21种中药材中黄曲霉毒素B1的污染状况及致癌风险分析

Analysis of aflatoxin B1 contamination and carcinogenic risk in 21 kinds of Chinese medicinal materials

目的了解柏子仁等21种中药材被黄曲霉毒素B1(AFB1)污染的状况并进行致癌风险分析。方法检索中国知网、维普、Pubmed、Elsevier、Springer等数据库,检索时间2000年1月1日至2022年1月1日,筛选受AFB1污染的中药材检测相关数据与文献,共得到43篇文献,获得数据520组。对数据进行灵敏度分析及风险评估。结果柏子仁、大枣、胖大海等10种中药材的AFB1检出率较高,均不低于50.00%;柏子仁、莲子、槟榔等6种中药材的合格率均低于70.00%;莲子、柏子仁、远志、陈皮、酸枣仁、延胡索的阳性最大值超出《中华人民共和国药典(2020年版)》(以下简称《中国药典》)规定值的15~110倍。21种中药材所含AFB1的日暴露量为0~3.1370ng/kg,超额风险为0~0.9411。柏子仁、远志、陈皮等9种中药材AFB1测定均值对超额风险的灵敏度均达到了97.000%以上,人体质量对超额风险的灵敏度均小于0。当样本量足够大时,中药材AFB1测定均值为超额风险的主要影响因素。结论21种中药材受AFB1污染严重,其中19种中药材受到了AFB1污染,并且14种出现了不同程度的AFB1含量超标情况。21种中药材均符合《中国药典》用法用量,其慢性致癌风险在可控制范围内。

Objective To understand the contamination of 21 kinds of Chinese medicinal materials,such as Semen Platycladi,by aflatoxin B1(AFB1)and carry out carcinogenic risk analysis.Methods The databases of CNKI,Vip,Pubmed,Elsevier,Springer were searched from January 1,2000 to January 1,2022.The relevant data and literature of AFB1 contaminated Chinese herbal medicines were screened.A total of 43 literatures and 520 groups of data were obtained.The sensitivity analysis and risk assessment were conducted on the datas.Results The detection rate of AFB1 in 10 kinds of Chinese medicinal materials,such as Semen Platycladi,Fructus Ziziphi Jujubae,and scaphium scaphigerum,were not less than 50.00%.The qualified rate of 6 kinds of Chinese medicinal materials,such as Semen Platycladi,Lotus Seed and Areca catechu,were lower than 70.00%.The maximum positive value of Lotus Seed,Semen Platycladi,Polygala tenuifolia,dried tangerine,Zizyphus jujuba and Corydalis ambig exceeded the value specified in the Pharmacopoeia of the"People's Re-public of China(2020 Edition)"(hereinafter referred to as the"Chinese Pharmacopoeia")by 15-110 times.The daily exposure of AFB1 contained in 21 kinds of Chinese medicinal materials was 0-3.1370 ng/kg,and the excess risk was 0-0.9411.The sensitivity of AFB1 of 9 kinds of Chinese medicinal materials,such as Se-men Platycladi,Polygala tenuifolia,and dried tangerine,to excess risk reached more than 97.000%,and the sensitivity of human body mass to excess risk was less than 0.When the sample size was large enough,the mean value of AFB1 determination of traditional Chinese medicine was the main influencing factor of excess risk.Conclusion 21 kinds of Chinese medicinal materials are seriously polluted by AFB1,19 of which are pol-luted by AFB1,and 14 of them have AFB1 content exceeding the standard in varying degrees.21 kinds of Chi-nese medicinal materials are in line with the usage and dosage of the Chinese Pharmacopoeia,and their chronic cancer risk is within the controllable range.