背景:对药用植物及其提取物的研究与使用单一化合物进行的研究不同。从植物中提取的提取物,藻类,真菌,地衣或动物提出了一些独特的挑战:它们是活性,部分活性和非活性物质,活动通常不在单个目标上进行。它们的组成根据制备方法和使用的植物材料而变化。这种复杂性和可变性影响药理学的可重复性和解释,毒理学和临床研究。目标:该项目制定最佳实践指南,以确保使用药用植物提取物进行研究的可重复性和准确解释。重点是药理学中使用的草药提取物,毒理学,和临床/干预研究。具体来说,基于共识的声明侧重于定义以下方面的要求:1)描述植物材料/草药物质,这些研究中使用的草药提取物和草药产品,和2)以可重复和透明的方式进行和报告这些研究中使用的植物提取物的植物化学分析。过程和方法:我们通过以下过程制定了指南:1)三种主要类型的提取物之间的区别(提取物类型A,B,andC),最初由主要作者(MH)概念化,领导了该项目的开发;2)对药用植物研究人员进行调查,以收集全球观点,机遇,以及在不同实验室基础设施下表征药用植物提取物所面临的总体挑战。调查答复是制定指南的核心,并由核心小组进行了审查;3)由9名专家组成的核心小组每月开会,通过德尔菲程序制定指南;和。4)最终准则草案,得到核心小组的认可,还分发给由20名专家组成的扩大咨询小组进行反馈和批准,包括许多期刊编辑。结果:主要结果是“关于药用植物提取物的植物化学表征的共识声明”(ConPhyMP),该声明定义了报告起始植物材料的最佳实践以及用于定义植物提取物化学成分的推荐化学方法在此类研究中使用。该清单旨在为药用植物研究的作者以及评估此类研究的同行评审员和编辑提供指导。
Background: Research on medicinal plants and extracts derived from them differs from studies performed with single compounds. Extracts obtained from plants, algae, fungi, lichens or animals pose some unique challenges: they are multicomponent mixtures of active, partially active and inactive substances, and the activity is often not exerted on a single target. Their composition varies depending on the method of preparation and the plant materials used. This complexity and variability impact the reproducibility and interpretation of pharmacological, toxicological and clinical research. Objectives: This project develops best practice guidelines to ensure reproducibility and accurate interpretations of studies using medicinal plant extracts. The focus is on herbal extracts used in pharmacological, toxicological, and clinical/intervention research. Specifically, the
consensus-based statement focuses on defining requirements for: 1) Describing the plant material/herbal substances, herbal extracts and herbal medicinal products used in these studies, and 2) Conducting and reporting the phytochemical analysis of the plant extracts used in these studies in a reproducible and transparent way. The process and methods: We developed the
guidelines through the following process: 1) The distinction between the three main types of extracts (extract types A, B, and C), initially conceptualised by the lead author (MH), led the development of the project as such; 2) A survey among researchers of medicinal plants to gather global perspectives, opportunities, and overarching challenges faced in characterising medicinal plant extracts under different laboratory infrastructures. The survey responses were central to developing the
guidelines and were reviewed by the core group; 3) A core group of 9 experts met monthly to develop the guidelines through a Delphi process; and. 4) The final draft
guidelines, endorsed by the core group, were also distributed for feedback and approval to an extended advisory group of 20 experts, including many journal editors. Outcome: The primary outcome is the \"
Consensus statement on the Phytochemical Characterisation of Medicinal Plant extracts\" (ConPhyMP) which defines the best practice for reporting the starting plant materials and the chemical methods recommended for defining the chemical compositions of the plant extracts used in such studies. The checklist is intended to be an orientation for authors in medicinal plant research as well as peer reviewers and editors assessing such research for publication.