| 新版中药材GAP建设规范化生产基地的要点探讨 |
| 投稿时间：2022-04-28 点此下载全文
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| 引用本文：王秋玲,魏建和,王文全,乔旭.新版中药材GAP建设规范化生产基地的要点探讨[J].中国现代中药,2022,24(5):758-765 |
| DOI：10.13313/j.issn.1673-4890.20220428005 |
| 摘要点击次数: 223 |
| 全文下载次数: 41 |
| 作者中文名 | 作者英文名 | 单位中文名 | 单位英文名 | E-Mail |
| 王秋玲 |
WANG Qiu-ling |
中国医学科学院 北京协和医学院 药用植物研究所/中草药物质基础与资源利用教育部重点实验室/ 濒危药材繁育国家工程实验室，北京 100193 |
Key Laboratory of Bioactive Substances and Resources Utilization of Chinese Herbal Medicine, Ministry of Education & National Engineering Laboratory for Breeding of Endangered Medicinal Materials, Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100193, China |
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| 魏建和* |
WEI Jian-he |
中国医学科学院 北京协和医学院 药用植物研究所/中草药物质基础与资源利用教育部重点实验室/ 濒危药材繁育国家工程实验室，北京 100193
中国医学科学院 北京协和医学院 药用植物研究所 海南分所/海南省南药资源保护与开发重点实验室/ 国家中医药管理局沉香可持续利用重点研究室，海南 海口 570311 |
Key Laboratory of Bioactive Substances and Resources Utilization of Chinese Herbal Medicine, Ministry of Education & National Engineering Laboratory for Breeding of Endangered Medicinal Materials, Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100193, China
Hainan Provincial Key Laboratory of Resources Conservation and Development of Southern Medicine & Key Laboratory of National Administration of Traditional Chinese Medicine for Agarwood Sustainable Utilization, Hainan Branch of the Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Haikou 570311, China |
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| 王文全 |
WANG Wen-quan |
中国医学科学院 北京协和医学院 药用植物研究所/中草药物质基础与资源利用教育部重点实验室/ 濒危药材繁育国家工程实验室，北京 100193 |
Key Laboratory of Bioactive Substances and Resources Utilization of Chinese Herbal Medicine, Ministry of Education & National Engineering Laboratory for Breeding of Endangered Medicinal Materials, Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100193, China |
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| 乔旭 |
QIAO Xu |
中国医学科学院 北京协和医学院 药用植物研究所/中草药物质基础与资源利用教育部重点实验室/ 濒危药材繁育国家工程实验室，北京 100193 |
Key Laboratory of Bioactive Substances and Resources Utilization of Chinese Herbal Medicine, Ministry of Education & National Engineering Laboratory for Breeding of Endangered Medicinal Materials, Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100193, China |
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| 基金项目:中国医学科学院医学与健康科技创新工程项目（2021-I2M-1-032）；财政部和农业农村部：国家现代农业产业技术体系项目；国家药品监督管理局委托研究课题（2019年）；国家中医药管理局委托办事课题（GZY-KJS-2018-016-01） |
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| 中文摘要:为更好推动新发布的《中药材生产质量管理规范》落地实施，分析了建设中药材规范化生产基地和质量管理体系建设的要点：明确影响中药材质量的关键环节、开展质量风险评估、实施“六统一”、生产全过程关键环节“可追溯”、不违反系列禁止性条款；其总体实施思路是“写我要做，做我所写，记我所做”。基地建设需从统一规划、文件编写、选址与准备、生产管理与质量控制、内审5个方面实施，其最终目标是保证中药材质量的均一、稳定和可控，并较好地控制生产成本。 |
| 中文关键词:新版《中药材生产质量管理规范》 中药材生产企业 规范化生产基地 质量管理 建设要点 |
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| Key Points to Build the Standardized Production Base According to Good Agricultural Practice for Traditional Chinese Medicinal Materials |
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| Abstract:To promote the implementation of Good Agricultural Practice for Traditional Chinese Medicinal Materials (GAP, new version), this article analyzed the key points to build the standardized production base and quality management system of medicinal materials. The key points include quality risk assessment, "six unification" (unified planning of production base, unified supply of reproductive materials including seeds and seedlings, unified management of inputs including chemical fertilizers and pesticides, unified planting or breeding technical regulations, unified procurement and origin processing technical regulations, and unified packaging and storage technical regulations), traceability of key links in the whole production process, and no violation of the prohibited clauses. The basic principle of implementing the GAP involves planning, acting, and recording. The standardized production bases should be built from five aspects: unified planning, document compilation, site selection and preparation, production management and quality control, and internal auditing. The ultimate goal of constructing the base is to ensure the uniform, stable, and controllable quality of Chinese medicinal materials while controlling the production costs. |
| keywords:new version Good Agricultural Practice for Traditional Chinese Medicinal Materials (GAP) producers of Chinese medicinal materials standardized production base quality management key points of construction |
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