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Discussion on the quality status of Arnebiae Radix based on the national drug sampling and testing in 2015 and 2022*
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Sheng-yun DAI1, Jie LIU1, Su-ning YUN2, Chao-jie LIAN1, Fei QIAO1, Ke ZAN1, Li-nong GUO1, Shuang-cheng MA1, **, Jian ZHENG1, **
Chinese Journal of Pharmaceutical Analysis | 2024, 44(5) : 740 - 749
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(5): 740-749
Column on Quality Evaluation of Arnebiae Radix
Discussion on the quality status of Arnebiae Radix based on the national drug sampling and testing in 2015 and 2022*
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Sheng-yun DAI1, Jie LIU1, Su-ning YUN2, Chao-jie LIAN1, Fei QIAO1, Ke ZAN1, Li-nong GUO1, Shuang-cheng MA1, **, Jian ZHENG1, **
Affiliations
  • 1.National Institutes for Food and Drug Control, Beijing 102629, China
  • 2.Yili Institute of Inspection, Testing and Certification, Yili 835000, China
Published: 2024-05-31 doi: 10.16155/j.0254-1793.2024.05.01
Outline
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The national drug sampling and inspection project is an important way of drug quality supervision in China which providing strong support for drug supervision and standard improvement. This article summarizes the national drug sampling and inspection project of Arnebiae Radix completed by Institute for Control of Chinese Traditional Medicine and Ethnic Medicine,National Institutes for Food and Drug Control in 2015 and 2022. The results illustrated that the qualification rate of Arnebiae Radix has increased from 43.9% in 2015 to 87.5%,and the qualification rate of Arnebiae Radix has significantly increased. The two nationwide inspections of Arnebiae Radix reflected the scarcity of Arnebiae Radix resources in Xinjiang and Inner Mongolia,resulting in a high market share of unqualified samples. The thin layer identification spots of the unqualified Arnebiae Radix sampled in 2015 were not consistent with the qualified samples. The thin layer identification of the unqualified samples sampled in 2022 was consistent with those of the qualified samples,but the depth of the spots were not consistent with those of the qualified samples,indicating that the current unqualified samples were adulterated samples,which posing greater challenges to the quality supervision of Arnebiae Radix. Through the exploratory research of twice National Drug Sampling and Inspection Project,it is preliminarily believed that it is of great significance to improve the standard test items of Arnebiae Radix,scientifically establish the limit value and strengthen the construction of the quality control system for the supervision.

Arnebiae Radix  /  national drug sampling and testing  /  quality standard  /  statutory examine  /  exploratory research
Sheng-yun DAI, Jie LIU, Su-ning YUN, Chao-jie LIAN, Fei QIAO, Ke ZAN, Li-nong GUO, Shuang-cheng MA, Jian ZHENG. Discussion on the quality status of Arnebiae Radix based on the national drug sampling and testing in 2015 and 2022*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (5) : 740 -749 . DOI: 10.16155/j.0254-1793.2024.05.01
Year 2024 volume 44 Issue 5
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doi: 10.16155/j.0254-1793.2024.05.01
  • Receive Date:2023-04-27
  • Online Date:2026-03-20
  • Published:2024-05-31
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  • Received:2023-04-27
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Affiliations
    1.National Institutes for Food and Drug Control, Beijing 102629, China
    2.Yili Institute of Inspection, Testing and Certification, Yili 835000, 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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