中药材重金属限量标准和农残限量标准研究及标准制定相关建议

发布时间：2018-01-11 04:20

本文关键词：中药材重金属限量标准和农残限量标准研究及标准制定相关建议　出处：《北京中医药大学》2017年硕士论文　论文类型：学位论文

【摘要】：中药作为中国的非物质文化遗产,是我国劳动人民智慧的结晶。改革开放以来,中国的中医药事业得到了迅速地发展。与此同时,我国的药品标准也得到了快速的发展。目前已建立了以《中国药典》为核心的药品标准体系。中药材重金属限量标准和中药材农药残留限量标准作为药品标准体系的中的组成部分,关系着中药材的用药安全和疗效的发挥。因此,为了保证中药的安全性与疗效,须制定科学合理的中药材重金属限量标准和中药材农药残留限量标准。1.研究目的及意义1.1研究目的本文主要通过文献查询与分析研究,了解国内外中药材重金属限量和农药残留限量情况,对现阶段我国中药材重金属限量和农药残留限量标准工作提出建议。本文内容分为两部分,一是对中药材重金属限量标准的现状分析;二是对中药材农药残留限量标准的现状分析。将我国与世界其他主要国家有关中药材(植物药)重金属限量标准和农药残留限量标准进行分析比较,从药事管理学的层面提出相关建议。1.2研究意义随着世界各国对中药材(植物药)认可程度的增加,中药材的安全问题也更加引起人们的关注。近年来,关于中药重金属和农药残留超标的报道屡见不鲜,这不仅严重影响中药的用药安全,而且也阻碍了中药的出口,制约了中医药事业的发展。我国中医药事业的发展离不开中药质量标准的完善。本研究对于中药材重金属限量标准以及中药材农残标准的研究具有一定的现实意义。2.研究内容主要研究内容分成两大方面:中药材重金属污染及重金属限量标准制定研究和中药材农药残留污染及农药残留限量标准制定研究。中药材重金属污染及限量标准制定研究包括:中药材中重金属污染的现状、中药材中重金属的检测方法研究、国内外中药材重金属限量标准现状及标准比较分析及对我国中药材重金属限量标准制定工作的建议。中药材农药残留污染及限量标准制定研究包括：中药材中农药残留污染的现状、中药材中农药残留检测方法概述、国内外中药材农药残留限量标准现状及标准比较分析及对我国中药材农药残留限量标准制定工作的建议。3.研究方法本课题主要研究方法为文献研究法。文献研究法指通过搜集、整理、鉴别文献,根据一定的研究目的或课题要求,从而全面正确地分析、掌握所要研究问题的一种方法。文献检索时间:2016年12月31日前发表的所有相关的主要文献。数据主要从中国学术文献网络出版总库、万方数据库、维普网、中国知网(CNKI)、标准网、国家标准网、标准下载网和中国农药信息网等网站获得。4.结语本论文通过对各国家(地区)中药材(植物药)重金属限量标准、中药材(植物药)农残限量标准以及我国相关法规政策的研究,提出如下若干意见与建议:(1)为保证中药材残留检测标准制定的科学与合理性,需要加强中药材中重金属及有害元素、农药残留的风险评估研究,建立有效的风险评估系统。在中药材中重金属及有害元素与农药残留风险评估研究过程中,重视样品筛查数据的利用。(2)中药材农药残留的检测方法和检测技术需要进一步完善。有必要建立一套更为简便、快捷、经济的中药材农药多残留分析方法。(3)中国药典标准规定的中药材中重金属检测方法与国际通行方法基本一致。但有待建立适用于重金属快速检测的方法,如离子免疫检测法,有效提高检测效率,适应基层或现场检测的需要。(4)目前,我国中药材种植中农药使用的管理制度尚不完善,需要根据栽培品种的实际情况限定农药的使用范围和种类;在充分考虑我国国情及用药实际需求的情况下,严格控制农药使用品种,有效降低农药残留量。(5)完善中药材农药登记管理制度并健全登记使用农药的中药材品种,需要农业部门和国家食品药品监督管理部门共同完成,二者协同管理。(6)目前我国食品中农药残留风险评估方面研究较完善,由于中药材与食品具有天然近似属性,建议中药材农药残留风险评估及评价研究可以参考《食品中农药残留风险评估指南》中规定的设计思路,借鉴有益的研究内容和手段,独立探索,多方论证,确立合乎我国国情的方法,从而为我国中药材残留检测标准的修订与完善提供科学依据。(7)中药材农残超标问题应从源头抓起,为减少中药材种植过程中滥用农药的现象,建议考虑制定中药材种植农药使用指导原则,并有效实施。(8)建议在未来我国中药材农药残留标准更加完善的基础上,再进一步加强中药材中重金属铜的限量方面的研究。
[Abstract]:As a traditional Chinese medicine China intangible cultural heritage, is the crystallization of the wisdom of working people in our country. Since the reform and opening up, Chinese medicine Chinese has been developing rapidly. At the same time, China's drug standard has also been a rapid development. The establishment of the drug standard system to China < > as the core in the Pharmacopoeia. Heavy metals limit and pesticide residue limits as part of the drug standard system of the relationship between drug safety and efficacy of Chinese herbal medicines play. Therefore, in order to ensure the safety and efficacy of traditional Chinese medicine, the research purpose and significance of the standard.1. limited residual shall establish a scientific and rational in the heavy metals limit and in the pesticide 1.1 the purpose of this study is mainly through literature search and analysis research, understand the medicinal materials at home and abroad in the limits of heavy metals and pesticide residues, the present stage of China Chinese herbal medicine and pesticide residue limits of heavy metals proposed limits. The paper is divided into two parts, one is the analysis of the present situation of heavy metals limit standard; two is the limit standard of the pesticide residue analysis. Our country will have the medicine and other major countries in the world (herbal) limited standards of heavy metal residue limits and pesticides were analyzed and compared, from the pharmacy management level put forward relevant suggestions.1.2 significance with the world of Chinese herbal medicine (herbal medicine) to increase the recognition degree, the security problem of Chinese herbal medicines also attracts more attention to people. In recent years, Chinese medicine on heavy metals and pesticide residues exceed the standard reports It is often seen. which not only seriously. The effect of Chinese drug safety, but also hinders the export of traditional Chinese medicine, has restricted the development of Chinese medicine. The development of the Chinese medicine industry cannot do without traditional Chinese Medicine To improve the quality standard of.2.. This study has certain practical significance for the research of Chinese herbal medicine and pesticide residue limits of heavy metals standard standards of Chinese herbal medicines. The main research contents are divided into two aspects: the Chinese heavy metal pollution limits of heavy metals and standard residue limit standards of pollution and pesticide research and Chinese herbal medicine. Chinese herbal medicine pesticide residue of heavy metal pollution and the limit of standard research includes: the current