地黄饮片中外源性有害物质残留情况分析  

Analysis of Exogenous Harmful Residues in Dihuang(Rehmannia glutinosa Libosch) Decoction Pieces

作　　者：黄霞 王晓燕[1] 李振国[1] 张红伟 杨元[1] 蒋芦荻 李海燕[1] HUANG Xia;WANG Xiaoyan;LI Zhenguo;ZHANG Hongwei;YANG Yuan;JIANG Ludi;LI Haiyan(Henan Institute for Food and Drug Control,NMPA Key Laboratory for Quality Control of Traditional Chinese Medicine,Chinese Materia Medica and Prepared Slices,Zhengzhou 450018,Henan,China)

机构地区：[1]河南省食品药品检验所,国家药品监督管理局中药材及饮片质量控制重点实验室,河南郑州450018

出　　处：《中华中医药学刊》2020年第11期113-117,共5页Chinese Archives of Traditional Chinese Medicine

基　　金：国家药品抽检计划中药饮片专项(食药监药化监[2017]131);国家药品标准提高任务([2018Z]0098);河南省科技攻关项目(202102310516)。

摘　　要：目的了解地黄饮片中外源性有害物质的残留状况。方法依据《中华人民共和国药典》和探索性研究方法对不同产地的地黄饮片中的二氧化硫残留量、脱硫剂、重金属及有害元素、200余种农药残留进行分析和评价。结果 187批样品中检出1批二氧化硫残留量超标,检出1批使用了脱硫剂;35批样品中重金属均有检出,但均不超标;55批样品中检出14种农药,其中检出3种植物生长调节剂(丁酰肼、吲哚丁酸、胺鲜酯),检出率100%,地黄农药残留存在一定风险。结论地黄饮片中外源性有害物质以农药残留为主,需要进一步加强生产监管,建议完善现行质量标准对农药残留进行限量控制。Objective Tounderstandthe exogenous harmful residues in Dihuang(Rehmannia glutinosa Libosch).Method According to the Chinese Pharmacopoeia and exploratory research methods, the residual sulfur dioxide, desulfurizer, heavy metals, harmful elements and pesticide residues in Dihuang(Rehmannia glutinosa Libosch) from different sources were analyzed and evaluated.Results The sulphur dioxide residues were detected in 187 batches, and desulfurizer of 1 batchwas detected.Heavy metals were detected in 35 batches of samples,without exceeding the standard.Among 55 batches,14 batcheswere found to contain the state prohibiting the use of pesticide residues(daminozide, 3-indolebutyric acid, diethyl aminoethyl hexanoate).The detection rate was 100%. Residues of pesticide had certain risks inDihuang(Rehmannia glutinosa Libosch).Conclusion Exogenous harmful substances in Dihuang(Rehmannia glutinosa Libosch) are mainly sulphur dioxide and pesticide residues. It is necessary to further strengthen production supervision. It is recommended to improve the current quality standards to limit the control of pesticide residues.

关 键 词：地黄饮片 二氧化硫 脱硫剂 重金属 农药残留 

分 类 号：R2-03[医药卫生—中医学]