Article(id=1322906910327972400, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887411688919265, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1628438400000, acceptedDateStr=2021-08-09, onlineDate=1793335185844, onlineDateStr=2026-10-30, pubDate=1636905600000, pubDateStr=2021-11-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793335185844, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793335185844, creator=13701087609, updateTime=1793335185844, updator=13701087609, issue=Issue{id=1322887411688919265, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='21', pageStart='1921', pageEnd='2016', issueExtLink='null', onlineDate='null', pubDate='1636905600000', pubDateStr='2021-11-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793330537006, creator='13701087609', updateTime=1793337443794, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322916380919608076, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887411688919265, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322916380919608077, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887411688919265, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1949, endPage=1955, ext={EN=ArticleExt(id=1322906910483161649, articleId=1322906910327972400, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Discussion on the related problems of supplementary testing methods and items of traditional Chinese medicine, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

The supplementary testing methods and items of traditional Chinese medicine are important contents to strengthen the quality research of traditional Chinese medicine after marketing, which reflect the concept of full-life cycle management of drug quality, aiming to find and solve the potential quality problem of the traditional Chinese medicine (TCM). It is the supplement and perfection of the current national drug standards, providing a strong technical support for cracking down on adulteration of traditional Chinese medicine and improvement of the quality of traditional Chinese medicine. This paper summarizes the supplementary testing methods and items of traditional Chinese medicine since 2003, discusses the problems existing in the testing methods and puts forward relevant suggestions for peer reference.

, authors=Xia CHEN1, Yong-wen ZHANG2, Gang ZHOU1, authorsList=Xia CHEN, Yong-wen ZHANG, Gang ZHOU, authorCompany=null, correspAuthors=Yong-wen ZHANG, Gang ZHOU, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322906910952923698, articleId=1322906910327972400, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=中药补充检验方法和检验项目相关问题探讨, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

中药补充检验方法和检验项目是加强中药上市后质量研究的重要内容,体现了药品质量全生命周期管理的理念,旨在发现和解决中药潜在质量问题,是对现行国家药品标准的补充和完善,对打击中药掺杂使假、提高中药质量提供了强有力的技术支撑。本文通过对2003年以来所颁布的中药补充检验方法进行综述和总结,对中药补充检验方法存在问题进行探讨,并提出建议,供同行参考。

, authors=陈霞1, 张永文2, 周刚1, authorsList=陈霞, 张永文, 周刚, authorCompany=null, correspAuthors=张永文, 周刚, authorNote=

陈霞,女,硕士,审评员,从事中药、天然药物药学技术审评工作。联系电话:(010)85242898,E-mail:。

, correspAuthorsNote=
张永文,男,博士,研究员,高级审评员,主要从事天然药物化学研究、中药和天然药物药学评价与研究。联系电话:(025)85816332,E-mail:。
周刚,男,博士,主任药师,高级审评员,主要从事中药药学评价与研究、审评管理工作。联系电话:(010)85243393,E-mail:。
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陈霞,女,硕士,审评员,从事中药、天然药物药学技术审评工作。联系电话:(010)85242898,E-mail:。

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陈霞,女,硕士,审评员,从事中药、天然药物药学技术审评工作。联系电话:(010)85242898,E-mail:。

