299欧盟对草药药品质量总体要求的新规定

2004年4月30日欧盟正式颁布了《欧盟传统草药药品注册指令》(Directive2004/24/EC,以下简称“24指令”)[1],不仅明确定义了草药药品、传统草药药品等概念,正式承认了传统草药药品作为药品的法律地位,而且制定了相应的简化注册程序,但并未因此降低对产品质量的要求,即欧盟对草药     

战略

中药制剂或重返欧洲 10月中旬,商务部与欧洲药品审评管理局联合发起了对中药企业的培训指导,以帮助中成药制剂以药品身份重返欧盟市场。欧洲药品审评管理局草药委员会主席和副主席、美国天然药品联盟主席等多个国家的专家,深入解读《欧盟传统草药注册程序指令》,对中药在欧盟登记注册的程序进行指导。     

对日本澳大利亚等国草药管理法规及国外草药注册技术要求的研究

在既往研究的基础上，进一步扩大了对国外草药市场管理法规的研究范围和成果，报告了日本和澳大利亚等国对草药管理法规和国外对草药注册技术要求的研究结果，为读者全面了解国外对草药的管理法规，提供了重要信息。     

欧洲议会对草药产品指导原则进行表决

2002年11月5日欧盟环境和公共卫生委员会举行会议,对欧盟委员会的草药产品指导原则原文中关于成立草药产品委员会、产品注册程序及产品分类等问题进行了修订。该委员会称,新成立的草药产品委员会应接管欧洲专利药品委员会(CPMP)对草药     

欧盟《传统植物药注册程序指令》过渡期限将至

到2011年3月31日,按欧盟2004年颁布的《传统植物药注册程序指令》要求,允许采用传统草药简化申请途径来获取药品合法地位的7年过渡期大限将至。但如今,我国中药企业仍未有一家在欧盟成功注册。     

英国在“欧盟草药指导原则”实施前未雨绸缪

当英国草药制造商们还在坐等“欧盟草药指导原则”最后批准的时候(2004年12月份的任何一天都有可能被欧洲议会批准),英国药品和卫生保健品管理局(MHRA)未雨绸缪,在草药领域采取了一系列行动。在“指导原则”实施前,该机构发布了一个过渡管理     

欧盟发布传统草药新法规

在欧盟所有成员国，工业制造的草药产品被大量地使用。在欧洲，草药正在大量用于医疗，尤其用于抗静脉曲张、止咳、促进血液循环、抗肌痛、助消化、镇静和催眠、缓泻，以及膀胱、肾和肝疾病的治疗。德国和法国分别占欧洲草药市场销售额的39％和29％。许多欧洲国家的草药市场主要依赖自开处方(在欧洲自我治疗占60％，其中非处方药中的草药占24％)。此外，还有相当数量的草药物质和制品用作食品补充剂和相关产品、调味品的天然资源，亦用于化妆品、香料和其他产品。     

1996年版《英国草药典》简介

英国是有使用植物药传统的欧盟国家,也是世界上最早出版草药典的国家。1996年由英国草药协会(British Herb Medicine Association,BHMA)出版的《英国草药典》是第一部专门收录植物药的草药典。《英国草药典》的编撰与出版也经历了几次再版与修订,第一版是1974年全部出版完成的(     

草药并不总是有益的Ⅰ：草药与合成药的相互作用

英国医师 Peter Mere Latham(1789-1875)有一句名言:Poisons and medicinesare oftentimes the same substances givenwith different intents.意即毒品和药品往往是提供不同作用的同一物质。无论草药,还是合成药,在这种剂量时是有治疗作用的药品,在那种剂量时就是致人死命的毒药。草药与合成药的相互作用可以提高或降低其中一种     

中美欧中药/植物药/传统草药质量标准差异分析

很多中药企业正在为中药的国际化进行着艰苦的努力,在中药国际化实践的进程中,自始至终存在的主要问题之一就是如何阐明中药质量的可控性和一致性,中药质量标准如何才能获得国际药政管理部门的认可。提升我国中药质量和质量标准是实现中药现代化和国际化的关键,同时只有识别差异才能缩短差距,通过分析中国、美国和欧盟对中药/植物药/传统草药质量标准的要求而对我国的中药研发和生产企业有所启示。     

中国抗冠心病中药海外市场概况

综述了国际天然药物市场发展的现状和前景,介绍了欧盟《传统药品法案》对中药出口的严格限制及中药进入欧美市场的瓶颈和国内抗冠心病中药海外销售概况。     

Review of the Regulations for Clinical Research in Herbal Medicines in USA

In 2012,USA Food and Drug Administration（FDA） approved 39 new drugs,however,there are only two botanical drugs（one topical and one oral）approved by FDA since the publication of the FDA＇s industry guidelines for the botanical drug product in June 2004.The approval shows the Western guideline can be used for herbal medicines,authors investigate current regulation on herbal medicine clinical research,identify challenges conducting clinical trials,and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area.Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials.Authors critically explore case study of the 1st FDA approved botanical drugs,Veregen（sinecatechins）,green tea leaves extract,a topical cream for perianal and genital condyloma.In consideration of current regulation environment in USA,based on the findings and analysis through the literature review and Veregen case study,authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considerina in a herbal medicine clinical trial.     

