Analysis of arsenic speciation in Sepiae Endoconcha and research on its limit standard / 中国中药杂志

Sepiae Endoconcha is a common marine animal medicine,which generally contains high concentration of arsenic( As).The Chinese Pharmacopoeia( 2010 edition,part I) stipulated that the total As content of Sepiae Endoconcha should not exceed 2 mg·kg~(-1),while this limit was revised to 10 mg·kg~(-1) in the 2015 edition. So far,there is no research on the speciation of As in Sepiae Endoconcha,which made it hard to accurately evaluate its security risk. In this study,32 batches of Sepiae Endoconcha from different sources were collected. The safety risk assessment was carried out by determining the total As content and As speciation,inorganic As[As( Ⅲ),As( Ⅴ) ]and organic As( MMA,DMA,As C,As B) by HPLC-ICP-MS,and then the limit standard was discussed. The results showed that As B was the main form of As in Sepiae Endoconcha,followed by DMA and As( Ⅴ) ． Of the 32 batches of Sepiae Endoconcha,9 batches( accounting for 28%) were detected possessing i As. The maximum concentration of As( Ⅲ) was 103. 3 μg·kg~(-1),and the maximum concentration of As( Ⅴ) was 222. 4 μg·kg~(-1). According to the limit of i As in food,18. 75% of the samples exceeded the standard. The results indicate that there is no simple positive correlation between total As and As morphology in Sepiae Endoconcha. Besides,there is a risk in the total As limit,especially after the relaxation of the total As limit. The problem of high i As content caused by pollution and other factors is difficult to regulate. Since the toxicity of inorganic As is much higher than that of organic As,it is of great practical significance to establish inorganic As form limits in Sepiae Endoconcha.

Speciation analysis of trace mercury and arsenic in 31 kinds of animal drugs and discussion about the limit standards / 药学学报

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.

Sulfur dioxide limit standard and residues in Chinese medicinal materials / 中国中药杂志

The traditional sulfur fumigation processing method has been widely used in the initial processing and storage of traditional Chinese medicinal materials due to its economy, efficiency, convenience, high operability and effect on mold and insect prevention. However, excessive sulfur fumigation of traditional Chinese medicinal materials would lead to the changes in chemical compositions, and even endanger human health. This study showed that traditional Chinese medicinal materials were sulfur fumigated directly after being harvested for quick drying, or fumigated after being weted in the storage process for preventing mold and insects. We found that the sulfur dioxide limits for traditional Chinese medicinal materials were stricter than those for foods. Based on the existing limit standards, we obtained the data of sulfur dioxide residues for 35 types of traditional Chinese medicinal materials in a total of 862 batches. According to the limit standard in the Chinese Pharmacopoeia (150， 400 mg·kg⁻¹), the average over-standard rate of sulfur dioxide was as high as 52.43%, but it was reduced to 29.47% if calculated based on the limit for vegetable additive standard (500 mg·kg⁻¹). Sulfur fumigation issue shall be considered correctly: sulfur dioxide is a type of low toxic substance and less dangerous than aflatoxin and other highly toxic substances, and a small amount of residue would not increase the toxicity of traditional Chinese medicinal materials. However, sulfur fumigation might change the content of chemical substances and affect the quality of traditional Chinese medicinal materials. Furthermore, the exposure hazards of toxic substances are comprehensively correlated with exposure cycle, exposure frequency, and application method. In conclusion, it is suggested to strengthen the studies on the limit standard of traditional Chinese medicinal materials, formulate practical and feasible limit standard for sulfur dioxide residues in traditional Chinese medicinal materials that are consistent with the medication characteristics of traditional Chinese medicinal materials and can guarantee people's demand for safe medication.

Explore a method for formulation of limit standard of toxic components in traditional Chinese medicine:aristolochic acid as a case study / 中国中药杂志

It is urgent to establish the limit standard of toxic components of Chinese herbal medicine, since the safety of traditional Chinese medicine (TCM) has attracted more and more attention.This paper analyzes the present situation and problems in the study of the limit standard of toxic components of Chinese herbal medicine. In addition, the current methods for setting the limit standards of toxic ingredients of TCM are reviewed in this paper, and we also propose a theoretical calculation method for setting the limit standards of toxic ingredients of TCM. Employing aristolochic acid as a case study, we formulate the limit standard of toxic components of Chinese herbal medicine. We believe this paper would provide some useful suggesting for formulating limits standard of toxic components of TCM.

Research progress of 5-hydroxymethylfurfural, a safety-related substance in traditional Chinese medicine injections / 中国中药杂志

Screening out the safety-related substances and establishing the corresponding standard has been a key research issue to improve the safety of traditional Chinese medicine injections(TCMIs). 5-HMF which widely exists in sugar-containing TCMIs has long been considered as an important safety-related substance. In this review, we summarizes the research progress on the toxicology of 5-HMF as well as the content and standards of 5-HMF in TCMIs.Therein, both literature summary and analysis results indicate that there are lack of toxicology researches of 5-HMF and its metabolites in TCMIs, although the potential toxicity of 5-HMF and its metabolites has been reported. Moreover, the content of 5-HMF largely varies from TCMIs to TCMIs, and even in the same TCMIs from different factories. To ensure the clinical efficacy of TCMIs, it urgent to carry out the study of the toxicology of 5-HMF in TCMIs comprehensively and systematically, so as to set up a relatively uniform standard as well as to develop process quality control method.

Current situation analysis and countermeasures on contamination of heavy metal in traditional Chinese medicinal materials in China / 中草药

Recent years, with the rapid development of industrialization in China, the contamination of heavy metal was worsening, and traditional Chinese medicinal materials (TCMM) were also suffered. The data were collected in the literatures in the past five years, and Green Trade Standard of Importing & Exporting Medicinal Plants & Preparations was used as the standard to evaluate the pollution conditions of lead (Pb), cadmium (Cd), mercury (Hg), arsenic (As), and copper (Cu). The five heavy metals exceeded the limits of the standard and the percentages were 9.66%, 26.35%, 13.0%, 9.32%, and 16.09%, respectively. Moreover, statistics on the residues of the heavy metals in different categories of TCMM from various origins were also carried out in this paper. The results showed that the contamination of heavy metals in TCMM differently depended on the origins and categories. Studies on the rapid detection methods and the limit standards of heavy metal should be established immediately. At the same time, the regulations should be formulated timely and supervision also should be intensified. To solve the problems of excessive amounts of heavy metals in TCMM, necessary measures should be taken to control the contamination of TCMM.