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pageEnd=null, url=null, language=null, rfNumber=[2], rfOrder=1, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局. 关于报请批准用补充检验方法和项目进行药品检验有关问题的通知[S]. 国药监〔2003〕91号, 2003., articleTitle=null, refAbstract=null), Reference(id=1322906914811683408, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[3], rfOrder=2, authorNames=null, journalName=null, refType=null, unstructuredReference=中国食品药品检定研究院. 药品检验补充检验方法和检验项目批准批件汇编(2003~2013年)[S]. 2014, articleTitle=null, refAbstract=null), Reference(id=1322906914870403665, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[4], rfOrder=3, authorNames=null, journalName=null, refType=null, unstructuredReference=尚汝瑶, 杨昭鹏. 国家药品补充检验方法管理工作的现状与思考[J]. 中国药事, 2014, 28(6): 576-579., articleTitle=null, refAbstract=null), Reference(id=1322906914937512530, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[5], rfOrder=4, authorNames=null, journalName=null, refType=null, unstructuredReference=中国食品药品检定研究院. 标准及补充检验方法查询[EB/OL]. (2020-12-30) [2021-05-28]. https://www.nifdc.org.cn/nifdc/bzhchx/index.html., articleTitle=null, refAbstract=null), Reference(id=1322906915000427091, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[6], rfOrder=5, authorNames=null, journalName=null, refType=null, unstructuredReference=刘翔. 药品补充检验方法亟待完善[N]. 中国医药报, 2014-10-27(003)., articleTitle=null, refAbstract=null), Reference(id=1322906915075924564, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[7], rfOrder=6, authorNames=null, journalName=null, refType=null, unstructuredReference=原国家食品药品监督管理局. 关于发布宫炎康颗粒中金胺O检查项等3项药品补充检验方法的公告(2018年第5号)[EB/OL]. (2018-01-15) [2021-05-28]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20180117180101482.html., articleTitle=null, refAbstract=null), Reference(id=1322906915155616341, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[8], rfOrder=7, authorNames=null, journalName=null, refType=null, unstructuredReference=原国家食品药品监督管理局. 关于发布胃康灵胶囊中金胺O检查项补充检验方法的公告(2017年第23号)[EB/OL]. (2017-02-28) [2021-05-28]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20170302163201861.html., articleTitle=null, refAbstract=null), Reference(id=1322906915226919510, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[9], rfOrder=8, authorNames=null, journalName=null, refType=null, unstructuredReference=原国家食品药品监督管理局. 关于发布沉香化气丸中松香酸检查项等7项药品补充检验方法的公告(2017年第159号)[EB/OL]. (2017-12-18) [2021-05-28]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20171222173301831.html., articleTitle=null, refAbstract=null), Reference(id=1322906915298222679, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[10], rfOrder=9, authorNames=null, journalName=null, refType=null, unstructuredReference=原国家食品药品监督管理局. 关于发布宫炎康颗粒中金胺O检查项等3项药品补充检验方法的公告(2018年第5号)[EB/OL]. (2018-01-15) [2021-05-28]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20180117180101482.html., articleTitle=null, refAbstract=null), Reference(id=1322906915361137240, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[11], rfOrder=10, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局. 关于发布心可宁胶囊中酸性红73检查项等17项药品补充检验方法的公告(2019年第58号)[EB/OL]. (2019-07-17) [2021-05-28]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20190718175301280.html., articleTitle=null, refAbstract=null), Reference(id=1322906915432440409, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[12], rfOrder=11, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局. 关于发布沉香化滞丸中松香酸检查项等5项补充检验方法的公告(2019年第99号)[EB/OL]. (2019-11-20) [2021-05-28]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20191126102201988.html., articleTitle=null, refAbstract=null), Reference(id=1322906915516326490, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[13], rfOrder=12, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局. 关于发布妇科调经片中金胺O检查项补充检验方法等3项补充检验方法的公告(2020年第151号)[EB/OL]. (2020-12-30) [2021-05-28]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210106172628129.html., articleTitle=null, refAbstract=null), Reference(id=1322906915608601179, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[14], rfOrder=13, authorNames=null, journalName=null, refType=null, unstructuredReference=原国家食品药品监督管理局. 关于发布精制冠心片中金橙Ⅱ检查项等3项药品补充检验方法的公告(2017年第141号)[EB/OL]. (2017-11-20) [2021-05-28]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20171124165801403.html., articleTitle=null, refAbstract=null), Reference(id=1322906915696681564, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[15], rfOrder=14, authorNames=null, journalName=null, refType=null, unstructuredReference=原国家食品药品监督管理总局. 关于发布柏子养心丸中808猩红检查项等4项补充检验方法的公告(2017年第98号)[S]. 2017., articleTitle=null, refAbstract=null), Reference(id=1322906917361820253, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[16], rfOrder=15, authorNames=null, journalName=null, refType=null, unstructuredReference=原国家食品药品监督管理总局. 关于发布牛黄清心丸(局方)和朱砂安神丸中808猩红检查项补充检验方法的公告(2016年第131号)[EB/OL]. (2016-08-01) [2021-05-28]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20160803164701745.html., articleTitle=null, refAbstract=null), Reference(id=1322906917437317726, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[17], rfOrder=16, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局. 