国内外药典中重金属检查方法及限量比较分析

Heavy Metal Inspection Methods and Limits analysis in Pharmacopoeia at Home and Abroad

本文对中国、韩国、日本、美国及中国台湾地区现行药典的中药材重金属限量要求及重金属化学检查法、仪器分析法进行研究,分析比较了各国药典中药材重金属检查法在显色剂、反应环境、测定方法等方面的异同,对各国药典在中药材重金属种类、设限的品种选择和限量值等方面进行比对。可为出口中药材企业、中药方面的检验机构、药物研究人员及相关监管单位开展工作提供参考依据。

In this paper, heavy metal limit requirements in herbals,heavy metals limit test and instrumental analysis methods are studied in the current Pharmacopoeia of China, South Korea, Japan, the United States and China Taiwan.This paper compare the main differences and similarities in heavy metals limit test in the developer, the reaction environment,determination Methods and other aspects of the national Pharmacopoeia.Meanwhile,the heavy metal species, limited selection of varieties and the limited value in Chinese herbal medicines are comparied in this paper.It can provide a reference for the work of exporting Chinese herbal medicine enterprises, testing institutions of Chinese medicine, drug researchers and relevant regulatory agencies.