直观易行的传统中药鉴定方法

现代中药的常用鉴定方法包括基原鉴定、性状鉴定、显微鉴定、理化鉴定和生物鉴定等,这些方法中很多动辄就要用到电子显微镜、各种化学试剂和高精尖的仪器设备。但是对于一些名贵的中药材,往往上述各种鉴定方法都用上也不一定能完全反映其真伪优劣。     

妊娠禁忌中药基原特点与药物性能特点的分类研究

目的：了解妊娠禁忌中药基原特点与药物性能特点的构成,确保孕妇用药安全。方法：从植物类、动物类和矿物类分类叙述妊娠禁忌中药的基原特点;从药性、药味、归经、毒性四个方面阐述妊娠禁忌中药的药物性能特点。结果与结论：妊娠禁忌中药以根及根茎类药物最多、寒性药物和苦味药最多;临床用药时更要考虑无毒中药的妊娠禁忌。     

中药鉴定在基层医院的应用

基层医院大多没有药品检验室及专职鉴定人员,其鉴定方法仍局限于传统的眼看、手摸、鼻闻、口尝、水泡和火烧等方法.目前一些名贵中药,由于价格昂贵,市场需求量大,不法商贩设法造假,增加了鉴别难度,严重扰乱了中药市场,影响了药物疗效.我们在基层医疗单位工作数年,对直观的认药积累了一定经验.现介绍如下. 　　……     

雷公藤药材基原考证及分子鉴定研究

目的 为确保雷公藤药材临床用药的安全性和有效性,对雷公藤药材基原进行文献考证,并建立特异性快速聚合酶链式反应(PCR)分子鉴定方法.方法 查阅文献对雷公藤基原进行考证;对雷公藤及混伪品DNA条形码进行对比分析,筛选具有稳定差异的特异性鉴别位点,设计鉴别引物,优选出特异性快速PCR扩增条件.结果 文献考证发现雷公藤和昆明...     

中国药典2020年版中药材基原问题探究

目的 查找中国药典2020年版中药材基原存在的问题，为完善修订中国药典药材基原内容奠定基础。方法 针对所有中国药典2020年版一部药材标准和四部附录基原内容，查询《中国植物志》（中英文版）、《中国动物志》等权威著作，中国自然标本馆等专题数据库和相关研究文献，对发现的问题进行考证或药材商品考察研究。结果 中国药典2020年版一部和四部附录中，存在中药材基原物种问题的品种共计10个，药材基原拉丁学名问题4个，药材基原中文名称问题3个；另基原有争议的品种3个。结论 经研究考订，中国药典2020年版上述涉及基原物种、拉丁学名和中文名称问题的共计17个品种均需修订完善，并提出了初步的修改建议；另外3个品种基原虽有争议，但认为不需修改。     

现代生物技术在中药鉴定中的应用

中药是一个巨大的宝库,在我国有几千年的应用历史.中药品种繁多,其疗效与药材品质密不可分;为保证用药的安全有效,需对药材的真伪、优劣作出准确的判断.中药鉴定的样品复杂,有完整的药材,有碎块、饮片和粉末等,中药鉴定的方法亦多种多样.常用的鉴定方法有来源鉴定、性状鉴定、显微鉴定及理化鉴定等,这些方法在保证临床用药安全有效等方面有着不可代替的重要作用,对推动中药鉴定学的发展也有非常重要的影响.近年来,随着现代生物技术的发展,许多新学科理论和试验技术不断渗透到中药鉴定领域.     

大黄药材基原物种叶绿体基因组分析与特异DNA条形码开发

大黄是我国常用大宗药材之一,其基原植物为唐古特大黄、药用大黄和掌叶大黄。不同基原的大黄药材活性成分和药效存在差异,为快速准确鉴定大黄药材3个基原物种,本文利用Illumina高通量测序技术对大黄药材基原物种叶绿体基因组进行测序,完成其组装注释与结构特征解析,并基于叶绿体基因组高变区开发精准鉴别大黄药材3个基原物种的特异DNA条形码,最后进行验证。结果如下:唐古特大黄、药用大黄和掌叶大黄叶绿体基因组全长分别为161 039 bp、161 093 bp和161 136 bp,呈典型四分体结构,均编码131个基因,包括86个蛋白质编码基因、37个tRNA基因和8个rRNA基因。基于高变区设计的5对引物均可对42份样品有效扩增,测序结果分析证明rps16-trnQ、psaA-ycf3、psbE-petL、ndhF-rpl32与trnT-trnL均可作为特异DNA条形码准确鉴定唐古特大黄、药用大黄和掌叶大黄。本文可为大黄药材3个基原物种分类鉴定、保证大黄药材临床用药安全及规范大黄药材市场提供依据。     