关于发布金鸡丸中毛两面针素检查项补充检验方法等5项补充检验方法的公告(2020年第12号)[EB/OL]. (2020-02-06) [2021-05-28]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20200210093801709.html., articleTitle=null, refAbstract=null), Reference(id=1322906917504426591, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[18], rfOrder=17, authorNames=null, journalName=null, refType=null, unstructuredReference=原国家食品药品监督管理总局. 关于发布枫香脂中松香酸检查项等两项药品补充检验方法的公告(2016年第201号)[EB/OL]. (2016-12-30) [2021-05-28]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20170104170301722.html., articleTitle=null, refAbstract=null), Reference(id=1322906917592506976, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[19], rfOrder=18, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局. 关于发布珍宝丸中松香酸检查项补充检验方法等2项补充检验方法的公告(2020年第100号)[EB/OL]. (2020-09-11) [2021-05-28]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200917173241129.html., articleTitle=null, refAbstract=null), Reference(id=1322906917668004449, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[20], rfOrder=19, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局. 关于发布阿胶补血膏中牛皮源成分检查项等2项药品补充检验方法的公告(2018年第19号)[EB/OL]. (2018-05-11) [2021-05-28]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20180518203701896.html., articleTitle=null, refAbstract=null), Reference(id=1322906917747696226, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[21], rfOrder=20, authorNames=null, journalName=null, refType=null, unstructuredReference=原国家食品药品监督管理总局. 关于发布红参药材及饮片中总还原糖检查项补充检验方法的公告(2017年第20号)[EB/OL]. (2017-02-22) [2021-05-28]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20170224162901802.html., articleTitle=null, refAbstract=null), Reference(id=1322906917823193699, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[22], rfOrder=21, authorNames=null, journalName=null, refType=null, unstructuredReference=原国家食品药品监督管理总局. 关于发布银杏叶软胶囊等药品补充检验方法的公告(2015年第142号)[EB/OL]. (2015-08-10) [2021-05-28]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20150810120001620.html., articleTitle=null, refAbstract=null), Reference(id=1322906917894496868, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[23], rfOrder=22, authorNames=null, journalName=null, refType=null, unstructuredReference=原国家食品药品监督管理总局. 关于发布银杏叶滴丸和银杏叶软胶囊中槐角苷检查项补充检验方法的公告(2016年第52号)[EB/OL]. (2016-03-04) [2021-05-28]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20160308110801879.html., articleTitle=null, refAbstract=null), Reference(id=1322906917986771557, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[24], rfOrder=23, authorNames=null, journalName=null, refType=null, unstructuredReference=原国家食品药品监督管理总局. 关于发布银杏叶药品补充检验方法的公告(2015年第66号)[EB/OL]. (2015-06-04) [2021-05-28]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20150604120001593.html., articleTitle=null, refAbstract=null), Reference(id=1322906918070657638, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[25], rfOrder=24, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局. 关于发布小败毒膏中莨菪碱类生物碱检查项补充检验方法的公告(2020年第129号)[EB/OL]. (2020-11-23) [2021-05-28]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20201203164053120.html., articleTitle=null, refAbstract=null), Reference(id=1322906918154543719, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[26], rfOrder=25, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局. 关于发布小活络丸(大蜜丸)中异性有机物补充检验方法的公告(2020年第89号)[EB/OL]. (2020-08-05) [2021-05-28]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200831170415108.html., articleTitle=null, refAbstract=null), Reference(id=1322906918238429800, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[27], rfOrder=26, authorNames=null, journalName=null, refType=null, unstructuredReference=钟名诚, 饶伟文, 刘剑云. 中药染色掺假检测方法的研究进展[J]. 海峡药学, 2018, 30(5): 32-35., articleTitle=null, refAbstract=null), Reference(id=1322906918339093097, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[28], rfOrder=27, authorNames=null, journalName=null, refType=null, unstructuredReference=刘静, 戴忠, 何轶, 等. 中药中常见染色成分分析[J]. 中国药事, 2017, 31(4): 364-373., articleTitle=null, refAbstract=null), Reference(id=1322906918418784874, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[29], rfOrder=28, authorNames=null, journalName=null, refType=null, unstructuredReference=宋德芳, 李恒. 药材和饮片非法染色物检测技术研究进展[J]. 中国药业, 2021, 30(3): 96-99., articleTitle=null, refAbstract=null), Reference(id=1322906918532031083, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906910327972400, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[30], rfOrder=29, authorNames=null, journalName=null, refType=null, unstructuredReference=刘静, 王翀, 冯磊, 等. 基于国家药品抽验工作的中成药质量和安全问题分析[J]. 中国现代中药, 2019, 21(3): 279-283., articleTitle=null, refAbstract=null), Reference(id=1322906918599139948, 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中药补充检验方法和检验项目相关问题探讨
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陈霞 1 , 张永文 2 , 周刚 1
中国新药杂志 | 新药注册与审评技术 2021,30(21): 1949-1955
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中国新药杂志 |新药注册与审评技术 2021 , 30 (21) : 1949 -1955
中药补充检验方法和检验项目相关问题探讨
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陈霞1 , 张永文2 , 周刚1
作者信息
  • 1国家药品监督管理局药品审评中心,北京 100022
  • 2南京中医药大学药学院,南京 210023
通讯作者:
张永文,男,博士,研究员,高级审评员,主要从事天然药物化学研究、中药和天然药物药学评价与研究。联系电话:(025)85816332,E-mail:。
周刚,男,博士,主任药师,高级审评员,主要从事中药药学评价与研究、审评管理工作。联系电话:(010)85243393,E-mail:。
作者简介:

