动物药中黄曲霉毒素B1的定量风险评估探索

Quantitative risk assessment of aflatoxin B1 in traditional animal medicines

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B,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602.35μg·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0.010~4.323ng·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 B_1 in traditional animal medicine was realized by calculating the daily exposure and population risk of aflatoxin B1 in traditional animal medicines.Results:Aflatoxin B_1 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.