中药有害残留物限量制定原则及其影响因素

Study on the principle of limit setting for harmful residues in traditional Chinese medicines and the influencing factors

人体长期过量摄入残留农药、重金属和生物毒素可能对身体健康造成损害。因此,中药材和其制剂质量标准中有害残留物的最大限量制定是构成标准的重要组成部分。本文通过查阅大量国外研究报道的有关农药残留、重金属和黄曲霉毒素的毒理学相关实验数据和国内外药品标准,分析有关标准中有害残留物理论最大限量计算方法,模拟计算其最大限量理论值,并将其与中外药品标准中已有最大限量标准进行比较,分析影响限量确定的因素,阐明了标准中有害残留物最大限量制定方法和原则。

Long- term intakes of pesticide residues,heavy metals and biotoxins may cause health problems to humans. Therefore,setting the maximum limits of harmful residues is an important part in specifications for traditional Chinese medicine and preparations. The calculation methods of theoretical maximum limits on harmful residues were analyzed by review of the related information from oversea studies and reports on toxicological research data of pesticide residues,heavy metals and biotoxins as well as guidelines or standards published at home and abroad. A comparison of the simulated theoretical limits and the maximum limits regulated in standards was conducted. The influencing factors of maximum limits setting were discussed. The setting methods and principles for maximum limits of harmful residues in specifications were elaborated.