摘要年版《中国药典》草案已经第十一届药典委员会执行委员会会议审议并通过。为了社会各界系统了解此版药典中药标准体系,本文从标准理念、主要增修订内容与编制思路三个方面介绍了以保障中药质量、满足临床需求而进行的相关标准工作,期望凝聚共识,促进新版药典标准的贯彻实施。
关键词:标准体系,中药,质量,标准化,适用性,安全性
中图分类号:R.2文献标识码:A文章编号:-()
doi:10./j.chp..00.
AGuidetoUnderstandingtheMonographsofTCMsinEditionofChinesePharmacopoeia
ZHANGPeng,SHENMingrui,LIHao,ZHAIWeimin,NILong,HAOBo,SHIShangmei*,YANGZhaopeng,LANFen,ZHANGWei
(ChinesePharmacopoeiaCommission,Beijing,China)
AbstractTheeditionofChinesePharmacopoeia(EleventhEditionofChP)hadbeenreviewedandadoptedbythePlenarySessionofthe11thChinesePharmacopoeiaCommissionExecutiveCommittee.ForabetterunderstandingofthestandardsystemoftraditionalChinesemedicines(TCMs)inthisedition,thisarticleintroducestherelevantworkwhichwasintendedtoensurethequalityofTCMsandmeettheclinicalneeds,fromaspectsofstandardconcept,mainrevisionsand