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Quality evaluation of Xiaoer Resuqing granules based on fingerprint and quantitative analysis of multi-index components combined with chemical pattern recognition analysis*
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Ai-xian ZHOU1, Zheng-gen LIAO1, Fu-shi LE2, Hui-xing LIU2, Guo-wei ZHAO1, Xin-li LIANG1, *
Chinese Journal of Pharmaceutical Analysis | 2024, 44(6) : 1062 - 1073
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(6): 1062-1073
Quality Control
Quality evaluation of Xiaoer Resuqing granules based on fingerprint and quantitative analysis of multi-index components combined with chemical pattern recognition analysis*
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Ai-xian ZHOU1, Zheng-gen LIAO1, Fu-shi LE2, Hui-xing LIU2, Guo-wei ZHAO1, Xin-li LIANG1, *
Affiliations
  • 1.Key Laboratory of Modern Preparation of Traditional Chinese Medicine, Ministry of Education, Jiangxi University of Chinese Medicine, Nanchang 330004, China
  • 2.Jiangxi Beken Pharmaceutical Co., Ltd., Yichun 336400, China
Published: 2024-06-30 doi: 10.16155/j.0254-1793.2024.06.18
Outline
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Objective:

To study different batches of Xiaoer Resuqing granules by combining the method of fingerprint, multi-index component content determination and chemical pattern recognition analysis technology, and to provide the basis for its quality evaluation.

Methods:

The chromatographic SuperLu C18(250 mm×4.6 mm, 5 μm) column was adopted with mobile phase composed of methanol (A)-0.1% phosphoric acid (B) with gradient elution at a flow rate of 1.0 mL·min-1. The column temperature was 30 ℃, and the detection wavelength was 280 nm. Eleven characteristic components were identified, and the contents of seven active components, including puerarin, forsythiaside A, phillyrin, baicalin, wogonoside, baicalein and wogonin were determined. Hierarchical cluster analysis (HCA) and principal component analysis (PCA) were used to classify 15 batches of samples, and orthogonal least partial squares discriminant analysis (OPLS-DA) was performed. To screen out the difference components between batches of Xiaoer Resuqing granules.

Results:

The HPLC fingerprint of Xiaoer Resuqing granules and the content determination method of 7 components were established, the results of the two methods met the requirements. Twenty-eight common peaks were identified, 11 chromatographic peaks were identified, and the similarities of 15 batches of samples ranged from 0.995 to 0.999. HCA and PCA results showed that 15 batches were clustered into two categories, and OPLS-DA screened out 13 markers that caused the differences among the 15 batches of samples. There was little difference in the contents of ingredients.

Conclusion:

The established HPLC fingerprint of Xiaoer Resuqing granules and the determination method of 7 components are specific, accurate and reliable. Combined with chemical pattern recognition, it can be effectively used for the quality control of Xiaoer Resuqing granules.

Xiaoer Resuqing granules  /  HPLC  /  fingerprint  /  similarity evaluation  /  chemical pattern recognition  /  principal component analysis  /  determination of multi-component content  /  quality evaluation  /  correlation analysis
Ai-xian ZHOU, Zheng-gen LIAO, Fu-shi LE, Hui-xing LIU, Guo-wei ZHAO, Xin-li LIANG. Quality evaluation of Xiaoer Resuqing granules based on fingerprint and quantitative analysis of multi-index components combined with chemical pattern recognition analysis*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (6) : 1062 -1073 . DOI: 10.16155/j.0254-1793.2024.06.18
Year 2024 volume 44 Issue 6
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Article Info
doi: 10.16155/j.0254-1793.2024.06.18
  • Online Date:2026-03-13
  • Published:2024-06-30
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History
  • Revised:2024-04-15
Affiliations
    1.Key Laboratory of Modern Preparation of Traditional Chinese Medicine, Ministry of Education, Jiangxi University of Chinese Medicine, Nanchang 330004, China
    2.Jiangxi Beken Pharmaceutical Co., Ltd., Yichun 336400, 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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