Article(id=1242136100035174490, tenantId=1146029695717560320, journalId=1146031591421210625, issueId=1242136140153692391, articleNumber=null, orderNo=16, doi=10.3981/j.issn.1000-7857.2017.11.010, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1472486400000, receivedDateStr=2016-08-30, revisedDate=1477756800000, revisedDateStr=2016-10-30, acceptedDate=null, acceptedDateStr=null, onlineDate=1497418017337, onlineDateStr=2017-06-14, pubDate=1499875200000, pubDateStr=2017-07-13, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1500280157520, onlineIssueDateStr=2017-07-17, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1774077924018, creator=sys-migrate, updateTime=1774077938277, updator=sys-migrate, issue=Issue{id=1242136140153692391, tenantId=1146029695717560320, journalId=1146031591421210625, year='2017', volume='35', issue='13', pageStart='1', pageEnd='104', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=3, issueType=-1, specialIssue=null, createTime=1774077933583, creator=sys-migrate, updateTime=1774077933583, updator=sys-migrate, preIssue=null, nextIssue=null, ext=null, issueFiles=null}, startPage=66, endPage=69, ext={EN=ArticleExt(id=1242136103440949359, articleId=1242136100035174490, tenantId=1146029695717560320, journalId=1146031591421210625, language=EN, title=Bioassays of biochemical drugs and their alternatives, columnId=1242116080374710456, journalTitle=Science & Technology Review, columnName=Articles, runingTitle=null, highlight=null, articleAbstract=An overview of the definition, the strengths and the limitations of bioassays in the quality control is made and the trend of their replacement by physical and chemical methods through a comparison of ChP and other countries’pharmacopeia is analyzed. Ideas and references of the establishment and the validation of the alternative methods are provided for different sorts of biochemical drugs. The review also summarizes the most common experimental design and two statistical analysis methods. At last, the importance of the combination and the promotion of different quality control modes is emphasized., correspAuthors=null, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=Zb4J3XQjZh3TWGtzWVr79A==, pdfFileSize=628084, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=National Institutes for Food and Drug Control, Beijing 100050, China, fund=null, authors=LI Zhen, ZHANG Yuan, GAO Hua, authorsList=LI Zhen, ZHANG Yuan, GAO Hua), CN=ArticleExt(id=1242136102425927780, articleId=1242136100035174490, tenantId=1146029695717560320, journalId=1146031591421210625, language=CN, title=生化药物生物活性测定方法及其替代方法研究, columnId=1146540929516700224, journalTitle=科技导报, columnName=研究论文, runingTitle=null, highlight=null, articleAbstract=通过比较中国和国外药典对于部分生化药物的生物活性测定方法的不同,分析了中国理化方法替代生物活性测定方法的趋势。针对生化药物活性组分的不同对其进行分类并分别提出了理化替代方法建立与验证的思路,总结了替代研究时的实验设计思路与实验结果的统计分析方法,探讨了不同质量控制模式之间的关系,对中国质量控制方法的发展提出了展望。, correspAuthors=null, authorNote=李震,硕士研究生,研究方向为药理学,电子信箱:cpu_lizhen@126.com, correspAuthorsNote=高华,研究员,研究方向为药理学,电子信箱:huag55@163.com, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=OFqxZaeFmgkEx4NCS3+J+A==, pdfFileSize=628084, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=中国食品药品检定研究院, 北京 100050, fund=2015年国家药品标准提高项目;“重大新药创制”科技重大专项(2015ZX09303-001), authors=李震, 张媛, 高华, authorsList=李震, 张媛, 高华)}, authors=null, keywords=[Keyword(id=1242136162203148564, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242136100035174490, language=CN, orderNo=1, keyword=生化药物), Keyword(id=1242136162291228949, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242136100035174490, language=CN, orderNo=1, keyword=生物活性测定法), Keyword(id=1242136162375115030, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242136100035174490, language=CN, orderNo=1, keyword=理化方法), Keyword(id=1242136162454806807, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242136100035174490, language=CN, orderNo=1, keyword=替代), Keyword(id=1242136164820394268, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242136100035174490, language=EN, orderNo=1, keyword=biochemical drugs), Keyword(id=1242136164895891741, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242136100035174490, language=EN, orderNo=1, keyword=bioassays), Keyword(id=1242136164971389214, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242136100035174490, language=EN, orderNo=1, keyword=physical and chemical methods), Keyword(id=1242136165051080991, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242136100035174490, language=EN, orderNo=1, keyword=alternative research)], refs=null, funds=null, companyList=null, figs=null, attaches=null, journal=Journal(id=1125356956822126595, delFlag=0, nameCn=科技导报, nameEn=Science & Technology Review, nameHistory1=null, nameHistory2=null, issn=1000-7857, eissn=, cn=11-1421/N, coden=null, periodic=3, language=CN, oaType=0, ccby=null, superviseOffice=null, ownerOffice=null, pubOffice=null, editorOffice=null, officeType=null, aims=null, clcCode=null, officeProv=null, officeCity=null, officeAddr=null, officeZip=null, officeEmail=null, officePhone=null, editDirector=null, officeDirector=null, officeDirectorPhone=null, officeStaffNum=null, officeEmpNum=null, coverPicUrl=aEuqdCNQUjPEKa3rm5A/8Q==, journalPrice=null, startedYear=null, abbrevIsoEn=Sci Technol Rev, journalRemark=null, publicationField=null, createdTime=null, updatedTime=1754267492363, createdBy=null, updatedBy=13701087609, firstLetterCn=S, firstLetterEn=S, subjectCode=Natural Sciences, subjectName=自然科学, subjectCodeEn=Natural