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Quantitative analysis of 11 components in Angong Niuhuang Pills and the assessment of their contents of the products and in vivo exposure in rats
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A-na HE1, Meng-bei XIA1, Ying PENG1, Ji-ye A1, 2, 3, *, Guang-ji WANG1, 2, 3
Acta Pharmaceutica Sinica | 2025, 60(8) : 2585 - 2594
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Acta Pharmaceutica Sinica | 2025, 60(8): 2585-2594
• Original Articles •
Quantitative analysis of 11 components in Angong Niuhuang Pills and the assessment of their contents of the products and in vivo exposure in rats
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A-na HE1, Meng-bei XIA1, Ying PENG1, Ji-ye A1, 2, 3, *, Guang-ji WANG1, 2, 3
Affiliations
  • 1The Key Laboratory of Drug Metabolism and Pharmacokinetics of Jiangsu Province, China Pharmaceutical University, Nanjing 210009, China
  • 2Component PK-PD Combination Research, Innovation Unit of Chinese Academy of Medical Sciences, Nanjing 210009, China
  • 3Key Laboratory of Pharmacokinetic Methods of Traditional Chinese Medicine Compounds, National Administration of Traditional Chinese Medicine, Nanjing 210009, China
Published: 2025-08-12 doi: 10.16438/j.0513-4870.2025-0194
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This study aimed to quantitatively evaluate the contents and in vivo exposure levels of 11 primary components in six commercially available Angong Niuhuang Pill (ANP) products. A chromatography-tandem mass spectrometry (LC-MS/MS) method was developed for the simultaneous quantification of deoxycholic acid (DCA), cholic acid (CA), hyodeoxycholic acid (HDCA), glycocholic acid (GCA), taurocholic acid (TCA), curcumin (CC), baicalin (BC), berberine (BBR), and crocetin (CRT). A gas chromatography-mass spectrometry (GC-MS) method was established to determine muscone (MCN) and borneol (BN). The analytical methods were validated and applied to assess the content of the 11 components in six ANP products and their plasma exposure levels following intragastric administration in rats (All animal experiments had been approved by the Experimental Animal Ethics Committee of China Pharmaceutical University, ethics number: 2024-07-131). The quantitative methods utilizing LC-MS/MS and GC-MS were successfully established and validated for the simultaneous quantification of DCA, CA, HDCA, GCA, TCA, CC, BC, BBR, CRT, MCN and BN both in vivo and in vitro samples, respectively. The contents of HDCA, DCA, CA, GCA, TCA, CC, BC, CRT, BBR, BN and MCN varied over the ranges between 0.22 ± 0.03-1.47 ± 0.41, 0.22 ± 0.03-1.48 ± 0.39, 0.65 ± 0.01-4.28 ± 0.30, 0.44 ± 0.01-0.80 ± 0.02, 0.49 ± 0.05-1.36 ± 0.04, 0.001 2 ± 0.000 1-0.007 1 ± 0.001 0, 3.49 ± 0.80-4.47 ± 0.13, 0.003 6 ± 0.001 1-0.013 7 ± 0.014 8, 1.77 ± 0.05-4.84 ± 0.41, 4.70 ± 2.09-10.91 ± 3.08, 0.20 ± 0.03-0.44 ± 0.04 mg·g-1, respectively. Similarly, the in vivo plasma exposure of HDCA, DCA, CA, GCA, TCA, BC, CRT covered the ranges over 5 088.63 ± 2 701.16-11 819.10 ± 7 585.61, 3 639.42 ± 1 970.63-18 853.46 ± 18 309.75, 19 397.89 ± 9 464.21-182 870.72 ± 236 816.06, 11 011.97 ± 4 236.99-57 331.79 ± 76 180.09, 53 607.57 ± 43 279.12-109 961.78 ± 82 288.37, 590.17 ± 175.72-2 424.90 ± 589.22, 74.95 ± 19.38-586.84 ± 194.49 h·ng·mL-1, respectively. The plasma concentrations of the other four components (CC, BBR, BN, MCN) were below the detection limit. Three robust quantitative analytical methods were established and applied to evaluate variations of the content and in vivo exposure levels of 11 components in six ANP commercial products. The results demonstrated that the contents and in vivo exposure of some of the 11 components are consistent in the 6 products, particularly in the products containing the same natural or artificial bezoar and musk, or those manufactured by the same company. However, the inconsistency of the contents and in vivo exposure of some other ingredients suggests variations in the selection of raw herb medicines or processing technology. It suggests the crucial importance to monitor the source and quality of the raw herb medicines, and unify the processing technology. Furthermore, this study provides the data and reference methods for the supervision and consistency evaluation of quality amongst the products.

Angong Niuhuang Pill  /  content  /  in vivo exposure
何阿娜, 夏梦贝, 彭英, 阿基业, 王广基. 安宫牛黄丸中11种主要成分含量测定及大鼠体内暴露研究. 药学学报, 2025 , 60 (8) : 2585 -2594 . DOI: 10.16438/j.0513-4870.2025-0194
A-na HE, Meng-bei XIA, Ying PENG, Ji-ye A, Guang-ji WANG. Quantitative analysis of 11 components in Angong Niuhuang Pills and the assessment of their contents of the products and in vivo exposure in rats[J]. Acta Pharmaceutica Sinica, 2025 , 60 (8) : 2585 -2594 . DOI: 10.16438/j.0513-4870.2025-0194
Year 2025 volume 60 Issue 8
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doi: 10.16438/j.0513-4870.2025-0194
  • Receive Date:2025-02-25
  • Online Date:2026-09-20
  • Published:2025-08-12
Article Data
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  • Received:2025-02-25
  • Revised:2025-05-28
Affiliations
    1The Key Laboratory of Drug Metabolism and Pharmacokinetics of Jiangsu Province, China Pharmaceutical University, Nanjing 210009, China
    2Component PK-PD Combination Research, Innovation Unit of Chinese Academy of Medical Sciences, Nanjing 210009, China
    3Key Laboratory of Pharmacokinetic Methods of Traditional Chinese Medicine Compounds, National Administration of Traditional Chinese Medicine, Nanjing 210009, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
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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