Critical quality attribute assessment of big brand traditional Chinese medicine: quality control of Tongren Niuhuang Qingxin Pills in texture and sensory attributes.
10.19540/j.cnki.cjcmm.20210309.301
- Author:
Jing-Qi ZENG
1
;
Qian-Qian LI
2
;
Li-Juan MA
2
;
Ming-Li ZHU
2
;
Ning MAO
2
;
Zhen-Feng WU
1
;
Lu YAO
3
;
Shu-Ying WANG
3
;
Zhi-Sheng WU
2
Author Information
1. Key Laboratory of Modern Preparation of Traditional Chinese Medicine, Ministry of Education, Jiangxi University of Traditional Chinese Medicine Nanchang 330103, 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. National Engineering Research Center for R&D of TCM Multi-ingredient Drugs, Institute of Science, Beijing Tongrentang Co.,Ltd. Beijing 100079, China.
- Publication Type:Journal Article
- Keywords:
Tongren Niuhuang Qingxin Pills;
big brand traditional Chinese medicine;
critical quality attributes;
lumping;
multivariate statistical process control(MSPC);
texture sensory attributes
- MeSH:
Drugs, Chinese Herbal;
Medicine, Chinese Traditional;
Quality Control
- From:
China Journal of Chinese Materia Medica
2021;46(7):1598-1605
- CountryChina
- Language:Chinese
-
Abstract:
Texture sensory attributes are the key items in quality control of Chinese medicinal honeyed pills. The purpose of this study is to develop a quality control method for assessing the texture sensory attributes of Chinese medicinal honeyed pills based on real-world Tongren Niuhuang Qingxin pilular masses and finished products. First, parameters of texture profile analysis(TPA) were optimized through single factor and central composite design(CCD) experiments to establish a detection method for texture sensory attri-butes of Tongren Niuhuang Qingxin Pills. The results showed that the established detection method was stable and reliable, with the optimal parameters set up as follows: deformation percentage of 70%, detection speed at 30 mm·min~(-1), and interval time of 15 s. Furthermore, 540 data points yielded form six texture sensory attributes of pills from 30 batches were subjected to multivariate statistical process control(MSPC) with Hotelling T~2 and squared prediction error(SPE) control charts to establish the quality control method of Tongren Niuhuang Qingxin Pills. This study is expected to provide a reference for improving the quality control system of Chinese medicinal honeyed pills.
