中药中外源性有害残留物监控的现状与建议

目的分析中药中以重金属及有害元素、黄曲霉毒素、农药残留为代表的外源性污染现状,提出安全性控制建议。方法分析了近年来中药材中外源性有害残留物危害种类、相关药害事件及样品普查情况。结果提出现阶段影响中药安全性的最主要外源性污染物为重金属和真菌毒素残留,农药残留则应区别对待,有机氯及部分有机磷类农残应重点监控。结论《中国药典》等国家药品标准应进一步提高完善检测技术,并在更广泛的基础上制订科学、可行的限量标准。

Current Situation and Suggestions on Control of Extrinsic Harmful Residues in Chinese Medicinal Materials

Objective To give suggestions on safety control of Chinese medicinal materials by analyzing current situation of extrinsic harmful pollutants such as heavy metals, mycotoxin and pesticide residues. Methods Adverse drug events caused by extrinsic harmful resides in Chinese medicinal materials were reviewed in this study, as well as general investigation results of samples and categories of hazards. Results The main extrinsic harmful pollutant influencing the safety of Chinese medicinal materials are residues of heavy metals and mycotoxin. Besides, pesticide residues should be treated distinctively. For example, organochlorine pesticides and certain kinds of organophosphorus pesticide should be monitored emphatically. Conclusions Following the principle of necessary, feasible and reliable, detection techniques adopted by national drug standard such as pharmacopeia of China should be improved and scientific and feasible maximum residue limits should be established.