Article(id=1322127311021912837, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127297054888908, 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=1625068800000, acceptedDateStr=2021-07-01, onlineDate=1793149314885, onlineDateStr=2026-10-28, pubDate=1639497600000, pubDateStr=2021-12-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793149314885, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793149314885, creator=13701087609, updateTime=1793149314885, updator=13701087609, issue=Issue{id=1322127297054888908, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='23', pageStart='2121', pageEnd='2224', issueExtLink='null', onlineDate='null', pubDate='1639497600000', pubDateStr='2021-12-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793149311555, creator='13701087609', updateTime=1793149538282, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322128248071369266, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127297054888908, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322128248075563571, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127297054888908, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2153, endPage=2156, ext={EN=ArticleExt(id=1322127311399400198, articleId=1322127311021912837, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=The standard expression of strength of Chinese patent medicines and discussion on related problems, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

In order to standardize the expression of the strength of Chinese patent medicine (CPM), the connotation, significance, characteristics and standard expression of CPM strengths are systematically summarized and analyzed in this paper. Furthermore, the related issues which need to be paid attention to in the implementation of “Technical Guideline for Strengths Expression of Chinese Patent Medicines” are discussed, and the following suggestions are put forward: According to the requirements of “Technical Guideline for Strengths Expression of Chinese Patent Medicine”, the theoretical amount (or marked amount) of prescription composition in each dosage should be indicated in the strengths of CPM. Drug strengths have nothing to do with the types of excipients used. It is suggested that the strengths should be reasonably expressed according to prescription composition, dosage form, usage and other characteristics of CPM. Drug strengths and capacity specification should be distinguished to facilitate the registration and management of drugs and to clarify the scope of powers of National Medical Product Administration and the Provincial Medical Product Administration. The strengths of CPM should be expressed according to the equivalent amount of decoction pieces in each dosage, which does not affect the check of capacity difference of the product.

, authors=Yue-hua ZHOU¹, Yan-long HONG², Zong-hua SONG³, Zhong DAI⁴, Shen JI⁵, Lei ZHANG², Hai-nan WANG⁶, authorsList=Yue-hua ZHOU, Yan-long HONG, Zong-hua SONG, Zhong DAI, Shen JI, Lei ZHANG, Hai-nan WANG, authorCompany=null, correspAuthors=Hai-nan WANG, 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=1322127311693001479, articleId=1322127311021912837, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=中成药规格的规范表述及相关问题探讨, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

本文对中成药规格的内涵、特点及规范表述等进行了较为系统的总结与分析，并就实施《中成药规格表述技术指导原则》需关注的相关问题进行了讨论，认为：按《中成药规格表述技术指导原则》要求，在中药说明书【规格】项标明单位制剂相当的处方药味的理论量（或标示量）是可行的。药品规格与所用辅料的种类和数量无关。需根据中成药的处方药味类别、剂型、用法用量等特点合理表述药品规格。区分药品规格与包装规格，便于厘清国家药品监督管理部门与省级药品监督管理部门的事权范围。中成药规格以单位制剂相当的饮片量表述，不影响药品的装量差异检查。

, authors=周跃华¹, 洪燕龙², 宋宗华³, 戴忠⁴, 季申⁵, 张磊², 王海南⁶, authorsList=周跃华, 洪燕龙, 宋宗华, 戴忠, 季申, 张磊, 王海南, authorCompany=null, correspAuthors=王海南, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=3gcvIEnVPYFUQ/fsYuDXmg==, magXml=ezKMzT+oNkekmAfwOsAGyg==, pdfUrl=null, pdf=qFb8kIODOF80yUTc90HQxw==, pdfFileSize=2592254, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=1pYZ4TnCDDDJLjYz1eeIhQ==, mapNumber=null, fund=null)}, authors=[Author(id=1322127312557028123, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322127311021912837, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=zhouyh@cde.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322127312670274333, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322127311021912837, authorId=1322127312557028123, language=EN, stringName=Yue-hua ZHOU, firstName=Yue-hua, middleName=null, lastName=ZHOU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=¹, address=¹Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322127312758354718, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322127311021912837, authorId=1322127312557028123, language=CN, stringName=周跃华, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=¹, address=¹国家药品监督管理局药品审评中心，北京　100022, bio={"content":"

周跃华，男，主任药师，研究方向：中药、天然药物的药学评价。联系电话：(010)85242879，E-mail：zhouyh@cde.org.cn。

"}, bioImg=null, bioContent=

周跃华，男，主任药师，研究方向：中药、天然药物的药学评价。联系电话：(010)85242879，E-mail：zhouyh@cde.org.cn。

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