Article(id=1322246446020149487, 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=1616860800000, acceptedDateStr=2021-03-28, onlineDate=1793177718881, onlineDateStr=2026-10-28, pubDate=1624982400000, pubDateStr=2021-06-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177718881, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177718881, creator=13701087609, updateTime=1793177718881, 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=1087, endPage=1092, ext={EN=ArticleExt(id=1322246446221476080, articleId=1322246446020149487, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Determination of MBS77E, a monoclonal antibody against Ebola virus, in monkey serum by indirect enzyme-linked immunosorbent assay (ELISA) and the pharmacokinetic study, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To establish an indirect enzyme-linked immunosorbent assay (ELISA) for determination of MBS77E, a novel monoclonal antibody against Ebola virus, in the serum of cynomolgus monkeys and to study its pharmacokinetics in monkeys.
Methods: An indirect ELISA method for quantitative detection of MBS77E in cynomolgus monkey serum was developed and fully validated. Four cynomolgus monkeys were divided into two groups. Each group of monkeys were administered with MBS77E via intravenous injection at dosage of 5 or 100 mg·kg-1, respectively. Blood samples were collected at different time points after administration. Serum was obtained and the concentration of MBS77E was determined using the established ELISA method. The pharmacokinetic parameters of MBS77E were analyzed using WinNonlin software.
Results: The linear range of the method was 0.098~12.5 μg·mL-1. The precision RSDs of the intra- and inter-assay were within 3.5%~9.9% and 7.4%~11.8%, respectively. After i.v. injection at dosage of 5 and 100 mg·kg-1, the terminal t1/2 of MBS77E was (8.88±5.24) and (6.38±2.57) d, CL was (7.55±1.48) and (6.22±0.99) mL·h-1·kg-1, V was (91.18±38.16) and (55.44±14.01) mL·kg-1, AUC was (631.58±76.75) and (16 004.13±2 230.73) μg·d·mL-1, respectively. The AUCs were proportional to the two dosages. The plasma clearances of MBS77E did not change with different dosages.
Conclusion: An indirect ELISA method was successfully established for the determination of MBS77E in monkey serum which met the requirements of preclinical pharmacokinetic research in terms of specificity, linear range, precision and stability et al. The pharmacokinetic characteristics of MBS77E in cynomolgus monkeys were obtained. This study provided support for the preclinical and clinical pharmacokinetic studies of MBS77E.
, authors=Ya-nan XIANG, You GAO, Long-long LUO, Wen-peng ZHANG, Xiao-mei ZHUANG, authorsList=Ya-nan XIANG, You GAO, Long-long LUO, Wen-peng ZHANG, Xiao-mei ZHUANG, authorCompany=null, correspAuthors=Xiao-mei ZHUANG, 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=1322246446477328625, articleId=1322246446020149487, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=间接ELISA法测定猴血清中埃博拉病毒单克隆抗体MBS77E及药动学研究, columnId=1236331161786569054, journalTitle=中国新药杂志, columnName=重大新药创制专项巡礼, runingTitle=null, highlight=null, articleAbstract=
目的： 建立食蟹猴血清中抗埃博拉病毒单克隆抗体MBS77E的间接酶联免疫吸附（ELISA）定量测定法，并进行食蟹猴体内药动学研究。
方法： 建立优化一种定量检测食蟹猴血清中抗埃博拉病毒单克隆抗体MBS77E浓度的间接ELISA法，并进行全面验证。4只食蟹猴分为2组，每组2只，分别静脉推注不同剂量的MBS77E（5和100 mg·kg-1），不同时间点采血，分离血清，采用ELISA法测定MBS77E浓度。使用WinNonlin软件计算药动学参数，分析药动学特征。
结果： 该方法的线性范围为0.098~12.5 μg·mL-1，板内精密度为3.5%~9.9%，板间精密度为7.4%~11.8%。食蟹猴静注5和100 mg·kg-1的MBS77E后，半衰期分别为（8.88±5.24）和（6.38±2.57）d，清除率分别为（7.55±1.48）和（6.22±0.99）mL·h-1·kg-1，表观分布容积分别为（91.18±38.16）和（55.44±14.01）mL·kg-1，药时曲线下面积（AUC）分别为（631.58±76.75）和（16 004.13±2 230.73）μg·d·mL-1，AUC与剂量成正比，清除率不随剂量改变而改变。
结论： 建立的间接ELISA法测定猴血清中MBS77E浓度在特异性、线性范围、精密度和稳定性等方面，满足临床前药动学研究需求，初步获得了MBS77E在食蟹猴中的药动学特征。本研究为MBS77E的临床前及临床药动学研究提供了支持。
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