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Comprehensive quality evaluation of Jieyu Anshen granules based on multi-indicator content determination and HPLC characteristic chromatogram combined with chemometrics
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Xia YAN, Tao ZHU, Song-hua HE**, Yi LUO**
Chinese Journal of Pharmaceutical Analysis | 2024, 44(9) : 1567 - 1577
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(9): 1567-1577
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Comprehensive quality evaluation of Jieyu Anshen granules based on multi-indicator content determination and HPLC characteristic chromatogram combined with chemometrics
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Xia YAN, Tao ZHU, Song-hua HE**, Yi LUO**
Affiliations
  • Guangxi Institute for Food and Drug Control NMPA Key Laboratory for Quality Monitpring and Evaluation of Traditional Chinese Medicine, Chinese Materia Medica, Nanning 530021, China
Published: 2024-09-30 doi: 10.16155/j.0254-1793.2024-0230
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Objective: To establish a multi-component content determination and characteristic chromatogram method for Jieyu Anshen granules, combined with chemometrics, to comprehensively evaluate the quality of Jieyu Anshen granules. Methods: The separation was performed on a CAPCELL PAK MG Ⅱ C18(250 mm×4.6 mm, 5 μm) column using acetonitrile (A) and 0.1% phosphoric acid aqueous solution (B) as the mobile phases with gradient elution at a flow rate of 1.0 mL·min-1. The column temperature was 30 ℃ and the detection wavelengths were set at 237 nm and 335 nm. The analysis method was validated. Based on the multi-component content determination method, characteristic chromatogram was established. The samples were analyzed and evaluated through chemometrics to identify the main factors affecting their quality. Results: A multi-component content determination method was established for Jieyu Anshen granules. The five components had good linear relationships within their respective ranges, with recovery rates ranging from 95.6% to 100.0%. And 145 batches of samples were tested, and a total of 54 batches were found to be unqualified, with a total unqualified rate of 37.2%. Establishing a characteristic chromatogram of Anshen granules, 12 characteristic peaks were attributed to 6 medicinal herbs. Through chemometric analysis, it was found that there were certain differences in the quality of samples from 10 manufacturers. The quality of fried gardenia and stir-baked licorice was the key factor. Conclusion: The established multi-component content determination method and characteristic chromatogram method for Jieyu Anshen granules are convenient and reliable, and can be used for comprehensive evaluation of the quality of Jieyu Anshen granules.

Jieyu Anshen granules  /  content determination  /  gardenoside  /  liquiritin  /  glycyrrhizic acid  /  spinosol  /  3, 6’-bisuccinoyl sucrose  /  characteristic chromatogram  /  quality evaluation
Xia YAN, Tao ZHU, Song-hua HE, Yi LUO. Comprehensive quality evaluation of Jieyu Anshen granules based on multi-indicator content determination and HPLC characteristic chromatogram combined with chemometrics[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (9) : 1567 -1577 . DOI: 10.16155/j.0254-1793.2024-0230
Year 2024 volume 44 Issue 9
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doi: 10.16155/j.0254-1793.2024-0230
  • Receive Date:2024-04-07
  • Online Date:2026-03-17
  • Published:2024-09-30
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  • Received:2024-04-07
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    Guangxi Institute for Food and Drug Control NMPA Key Laboratory for Quality Monitpring and Evaluation of Traditional Chinese Medicine, Chinese Materia Medica, Nanning 530021, 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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