试论火试法在中药鉴定中的应用

我国中药材品种繁多,中药材鉴定有很大难度.常用的鉴定方法有:来源(原植物、原动物和矿物)鉴定、性状鉴定、显微鉴定及理化鉴定等四大鉴定方法.各种方法均有其特点和适用对象,有时候还需要几种方法配合才能完成对一种中药材的准确鉴定.所以一般的医药工作者甚至是专业药监人员在没有特定的工作环境及仪器设备的情况下是难以对一些中药材进行准确鉴定的.笔者十几年来在药检所的药品监督检验及质保工作中总结出用火试方法鉴定中药材.     

植物代谢组学技术在中药资源研究中的应用

植物代谢组学技术是借助多种检测手段以植物提取物中代谢物为研究对象进行全面定性、定量分析,继基因组学和蛋白质组学之后发展起来的一门新兴学科。随着核磁共振（NMR）、液相色谱-质谱联用（LC-MS）、气相色谱-质谱联用（GC-MS）等技术的快速发展,植物代谢组学已广泛应用于中药资源研究中。对该技术在中药基原鉴别、野生与栽培品的鉴别、药用部位鉴别、不同发育期的成分鉴定及不同产地药材的品质差异等方面研究进展进行综述,从而揭示植物代谢物动态变化趋势,为中药质量评价奠定基础。     

浅谈中药注射剂生产过程中热原的产生与处理

注射剂无热原是确保注射剂质量和使用安全的条件,特别是中药注射剂更容易产生热原而危害人类健康,中药注射剂的质量要求更加严格.注射剂生产过程中热原的来源包括溶剂、原料或器具带入、制备过程中污染等,去除热原的方法也较多,各有不同特点.本文对中药注射剂热原的产生及处理方法进行了阐述,为该药品的生产质量控制提供参考.     

简析化学药品注册分类改革对药品研发的影响

国家食品药品监督管理总局于2016年调整了化学药品注册分类。分析化学药品新旧注册分类中的新药、仿制药概念、内涵以及技术标准的变化。与2007年版法规相比,新法规对新药和仿制药的定义均发生了明显变化,新药的范围缩小,要求更为严格和准确,仿制药的适用范围扩大,在技术标准方面达到国际要求。药品注册制度改革对医药研发产生了深远影响：促使国内医药市场重新洗牌,鼓励企业加大研发和创新力度,加快进入国际市场的步伐。     

The "treatment IND (investigational new drugs)": public policy considerations.

A major activity occupying the U.S. Food and Drug Administration for several years has been a rewrite of the FDA's IND and NDA regulations which govern the clinical testing of investigational new drugs and the process for subsequent market approval for those drug entities. In March of 1987, the FDA "reproposed" that portion of the 1983 IND rewrite dealing with the "treatment use" of investigational new drugs during the clinical testing phases of new drug development or during the period between the completion of clinical testing and NDA approval. The Treatment IND reproposal resulted in substantial controversy immediately following its publication in the Federal Register. This article compares the key features of the Treatment IND regulations as reproposed with those of the Final Rule and summarizes the major points of contention among the various interest groups affected. With its new Treatment IND regulations, the FDA appears to have placed itself squarely between competing interests and public policy considerations. The essential purpose and role of the FDA is to determine the inherent safety and effectiveness of new therapeutic medications. Debate on the Treatment IND regulations has raised a number of questions as to the regulations' own safety and efficacy in achieving that objective. It is likely the Treatment IND implementation will engender as much controversy as the regulations as originally reproposed.     

2010年美国FDA批准新药简析

2010年美国食品药品监督管理局(FDA)共批准21个新药,简要介绍其中的重点品种,并就新药研发的现状与趋势进行分析.在FDA批准上市的新药中,迪诺苏单抗(Prolia(TM)),denosumab)、达比加群酯(Pradaxa(R),dabigatran erexilate)、芬戈莱默(Gilenya(R),fing...     

