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Quality Evaluation of Mailuoshutong Pills Based On Multi-Wavelength Switching HPLC Fingerprint Combined With Chemometrics and Multi-Indicator Content Determination
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Yu SUN1, 2, Lili XU1, 2, 3, Wenyan GAO3, Bing WANG2, Huifen LI1, Yongxia GUAN5, Qian SUN1, 2, Weiliang CUI1, 2, 5, *, Yongqiang LIN1, 2, *
Chinese Pharmaceutical Journal | 2024, 59(21) : 2065 - 2074
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Chinese Pharmaceutical Journal | 2024, 59(21): 2065-2074
Quality Evaluation of Mailuoshutong Pills Based On Multi-Wavelength Switching HPLC Fingerprint Combined With Chemometrics and Multi-Indicator Content Determination
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Yu SUN1, 2, Lili XU1, 2, 3, Wenyan GAO3, Bing WANG2, Huifen LI1, Yongxia GUAN5, Qian SUN1, 2, Weiliang CUI1, 2, 5, *, Yongqiang LIN1, 2, *
Affiliations
  • 1 Shandong University of Traditional Chinese Medicine, Jinan 250355, China
  • 2 Shandong Engineering Laboratory for Standard Innovation and Quality Evaluation of TCM, Shandong Provincial Institute for Food and Drug Control, jinan 250101,China
  • 3 Shandong Academy of Innovation and Development, Jinan 271039, China
  • 4 Otolaryngology Department, The People's Hospital of Xintai City, Taian 271200, China
  • 5 National Key Laboratory of Integration and Innovation of Classic Prescriptions and Modern Traditional Chinese Medicine, Lunan Pharmaceutical Group, Linyi 276005, China
Published: 2024-11-08 doi: 10.11669/cpj.2024.21.010
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OBJECTIVE To establish a quality evaluation method for Mailuoshutong Pills by combining fingerprints and multi indicator quantification combined with chemometrics. METHODS Agilent ZORBAX SB-Aq C18 chromatography column (4.6 mm×250 mm, 5 μm) was used, and the column temperature was maintained at 30 ℃. The mobile phase was acetonitrile-0.1% phosphoric acid aqueous solution. Gradient elution was carried out at a flow rate of 1.0 mL·min-1, and the detection wavelengths were 216, 230, 280, 248, 327, 280 and 254 nm. The fingerprints of Mailuoshutong Pills(MLSTP) were established, the common peaks were determined combined with chemometric analysis, and the contents of 11 indicator components were determined. RESULTS A total of 30 common peaks were labeled in the fingerprints, and 12 components were identified through comparison with reference materials. The similarity of fingerprints of 16 batches of MLSTP were more than 0.990. Through cluster analysis, principal component analysis, and partial least squares discriminant analysis, it was found that gallic acid, neochlorogenic acid, cryptochlorogenic acid, chlorogenic acid, paeoniflorin, berberine hydrochloride, calycosin-7-glucoside, isochlorogenic acid A, isochlorogenic acid C, hapargoside, and berberine hydrochloride were the main factors affecting the quality of MLSTP, and the variation ranges of the content determination of the 11 components mentioned above were 0.62-0.84, 1.45-2.50, 1.30-2.78, 3.35-5.28, 2.44-4.02, 0.54-0.88, 0.16-0.23, 0.61-0.76, 1.39-1.76, 0.41-0.54 and 2.28-3.34 mg·g-1, respectively. CONCLUSION The established multi-wavelength switching fingerprint spectrum combined with chemometric analysis and multi index content determination method is stable and reliable, which can provide scientific basis for the quality control and comprehensive evaluation of MLSTP.

Mailuoshutong Pills  /  fingerprint  /  chemometrics  /  content determination  /  quality evaluation
Yu SUN, Lili XU, Wenyan GAO, Bing WANG, Huifen LI, Yongxia GUAN, Qian SUN, Weiliang CUI, Yongqiang LIN. Quality Evaluation of Mailuoshutong Pills Based On Multi-Wavelength Switching HPLC Fingerprint Combined With Chemometrics and Multi-Indicator Content Determination[J]. Chinese Pharmaceutical Journal, 2024 , 59 (21) : 2065 -2074 . DOI: 10.11669/cpj.2024.21.010
Year 2024 volume 59 Issue 21
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doi: 10.11669/cpj.2024.21.010
  • Receive Date:2024-05-24
  • Online Date:2025-11-16
  • Published:2024-11-08
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  • Received:2024-05-24
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Affiliations
    1 Shandong University of Traditional Chinese Medicine, Jinan 250355, China
    2 Shandong Engineering Laboratory for Standard Innovation and Quality Evaluation of TCM, Shandong Provincial Institute for Food and Drug Control, jinan 250101,China
    3 Shandong Academy of Innovation and Development, Jinan 271039, China
    4 Otolaryngology Department, The People's Hospital of Xintai City, Taian 271200, China
    5 National Key Laboratory of Integration and Innovation of Classic Prescriptions and Modern Traditional Chinese Medicine, Lunan Pharmaceutical Group, Linyi 276005, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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