Arsenic-Related Health Risk Assessment of Realgar-Containing NiuHuangJieDu Tablets in Healthy Volunteers Po Administration

Realgar, an arsenic-containing traditional Chinese medicine of As2S2, has significant therapeutic effects for hundreds of years. NiuHuangJieDu tablets (NHJDT) is one of the most commonly prescribed realgar-containing preparations for the treatment of sore throat, swelling, and aching of gums. Howeve...

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Main Authors: Xiao Wu, Ruoning Yan, Rong Guan, Yi Du, Yuexin Liu, Shanhu Wu, Song Zhu, Min Song, Taijun Hang
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-01-01
Series:Frontiers in Pharmacology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2021.761801/full
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author Xiao Wu
Xiao Wu
Ruoning Yan
Rong Guan
Yi Du
Yuexin Liu
Shanhu Wu
Song Zhu
Min Song
Taijun Hang
author_facet Xiao Wu
Xiao Wu
Ruoning Yan
Rong Guan
Yi Du
Yuexin Liu
Shanhu Wu
Song Zhu
Min Song
Taijun Hang
author_sort Xiao Wu
collection DOAJ
description Realgar, an arsenic-containing traditional Chinese medicine of As2S2, has significant therapeutic effects for hundreds of years. NiuHuangJieDu tablets (NHJDT) is one of the most commonly prescribed realgar-containing preparations for the treatment of sore throat, swelling, and aching of gums. However, realgar-containing TCMs raise great safety concerns due to the adverse effects reported by arsenic poisoning. In this study, the arsenic-related health risk assessment of NHJDT was conducted in healthy volunteers after single and multiple doses oral administration. Blood, plasma, and urine samples were collected after dosing at predetermined time points or periods. Simple, rapid, and sensitive methods were established for the quantification of total arsenic and arsenic speciation in biological samples. The total arsenic and arsenic speciation were determined by hydride generation-atomic fluorescence spectrometry (HG-AFS) and high-performance liquid chromatography–hydride generation–atomic fluorescence spectrometry (HPLC-HG-AFS), respectively. No significant fluctuation of total arsenic was observed in human blood, and no traces of arsenic speciation were found in human plasma. Dimethylarsenic acid was detected as the predominated arsenic species in human urine after dosing. Therapeutic dose administration of NHJDT was relatively safe in single dose for the limited blood arsenic exposure, but long-term medication may still pose health risks due to the accumulation of arsenics in blood and its extremely slow excretion rate. Therefore, arsenic exposure should be carefully monitored during realgar-containing TCM medication, especially for long-term regimen. The results obtained in this study will provide scientific references for the clinical application of realgar and its-containing TCMs.
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spelling doaj.art-11b1949d719c4af08b8f947bbf22fc912022-12-21T17:22:19ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-01-011210.3389/fphar.2021.761801761801Arsenic-Related Health Risk Assessment of Realgar-Containing NiuHuangJieDu Tablets in Healthy Volunteers Po AdministrationXiao Wu0Xiao Wu1Ruoning Yan2Rong Guan3Yi Du4Yuexin Liu5Shanhu Wu6Song Zhu7Min Song8Taijun Hang9School of Medicine and Holistic Integrative Medicine, Nanjing University of Chinese Medicine, Nanjing, ChinaKey Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, ChinaKey Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, ChinaKey Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, ChinaDepartment of Pharmacy, First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine), Hangzhou, ChinaKey Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, ChinaKey Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, ChinaKey Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, ChinaKey Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, ChinaKey Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, ChinaRealgar, an arsenic-containing traditional Chinese medicine of As2S2, has significant therapeutic effects for hundreds of years. NiuHuangJieDu tablets (NHJDT) is one of the most commonly prescribed realgar-containing preparations for the treatment of sore throat, swelling, and aching of gums. However, realgar-containing TCMs raise great safety concerns due to the adverse effects reported by arsenic poisoning. In this study, the arsenic-related health risk assessment of NHJDT was conducted in healthy volunteers after single and multiple doses oral administration. Blood, plasma, and urine samples were collected after dosing at predetermined time points or periods. Simple, rapid, and sensitive methods were established for the quantification of total arsenic and arsenic speciation in biological samples. The total arsenic and arsenic speciation were determined by hydride generation-atomic fluorescence spectrometry (HG-AFS) and high-performance liquid chromatography–hydride generation–atomic fluorescence spectrometry (HPLC-HG-AFS), respectively. No significant fluctuation of total arsenic was observed in human blood, and no traces of arsenic speciation were found in human plasma. Dimethylarsenic acid was detected as the predominated arsenic species in human urine after dosing. Therapeutic dose administration of NHJDT was relatively safe in single dose for the limited blood arsenic exposure, but long-term medication may still pose health risks due to the accumulation of arsenics in blood and its extremely slow excretion rate. Therefore, arsenic exposure should be carefully monitored during realgar-containing TCM medication, especially for long-term regimen. The results obtained in this study will provide scientific references for the clinical application of realgar and its-containing TCMs.https://www.frontiersin.org/articles/10.3389/fphar.2021.761801/fullrealgarNiuhuangjiedu tabletsarsenichealth risk assessmenthealthy volunteershydride generation-atomic fluorescence spectrometry
spellingShingle Xiao Wu
Xiao Wu
Ruoning Yan
Rong Guan
Yi Du
Yuexin Liu
Shanhu Wu
Song Zhu
Min Song
Taijun Hang
Arsenic-Related Health Risk Assessment of Realgar-Containing NiuHuangJieDu Tablets in Healthy Volunteers Po Administration
Frontiers in Pharmacology
realgar
Niuhuangjiedu tablets
arsenic
health risk assessment
healthy volunteers
hydride generation-atomic fluorescence spectrometry
title Arsenic-Related Health Risk Assessment of Realgar-Containing NiuHuangJieDu Tablets in Healthy Volunteers Po Administration
title_full Arsenic-Related Health Risk Assessment of Realgar-Containing NiuHuangJieDu Tablets in Healthy Volunteers Po Administration
title_fullStr Arsenic-Related Health Risk Assessment of Realgar-Containing NiuHuangJieDu Tablets in Healthy Volunteers Po Administration
title_full_unstemmed Arsenic-Related Health Risk Assessment of Realgar-Containing NiuHuangJieDu Tablets in Healthy Volunteers Po Administration
title_short Arsenic-Related Health Risk Assessment of Realgar-Containing NiuHuangJieDu Tablets in Healthy Volunteers Po Administration
title_sort arsenic related health risk assessment of realgar containing niuhuangjiedu tablets in healthy volunteers po administration
topic realgar
Niuhuangjiedu tablets
arsenic
health risk assessment
healthy volunteers
hydride generation-atomic fluorescence spectrometry
url https://www.frontiersin.org/articles/10.3389/fphar.2021.761801/full
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