| 经典名方清肺汤的基准样品关键质量属性量值传递研究 |
| 投稿时间：2024-04-10 点此下载全文
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| 引用本文：曹春琪,周亚楠,苏建,徐冰,刘永利.经典名方清肺汤的基准样品关键质量属性量值传递研究[J].中国现代中药,2024,26(10):1663-1671 |
| DOI：10.13313/j.issn.1673-4890.20240410004 |
| 摘要点击次数: 396 |
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| 作者中文名 | 作者英文名 | 单位中文名 | 单位英文名 | E-Mail |
| 曹春琪 |
CAO Chun-qi |
河北省药品医疗器械检验研究院，河北 石家庄 050227
国家药品监督管理局中药材质量监测评价重点实验室，河北 石家庄 050227 |
Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050227, China
Key Laboratory for Quality Monitoring and Evaluation of National Medical Products Administration, Shijiazhuang 050227, China |
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| 周亚楠 |
ZHOU Ya-nan |
河北省药品医疗器械检验研究院，河北 石家庄 050227
国家药品监督管理局中药材质量监测评价重点实验室，河北 石家庄 050227 |
Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050227, China
Key Laboratory for Quality Monitoring and Evaluation of National Medical Products Administration, Shijiazhuang 050227, China |
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| 苏建 |
SU Jian |
河北省药品医疗器械检验研究院，河北 石家庄 050227
国家药品监督管理局中药材质量监测评价重点实验室，河北 石家庄 050227 |
Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050227, China
Key Laboratory for Quality Monitoring and Evaluation of National Medical Products Administration, Shijiazhuang 050227, China |
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| 徐冰* |
XU Bing |
北京中医药大学 中药学院，北京 102488 |
School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China |
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| 刘永利* |
LIU Yong-li |
河北省药品医疗器械检验研究院，河北 石家庄 050227
国家药品监督管理局中药材质量监测评价重点实验室，河北 石家庄 050227 |
Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050227, China
Key Laboratory for Quality Monitoring and Evaluation of National Medical Products Administration, Shijiazhuang 050227, China |
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| 基金项目:河北省自然科学基金项目（H2022329003）；河北省药品监督管理局科技计划项目（2022ZC1019） |
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| 中文摘要:目的 建立经典名方清肺汤基准样品的特征图谱及指标性成分含量测定方法，阐明清肺汤的关键质量属性。方法 制备15批清肺汤基准样品，建立高效液相色谱法（HPLC）特征图谱方法，并进行特征峰归属和相似度分析；以苦杏仁苷、栀子苷、橙皮苷、黄芩苷、汉黄芩苷、黄芩素、甘草酸为指标性成分建立清肺汤多成分含量测定方法，对指标成分的含量和转移率进行分析研究，以均值的70%~130%为界限设定各质量控制指标的量值波动范围。结果 15批清肺汤基准样品的HPLC特征图谱相似度为0.986~0.999，共16个特征峰，经对照品指认出12个特征峰，分别为京尼平龙胆二糖苷、苦杏仁苷、栀子苷、橙皮苷、黄芩苷、去甲汉黄芩苷、千层纸素A-7-O-β-D-葡萄糖醛酸苷、汉黄芩苷、黄芩素、汉黄芩素、五味子醇甲、千层纸素A；指标性成分从饮片到物质基准的转移率分别为苦杏仁苷24.35%~33.13%、栀子苷36.78%~49.55%、橙皮苷23.11%~35.92%、黄芩苷60.62%~74.15%、汉黄芩苷61.81%~76.90%、黄芩素9.21%~15.77%、甘草酸10.35%~18.46%。结论 采用特征图谱结合多指标成分含量测定对清肺汤基准样品的量值传递规律进行研究，该方法重现性好、简便、准确、稳定，为经典名方清肺汤基准样品的质量控制及复方制剂的开发提供参考。 |
| 中文关键词:经典名方 清肺汤 物质基准 特征图谱 含量测定 量值传递 |
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| Quantitative Value Transfer of Key Quality Attributes of Benchmark Samples of Classical Prescription Qingfei Decoction |
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| Abstract:Objective To establish the characteristic chromatogram and index component content determination method for Qingfei Decoction benchmark samples, and clarify the key quality attributes of Qingfei Decoction.Methods Fifteen batches of Qingfei Decoction benchmark samples were prepared. The HPLC characteristic chromatogram method was established, followed by characteristic peak attribution and similarity analysis. A multi-component content determination method for Qingfei Decoction was established using amygdalin, geniposide, hesperidin, baicalin, wogonoside, baicalein, and glycyrrhizic acid as indicator components. The content and transfer rates of the indicator components were analyzed, and 70%-130% of the average mass was regarded as the limit for the quantity value range of quality control indexes.Results The similarity of the 15 batches of Qingfei Decoction benchmark samples was 0.986-0.999, with a total of 16 characteristic peaks. Twelve characteristic peaks were identified using reference substances: genipin 1-gentiobioside, amygdalin, geniposide, hesperidin, baicalin, norwogonoside, oroxylin A-7-O-β-D-glucuronide, wogonoside, baicalein, wogonin, schisandrin, and oroxylin A. The transfer rates from the decoction pieces to the benchmark samples were 24.35%-33.13% for amygdalin, 36.78%-49.55% for geniposide, 23.11%-35.92% for hesperidin, 60.62%-74.15% for baicalin, 61.81%-76.90% for wogonoside, 9.21%-15.77% for baicalein, and 10.35%-18.46% for glycyrrhizic acid.Conclusion The characteristic chromatogram combined with the content determination of multiple index components was used to study the value transfer law of the benchmark samples of Qingfei Decoction. The method showed good reproducibility, simplicity, accuracy, and stability, providing a reference for the quality control of the classical prescription Qingfei Decoction benchmark samples and the development of Qingfei Decoction compound formulations. |
| keywords:famous classical prescription Qingfei Decoction substance benchmark characteristic chromatogram content determination quality value transfer |
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