Arsenic-Related Health Risk Assessment of Realgar-Containing NiuHuangJieDu Tablets in Healthy Volunteers Po Administration
Authors
Xiao Wu
School of Medicine and Holistic Integrative Medicine, Nanjing University of Chinese Medicine, Nanjing, China
Ruoning Yan
Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, China
Rong Guan
Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, China
Yi Du
Department of Pharmacy, First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine), Hangzhou, China
Yuexin Liu
Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, China
Shanhu Wu
Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, China
Song Zhu
Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, China
Min Song
Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, China
Taijun Hang
Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, China
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.
Keywords: realgar, Niuhuangjiedu tablets, arsenic, health risk assessment, healthy volunteers, hydride generation-atomic fluorescence spectrometry
Author Biography
Xiao Wu, School of Medicine and Holistic Integrative Medicine, Nanjing University of Chinese Medicine, Nanjing, China
Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, China
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