Article(id=1322627832761660264, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627786464936095, 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=1590163200000, acceptedDateStr=2020-05-23, onlineDate=1793268648567, onlineDateStr=2026-10-29, pubDate=1615737600000, pubDateStr=2021-03-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793268648567, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793268648567, creator=13701087609, updateTime=1793268648567, updator=13701087609, issue=Issue{id=1322627786464936095, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='5', pageStart='385', pageEnd='480', issueExtLink='null', onlineDate='null', pubDate='1615737600000', pubDateStr='2021-03-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793268637529, creator='13701087609', updateTime=1793269201588, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322630152530539005, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627786464936095, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322630152530539006, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627786464936095, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=399, endPage=402, ext={EN=ArticleExt(id=1322627832954598249, articleId=1322627832761660264, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Bioequivalence of glucosamine sulfate capsules after single dose in healthy volunteers, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To evaluate the bioequivalence of reference and test formulations of glucosamine sulfate capsules after single dose in healthy Chinese volunteers under fasting condition.
Methods: A total of 30 healthy human volunteers participated in a randomized, open, single-dose, three-cycle, partial repeated, three-crossover study. Volunteers were given single dose (0.25 g) of tested and reference formulations of glucosamine sulfate capsules under fasting state. Plasma concentration of glucosamine after administration was analyzed by LC-MS/MS method. Non-compartmental pharmacokinetics parameters were calculated by WinNonlin 6.3, and bioequivalence was evaluated using reference-scaled average bioequivalence (RSABE) method by SAS 7.1.
Results: For test and reference formulations, Cmax of glucamine (after baseline correction) were (585.0±282.2) and (641.0±293.6) ng·mL-1, Tmax were 1.5 (0.5, 5.0) and 1.5 (0.5, 5.0) h, t1/2 were (1.8±1.4) and (1.5±0.5) h, AUC0~t were (2 089.2±749.5) and (2 298.2±928.4), AUC0~∞ were (2 095.3±749.7) and (2 303.1±929.0), respectively. The geometric mean ratios (GMR) of AUC0~t, AUC0~∞ and Cmax between test and reference formulations were both within 90% confidence interval broadened bioequivalent rage 74.9% to 133.6% and 70.1% to 142.7%, and regular bioequivalent range (80% to 125%).
Conclusion: Two formulations were equivalent under fasting condition.
, authors=Ke-xu YANG
1, Shan JING
1, Wen-fang LIU
1, Chun-yan LU
1, Xin WANG
2, Yang LIN
1, authorsList=Ke-xu YANG, Shan JING, Wen-fang LIU, Chun-yan LU, Xin WANG, Yang LIN, authorCompany=null, correspAuthors=Yang LIN, 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=1322627833722155882, articleId=1322627832761660264, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=硫酸氨基葡萄糖胶囊在中国健康人体内的生物等效性试验, 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： 评价空腹单剂量口服硫酸氨基葡萄糖胶囊受试制剂与参比制剂在中国健康人体中的生物等效性。
方法： 本研究采用随机、开放、单剂量、三周期、部分重复、三交叉试验设计，共入组健康男性和女性30例，单剂量空腹口服受试制剂和参比制剂硫酸氨基葡萄糖胶囊0.25 g。采用LC-MS/MS测定给药后血浆氨基葡萄糖药物浓度。使用WinNonlin 6.3软件计算非房室模型药动学（PK）参数，采用参比制剂标度的平均生物等效性（RSABE）方法，使用SAS企业版7.1版软件进行等效性评价。
结果： 经基线校正后的受试制剂和参比制剂中氨基葡萄糖Cmax分别为（585.0±282.2）和（641.0±293.6）ng·mL-1，Tmax分别为1.5 h（0.5，5.0 h）和1.5 h（0.5，5.0 h），t1/2分别为（1.8±1.4）和（1.5±0.5）h，AUC0~t分别为（2 089.2±749.5）和（2 298.2±928.4）ng·h·mL-1，AUC0~∞分别为（2 095.3±749.7）和（2 303.1±929.0）ng·h·mL-1。受试制剂和参比制剂的AUC0~t，AUC0~∞和Cmax的几何均数比值（受试制剂/参比制剂）的90%置信区间介于拓宽的等效范围74.9%~133.6%和70.1%~142.7%，同时介于未拓宽的等效范围80.0%~125.0%。
结论： 硫酸氨基葡萄糖胶囊受试制剂与参比制剂在空腹服用的情况下生物等效。
, authors=杨克旭
1, 荆珊
1, 刘文芳
1, 鲁春艳
1, 王欣
2, 林阳
1, authorsList=杨克旭, 荆珊, 刘文芳, 鲁春艳, 王欣, 林阳, authorCompany=null, correspAuthors=林阳, authorNote=
, correspAuthorsNote=
, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=aTcrwae+X7TVl7PJFz7ZqQ==, magXml=1XWpjSq5+eTtiVG+WHV+GA==, pdfUrl=null, pdf=DNJiR8yc3zR4/4F+kvmMng==, pdfFileSize=835808, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=BdH1J8+W0PUi2eL2UJhMaw==, mapNumber=null, fund=null)}, authors=[Author(id=1322627834099643250, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=yangkexu@anzhengcp.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322627834170946420, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, authorId=1322627834099643250, language=EN, stringName=Ke-xu YANG, firstName=Ke-xu, middleName=null, lastName=YANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
1, address=
1Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322627834242249589, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, authorId=1322627834099643250, language=CN, stringName=杨克旭, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
1, address=
1首都医科大学附属北京安贞医院，北京 100029, bio={"content":"
