Assessment of Genotoxicity of Herbal Medicinal Preparations According to the Guideline EMEA/HMPC/107079/2007 - A Model Project of Kooperation Phytopharmaka, Bonn, Germany

机译：根据指南/ HMPC / 107079/2007评估草药制剂的遗传毒性 - 德国Kooperation植物植物植物的模型项目

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The "Guideline on the Assessment of Genotoxicity of Herbal Substances/ Prepa-rations" was published by HMPC, the Herbal Medicinal Product Committee of the European regulatory agency EMEA, on 1 December 2008, giving guidance on the assessment of genotoxicity of herbal medicinal substances/ preparations [1]. In this guideline it is stated, that for many herbal substances/ preparations, contained in well established or traditional herbal medicinal products (HMPs), an adequate safety profile may be confirmed by their documented history of medicinal use. However, the complete lack of some specific non-clinical stud-ies (e.g. genotoxicity studies) may present a safety concern, because important. questions relating to product safety would remain unanswered.

机译：欧洲监管机构emea的草药产品委员会于2008年12月1日发表“草药物质遗传毒性评估指南”，于2008年12月1日发表了关于草药药物遗传毒性的评估指导/准备[1]。在本指南中，据说，对于许多含有成熟或传统草药产品（HMPS）的许多草药物质/制剂，可以通过其记录的药用历史来确认适当的安全性。然而，完全缺乏一些特定的非临床验光（例如遗传毒性研究）可能存在安全问题，因为重要的是。与产品安全有关的问题将保持未答复。

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《Symposium on Risk Assessment of Phytochemicals in Food: Novel Approaches》|2010年||共5页
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作者
Frauke Gaedcke; Olaf Kelber; Karin Kraft; Barbara Steinhoff; Hilke Winterhoff;
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原文格式 PDF
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中图分类 R155.5-532;
关键词
Assessment; Preparations; Guideline;

机译：评估;准备;指导;

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1. Assessment of genotoxicity of herbal medicinal products: Application of the "bracketing and matrixing" concept using the example of Valerianae radix (valerian root) [J] . KelberO., WegenerT., SteinhoffB., Phytomedicine : . 2014,第8a9期

机译：草药的遗传毒性评估：以缬草（缬草根）为例，“包围和基质化”概念的应用
2. Assessment of genotoxicity of herbal medicinal products: A co-ordinated approach [J] . KelberO., SteinhoffB., KraftK. Phytomedicine : . 2012,第5期

机译：草药的遗传毒性评估：一种协调的方法
3. Combinative method using HPLC quantitative and qualitative analyses for quality consistency assessment of a herbal medicinal preparation [J] . Ying Xie, Zhi-Hong Jiang, Hua Zhou, Journal of Pharmaceutical and Biomedical Analysis: An International Journal on All Drug-Related Topics in Pharmaceutical, Biomedical and Clinical Analysis . 2007,第1期

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4. Assessment of Genotoxicity of Herbal Medicinal Preparations According to the Guideline EMEA/HMPC/107079/2007 - A Model Project of Kooperation Phytopharmaka, Bonn, Germany [C] . Frauke Gaedcke, Olaf Kelber, Karin Kraft, Symposium on Risk Assessment of Phytochemicals in Food: Novel Approaches . 2010

机译：根据指南/ HMPC / 107079/2007评估草药制剂的遗传毒性 - 德国Kooperation植物植物植物的模型项目
5. Heavy metal content and health risk assessment of commonly patronized herbal medicinal preparations from the Kumasi metropolis of Ghana [O] . Frank Adusei-Mensah, David Kofi Essumang, Richard Osei Agjei, 2019

机译：加纳库马西大都会常用的中草药制剂中的重金属含量和健康风险评估
6. Assessment of genotoxicity of herbal medicinal products: Application of the “bracketing and matrixing” concept using the example of Valerianae radix (valerian root) [O] . Kelber Olaf, Wegener Tankred, Steinhoff Barbara, 2014

机译：草药的遗传毒性评估：以缬草（缬草根）为例，应用“包围和基质化”概念
7. Guidelines for the Chemical and Biological Assessment of Herbals and Herbal Preparations [R] . Bonati, A. 1990

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Assessment of Genotoxicity of Herbal Medicinal Preparations According to the Guideline EMEA/HMPC/107079/2007 - A Model Project of Kooperation Phytopharmaka, Bonn, Germany

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