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Assessment of ochratoxin A exposure in Gejie Dingchuan Pills and evaluation of its maximum limit levels
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Xiao-Yan HUANG1, Jia-Hong SONG1, Yue WU1, Jian-Hong WU2, Xiao-Yi HUA1, *
Laboratory Testing | 2024, 2(10) : 87 - 90
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Laboratory Testing | 2024, 2(10): 87-90
Evaluation and Analysis
Assessment of ochratoxin A exposure in Gejie Dingchuan Pills and evaluation of its maximum limit levels
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Xiao-Yan HUANG1, Jia-Hong SONG1, Yue WU1, Jian-Hong WU2, Xiao-Yi HUA1, *
Affiliations
  • 1 Wuxi Institute of Drug Safety Control Wuxi 214000 China
  • 2 The Affiliated Mental Health Center of Jiangnan University Wuxi 214000 China
Outline
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Objective Evaluation of ochratoxin A (OTA) contamination inGejie Dingchuan Pills. Methods Eighty-six samples from sevenpharmaceutical manufacturers were analyzed for OTA content usingultra-high-performance liquid chromatography-tandem mass spectrometry.Results The method displayed excellent linearity within the range ofconcentrations ${0.1}\sim {10}\mathrm{{ng}}/\mathrm{{mL}}$ .The limits of detection and quantification were ${0.2}\mathrm{{\mu g}}/\mathrm{{kg}}$ and $1\mathrm{{\mu g}}/\mathrm{{kg}}$ ,respectively. Seventy-two samples were detected to be contaminated withOTA, resulting in an 84% positive rate. Furthermore, ten samples failedto meet the required standards, reflecting a failure rate of 12%. Theactual sample test results showed that the OTA detection rate of GejieDingchuan pills was high and the pollution was serious, which suggestedthe urgency of detecting and determining the maximum OTA limit ofproprietary Chinese medicine. Conclusion This study assesses the extentof OTA contamination in Gejie Dingchuan pills, offering a scientificbasis for future investigations of OTA maximum limits in Chineseproprietary medicines.

ochratoxin A (OTA)  /  Gejie Dingchuan Pills  /  maximum limit  /  Chinese proprietary medicine
Xiao-Yan HUANG, Jia-Hong SONG, Yue WU, Jian-Hong WU, Xiao-Yi HUA. Assessment of ochratoxin A exposure in Gejie Dingchuan Pills and evaluation of its maximum limit levels[J]. Laboratory Testing, 2024 , 2 (10) : 87 -90 .
  • Jiangsu Provincial Market Supervision Administration Science and Technology Plan Project "Research on Quality Control of Animal Drugs and Mineral Drugs"(KJ2023044)
Year 2024 volume 2 Issue 10
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  • Online Date:2025-07-29
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Jiangsu Provincial Market Supervision Administration Science and Technology Plan Project "Research on Quality Control of Animal Drugs and Mineral Drugs"(KJ2023044)
Affiliations
    1 Wuxi Institute of Drug Safety Control Wuxi 214000 China
    2 The Affiliated Mental Health Center of Jiangnan University Wuxi 214000 China

Corresponding:

*HUA Xiao-Yi, Ph.D, Deputy Chief Pharmacist, Wuxi Institute of Drug Safety Control, Wuxi 214000, China. E-mail:
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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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