杨克旭，女，主管药师，主要从事Ⅰ期临床试验工作。联系电话：（010）64426153，E-mail：yangkexu@anzhengcp.com。
"}, bioImg=null, bioContent=
杨克旭，女，主管药师，主要从事Ⅰ期临床试验工作。联系电话：（010）64426153，E-mail：yangkexu@anzhengcp.com。
, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322627833931871083, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, xref=1, ext=[AuthorCompanyExt(id=1322627833940259692, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, companyId=1322627833931871083, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
1Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China), AuthorCompanyExt(id=1322627833948648301, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, companyId=1322627833931871083, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
1首都医科大学附属北京安贞医院，北京 100029)])]), Author(id=1322627834330329975, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, orderNo=1, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322627834410021753, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, authorId=1322627834330329975, language=EN, stringName=Shan JING, firstName=Shan, middleName=null, lastName=JING, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
1, address=
1Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322627834477130618, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, authorId=1322627834330329975, language=CN, stringName=荆珊, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
1, address=
1首都医科大学附属北京安贞医院，北京 100029, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322627833931871083, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, xref=1, ext=[AuthorCompanyExt(id=1322627833940259692, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, companyId=1322627833931871083, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
1Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China), AuthorCompanyExt(id=1322627833948648301, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, companyId=1322627833931871083, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
1首都医科大学附属北京安贞医院，北京 100029)])]), Author(id=1322627836133880700, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, orderNo=2, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322627836209378174, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, authorId=1322627836133880700, language=EN, stringName=Wen-fang LIU, firstName=Wen-fang, middleName=null, lastName=LIU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
1, address=
1Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322627836280681343, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, authorId=1322627836133880700, language=CN, stringName=刘文芳, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
1, address=
1首都医科大学附属北京安贞医院，北京 100029, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322627833931871083, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, xref=1, ext=[AuthorCompanyExt(id=1322627833940259692, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, companyId=1322627833931871083, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
1Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China), AuthorCompanyExt(id=1322627833948648301, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, companyId=1322627833931871083, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
1首都医科大学附属北京安贞医院，北京 100029)])]), Author(id=1322627836343595905, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, orderNo=3, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322627836431676291, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, authorId=1322627836343595905, language=EN, stringName=Chun-yan LU, firstName=Chun-yan, middleName=null, lastName=LU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
1, address=
1Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322627836515562372, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, authorId=1322627836343595905, language=CN, stringName=鲁春艳, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
1, address=
1首都医科大学附属北京安贞医院，北京 100029, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322627833931871083, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, xref=1, ext=[AuthorCompanyExt(id=1322627833940259692, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, companyId=1322627833931871083, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
1Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China), AuthorCompanyExt(id=1322627833948648301, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, companyId=1322627833931871083, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
1首都医科大学附属北京安贞医院，北京 100029)])]), Author(id=1322627836599448454, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, orderNo=4, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322627836670751624, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, authorId=1322627836599448454, language=EN, stringName=Xin WANG, firstName=Xin, middleName=null, lastName=WANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
2, address=
