动物药中黄曲霉毒素B₁的定量风险评估探索

目的：通过对动物药黄曲霉毒素B₁的定量风险评估，为完善动物药中黄曲霉素的限量标准，保证动物药的用药安全，提供参考依据。方法：根据风险评估的4个基本步骤，通过考察动物药中黄曲霉毒素B₁的日暴露量以及超额风险，实现动物药中黄曲霉毒素B₁的定量风险评估。结果：在土鳖虫、蜂房、九香虫、水蛭中分别检出黄曲霉毒素B₁。其中土鳖虫、九香虫、蜂房的最大检出值分别为28.81、336.69和602.35 μg·kg^-1，分别超出限量标准数倍、数十倍和百倍。风险评估的结果表明，动物药的日暴露量为0.010~4.323 ng·kg^-1。蜂房的超额风险为每年1.297例癌症病例每100万人，风险应予以关注。其他动物药的超额风险均小于1，风险可控。结论：本文尝试对动物药中黄曲霉毒素B₁进行定量风险评估，为中药材及制剂中黄曲霉毒素的风险评估打开新的思路。建议进一步完善动物药中黄曲霉素等真菌毒素的风险评估技术手段，为动物药的科学监管以及黄曲霉毒素标准的制修订提供技术支撑。

Objective:To improve the standards of aflatoxins and ensure the safe use of traditional animal medicines,quantitative risk assessment of aflatoxin B₁ in traditional animal medicines was performed,so as to provide the reference evidence. Methods:According to the 4 basic steps of risk assessment,the quantitative risk assessment of aflatoxin B₁ in traditional animal medicine was realized by calculating the daily exposure and population risk of aflatoxin B₁ in traditional animal medicines. Results:Aflatoxin B₁ was detected in Eupolyphaga Steleophaga,Vespae Nidus,Aspongopus,and Hirudo with maximum detection values of 28.81,336.69 and 602.35 μg·kg^-1,respectively,which exceeded the limit by several times,dozens of times and one hundred times,respectively. The results of risk assessment showed that the daily exposure of traditional animal medicines ranged from 0.010 to 4.323 ng·kg^-1. The population risk of Vespae Nidus was 1.297 cases of cancer per year per 1 million people,the risk of which worth concerning. The population risk of other traditional animal medicines was less than 1,which was controllable. Conclusion:This paper accomplished the quantitative risk assessment of aflatoxin B₁ in traditional animal medicines for the first time,and provided a new idea for the risk assessment of aflatoxin in traditional Chinese medicinal materials and preparations. It is suggested to further improve the risk assessment technique of mycotoxins in traditional animal medicines,to provide technical support for the scientific supervision and the revision of limit for aflatoxins in traditional animal medicines.

[1] 张牧臣,郑楠,王加启.食品中黄曲霉毒素B₁污染研究进展[J].食品科学,2018,39(7):312 ZHANG MC,ZHENG N,WANG JQ.Aflatoxin B₁ contamination in foods:a review[J].Food Sci,2018,39(7):312
[2] PROBST C,NJAPAU H,COTTY PJ.Outbreak of an acute aflatoxicosis in Kenya in 2004:identification of the causal agent[J].Appl Environ Microbiol,2007,73(8):2762
[3] VERHEECKE C,LIBOZ T,MATHIEU F.Microbial degradation of aflatoxin B₁:current status and future advances[J].Int J Food Microbiol,2016,237:1
[4] LEWIS L,ONSONGO M,NJAPAU H,et al.Aflatoxin contamination of commercial maize products during an outbreak of acute aflatoxicosis in eastern and central Kenya[J].Environ Health Perspect,2005,113(12):1763
[5] DING XX,WU LX,LI PW,et al.Risk assessment on dietary exposure to aflatoxin B₁ in post-harvest peanuts in the Yangtze River ecological region[J].Toxins(Basel),2015,7(10):4157
[6] DING XX,LI PP,BAI YZ,et al.Aflatoxin B₁ in post-harvest peanuts and dietary risk in China[J].Food Control,2012,23:143
[7] SHEPHARD GS.Risk assessment of aflatoxins in food in Africa[J].Food Addit Contam Part A Chem Anal Control Expo Risk Assess,2008,25(10):1246
[8] 吴桐,赵月,刘苗苗,等.动物药抗肿瘤药理活性研究进展[J].亚太传统医药,2017,13(18):81 WU T,ZHAO Y,LIU MM,et al.Research in antitumor pharmacological activity of animal medicines[J].Asia Pac Tradit Med,2017,13(18):81
[9] 黄招明.浅谈动物药的应用[J].光明中医,2003,21(1):27 HUANG ZM.Discussion on the application of animal medicines[J].Guangming J Chin Med,2003,21(1):27
[10] 刘丽娜,李耀磊,金红宇,等.免疫亲和净化HPLC柱后光化学衍生荧光法测定动物药中黄曲霉毒素[J].中草药,2017,48(6):1220 LIU LN,LI YL,JIN HY,et al.Determination of aflatoxins in animal medicines by immunoaffinity column and HPLC-FLD with photochemical derivatization fluorescence detection[J].Chin Tradit Herb Drugs,2017,48(6):1220
[11] Joint FAO/WHO Expert Committee on Food Additives.Evaluation of certain food additives and contaminants[J].WHO Tech Rep Ser,1987(759):359
[12] European Food Safety Authority.Opinion of the scientific panel on contaminants in the food chain on a request from the commission related to the potential increase of consumer health risk by a possible increase of the existing maximum levels for aflatoxins in almonds,hazelnuts and pistachios and derived products[J].EFSA J,2007,446:1
[13] KONISHI YS,SATO T,SAITO S,et al.Exposure to aflatoxins in Japan:risk assessment for aflatoxin B₁[J].Food Addit Contam,2010,27(3):365
[14] BRERA C,CAPUTI R,MIRAGLIA M,et al.Exposure assessment to mycotoxins in workplaces:aflatoxins and ochratoxin A occurrence in airborne dusts and human sera[J].Microchem J,2002,73:167
[15] Joint FAO/WHO Expert Committee on Food Additives.Evaluation of certain food additives and contaminants[J].WHO Tech Rep Ser,1999(884):45
[16] 赵丹宇,张志强,李晓辉,等.危险性分析原则及其在食品标准中的应用[M].北京:中国标准出版社,2001:1 ZHAO DY,ZHANG ZQ,LI XH,et al.General Principle and Application of Risk Analysis on Food Safety[M].Beijing:Chinese Standards Press,2001:1
[17] 中华人民共和国药典2015年版.一部[S].2015:123 ChP 2015.Vol Ⅰ[S].2015:123