situation of heavy metal pollution in Chinese herbal medicine, research on detection methods of heavy metals in Chinese medicinal materials, heavy metals limit standard status and standards at home and abroad in the analysis and comparison of Chinese medicine standards work of the heavy metals. The pesticide residue pollution and limits making the research as follows: the current situation of pesticide pollution residues in Chinese herbal medicines, detection methods of pesticide residues in Chinese herbal medicines, Chinese herbal medicine agriculture at home and abroad A comparative analysis of the status and the standard drug residue limits of Chinese herbal medicine and pesticide residue standards recommended by the.3. the research methods the main research methods are literature research method. The research method of literature by means of collecting, sorting, identification documents, according to the requirements of a certain subject or purpose, in order to fully and correctly grasp the analysis. A method to study the problem. Literature retrieval time: December 31, 2016 before the publication of all relevant documents. The main data mainly from the Academic Literature Publishing Database Chinese network, Wanfang database, VIP network, China (CNKI), HowNet standard, national standard, standard download network and information network website to obtain Chinese pesticide conclusion.4. in the various countries (regions) of Chinese herbal medicine (herbal medicine) heavy metal criteria, Chinese herbal medicine (herbal medicine) MRL standards and related policies and regulations of our country The research, put forward the following opinions and suggestions: (1) for the detection of residues in the standard medicines to ensure scientific and rational, the need to strengthen the heavy metals and harmful elements in Chinese herbal medicine, the research on risk assessment of pesticide residues, establish effective risk assessment systems. Residues of heavy metals and harmful elements in Chinese herbal medicine and pesticide risk assessment research, attention to the use of sample screening data. (2) Chinese herbal medicine detection method of pesticide residue detection technology and the need for further improvement. It is necessary to establish a more convenient, fast, multi residue analysis method of pesticide economy. (3) the provisions of Chinese heavy metals in Chinese herbal pharmacopoeia standard detection method with international the method is basically the same. But the methods should be established for rapid detection of heavy metal ion, such as immunoassay method, effectively improve the detection efficiency, to meet the needs of grass-roots or field testing. (4). Before the Chinese herbal medicine planting in the use of pesticides and the management system is not perfect, according to the actual situation of cultivated varieties and types of pesticide use limited scope; fully consider China's national conditions and the use of the actual demand, and strictly control the use of pesticide varieties, effectively reduce pesticide residues. (5) improvement of traditional Chinese medicine pesticide registration and management system and improve the registration of pesticide use varieties of Chinese herbal medicines, to the agricultural sector and the State Food and drug supervision and management departments jointly completed two collaborative management. (6) China's pesticide residues in food risk assessment research is perfect, because the Chinese herbal medicine and food has a natural approximation property, proposed the pesticide the residual risk assessment and evaluation of design ideas can be specified in the "guidelines for the risk assessment of pesticide residues in food beneficial reference", the research contents and methods, independent exploration, multi To establish the method of demonstration, conform to the situation in our country, and revised standard for residue detection of Chinese herbal medicine and provide scientific basis. (7) Chinese herbal medicines from pesticide residues exceed the standard source, to reduce pesticide abuse phenomenon in the process of cultivation of Chinese herbal medicines, Chinese herbal medicine planting proposal to consider making use of pesticides and the effective implementation of guidelines. (8) suggested more improvement in the Chinese herbal medicine pesticide residue standard in the future, further strengthen the study of heavy metals in Chinese herbal medicine limited aspects.

【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R288

【参考文献】