ABSTRACT
Inductively coupled plasma mass spectrometry (ICP-MS) was applied to determine the concentrations of lead (Pb), cadmium (Cd) and arsenic (As) in Lindera aggregata (Sims) Kosterm. The physiologically based extraction test (PBET) digestion in vitro/Caco-2 cell model was established to investigate the bioaccessible contents of Pb, Cd and As in decoction of Lindera aggregata (Sims) Kosterm. The target-organ toxicity dose modification of HI method (TTD) was used to evaluate the cumulative risk caused by the combined exposure of the total levels of Pb, Cd and As in Lindera aggregata (Sims) Kosterm. and the bioaccessible contents in the decoction. The results showed that the total contents of Pb, Cd and As in 4 batches of samples were in the range of 2.901-3.872, 1.299-1.800 and 0.062-0.216 mg·kg-1, respectively. After transportation by Cacco-2 cells, the bioaccessible contents of Pb, Cd, and As in the decoction were in the range of 0.045-0.080, 0.070-0.112 and 0.004-0.018 mg·kg-1. The results of risk assessment showed that calculated by the total amounts of heavy metals in the Lindera aggregata (Sims) Kosterm., for the end points of nervous system, the cumulative risks of co-exposure of heavy metals in 3 batches of samples were of concern. After decoction and transportation by Caco-2 cells, for the end points of cardiovascular system, blood, nervous system, kidney and testis, the TTD modification of HI values of all batches of samples were less than 1, and the health risks were acceptable. The study provided methodology basis for a more objective assessment of the health risks of heavy metals and harmful elements in traditional Chinese medicine and for a more scientific limit standard of heavy metals and harmful elements.
ABSTRACT
Objective: Heavy metal and harmful element contamination are frequently reported in Chinese herbal medicines (CHMs), and roots and rhizomes parts showed a higher content than other parts. To investigate the residue level and assess the potential human health risk of heavy metals and harmful elements in roots and rhizomes, 720 batches of the sample representing 20 species of herbs from different sources were collected. Methods: The content of Pb, Cd, As, Hg, and Cu in the digests was determined using ICP-MS. The chronic hazard index estimate based on non-cancer hazard quotient (HQ) was applied for potential health risk assessment of Pb, Cd, As, Hg, and Cu via consumption of CHMs. Results: Compared with the Chinese limit standard (Chinese Pharmacopoeia Commission, 2020 edition) of Pb, Cd, As, Hg, and Cu in Ginseng Radix et Rhizoma, the exceedance percentage of Pb in total samples was 14.1%, which were generally far higher than Cd, As, Hg, and Cu. Health risk assessment results based on hazard quotient calculating showed that total HQ of Cu, Pb, As, Cd, and Hg in Pulsatillae Radix and Clematidis Radix et Rhizoma exceeded 1, with the value of 1.543 and 1.235. Besides, Arsenic had the highest HQ value (0.957) in Pulsatillae Radix. Conclusion: Consuming raw materials of Pulsatillae Radix and Clematidis Radix et Rhizoma may pose a potential risk and Arsenic residues in Pulsatillae Radix deserved special attention.
ABSTRACT
Heavy metals and other harmful elements in traditional Chinese medicines inflict serious damage on public health. Therefore, risk assessment of Chinese raw materials has gained increasing attention. To date, few reports have been published on the health risk assessment of heavy metals and harmful elements in Chinese patent medicines. To gain a comprehensive understanding of heavy metals and other harmful elements in Chinese patent medicines and to establish proper limits, residual Pb, Cd, As, Hg, Cu and Cr in 15 054 samples of 295 drugs was analyzed with regard to distribution and variation between elements and dosage forms. In addition, in accord with procedures including hazard identification, hazard characterization, exposure assessment and risk characterization, basic procedures and specific parameters for risk assessment of heavy metals and harmful elements in Chinese patent medicines were clarified based on the health risk assessment of 14 787 samples and 276 drugs. A method and equation for establishing residual limits is proposed. The results show that content and target hazard quotients (THQs) of the investigated elements in all samples showed a skewed distribution approaching 0. Content of Pb, As, Cu, Hg, Cd or Cr in the samples exceeded 100 mg·kg-1 and the content of Pb, As, or Cu in individual samples exceeded 1 000 mg·kg-1. THQs of 586 samples and four drugs were above 1. We believe that the health risk of Hg, Pb and As in Chinese patent medicines with dosage forms of pill, capsule, tablet and powder, especially those in raw powder preparations, warrant concern.
