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Simultaneous Determination of Pyrrolizidine Alkaloids and Aristolochic Acids in Fufang Banxia Tablets by UPLC-MS/MS and Risk Assessment
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Chunmei TAN, Cuifen FANG, Juanjuan WANG, Ting DONG, Linlin ZHANG, Cheng ZHENG, Bilian CHEN*
Chinese Pharmaceutical Journal | 2024, 59(17) : 1637 - 1642
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Chinese Pharmaceutical Journal | 2024, 59(17): 1637-1642
Simultaneous Determination of Pyrrolizidine Alkaloids and Aristolochic Acids in Fufang Banxia Tablets by UPLC-MS/MS and Risk Assessment
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Chunmei TAN, Cuifen FANG, Juanjuan WANG, Ting DONG, Linlin ZHANG, Cheng ZHENG, Bilian CHEN*
Affiliations
  • NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine (Traditional Chinese Patent Medicine), Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China
Published: 2024-09-08 doi: 10.11669/cpj.2024.17.011
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OBJECTIVE To establish an ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method for simultaneous determination of three pyrrolizidine alkaloids and five aristolochic acids in Fufang Banxia Tablets, and carry out preliminary risk assessment. METHODS ACQUITY UPLC BEH C18 column (2.1 mm×100 mm, 1.7 μm) was used. The mixed solution of methanol-acetonitrile (1∶1) was used as mobile phase A, and 0.1% formic acid solution and 5 mmol·L-1 ammonium formate were used as mobile phase B. Gradient elution was performed at a flow rate of 0.3 mL·min-1 and the column temperature was maintainedat 30 ℃. Electrospray ion source (ESI), multiple reaction monitoring mode (MRM) and positive ion scanning were used. RESULTS Three pyrrolizidine alkaloids showed a good linear relationship in the range of 0.48-482.60 pg, and five aristolochic acids showed a good linear relationship in the range of 0.51-538.51 pg. The correlation coefficients were higher than 0.99. The average recoveries were between 60.4%% and 120.5%, with RSDs of 2.1%-9.7%. Pyrrolizidine alkaloids and aristolochic acids were detected in all five batches, the total content of pyrrolizidine alkaloids was 5.42-5.46 mg·kg-1, and the total content of aristolochic acids in positive samples were 1.04-1.70 mg·kg-1. CONCLUSION The established method is simple and accurate, and can simultaneously determine the contents of three pyrrolizidine alkaloids and five aristolochic acids in Fufang Banxia Tablets. The preliminary risk assessment shows that the safety risk of Fufang Banxia Tablets is low.

Fufang Banxia Tablets  /  pyrrolizidine alkaloid  /  aristolochic acid  /  UPLC-MS/MS  /  content determination  /  risk assessment
Chunmei TAN, Cuifen FANG, Juanjuan WANG, Ting DONG, Linlin ZHANG, Cheng ZHENG, Bilian CHEN. Simultaneous Determination of Pyrrolizidine Alkaloids and Aristolochic Acids in Fufang Banxia Tablets by UPLC-MS/MS and Risk Assessment[J]. Chinese Pharmaceutical Journal, 2024 , 59 (17) : 1637 -1642 . DOI: 10.11669/cpj.2024.17.011
Year 2024 volume 59 Issue 17
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doi: 10.11669/cpj.2024.17.011
  • Receive Date:2024-02-04
  • Online Date:2025-12-30
  • Published:2024-09-08
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  • Received:2024-02-04
Affiliations
    NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine (Traditional Chinese Patent Medicine), Zhejiang Institute for Food and Drug Control, Hangzhou 310052, 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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