陈霞,女,硕士,审评员,从事中药、天然药物药学技术审评工作。联系电话:(010)85242898,E-mail:。

Discussion on the related problems of supplementary testing methods and items of traditional Chinese medicine
Xia CHEN1 , Yong-wen ZHANG2 , Gang ZHOU1
Affiliations
  • 1Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
  • 2College of Pharmacy, Nanjing University of Chinese Medicine, Nanjing 210023, China
出版时间: 2021-11-15
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中药补充检验方法和检验项目是加强中药上市后质量研究的重要内容,体现了药品质量全生命周期管理的理念,旨在发现和解决中药潜在质量问题,是对现行国家药品标准的补充和完善,对打击中药掺杂使假、提高中药质量提供了强有力的技术支撑。本文通过对2003年以来所颁布的中药补充检验方法进行综述和总结,对中药补充检验方法存在问题进行探讨,并提出建议,供同行参考。

中药补充检验方法和检验项目  /  潜在质量问题  /  质量标准

The supplementary testing methods and items of traditional Chinese medicine are important contents to strengthen the quality research of traditional Chinese medicine after marketing, which reflect the concept of full-life cycle management of drug quality, aiming to find and solve the potential quality problem of the traditional Chinese medicine (TCM). It is the supplement and perfection of the current national drug standards, providing a strong technical support for cracking down on adulteration of traditional Chinese medicine and improvement of the quality of traditional Chinese medicine. This paper summarizes the supplementary testing methods and items of traditional Chinese medicine since 2003, discusses the problems existing in the testing methods and puts forward relevant suggestions for peer reference.