2Zhejiang Hisun Pharmaceutical Co., Ltd., Taizhou 318000, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322627836754637705, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, authorId=1322627836599448454, language=CN, stringName=王欣, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
2, address=
2浙江海正药业股份有限公司，台州 318000, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322627834011562862, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, xref=2, ext=[AuthorCompanyExt(id=1322627834019951471, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, companyId=1322627834011562862, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
2Zhejiang Hisun Pharmaceutical Co., Ltd., Taizhou 318000, China), AuthorCompanyExt(id=1322627834032534384, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, companyId=1322627834011562862, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
2浙江海正药业股份有限公司，台州 318000)])]), Author(id=1322627836830135179, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, orderNo=5, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=linyang3623@163.com, emailSecond=null, emailThird=null, correspondingAuthor=1, authorType=1, ext={EN=AuthorExt(id=1322627836901438349, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, authorId=1322627836830135179, language=EN, stringName=Yang LIN, firstName=Yang, middleName=null, lastName=LIN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
1, address=
1Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322627836972741518, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, authorId=1322627836830135179, language=CN, stringName=林阳, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
1, address=
1首都医科大学附属北京安贞医院，北京 100029, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322627833931871083, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, xref=1, ext=[AuthorCompanyExt(id=1322627833940259692, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, companyId=1322627833931871083, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
1Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China), AuthorCompanyExt(id=1322627833948648301, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, companyId=1322627833931871083, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
1首都医科大学附属北京安贞医院，北京 100029)])])], keywords=[Keyword(id=1322627837069210511, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, language=EN, orderNo=1, keyword=glucosamine sulfate), Keyword(id=1322627837127930768, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, language=EN, orderNo=2, keyword=highly variable drug), Keyword(id=1322627837186651025, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, language=EN, orderNo=3, keyword=endogenous), Keyword(id=1322627837274731410, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, language=EN, orderNo=4, keyword=bioequivalence), Keyword(id=1322627837337645971, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, language=EN, orderNo=5, keyword=reference-scaled average bioequivalence (RSABE)), Keyword(id=1322627837400560532, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, language=CN, orderNo=1, keyword=硫酸氨基葡萄糖), Keyword(id=1322627837459280789, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, language=CN, orderNo=2, keyword=高变异药物), Keyword(id=1322627837518001046, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, language=CN, orderNo=3, keyword=内源性药物), Keyword(id=1322627837585109911, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, language=CN, orderNo=4, keyword=生物等效性), Keyword(id=1322627837652218776, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, language=CN, orderNo=5, keyword=参比制剂标度的平均生物等效性)], refs=[Reference(id=1322627837941625754, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[1], rfOrder=0, authorNames=null, journalName=null, refType=null, unstructuredReference=PERSIANI S, RODA E, ROVATI LC,
et al. Glucosamine oral bioavailability and plasma pharmacokinetics after increasing doses of crystalline glucosamine sulfate in man[J].
Osteoarthr Cartilage, 2005, 13(12): 1041-1049., articleTitle=null, refAbstract=null), Reference(id=1322627838021317531, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[2], rfOrder=1, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Product-Specific Guidances for Generic Drug Development[EB/OL]. (2020-04-03). https://www.fda.gov/drugs/guidances-drugs/product-specific-guidances-generic-drug-development., articleTitle=null, refAbstract=null), Reference(id=1322627838088426396, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[3], rfOrder=2, authorNames=null, journalName=null, refType=null, unstructuredReference=PUJALTE JM, LLAVORE EP, YLESCUPIDEZ FR. Double-blind clinical evaluation of oral glucosamine sulphate in the basic treatment of osteoarthritis[J].
Curr Med Res Opin, 1980, 7(2): 110-114., articleTitle=null, refAbstract=null), Reference(id=1322627838172312477, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[4], rfOrder=3, authorNames=null, journalName=null, refType=null, unstructuredReference=PAVELKA K, GATTEROVA J, OLEJAROVA M,
et al. Glucosamine sulfate use and delay of progression of knee osteoarthritis[J].
