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| Optimization of dry granulation process for Shaoge Granules using box-behnken response surface methodology and quality control research |
| Hits 599 Download times 254 Received:January 17, 2025 |
| View Full Text View/Add Comment Download reader |
| DOI
10.11656/j.issn.1672-1519.2025.06.14 |
| Key Words
Shaoge Granules;dry granulation;response surface methodology;HPLC;quality control |
| Author Name | Affiliation | E-mail | | JIAO Guorui | School of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Tianjin University of Traditional Chinese Medicine, Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Ministry of Education, Tianjin 301617, China
Tianjin University of Traditional Chinese Medicine, State Key Laboratory of Component-Based Chinese Medicine, Tianjin 301617, China | | | LIU Yanling | School of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Tianjin University of Traditional Chinese Medicine, Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Ministry of Education, Tianjin 301617, China
Tianjin University of Traditional Chinese Medicine, State Key Laboratory of Component-Based Chinese Medicine, Tianjin 301617, China | | | LI Yangyang | School of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Tianjin University of Traditional Chinese Medicine, Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Ministry of Education, Tianjin 301617, China
Tianjin University of Traditional Chinese Medicine, State Key Laboratory of Component-Based Chinese Medicine, Tianjin 301617, China | | | CHEN Yanan | School of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Tianjin University of Traditional Chinese Medicine, Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Ministry of Education, Tianjin 301617, China
Tianjin University of Traditional Chinese Medicine, State Key Laboratory of Component-Based Chinese Medicine, Tianjin 301617, China | | | LI Jiawei | School of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Tianjin University of Traditional Chinese Medicine, Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Ministry of Education, Tianjin 301617, China
Tianjin University of Traditional Chinese Medicine, State Key Laboratory of Component-Based Chinese Medicine, Tianjin 301617, China | lijiawei1981@163.com | | LIU Zhidong | School of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Tianjin University of Traditional Chinese Medicine, Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Ministry of Education, Tianjin 301617, China
Tianjin University of Traditional Chinese Medicine, State Key Laboratory of Component-Based Chinese Medicine, Tianjin 301617, China | lonerliuzd@163.com |
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| Abstract
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| [Objective] To optimize the granulation process of Shaoge Granules and conduct a preliminary study on its quality control. [Methods] Shaoge Granules were prepared by dry granulation method；roller pressure，feeding speed，and pressing speed were used as independent variables；granule yield，moisture absorption rate，angle of repose，and dissolution rate were used as response variables；Box-Behnken response surface methodology was used to optimize the dry granulation process；and the content of puerarin，paeoniflorin，naringin，and 1，4-bis[4-（glucosyloxy）benzyl]-2-isobutylmalate in Shaoge Granules was determined by high-performance liquid chromatography（HPLC）. [Results] The optimal conditions were a roller pressure of 20 kg/cm2，feeding speed of 31 Hz，and pressing speed of 15 Hz，resulting in a granule yield of 91.83%，indicating high granulation efficiency；the average critical relative humidity of the three batches of granules was 66.55%，with an RSD of 0.06%；the content determination results showed that the three batches of granules had uniform content of each index component，with stable and controllable quality. [Conclusion] Box-Behnken response surface methodology can be used to optimize the dry granulation process of Shaoge Granules，and the optimized process is stable and feasible，with controllable product quality. |
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