supplementary testing methods and items of traditional Chinese medicine  /  potential quality problems  /  quality standard
陈霞, 张永文, 周刚. 中药补充检验方法和检验项目相关问题探讨. 中国新药杂志, 2021 , 30 (21) : 1949 -1955 .
Xia CHEN, Yong-wen ZHANG, Gang ZHOU. Discussion on the related problems of supplementary testing methods and items of traditional Chinese medicine[J]. Chinese Journal of New Drugs, 2021 , 30 (21) : 1949 -1955 .

参考文献 引证文献
排序方式:
[1]
药品管理法实施条例[S]. 中华人民共和国国务院令第360号, 2002.
[2]
国家药品监督管理局. 关于报请批准用补充检验方法和项目进行药品检验有关问题的通知[S]. 国药监〔2003〕91号, 2003.
[3]
中国食品药品检定研究院. 药品检验补充检验方法和检验项目批准批件汇编(2003~2013年)[S]. 2014
[4]
尚汝瑶, 杨昭鹏. 国家药品补充检验方法管理工作的现状与思考[J]. 中国药事, 2014, 28(6): 576-579.
[5]
中国食品药品检定研究院. 标准及补充检验方法查询[EB/OL]. (2020-12-30) [2021-05-28]. https://www.nifdc.org.cn/nifdc/bzhchx/index.html.
[6]
刘翔. 药品补充检验方法亟待完善[N]. 中国医药报, 2014-10-27(003).
[7]
原国家食品药品监督管理局. 关于发布宫炎康颗粒中金胺O检查项等3项药品补充检验方法的公告(2018年第5号)[EB/OL]. (2018-01-15) [2021-05-28]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20180117180101482.html.
[8]
原国家食品药品监督管理局. 关于发布胃康灵胶囊中金胺O检查项补充检验方法的公告(2017年第23号)[EB/OL]. (2017-02-28) [2021-05-28]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20170302163201861.html.
[9]
原国家食品药品监督管理局. 关于发布沉香化气丸中松香酸检查项等7项药品补充检验方法的公告(2017年第159号)[EB/OL]. (2017-12-18) [2021-05-28]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20171222173301831.html.
[10]
原国家食品药品监督管理局. 关于发布宫炎康颗粒中金胺O检查项等3项药品补充检验方法的公告(2018年第5号)[EB/OL]. (2018-01-15) [2021-05-28]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20180117180101482.html.
[11]
国家药品监督管理局. 关于发布心可宁胶囊中酸性红73检查项等17项药品补充检验方法的公告(2019年第58号)[EB/OL]. (2019-07-17) [2021-05-28]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20190718175301280.html.
[12]
国家药品监督管理局. 关于发布沉香化滞丸中松香酸检查项等5项补充检验方法的公告(2019年第99号)[EB/OL]. (2019-11-20) [2021-05-28]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20191126102201988.html.
[13]
国家药品监督管理局. 关于发布妇科调经片中金胺O检查项补充检验方法等3项补充检验方法的公告(2020年第151号)[EB/OL]. (2020-12-30) [2021-05-28]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210106172628129.html.
[14]
原国家食品药品监督管理局. 关于发布精制冠心片中金橙Ⅱ检查项等3项药品补充检验方法的公告(2017年第141号)[EB/OL]. (2017-11-20) [2021-05-28]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20171124165801403.html.
[15]
原国家食品药品监督管理总局. 关于发布柏子养心丸中808猩红检查项等4项补充检验方法的公告(2017年第98号)[S]. 2017.
[16]
原国家食品药品监督管理总局. 关于发布牛黄清心丸(局方)和朱砂安神丸中808猩红检查项补充检验方法的公告(2016年第131号)[EB/OL]. (2016-08-01) [2021-05-28]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20160803164701745.html.
[17]
国家药品监督管理局. 关于发布金鸡丸中毛两面针素检查项补充检验方法等5项补充检验方法的公告(2020年第12号)[EB/OL]. (2020-02-06) [2021-05-28]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20200210093801709.html.