Sciences, subjectNameEn=null, picCn=aEuqdCNQUjPEKa3rm5A/8Q==, picEn=4AIQ9/oc3H8lvjeELJ6WWw==, jcr=null, cjcr=null, exts=[JournalExt(id=1159045127382855686, language=CN, name=科技导报, nameHistory1=null, nameHistory2=null, managedBy=中国科学技术协会, sponsoredBy=中国科学技术协会, publishedBy=科技导报社, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=null, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=http://www.kjdb.org/CN/home, createdTime=1754267492385, updatedTime=1754267492385, createdBy=13701087609, updatedBy=13701087609, submissionGuidelinesUrl=http://www.kjdb.org/CN/column/column7.shtml, submissionAuthorUrl=https://kjdbauthor.cast.org.cn/webm, submissionEditorUrl=https://kjdbeditor.cast.org.cn/webm/, submissionReviewUrl=https://kjdbauthor.cast.org.cn/webm, submissionCeEditorUrl=https://kjdbeditor.cast.org.cn/webm/, submissionAeEditorUrl=https://kjdbeditor.cast.org.cn/webm/, option={"copyright":""}), JournalExt(id=1159045127433187335, language=EN, name=Science & Technology Review, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=null, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=http://www.kjdb.org/EN/home, createdTime=1754267492398, updatedTime=1754267492398, createdBy=13701087609, updatedBy=13701087609, submissionGuidelinesUrl=http://www.kjdb.org/EN/column/column7.shtml, submissionAuthorUrl=https://kjdbauthor.manuscriptcloud.com/login, submissionEditorUrl=https://kjdbeditor.manuscriptcloud.com/login, submissionReviewUrl=https://kjdbauthor.manuscriptcloud.com/login, submissionCeEditorUrl=https://kjdbeditor.manuscriptcloud.com/login, submissionAeEditorUrl=https://kjdbeditor.manuscriptcloud.com/login, option={"copyright":""})], databaseList=null, tenantJournalId=1146031591421210625, websiteList=[Website(id=1146104741081231361, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1146031591421210625, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/kjdb/CN, language=CN, createTime=1751182263881, createBy=18614031015, updateTime=1751778001962, updateBy=18614031015, name=科技导报, tplId=1146099689490845704, title=科技导报, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1148021146403992296, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146104741081231361, code=articleTextType, value=kx, createTime=1751639170504, updateTime=1751639170504, creator=18614031015, updator=18614031015), WebsiteProps(id=1148021146378826469, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146104741081231361, code=banner, value=null, createTime=1751639170498, updateTime=1751639170498, creator=18614031015, updator=18614031015), WebsiteProps(id=1148021146366243556, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146104741081231361, code=logo, value=https://castjournals.cast.org.cn/joweb/kjdb/CN/file/pic?fileId=9GHSf7eGlIPH0Tv/OOdstA==, createTime=1751639170495, updateTime=1751639170495, creator=18614031015, updator=18614031015), WebsiteProps(id=1148021146395603687, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146104741081231361, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/kjdb/CN/file/pic, createTime=1751639170502, updateTime=1751639170502, creator=18614031015, updator=18614031015), WebsiteProps(id=1148021146387215078, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146104741081231361, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_cn_619/, createTime=1751639170500, updateTime=1751639170500, creator=18614031015, updator=18614031015)]), Website(id=1146105254833139715, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1146031591421210625, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/kjdb/EN, language=EN, createTime=1751182386363, createBy=18614031015, updateTime=1753500121937, updateBy=18614031015, name=科技导报, tplId=1146101810881728533, title=Science & Technology Review, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1155838567709528217, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146105254833139715, code=articleTextType, value=kx, createTime=1753502988984, updateTime=1753502988984, creator=18614031015, updator=18614031015), WebsiteProps(id=1155838567692750998, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146105254833139715, code=banner, value=null, createTime=1753502988980, updateTime=1753502988980, creator=18614031015, updator=18614031015), WebsiteProps(id=1155838567688556693, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146105254833139715, code=logo, value=https://castjournals.cast.org.cn/joweb/kjdb/EN/file/pic?fileId=9GHSf7eGlIPH0Tv/OOdstA==, createTime=1753502988979, updateTime=1753502988979, creator=18614031015, updator=18614031015), WebsiteProps(id=1155838567705333912, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146105254833139715, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/kjdb/EN/file/pic, createTime=1753502988983, updateTime=1753502988983, creator=18614031015, updator=18614031015), WebsiteProps(id=1155838567701139607, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146105254833139715, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_en_623/, createTime=1753502988982, updateTime=1753502988982, creator=18614031015, updator=18614031015)])], journalTitle=科技导报, weixinUrl=null, journalUrl=null, iacademicId=null, status=0, seqNo=null, journalTitleEn=Science & Technology Review, journalPhotoCn=aEuqdCNQUjPEKa3rm5A/8Q==, journalPhotoEn=4AIQ9/oc3H8lvjeELJ6WWw==, journalFirstLetter=S, journalRecommend=null, journalNew=null, journalCollection=1, jcrJf=null, cjcrJf=0.91, jcrJfStr=null, cjcrJfStr=null, submissionFirstDecision=null, sciSubjectClassification=null, casSubjectClassification=null, citeScore=null, totalCitationFrequency=null, icpCode=null, psCode=null, advertisingLicenseCode=null, copyrightInformation=null, country=null, option=null, provinceCode=null, provinceName=null, collectFlag=false), detailUrlCn=https://castjournals.cast.org.cn/joweb/kjdb/CN/10.3981/j.issn.1000-7857.2017.11.010, detailUrlEn=https://castjournals.cast.org.cn/joweb/kjdb/EN/10.3981/j.issn.1000-7857.2017.11.010, pdfUrlCn=https://castjournals.cast.org.cn/joweb/kjdb/CN/PDF/10.3981/j.issn.1000-7857.2017.11.010, pdfUrlEn=https://castjournals.cast.org.cn/joweb/kjdb/EN/PDF/10.3981/j.issn.1000-7857.2017.11.010, aliStartDate=null, aliEndDate=null, collectionFlag=false, citedCount=null, citedUrl=null, reference=null)
收藏切换
生化药物生物活性测定方法及其替代方法研究
收藏切换
PDF下载
科技导报 | 研究论文 2017,35(13): 66-69
收起
收藏切换
科技导报 | 研究论文 2017, 35(13): 66-69
生化药物生物活性测定方法及其替代方法研究
全屏
李震, 张媛, 高华
作者信息
    中国食品药品检定研究院, 北京 100050

