Article(id=1322246458670174971, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246421869346895, 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=1616083200000, acceptedDateStr=2021-03-19, onlineDate=1793177721898, onlineDateStr=2026-10-28, pubDate=1624982400000, pubDateStr=2021-06-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177721898, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177721898, creator=13701087609, updateTime=1793177721898, updator=13701087609, issue=Issue{id=1322246421869346895, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='12', pageStart='1057', pageEnd='1152', issueExtLink='null', onlineDate='null', pubDate='1624982400000', pubDateStr='2021-06-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793177713123, creator='13701087609', updateTime=1793178158604, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322248290402414824, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246421869346895, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322248290402414825, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246421869346895, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1063, endPage=1067, ext={EN=ArticleExt(id=1322246458825364220, articleId=1322246458670174971, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Interpretation of the antimicrobial effectiveness test of Chinese Pharmacopoeia 2020 edition, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

By analyzing the main content of the antimicrobial efficacy test of the Chinese Pharmacopoeia 2020 edition, the inherent requirements of the method were explored. The requirements of the Chinese Pharmacopoeia 2020 edition on the test bacteria, preparation of the bacterial solution, inoculation of test products, determination of viable bacteria, and determination of results have been further supplemented, and the standards have become more scientific and reasonable. The antimicrobial efficacy test of Chinese Pharmacopoeia 2020 edition has been further improved to become a more comprehensive testing method, which was beneficial to the screening and evaluation of antimicrobial agents in the research and development phase of new drugs.

, authors=Hui LI1, Fa-you ZHOU2, Xiao-li YANG3, Shi-hong MA2, Jin-fang SHENG4, authorsList=Hui LI, Fa-you ZHOU, Xiao-li YANG, Shi-hong MA, Jin-fang SHENG, authorCompany=null, correspAuthors=Jin-fang SHENG, 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=1322246459035079421, articleId=1322246458670174971, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=《中华人民共和国药典》2020年版抑菌效力检查法解析, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

通过分析《中华人民共和国药典》2020年版抑菌效力检查法的主要内容,探讨方法的内在要求。其中抑菌效力检查法的测试菌种、菌液制备、供试品接种、存活菌数测定、结果判断等方面的要求进一步补充完善,标准科学合理。《中华人民共和国药典》2020年版抑菌效力检查法进一步提高成为更加完善的检查方法,有利于新药研发阶段抑菌剂的筛选和评价。

, authors=李辉1, 周发友2, 杨晓莉3, 马仕洪2, 绳金房4, authorsList=李辉, 周发友, 杨晓莉, 马仕洪, 绳金房, authorCompany=null, correspAuthors=绳金房, authorNote=

李辉,男,硕士研究生,副主任药师,主要从事药品微生物检测与控制研究。E-mail:。

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绳金房,男,主任药师,主要从事药物分析与质量控制标准研究。E-mail:。
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李辉,男,硕士研究生,副主任药师,主要从事药品微生物检测与控制研究。E-mail:。

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李辉,男,硕士研究生,副主任药师,主要从事药品微生物检测与控制研究。E-mail:。

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《中华人民共和国药典》2020年版抑菌效力检查法解析
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李辉 1 , 周发友 2 , 杨晓莉 3 , 马仕洪 2 , 绳金房 4
中国新药杂志 | 新药述评与论坛 2021,30(12): 1063-1067
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中国新药杂志 |新药述评与论坛 2021 , 30 (12) : 1063 -1067
《中华人民共和国药典》2020年版抑菌效力检查法解析
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李辉1 , 周发友2, 杨晓莉3, 马仕洪2, 绳金房4
作者信息
  • 1陕西盛德泰林生物安全技术检测有限公司,西安 710065
  • 2中国食品药品检定研究院,北京 100050
  • 3陕西省食品药品监督检验研究院,西安 710065
  • 4陕西省药品技术审评中心,西安 710065
通讯作者:
绳金房,男,主任药师,主要从事药物分析与质量控制标准研究。E-mail:。
作者简介:

李辉,男,硕士研究生,副主任药师,主要从事药品微生物检测与控制研究。E-mail:。

Interpretation of the antimicrobial effectiveness test of Chinese Pharmacopoeia 2020 edition
Hui LI1 , Fa-you ZHOU2, Xiao-li YANG3, Shi-hong MA2, Jin-fang SHENG4
Affiliations
  • 1Shaanxi ShengDeTaiLin Biological Safety Technical Testing Co., Ltd., Xi'an 710065, China
  • 2National Institutes for Food and Drug Control, Beijing 100050, China
  • 3Shaanxi Institute for Food and Drug Control, Xi'an 710065, China
  • 4Shaanxi Center for Drug Evaluation, Xi'an 710065, China
出版时间: 2021-06-30
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通过分析《中华人民共和国药典》2020年版抑菌效力检查法的主要内容,探讨方法的内在要求。其中抑菌效力检查法的测试菌种、菌液制备、供试品接种、存活菌数测定、结果判断等方面的要求进一步补充完善,标准科学合理。《中华人民共和国药典》2020年版抑菌效力检查法进一步提高成为更加完善的检查方法,有利于新药研发阶段抑菌剂的筛选和评价。

抑菌效力  /  抑菌剂  /  抑菌效力检查法  /  《中华人民共和国药典》2020年版  /  药典修订  /  微生物控制  /  水分活度  /  抑菌体系

By analyzing the main content of the antimicrobial efficacy test of the Chinese Pharmacopoeia 2020 edition, the inherent requirements of the method were explored. The requirements of the Chinese Pharmacopoeia 2020 edition on the test bacteria, preparation of the bacterial solution, inoculation of test products, determination of viable bacteria, and determination of results have been further supplemented, and the standards have become more scientific and reasonable. The antimicrobial efficacy test of Chinese Pharmacopoeia 2020 edition has been further improved to become a more comprehensive testing method, which was beneficial to the screening and evaluation of antimicrobial agents in the research and development phase of new drugs.

antimicrobial effectiveness  /  antimicrobial agent  /  antimicrobial effectiveness testing  /  Chinese Pharmacopoeia 2020 edition  /  pharmacopoeia revision  /  microbial control  /  water activity  /  antimicrobial system
李辉, 周发友, 杨晓莉, 马仕洪, 绳金房. 《中华人民共和国药典》2020年版抑菌效力检查法解析. 中国新药杂志, 2021 , 30 (12) : 1063 -1067 .
Hui LI, Fa-you ZHOU, Xiao-li YANG, Shi-hong MA, Jin-fang SHENG. Interpretation of the antimicrobial effectiveness test of Chinese Pharmacopoeia 2020 edition[J]. Chinese Journal of New Drugs, 2021 , 30 (12) : 1063 -1067 .
  • 国家药典委员会课题资助项目(15)
  • 水分活度测定在非无菌制剂微生物控制中的应用
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2021年第30卷第12期
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  • 首发时间:2026-10-28
  • 出版时间:2021-06-30
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  • 录用日期:2021-03-19
基金
国家药典委员会课题资助项目(15)
水分活度测定在非无菌制剂微生物控制中的应用
作者信息
    1陕西盛德泰林生物安全技术检测有限公司,西安 710065
    2中国食品药品检定研究院,北京 100050
    3陕西省食品药品监督检验研究院,西安 710065
    4陕西省药品技术审评中心,西安 710065

通讯作者:

绳金房,男,主任药师,主要从事药物分析与质量控制标准研究。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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