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| Exploratory study on the compatibility of several commonly used excipients with raw material of traditional Chinese medicine extract |
| Hits 483 Download times 286 Received:February 28, 2025 |
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| DOI
10.11656/j.issn.1672-1519.2025.08.14 |
| Key Words
Erzhi Formula;compatibility of drug and excipients;theoretical prediction;high performance liquid chromatography;differential scanning calorimetry;fourier transform infrared spectroscopy;X-ray powder diffraction |
| Author Name | Affiliation | E-mail | | AN Guangtao | State Key Laboratory of Component-based Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Ministry of Education, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | YANG Yaguang | State Key Laboratory of Component-based Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Ministry of Education, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | YAN Yuan | State Key Laboratory of Component-based Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Ministry of Education, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | ZHAO Yu | State Key Laboratory of Component-based Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Ministry of Education, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | WU Yiyao | State Key Laboratory of Component-based Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Ministry of Education, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | WANG Yajing | State Key Laboratory of Component-based Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Ministry of Education, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | yajing022@163.com | | QI Dongli | State Key Laboratory of Component-based Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Ministry of Education, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | qidongli2013@163.com |
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| Abstract
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| [Objective] To study the compatibility between several commonly used excipients（sucralose，citric acid，silica，maltodextrin，dextrin） in traditional Chinese medicine preparations and the raw material of Erzhi Formula extract，to explore the applicability of current conventional methods for compatibility studies of traditional Chinese medicine，and provide reference for the screening of excipients in traditional Chinese medicine preparations. [Methods] Specnuezhenide from Erzhi Formula extract was used as the indicator component. Firstly，the PharmDE platform was used to predict the compatibility risk between above mentioned excipients and specnuezhenide. Then，the compatibility of these excipients with specnuezhenide was investigated from multiple perspectives using high performance liquid chromatography（HPLC），differential scanning calorimetry（DSC），fourier transform infrared spectroscopy（FTIR），and X-ray powder diffraction（XRPD）. [Results] Theoretical predictions indicated that there was a high risk of compatibility between citric acid and specnuezhenide. The content determination results by HPLC showed that all excipients had good compatibility with specnuezhenide under lighting condition，compatibility between citric acid and specnuezhenide was poor under high temperature condition，and compatibility between sucralose，dextrin，and specnuezhenide was poor under high temperature and high humidity. DSC，FTIR，and XRPD indicated that there was no significant interaction between excipients and the extract. [Conclusion] In high temperature and high humidity environments，certain excipients have a certain impact on specnuezhenide of Erzhi Formula extract. |
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