中药材及部分制剂中黄曲霉毒素残留筛查报告及初步风险评估

General Investigation and Preliminary Risk Assessment of Aflatoxins in Traditional Chinese Medicines and Their Preparations

目的通过风险评估来指导黄曲霉毒素限量的制定。方法按《中国药典》2010年版黄曲霉毒素测定法对中药材及部分制剂中黄曲霉毒素残留进行筛查,并对测定过程进行随行质量控制;按照风险评估的基本步骤对中药材及部分制剂中黄曲霉毒素做初步的风险评估。结果根据中药材及部分制剂中黄曲霉毒素的初步风险评估结果,对《中国药典》中黄曲霉毒素限量标准提出建议。结论黄曲霉毒素在中药中并不是一种普遍污染,但针对部分高风险品种需要增加黄曲霉毒素限量检查,并建立适宜的限量标准。

OBJECTIVE To guide the establishment of limits of aflatoxins in traditional Chinese medicines and their preparations by a preliminary risk assessment. METHODS According to the ＂Chinese Pharmacopoeia＂ aflatoxin determination method, aflatoxins in traditional Chinese medicines and some preparations were determined, and quality control procedures were carried out. In accordance with the basic steps of risk assessment, a preliminary risk assessment was done for traditional Chinese medicines and some preparations. RESULTS According to the results of preliminary risk assessment of aflatoxins in Chinese crude medicines and preparations, the limits of aflatoxins in the Chinese Pharmacopoeia were recommended. CONCLUSION Ailatoxins are not a universal contaminationin traditional Chinese medicines and their preparations, but for some species which are at high risks, the detection of aflatoxins is needed and appropriate limits should be established.