9, and the SPE scores of A_1 and C_(10) powder exceeded the 95% confidence control limit by 16.099 2, realizing the determination of abnormal samples in the materials of GLE from the production in real world. Finally, the physical quality control method of GLE in the production process of ginkgo leaves preparations was established in this study, providing a reference for the quality control methods of ginkgo leaves preparations in their manufacturing process.
