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Quality Analysis of Cyathulae Radix Based on National Drug Sampling and Testing and Some Suggestions
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GAO Bixing, QI Jingliang, LI Qian, GENG Zhao, ZHONG Lian, GAO Chi, DENG Xi, WANG Ying, BAO Xiaohong, YANG Lei*, GOU Yan*
Chinese Pharmaceutical Journal | 2024, 59(3) : 275 - 280
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Chinese Pharmaceutical Journal | 2024, 59(3): 275-280
Quality Analysis of Cyathulae Radix Based on National Drug Sampling and Testing and Some Suggestions
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GAO Bixing, QI Jingliang, LI Qian, GENG Zhao, ZHONG Lian, GAO Chi, DENG Xi, WANG Ying, BAO Xiaohong, YANG Lei*, GOU Yan*
Affiliations
  • NMPA Key Laboratory for Quality Evaluation of Chinese Patent Medicines, Sichuan Institute for Food and Drug Control, Chengdu 611731, China
Published: 2024-02-08 doi: 10.11669/cpj.2024.03.012
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OBJECTIVE To analyze the quality differences of Cyathulae Radix from different manufacturers on the market based on national drug sampling and testing in 2022, then analyze the problems and put forward suggestions to provide basis for the quality supervision and standard improvement of Cyathulae Radix. OBJECTIVE Inspection was conducted according to corresponding standards, inspection reports were issued, and then quality evaluation and analysis were conducted. At the same time, problems were found and suggestions were made based on targeted exploratory research on quality problems, standard problems and other related problems found in the inspection. RESULTS A total of 334 batches of Cyathulae Radix samples were taken. According to the standard inspection, two batches of samples were found to be substandard in character, and Cyathulae capitatae Radix was used as Cyathulae Radix. At the same time, it was found that the content determination methods in the standard were too complex, and the specified limit for content determination was too low. In the exploratory study, the unique component achybidensaponin I was detected in 27 batches of Cyathulae Radix and 7 batches exceeded the specified limit, which was mixed with Achyranthes bidentata. Plant growth regulator (paclobutrazol) was detected in 270 batches of Cyathulae capitatae Radix. The detection of heavy metals and harmful elements cadmium(Cd) in 114 batches exceeded the limit. Finally, the quality standard of Cyathulae Radix was improved, the supplementary test method was established, and the risk warning was put forward. CONCLUSION Through the national sampling inspection, the relevant problems in the prepared slices and quality standards of Cyathulae Radix are found, suggesting that the quality standards should be improved and the quality supervision of Cyathulae Radix should be strengthened.

Cyathulae Radix  /  Cyathulae capitatae Radix  /  national drug sampling and testing  /  quality analysis  /  paclobutrazol
GAO Bixing, QI Jingliang, LI Qian, GENG Zhao, ZHONG Lian, GAO Chi, DENG Xi, WANG Ying, BAO Xiaohong, YANG Lei, GOU Yan. Quality Analysis of Cyathulae Radix Based on National Drug Sampling and Testing and Some Suggestions[J]. Chinese Pharmaceutical Journal, 2024 , 59 (3) : 275 -280 . DOI: 10.11669/cpj.2024.03.012
Year 2024 volume 59 Issue 3
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doi: 10.11669/cpj.2024.03.012
  • Receive Date:2023-02-13
  • Online Date:2025-11-13
  • Published:2024-02-08
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  • Received:2023-02-13
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    NMPA Key Laboratory for Quality Evaluation of Chinese Patent Medicines, Sichuan Institute for Food and Drug Control, Chengdu 611731, 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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