《中国药典》(一部)中药材及饮片的有害物质限量分析

Analysis on the limit of harmful substances in Chinese Medicinal Materials and decoction pieces in Chinese Pharmacopoeia(Part Ⅰ)

目的:对《中国药典》(一部)中的药材及饮片有重金属、有害元素、农药残留量、黄曲霉毒素等限量变化进行归纳,为中药的临床使用安全提供参考。结果:历届《中国药典》(一部)中有害物质限量品种呈递增趋势,到2020年版《中国药典》(一部)重金属及有害元素限量规定的药材达到40种,增加了人参、三七、山茱萸、白芷、当归、栀子、桃仁、黄精、葛根、酸枣仁、冬虫夏草、朱砂等12种,但只有人参等12种药材的饮片也有重金属及有害元素限量规定;人参等5种药材(及饮片)有农药残留量规定,增加了红参,但甘草饮片一直都没有农残量规定;有黄曲霉毒素含量限定的药材有24种,增加了马钱子、延胡索、九香虫、土鳖虫、蜂房等5种,桃仁等17种药材的饮片也有黄曲霉毒素限量。讨论:《中国药典》上药材与饮片的有害物质限量规定是不一致的,所以中药材与其饮片的有害物质含量是否相同任需要进一步的研究。

Objective:The limit changes of heavy metals and harmful elements,pesticide residues and aflatoxin in Chinese Pharmacopoeia(partⅠ)were summarized to provide reference for the safety of clinical use of traditional Chinese medicine.Results:The results showed that the limit variety of harmful substances in the Chinese Pharmacopoeia(PartⅠ)is increasing.The limit of heavy metals and harmful elements in the 2020 edition of the Chinese Pharmacopoeia(PartⅠ)had reached 40 kinds of medicinal materials,Ginseng Radix et Rhizoma,Notoginseng Radix et Rhizoma,Corni Fructus,Angelicae Dahuricae Radix,Angelicae Sinensis Radix,Gardeniae Fructus,Pruni Semen,Polygonati Rhizoma,Puerariae Lobatae Radix,Ziziphi Spinosae Semen,Cordyceps and Cinnabaris,etc.12 species were new varieties,but only ginseng and other 12 kinds of medicinal pieces also have heavy metals and harmful elements limit regulations.Ginseng and other 5 medicinal herbs(and pieces)had pesticide residue limit in the 2020 edition of the Chinese Pharmacopoeia(PartⅠ),increased Ginseng Radix et Rhizoma Rubra,but the Glycyrrhizae Radix et Rhizoma pieces had no agricultural residue limit.There are 24 kinds of medicinal herbs with aflatoxin content limit in the 2020 edition of the Chinese Pharmacopoeia(PartⅠ),increased 5 kinds of Strychni Semen,Corydalis Rhizoma,Aspongopus,Eupolyphaga Steleophaga,and Vespae Nidus,Persicae Semen and other 17 kinds of medicinal herbs also hadaflatoxin limit.Discussion:The limit of harmful substances in Chinese Pharmacopoeia is inconsistent,so whether the content of harmful substances in Chinese Herbal Medicine and its pieces is the same needs further study.