| Areca catechu L.is a palm plant,which mainly contains alkaloids,amino acids,tannins and other active components;It has pharmacological activities such as killing insects,eliminating accumulation and promoting qi.Arecae Semen has been spread to this day because of its great potential medicinal value and good clinical efficacy.The2020 edition of Chinese Pharmacopoeia（Volume I）has included about 52 kinds of prescription preparations related to Arecae Semen.In terms of compound medicine,the"Da Yuan Yin"included in the"theory of plague"plays an important role in the epidemic situation in 2020,while Arecae Semen,as a king medicine,plays a role in relieving dampness and evil,resolving phlegm and breaking knot,and making evil quickly collapse.However,the quality and safety of Arecae Semen are widely concerned because of its addiction,carcinogenicity and other negative effects,and Arecae Semen itself is easy to be polluted by exogenous pollutants such as aflatoxin.In addition,the quality of Arecae Semen Decoction Pieces will not only directly affect the clinical efficacy of traditional Chinese medicine,but also hinder its international trade.Therefore,it is of great significance to establish a perfect quality and safety evaluation system.Based on the traceable and representative information sources of areca nut pieces,this study systematically carried out TLC identification,water,extract,alkaloid,aflatoxin,heavy metals and toxic elements;The contents of four alkaloids in Arecae Semen were detected by HPLC and cluster analysis was done;The content of aflatoxin in Arecae Semen Decoction Pieces was detected by IAC-HPLC-FLD,and the health risk of aflatoxin B1 exposure was assessed by Monte Carlo method of Oracle crystal ball risk assessment software;ICP-MS method was used to detect the contents of heavy metals and toxic elements in Arecae Semen Decoction Pieces,and the target hazard coefficient method was used to evaluate the carcinogenic and non carcinogenic risk assessment model of Arecae Semen Decoction Pieces for adults and children.The results show that:1.Study on the quality control standard of Arecae Semen Decoction Pieces 36batches of commercial Arecae Semen Decoction Pieces are unqualified under different determination items.For example,38.89%of the water-soluble extract of Arecae Semen Decoction Pieces do not meet the provisions of the 2014 edition of Hong Kong Standard for traditional Chinese medicine（i.e.less than 12%）83.33%of arecoline content complies with the provisions of the 2020 edition of the Chinese Pharmacopoeia,and 13.89%of Arecae Semen Decoction Pieces exceed the standard of aflatoxin.A total of 12 batches（33.33%）of Arecae Semen Decoction Pieces do not comply with the provisions of the 2020 edition of the Chinese Pharmacopoeia,and 23 batches（63.89%）do not comply with the provisions of the 2014 edition of the Hong Kong Standard of traditional Chinese medicine.Attention should be paid to the detection data,which can provide basic data support for the quality standard of Arecae Semen Decoction Pieces.2.On the basis of comparing the Pharmacopoeia and standards of different countries or regions,this study carried out the study on the distribution of index components in Arecae Semen Decoction Pieces.It was found that the test results of arecoline and other alkaloids showed that 30 batches met the limit standard of Chinese Pharmacopoeia,and 7 batches did not meet the provisions of Hong Kong Traditional Chinese medicine standard in 2014,This may be related to the content and distribution of alkaloids in Arecae Semen itself;The 36 batches of areca nuts do not meet the limit requirements of the Pharmacopoeia of Thailand in 2018,which may be related to the cultural background of different countries or regions.In addition,through cluster analysis,it was found that 36 batches of arecoline decoction pieces were divided into arecoline rich category（arecoline:>0.29%）,lower than the limit category（arecoline:<0.20%）and higher than the limit category（arecoline content between 0.21～0.30%）.In addition,it was found that there was no correlation between the alkaloid content in36 batches of Arecae Semen and the place of origin.3.In this study,the content of aflatoxin in 36 batches of Arecae Semen Decoction Pieces was determined by IAC-HPLC-FLD,and the health risk of taking aflatoxin B1by taking Arecae Semen Decoction Pieces was evaluated.The results showed that the contamination level of AFB1 in 36 batches of commercial Arecae Semen samples ranged from 2.124 to 16.334 ng/g,the detection rate of AFB1 was 63.89%,and the average contamination level was 2.856 ng/g.The Monte Carlo method of Oracle crystal ball risk assessment software is used to simulate and calculate the add probability distribution of AFB1 intake by taking Arecae Semen Decoction Pieces.It shows that compared with the average population,the high intake group is the high-risk group of AFB1 exposure.By comparing the harm degree value and MOE value,it was confirmed that the health risk of AFB1 exposure caused by Arecae Semen decoction slices was low,and it was identified that the population with high intake of Arecae Semen decoction slices was the high-risk group of health risk caused by AFB1 exposure caused by Arecae Semen decoction slices.Although 52%batches of Arecae Semen Decoction Pieces have reached the safety threshold,we have to pay attention to the pollution of aflatoxin due to the high harm of AFB1 to the body（especially patients）4.The contents of five heavy metals and toxic elements in 36 batches of Arecae Semen Decoction Pieces were determined by ICP-MS.at the same time,the limit standard values of heavy metals and toxic elements in the 2020 edition of Chinese Pharmacopoeia（Part IV）were referred.The experimental results showed that Pb was not detected,the average content of Cu was the highest,but did not exceed the standard The detection rate of Cd was 77.78%,and one batch of as（Guangxi）and Hg（Hainan）exceeded the standard respectively.In addition,this paper also established the health risk assessment model of heavy metals and toxic elements in Arecae Semen Decoction Pieces.We found that the THQ of the above five heavy metals to adults and children is lower than its standard value,so there is no health risk.However,for adults,its total Cr is slightly higher than the cancer risk threshold,indicating a potential cancer risk.Through this study,it is found that there are differences in the standards of Arecae Semen Decoction Pieces in different countries or regions,which will hinder the smooth circulation of Arecae Semen Decoction Pieces in international trade.In addition,due to the influence of factors such as Arecae Semen planting place and processing technology,the quality and safety of Arecae Semen Decoction Pieces do not meet the standard,such as the content of arecoline and water-soluble extract does not meet the standard,and the content of aflatoxin,heavy metals and toxic elements exceeds the standard.The above research results will provide important reference information for the research on the quality and safety standard of areca,and provide reference value for the establishment of health risk assessment model of other traditional Chinese medicine.It is expected that relevant departments will form a complete standard system for the planting,processing and storage of raw materials of Arecae Semen Decoction Pieces,so as to ensure the safe use of Arecae Semen Decoction Pieces. |
