Campbell D J
J Assoc Off Anal Chem. 1978 Sep;61(5):1194-7.
Today it is almost impossible to produce food of animal origin which is free from traces of drugs or chemicals. In Canada the problem of drug residues is controlled by a method of assessment of human safety which involves many factors. The toxicity of the drug in laboratory animals or, if possible, in man, is established and a no-effect dose is then estimated. These studies require oral administration of the drug and include acute, subacute, and teratogenicity studies. Depending on these results, chronic reproductive or carcinogenicity studies may be required before a no-effect dose can be estimated. Residue studies must encompass data on metabolism, pharmacokinetics, and depletion studies in edible tissues and for products such as milk and eggs. For veterinary drug residues, we must consider the target food animal with its particular metabolism, tissue disposition, and excretion patterns. The analytical method for residue detection must be acceptable and its sensitivity limits suitable for the drug and its major metabolites.
如今，要生产出完全不含药物或化学物质痕迹的动物源性食品几乎是不可能的。在加拿大，药物残留问题通过一种涉及诸多因素的人体安全性评估方法来控制。首先要确定该药物在实验动物身上，或者如果可能的话，在人体中的毒性，然后估算出无作用剂量。这些研究需要口服该药物，包括急性、亚急性和致畸性研究。根据这些结果，在估算出无作用剂量之前，可能需要进行慢性生殖或致癌性研究。残留研究必须包括有关可食用组织以及牛奶和鸡蛋等产品的代谢、药代动力学和消除研究的数据。对于兽药残留，我们必须考虑目标食用动物及其特定的代谢、组织分布和排泄模式。残留检测的分析方法必须是可接受的，其灵敏度限值要适合该药物及其主要代谢物。