通讯作者:

高华,研究员,研究方向为药理学,电子信箱:huag55@163.com
Bioassays of biochemical drugs and their alternatives
Affiliations
出版时间: 2017-07-13 doi: 10.3981/j.issn.1000-7857.2017.11.010
文章导航
收藏切换
通过比较中国和国外药典对于部分生化药物的生物活性测定方法的不同,分析了中国理化方法替代生物活性测定方法的趋势。针对生化药物活性组分的不同对其进行分类并分别提出了理化替代方法建立与验证的思路,总结了替代研究时的实验设计思路与实验结果的统计分析方法,探讨了不同质量控制模式之间的关系,对中国质量控制方法的发展提出了展望。
生化药物  /  生物活性测定法  /  理化方法  /  替代
An overview of the definition, the strengths and the limitations of bioassays in the quality control is made and the trend of their replacement by physical and chemical methods through a comparison of ChP and other countries’pharmacopeia is analyzed. Ideas and references of the establishment and the validation of the alternative methods are provided for different sorts of biochemical drugs. The review also summarizes the most common experimental design and two statistical analysis methods. At last, the importance of the combination and the promotion of different quality control modes is emphasized.
biochemical drugs  /  bioassays  /  physical and chemical methods  /  alternative research
李震, 张媛, 高华. 生化药物生物活性测定方法及其替代方法研究. 科技导报, 2017 , 35 (13) : 66 -69 . DOI: 10.3981/j.issn.1000-7857.2017.11.010
LI Zhen, ZHANG Yuan, GAO Hua. Bioassays of biochemical drugs and their alternatives[J]. Science & Technology Review, 2017 , 35 (13) : 66 -69 . DOI: 10.3981/j.issn.1000-7857.2017.11.010
2017年第35卷第13期
PDF下载
296
70
引用本文
BibTeX
文章信息
doi: 10.3981/j.issn.1000-7857.2017.11.010
  • 接收时间:2016-08-30
  • 首发时间:2017-06-14
  • 出版时间:2017-07-13
补充材料
相关文章
文章信息
作者
出版历史
  • 收稿日期:2016-08-30
  • 修回日期:2016-10-30
基金
作者信息

通讯作者:

高华,研究员,研究方向为药理学,电子信箱:huag55@163.com
参考文献
分享链接
https://castjournals.cast.org.cn/joweb/kjdb/CN/10.3981/j.issn.1000-7857.2017.11.010
分享至
全文二维码

扫描看全文

引用本文
BibTeX
本文的引用情况
2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

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
关闭全屏