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| Quality control of Qingfei Mixture：thin-layer chromatography identification，high-performance liquid chromatography fingerprint development，and multi-component quantification |
| Hits 501 Download times 502 Received:January 03, 2025 |
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| DOI
10.11656/j.issn.1673-9043.2025.06.04 |
| Key Words
Qingfei Mixture;TLC;HPLC;fingerprint;effective ingredients;content determination |
| Author Name | Affiliation | E-mail | | LI Yu | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medcine Acupuncture and Moxibastion, Tianjin 300381, China | | | LIU Fang | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medcine Acupuncture and Moxibastion, Tianjin 300381, China | | | ZHANG Meiwei | Tianjin Pharmaceutical Da Ren Tang Group Corporation Limited., Tianjin 300000, China | | | CHEN Yu | Tianjin Pharmaceutical Da Ren Tang Group Corporation Limited., Tianjin 300000, China | | | QU Jingtian | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medcine Acupuncture and Moxibastion, Tianjin 300381, China | | | CHEN Tao | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medcine Acupuncture and Moxibastion, Tianjin 300381, China | | | WANG Yang | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medcine Acupuncture and Moxibastion, Tianjin 300381, China | | | FAN Baishuang | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medcine Acupuncture and Moxibastion, Tianjin 300381, China | | | CHAI Shiwei | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medcine Acupuncture and Moxibastion, Tianjin 300381, China | | | FAN Guanwei | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medcine Acupuncture and Moxibastion, Tianjin 300381, China | fgw1005@hotmail.com |
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| Abstract
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| [Objective] To establish quality control methods for Qingfei mixture, including thin-layer chromatography(TLC) identification, high-performance liquid chromatography(HPLC) fingerprint analysis, and content determination of naringin, neohesperidin, baicalin, and ephedrine hydrochloride.[Methods] TLC was used for qualitative identification of Houttuynia cordata, Indigo naturalis, and Glycyrrhiza uralensis. HPLC analysis was performed on an Agilent Eclipse XDB-C18 column(4.6 mm×250 mm, 5 μm) with a gradient elution of acetonitrile and 0.1% aqueous phosphoric acid solution. The column temperature was 30℃, with an injection volume of 10 μL, a flow rate of 1.0 mL/min, and a detection wavelength of 280 nm. HPLC fingerprints of 15 batches of Qingfei mixture were established and evaluated using the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(Version A). The contents of four active components were simultaneously determined.[Results] The TLC methods for Houttuynia cordata, Indigo naturalis, and Glycyrrhiza uralensis showed strong specificity without interference. Methodological validation of the HPLC fingerprint and content determination met regulatory requirements. The similarity of fingerprints from different batches reached 0.999. Eighteen common peaks were labeled, and seven components were identified:ephedrine hydrochloride, amygdalin, liquiritin, naringin, neohesperidin, baicalin, and peucedanum praeruptorum A. The average contents of naringin, neohesperidin, baicalin, and ephedrine hydrochloride were 3.517, 2.137, 6.417, and 0.204 mg/mL, respectively.[Conclusion] The established TLC identification, HPLC fingerprint, and content determination methods are specific, stable, reliable, and practical for comprehensive quality control of Qingfei mixture. |
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