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Development and calibration of new traditional Chinese medicine chemical reference substance 2-acetate regaloside A
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Jing LIU, Yang LIU*, Zhong DAI, Shuang-cheng MA*
Chinese Journal of Pharmaceutical Analysis | 2024, 44(1) : 168 - 173
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(1): 168-173
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Development and calibration of new traditional Chinese medicine chemical reference substance 2-acetate regaloside A
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Jing LIU, Yang LIU*, Zhong DAI, Shuang-cheng MA*
Affiliations
  • National Institutes for Food and Drug Control, Beijing 100050, China
Published: 2024-01-31 doi: 10.16155/j.0254-1793.2024.01.17
Outline
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Objective:

To develop the first batch of traditional Chinese medicine chemical reference substance 2-acetate regaloside A used in standard of Baihe (Juandan) Peifang Keli.

Methods:

The structure was elucidated by nuclear magnetic resonance spectrometry, mass spectrometry, ultraviolet spectroscopy and infrared spectroscopy. Purity analysis, determination of related substance and investigation of other physical and chemical parameters were carried out by using analytical different techniques such as high performance liquid chromatography, gas chromatography, coulometry and ignition residue method. On the above basis, the mass balance was used for value determination, and the 1H quantitative nuclear magnetic resonance method was applied for further verification.

Results:

The structure of the traditional Chinese medicine chemical reference substance was determined as 2-acetate regaloside A, and it was identified as a new compound by SciFinder search. The calibration value by mass balance method was 99.31%, and result of 1H quantitative nuclear magnetic resonance method was 100.06% (n=3, RSD=0.47%).

Conclusion:

The accurate development and calibration of the first batch of 2-acetate regaloside A fully ensures the implementation of the standard for Baihe (Juandan) Peifang Keli.

2-acetate regaloside A  /  reference substance  /  structure  /  identification  /  nuclear magnetic resonance  /  purity  /  assay
Jing LIU, Yang LIU, Zhong DAI, Shuang-cheng MA. Development and calibration of new traditional Chinese medicine chemical reference substance 2-acetate regaloside A[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (1) : 168 -173 . DOI: 10.16155/j.0254-1793.2024.01.17
Year 2024 volume 44 Issue 1
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doi: 10.16155/j.0254-1793.2024.01.17
  • Online Date:2026-03-16
  • Published:2024-01-31
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  • Revised:2023-10-24
Affiliations
    National Institutes for Food and Drug Control, Beijing 100050, 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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