|
| Analysis on transfer law of critical quality attributes of Danggui Sini Decoction material benchmarks |
| Hits 636 Download times 472 Received:March 02, 2022 |
| View Full Text View/Add Comment Download reader |
| DOI
10.11656/j.issn.1673-9043.2022.03.21 |
| Key Words
classic prescription;Danggui Sini Decoction;material benchmarks;critical quality attributes;quantity-quality correlation |
| Author Name | Affiliation | E-mail | | JIANG Yuhang | School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China | | | MIAO Jiayan | School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China | | | LIU Yuhan | School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China | | | HAN Chen | School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China | | | LUO Gan | School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China | | | GAO Xiaoyan | School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China | gaoxiaoyan@bucm.edu.cn |
|
| Abstract
|
| [Objective] To explore the transfer law of critical quality attributes of Danggui Sini Decoction (DSD) material benchmarks.[Methods] The 15 batches of lyophilized powder samples of DSD were prepared as the material benchmarks. Index component contents, specific chromatograms and dry extract rates were determined and the transfer rates of the above indexes in the process of medicinal material-decoction piece-decoction-material benchmarks were calculated.[Results] The transfer rates from medicinal material to material benchmarks of ligustilide, cinnamaldehyde, paeoniflorin, asarcin and glycyrrhizin were 0.65%~1.18%, 0.08%~0.30%, 10.40%~37.05%, 23.96%~48.18%, 0.83%~1.32%, 4.94%~11.83%, respectively. The 20 characteristic peaks originated from the characteristic spectrums were not lost across the whole process, and most of the transfer rates of relative areas of characteristic peaks were in the range of 70%~130% of the mean. The transfer rates of the dry extract rates from decoction piece to material benchmarks were 47.87%~61.53%.[Conclusion] The critical quality attributes of DSD material benchmarks can be transmitted stably across the process of medicinal material-decoction pieces-decoction-material benchmarks. This study preliminarily constructed the whole process quality control system of DSD, which provided data support for the development of subsequent compound preparations. |
|
|
|
|
|