Potential of Malawi's medicinal plants in Covid-19 disease management: A review

The Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has triggered an international pandemic that has led to significant public health problems. To date, limited evidence exists to suggest that drugs are effective against the disease. As possible treatments are being investigated, herbal medicines have shown potential for producing novel antiviral agents for the COVID-19 disease.AimThis review explored the potential of Malawi''s traditional medicinal plants for the management of COVID-19.MethodsThe authors searched on PubMed and Google scholar for medicinal plants that are used in Malawi and published in openly available peer reviewed journals. Plants linked with antiviral treatment, anti-COVID-19 activity or COVID-19 symptoms management were targeted. These included activity against pneumonia, inflammation, cough, difficulty in breathing, pain/aches, fever, diarrhoea, rheumatism, fatigue, asthma, immunocompromised and cardiovascular diseases.Results11 studies were found with 306 plant species. 127 plant species had at least one COVID-19 related pharmacological activity. Of these plant species, the number of herbal entities used for each indication was: pain/aches (87), fever (2), pneumonia (9), breathing/asthma problems (5), coughing (11), diarrhoea (1), immunosuppression (8), blood issues (10), fatigue (2), heart problems (11), inflammation (8), rheumatism (10) and viral diseases (12). Thirty (30) species were used for more than one disease and Azedarachta indica topped the list (6 of the 13 COVID-19 related diseases). The majority of the species had phytochemicals known to have antiviral activity or mechanisms of actions linked to COVID-19 and consequent diseases'' treatment pathways.ConclusionMedicinal plants are a promising source of compounds that can be used for drug development of COVID-19 related diseases. This review highlights potential targets for the World Health Organization and other research entities to explore in order to assist in controlling the pandemic.     

药用金钮扣属植物研究综述

植物药在人类的医学实践中已有上千年的应用历史,特别是在亚洲的一些国家,植物药用资源被认为是一种可以随时取用的宝贵的医疗保健资源。印度拥有众多种类的药用植物,然而,其中很大一部分传统药用植物并没有被开发使用或未被现代医学科学研究证明其功效。因此,目前很有必要开发传统药用植物并使其最大限度地造福人类。本篇综述总结报道了一种很有潜力的药用植物即金钮扣属植物。过去几年中,很多从这类植物中提取的新化合物及其功效已经得到证实,因此本文旨在总结最新的有关金钮扣属植物的植物化学及民族药物学应用、药理学作用及物种保护方法的科学研究报道。     

New Progress in Modern Research on Chinese Herbal Medicines Published in Chinese Traditional and Herbal Drugs in 2010: Annual Highlights and Comments

As a series of and continuous publication, the papers published on Chinese Traditional and Herbal Drugs in 2010 were selectively and briefly highlighted to reflect the new progress on modern research of Chinese herbal medicines. Within 617 articles, chemical constituents (127), pharmaceutics and technology (149), pharmacological studies and clinical observation, and medicinal materials are still major categories. Some comments have also been personally provided.     

中医古籍芳香类方药外治数据挖掘系统构建及应用

基于南京中医药大学中医药古籍全文数据库,采集、整理历代典籍中芳香类方药对疾病防治的信息,并通过“理-法-方-药”之间的多维角度分析总结用药特点及处方规律,梳理影响疾病的相关因素及相关方药的作用机制,建立独具特色的芳香医药学科体系,不但能促进芳香类方药外治的理论与实践的发展,而且为中医外科学、方剂学提供可靠的文献学依据。     

金银花的品种及临床应用分析

目的了解当前中药市场上金银花品种情况,规范金银花品种在临床上的运用。方法通过调查收集川渝两地市场金银花品种的情况,对照2005版《药典》以及《湖南省中药材标准》、《贵州省中药材标准》、《云南省药品标准》和《四川省中药材标准》等中的忍冬科植物的品种及标准,分析市售金银花的品种情况。结果金银花正品所占比例仅约为71．54％,山银花作金银花出售的约占23．34％,其他品种约占5．11％,且其他类的有4种以上,整个样品群中,还有掺杂、掺假现象。结论川渝中药市场上金银花的品种混乱,甚至有部分的掺杂冒充现象,应引起相关部门的高度重视。     

中医有望在英国立法的回顾与展望-兼评英国卫生部公布的《草药与针灸立法管理议案》

英国卫生部于 2 0 0 4年 3月 2日公布了《草药与针灸立法管理议案》 ,在兼评议案的同时 ,对英国中医立法背景进行回顾 ;简述了草药、针灸分割为两部分立法的过程 ;对英国卫生部草药和针灸立法管理议案公布后的态势进行展望 ,中医有望在英国“正名”。      

利用共同条件分析及中草药配伍确定微观层次上痴呆的研究方向

Objective： To identify the position of traditional herbal medicine in dementia research field using mapping technology. Methods： Keywords for dementia and traditional herbal medicine for treating dementia were used to extract scientific articles from the Web of Science database from January 2000 to July 2010. A co- occurrence matrix was created based on the concurrent set of author＇s keywords occurring in each scientific article, and technology network maps were created from similarity index matrices. Results： Twenty specialized research areas were identified in the dementia field, and the relationship strength was 0.2-0.6. Many research fields were associated with diagnosis and risk factors for dementia. Additionally, the mechanism or cause of dementia is an actively studied field. Traditional herbal medicine for treating dementia was located on a map near the cortical dementia diagnosis and therapy, and frontotemporal dementia research field with a relationship strength of 0.53 and 0.31-0.33 respectively, which demonstrates that traditional herbal medicine for dementia occupies an independent research area with a relationship to existing scientific research fields. Conclusion： Traditional herbal medicine can provide an alternative and complementary approach for treating dementia as evidenced by a scientific mapping analysis.     

联系专业实际进行药用植物学野外实习

为适应农业院校中药学专业课程体系中既有中药学专业的特点,又有农学专业的优势和特色,本文分析了农业院校药用植物学野外实习在中药学专业课程体系建设中的地位和作用,探索了实习各个环节,如标本采集、鉴定整理、样方调查等与药用植物资源学、中药学、中药鉴定学、药用植物栽培学等课程的联系。通过联系专业实际,提高了野外实习效果,增强了学生专业学习的兴趣,为后期的专业课学习奠定了基础。