Adverse effects in women: implications for drug development and regulatory policies

The requirement to establish safety of drugs prior to marketing has been in place since 1938 by the US Food, Drug and Cosmetic Act and is by no means a new concept. The efficacy regulations were enacted in 1962 via the Kefauver-Harris Amendment and the drug approval process has evolved thereafter. The assessment of safety and efficacy of drug products is made by pharmaceutical companies during drug development, which then goes through a regulatory review by the US FDA for the determination of market approval or nonapproval. The drug development and regulatory approval processes have endured close ongoing scrutiny by regulatory bodies, the public, US Congress and academic and private organizations and, as a result, have ensured continual refinement. Over the years, evidence has been emerging on varied drug responses in subgroup populations, and the underlying biology associated with age, race and sex as demographic variables have been examined. The resulting growing knowledge of disease burden, treatment response and disparate outcomes has generated opportunities to streamline and improve treatment outcomes in these populations. This article discusses the historical context of women's participation in clinical drug trials submitted to the FDA for regulatory review and approval purposes. The inadvertent consequences of women's exclusion or inadequate representation in past clinical trials and the evidentiary basis for understanding sex differences are also evaluated. Advances in the US regulatory processes to address treatment outcomes that are tied to the topic of this paper, specifically, adverse drug effects in women, are also discussed.     

2020年1—2月美国、欧盟和日本新批准药物概述

2020年1—2月,美国、欧盟和日本共批准47个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。对全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。     

The drug approval process and the information it provides

By law, the commissioner of the Food and Drug Administration (FDA) is responsible for determining whether a new drug is safe and efficacious before it is approved for marketing in the U.S. and for monitoring its use after approval. This paper provides a brief overview of the approval process, in terms of responsibilities of the sponsor in submitting an application for review to the FDA and FDA's responsibilities and organizational procedures for reviewing and approving those applications. A brief history on the legislation regarding the FDA's responsibility in the drug approval area is discussed along with recent regulations, legislation, and FDA initiatives aimed at improving the drug approval process. Specific information that can be released to the public upon request is also discussed. This paper is limited to the regulation of drugs; somewhat different regulations govern the review and regulation of biological products and abbreviated new drug applications.     

我国药品附条件批准程序实施情况及相关思考

目的：对我国药品附条件批准上市相关政策和实施情况进行深入分析和探讨,参考美国与欧盟药品附条件上市政策,对我国附条件批准上市的实施和推进提出建议。方法：通过梳理药品注册管理办法发布后国家药品监督管理局(NMPA)药品附条件批准上市申请审评审批法规政策实施情况,重点围绕当前法规中的准入条件、准入程序、上市后监管要求、撤销情形以及撤销程序进行综述,针对实施过程中发现的问题,借鉴美国食品药品管理局(FDA)药品加速审批(Accelerate Approval)与欧洲药品管理局(EMA)药品附条件批准(Conditional Marketing Authorisation)经验以及对各国附条件政策进行比较分析,探讨我国药品附条件批准上市政策的发展方向。结果与结论：为了加快具有突出价值的临床急需药品上市,缩短新技术临床应用时间,美国与欧盟均设立了相对完备的附条件上市法规政策及程序。我国的附条件批准制度虽然建立时间较短,但有欧美的经验作为参考,结合我国的临床实践和监管需要, 相关法规也在趋于完善。未来,监管部门更多需要考虑的是对程序和技术要求的细化、制度之间的衔接 (如疫苗的紧急使用授权与附条件批准制度),以及加强上市后监管等方面。     

药包材变更管理的分析与探讨

目的：通过汇总分析美国对药包材变更的管理法规和管理方式,为我国实施关联审评审批后对药包材变更管理提供借鉴,从而保证药品在整个生命周期内的安全、有效和质量可控。方法：从法规和技术层面分析美国FDA对制药企业以及药包材企业的变更监管,探讨其优势和存在的问题,对比中国与美国行业的特点。结果：中国与美国在监管理念和法规上日渐趋同,但是国内药包材企业与美国在规模和管理上还存在较大差异。结论：药包材变更是药品生命周期维护的组成部分,行业监管机构需要出具相应的变更技术指导原则以及相应的法规路径作为研发人员对变更评估的重要参考依据。     

The role of DMPK science in improving pharmaceutical research and development efficiency

The successful regulatory authority approval rate of drug candidates in the drug development pipeline is crucial for determining pharmaceutical research and development (R&D) efficiency. Regulatory authorities include the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceutical and Food Safety Bureau Japan (PFSB), among others. Optimal drug metabolism and pharmacokinetics (DMPK) properties influence the progression of a drug candidate from the preclinical to the clinical phase. In this review, we provide a comprehensive assessment of essential concepts, methods, improvements, and challenges in DMPK science and its significance in drug development. This information provides insights into the association of DMPK science with pharmaceutical R&D efficiency.