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| 麸炒苍术标准汤剂的质量评价 |
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周南1,2, 张志强1,2, 周永康1,2, 闫晓鑫1,2, 程立伟1,2, 董晨红1,2
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1.北京康仁堂药业有限公司中药配方颗粒关键技术国家地方联合工程研究中心, 北京 101300;2.北京市中药配方颗粒工程技术研究中心, 北京 101300
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| 摘要: |
| [目的] 建立麸炒苍术标准汤剂的质量评价方法，为麸炒苍术汤剂和配方颗粒等常用剂型的质量控制提供参考依据。[方法] 收集合格的18批麸炒苍术饮片，制备相应标准汤剂，采用超高效液相色谱（UPLC）法测定指标成分绿原酸的含量，计算相应转移率及出膏率，并建立麸炒苍术标准汤剂指纹图谱，采用液相-质谱联用（LC-MS）法对共有峰进行结构确认。[结果] 18批麸炒苍术标准汤剂出膏率为30.4%~41.4%，绿原酸含量为0.121~0.745 mg/g，转移率为30.7%~79.5%，麸炒苍术标准汤剂指纹图谱共标定18个共有峰，相似度均在0.90以上，并确认5-羟甲基糠醛、绿原酸、咖啡酸等特征峰。[结论] 麸炒苍术标准汤剂制备规范，工艺稳定，检测方法的精密度、稳定性和重复性良好，可为麸炒苍术标准汤剂终端产品的质量控制提供参考。 |
| 关键词: 麸炒苍术 标准汤剂 出膏率 转移率 指纹图谱 |
| DOI：10.11656/j.issn.1673-9043.2021.05.21 |
| 分类号:R284 |
| 基金项目: |
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| Quality evaluation of bran-processed Atractylodis Rhizoma standard decoction |
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ZHOU Nan1,2, ZHANG Zhiqiang1,2, ZHOU Yongkang1,2, YAN Xiaoxin1,2, CHENG Liwei1,2, DONG Chenhong1,2
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1.National and Local Joint Engineering Research Center for Key Technology of Chinese Medicinal Composition Granules of Beijing Tcmages Pharmaceutical Co. Ltd., Beijing 101300, China;2.Beijing Engineering Technology Research Center for Chinese Medicinal Composition Granules, Beijing 101300, China
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| Abstract: |
| [Objective] To establish the quality evaluation method for bran-processed Atractylodis Rhizoma standard decoction, and to provide reference for the quality control of common dosage forms such as Atractylodis Rhizoma decoction and formula granule.[Methods] A total of 18 batches of qualified Atractylodis Rhizoma pieces were collected, and the corresponding standard decoction were prepared. The content of chlorogenic acid was determined by UPLC, and the corresponding transfer rate and extraction ratio were calculated. The UPLC fingerprint spectrum of bran-processed Atractylodis Rhizoma standard decoction was established, and the chemical structures of commom peaks were identified with liquid chromatography-mass spectrometry (LC-MS).[Results] The extraction rates of 18 batches of bran-processed Atractylodis Rhizoma standard decoction were 30.4%~41.4%, the contents of chlorogenic acid were 0.121~0.745 mg/g, and the transfer rates were 30.7%~79.5%. The characteristic atlas of the bran-processed Atractylodis Rhizoma standard decoction has 18 common peaks, the similarity of 18 batches of samples were all higher than 0.9, and the common peaks were identified, including 5-HMF, Chlorogenic acid, Caffeic acid.[Conclusion] The preparation technology of bran-processed Atractylodis Rhizoma standard decoction is standard and stable, the precision, stability and repeatability of the method are good, which can provide references for the quality control of terminal products from bran-processed Atractylodis Rhizoma decoction. |
| Key words: bran-processed Atractylodis Rhizoma standard decoction extraction ratio transfer rate fingerprint spectrum |