[18]
原国家食品药品监督管理总局. 关于发布枫香脂中松香酸检查项等两项药品补充检验方法的公告(2016年第201号)[EB/OL]. (2016-12-30) [2021-05-28]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20170104170301722.html.
[19]
国家药品监督管理局. 关于发布珍宝丸中松香酸检查项补充检验方法等2项补充检验方法的公告(2020年第100号)[EB/OL]. (2020-09-11) [2021-05-28]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200917173241129.html.
[20]
国家药品监督管理局. 关于发布阿胶补血膏中牛皮源成分检查项等2项药品补充检验方法的公告(2018年第19号)[EB/OL]. (2018-05-11) [2021-05-28]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20180518203701896.html.
[21]
原国家食品药品监督管理总局. 关于发布红参药材及饮片中总还原糖检查项补充检验方法的公告(2017年第20号)[EB/OL]. (2017-02-22) [2021-05-28]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20170224162901802.html.
[22]
原国家食品药品监督管理总局. 关于发布银杏叶软胶囊等药品补充检验方法的公告(2015年第142号)[EB/OL]. (2015-08-10) [2021-05-28]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20150810120001620.html.
[23]
原国家食品药品监督管理总局. 关于发布银杏叶滴丸和银杏叶软胶囊中槐角苷检查项补充检验方法的公告(2016年第52号)[EB/OL]. (2016-03-04) [2021-05-28]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20160308110801879.html.
[24]
原国家食品药品监督管理总局. 关于发布银杏叶药品补充检验方法的公告(2015年第66号)[EB/OL]. (2015-06-04) [2021-05-28]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20150604120001593.html.
[25]
国家药品监督管理局. 关于发布小败毒膏中莨菪碱类生物碱检查项补充检验方法的公告(2020年第129号)[EB/OL]. (2020-11-23) [2021-05-28]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20201203164053120.html.
[26]
国家药品监督管理局. 关于发布小活络丸(大蜜丸)中异性有机物补充检验方法的公告(2020年第89号)[EB/OL]. (2020-08-05) [2021-05-28]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200831170415108.html.
[27]
钟名诚, 饶伟文, 刘剑云. 中药染色掺假检测方法的研究进展[J]. 海峡药学, 2018, 30(5): 32-35.
[28]
刘静, 戴忠, 何轶, 等. 中药中常见染色成分分析[J]. 中国药事, 2017, 31(4): 364-373.
[29]
宋德芳, 李恒. 药材和饮片非法染色物检测技术研究进展[J]. 中国药业, 2021, 30(3): 96-99.
[30]
刘静, 王翀, 冯磊, 等. 基于国家药品抽验工作的中成药质量和安全问题分析[J]. 中国现代中药, 2019, 21(3): 279-283.
[31]
姜梦华, 孙娥, 封亮, 等. 中药产品生产全过程动态质量控制技术与发展[J]. 世界中医药, 2020, 15(15): 2210-2215.
2021年第30卷第21期
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  • 首发时间:2026-10-30
  • 出版时间:2021-11-15
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  • 录用日期:2021-08-09
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    1国家药品监督管理局药品审评中心,北京 100022
    2南京中医药大学药学院,南京 210023

通讯作者:

张永文,男,博士,研究员,高级审评员,主要从事天然药物化学研究、中药和天然药物药学评价与研究。联系电话:(025)85816332,E-mail:。
周刚,男,博士,主任药师,高级审评员,主要从事中药药学评价与研究、审评管理工作。联系电话:(010)85243393,E-mail:。
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2种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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