ABSTRACT
OBJECTIVE: To discuss the quality status of TCM raw powder preparations based on TCM raw powder preparation special project of national post-market drug surveillance in 2018. METHODS: The statutory standards of seven TCM raw powder preparations, including Qingwei Huanglian pills, Jianpi pills, Qipi pills, Shangqing pills, Renshen Guipi pills, Yimu pills and Niuhuang Qingwei pills, were analyzed. The test methods for adulteration, dyeing, sulfur dioxide, pesticide residues, aflatoxins, heavy metals and harmful elements and irradiation were established to reveal the safety risk. Whole-ingredient identification methods were developed to evaluate the authenticity of the drug. RESULTS: The statutory standards of the TCM raw powder preparations tested in national post market surveillance in 2018 are simple and inadequate to comprehensively control the quality of the drugs. Unqualified feeding, adulteration, and contamination with Pb, As and Hg were the main problems currently. Dyeing, aflatoxins and pesticide residues were found in very few samples. Contamination risk of sulfur dioxide was low in TCM raw powder preparations. Most manufacturers adopted irradiation for sterilization. CONCLUSION: The standards of TCM raw powder preparations should be improved to realize whole-ingredient identification. And heavy metals and harmful elements should be investigated. The manufacturers should enhance quality control of the raw material and pay attention to the risk of adulteration and harmful residues. Special project of national post-market surveillance can reveal common problems of similar drugs, which is a powerful measure for drug regulation.
ABSTRACT
The toxicity of heavy metals and harmful elements is close related to their speciation. In the present study, the methods for mercury and arsenic speciation analysis based on high-performance liquid chromatography conjunction with inductively coupled plasma mass spectrometry (HPLC-ICP-MS) were established and applied to the determination of 31 kinds of animal drugs, 29 of which were included in the Chinese Pharmacopeia (2015 edition). The results showed that the LODs for all the speciation were within 0.1-0.65 μg·kg-1, and the recoveries were within 86.9%-116.6% with the RSD of 1.49%-4.23%. Inorganic mercury (Hg2+) was detected in all the 87 batches of samples that came from 31 kinds of animal drugs, and the contents were 2.39-6567 μg·kg-1. Methylmercury (MeHg) was detected in 33 batches of samples that came from 12 kinds of animal drugs, and the contents were 2.83-319.7 μg·kg-1. Ethylmercury (EtHg) were detected in none of the samples. The detection rates of As(Ⅲ), As(V), monomethylarsononous acid (MMA), dimethylarsinic acid (DMA), arsenobetaine (AsB) and arsenocholine (AsC) in the 31 batches of animal drugs was 96.77%, 100%, 45.16%, 90.32%, 93.55% and 22.58%, respectively. According to the toxic level of different speciation, the animal drugs with high risks of mercury were Agkistrodon, Bungarus Parvus, Zaocys, and Scolopendra; the animal drugs with high risks were Pheretima, Agkistrodon, Zaocys, and Aspongopus. This study can provide important evidence for the risk assessment, setting and revision of the limit standards of heavy metals and harmful elements.
ABSTRACT
OBJECTIVE: To establish the quality standard of Wuziyanzong pills so as to improve the quality control capacity. METHODS: Thin-layer chromatography (TLC) was used for the qualitative analysis of Lycii Fructus in the formula. The fingerprint of Wuziyanzong pills based on combined control herbs, the screening method of Schisandrae Sphenantherae Fructus and the determination of hyperoside and schisandrin in the formula were established by HPLC. The contents of Pb, Cd, As, Hg, Cu and Cr were determined by ICP-MS method. RESULTS: The TLC identification method showed good separation effect and specificity. The fingerprint, using the combined control herbs, could simultaneously identify Rubi Fructus, Cuscutae Semen, Plantaginis Semen, and Schisandrae Chinensis Fructus with good method validation results. According to the peak area ratio of schisantherin A and schisandrin, it could screen out Schisandrae Sphenantherae Fructus in the formula when the ratio was proposed to be 0.20. In the assay, the content limits of hyperoside and schisandrin in Wuziyanzong pills were proposed. Three harmful elements, ie As, Hg and Pb exceeded the permitted limits in 19 batches of samples. This may be caused by using the same production line for different products and the samples may be contaminated by the residue of previous products. CONCLUSION: The established quality standard is simple and accurate and shows good specificity and reproducibility. It could be used for the comprehensive and overall quality evaluation of Wuziyanzong pills.