Arch Intern Med, 2002, 162(18): 2113-2123., articleTitle=null, refAbstract=null), Reference(id=1322627838239421342, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[5], rfOrder=4, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局. 高变异药物生物等效性研究技术指导原则[EB/OL]. (2018-10-17). http://www.cde.org.cn/news.do?method=largeInfo&id=314799., articleTitle=null, refAbstract=null), Reference(id=1322627838306530207, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[6], rfOrder=5, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA[EB/OL]. (2013-12). https://www.fda.gov/media/87219/download., articleTitle=null, refAbstract=null), Reference(id=1322627838377833376, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[7], rfOrder=6, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局. 以药动学参数为终点评价指标的化学药物仿制药人体生物等效性研究技术指导原则[EB/OL]. (2016-03-18). https://www.nmpa.gov.cn/zhuanti/ypqxgg/ggzhcfg/20160318210001633.html., articleTitle=null, refAbstract=null), Reference(id=1322627838470108065, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[8], rfOrder=7, authorNames=null, journalName=null, refType=null, unstructuredReference=王玉. 硫酸氨基葡萄糖胶囊生物等效性研究基本考虑[J]. 中国新药杂志, 2018, 27(6): 634-636., articleTitle=null, refAbstract=null), Reference(id=1322627838541411234, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[9], rfOrder=8, authorNames=null, journalName=null, refType=null, unstructuredReference=ZHU Y, ZOU J, XIAO D,
et al. Bioequivalence of two formulations of glucosamine sulfate 500-mg capsules in healthy male chinese volunteers: an open-lable, randomized-sequences, single-dose, fasting, two-way cross over study[J].
Clin Ther, 2009, 7(31): 1551-1559., articleTitle=null, refAbstract=null), Reference(id=1322627838600131491, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[10], rfOrder=9, authorNames=null, journalName=null, refType=null, unstructuredReference=AKARASEREENONT P, CHATSIRICHAROENKUL S, PONGNARIN P,
et al. Bioequivalence study of 500 mg glucosamine sulfate in Thai healthy volunteers[J].
J Med Assoc Thai, 2009, 92(9): 1234-1239., articleTitle=null, refAbstract=null)], funds=[Fund(id=1322627837849351065, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, awardId=2017XZ09304017, language=CN, fundingSource=国家“重大新药创制”科技重大专项资助项目：心血管疾病药物临床研究示范性平台(2017XZ09304017), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1322627833931871083, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, xref=1, ext=[AuthorCompanyExt(id=1322627833940259692, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, companyId=1322627833931871083, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
1Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China), AuthorCompanyExt(id=1322627833948648301, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, companyId=1322627833931871083, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
1首都医科大学附属北京安贞医院，北京 100029)]), AuthorCompany(id=1322627834011562862, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, xref=2, ext=[AuthorCompanyExt(id=1322627834019951471, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, companyId=1322627834011562862, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
2Zhejiang Hisun Pharmaceutical Co., Ltd., Taizhou 318000, China), AuthorCompanyExt(id=1322627834032534384, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627832761660264, companyId=1322627834011562862, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
2浙江海正药业股份有限公司，台州 318000)])], figs=null, attaches=null, journal=Journal(id=1235980159023624194, delFlag=0, nameCn=中国新药杂志, nameEn=Chinese Journal of New Drugs, nameHistory1=null, nameHistory2=null, issn=1003-3734, eissn=null, cn=11-2850/R, coden=ZXZHA6, periodic=3, language=CN, oaType=null, 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=ohPEEN//Vz1tDT3ZBNTp4Q==, journalPrice=null, startedYear=null, abbrevIsoEn=Chinese Journal of New Drugs, journalRemark=null, publicationField=null, createdTime=1772610233314, updatedTime=1788948968376, createdBy=18614031015, updatedBy=13041195026, firstLetterCn=Z, firstLetterEn=Z, subjectCode=Medical and Pharmaceutical Sciences, subjectName=null, subjectCodeEn=Medical and Pharmaceutical Sciences, subjectNameEn=null, picCn=ohPEEN//Vz1tDT3ZBNTp4Q==, picEn=f9WK9bvTM4guTmS/iGhOMg==, jcr=null, cjcr=null, exts=[JournalExt(id=1304509780974924039, language=CN, name=中国新药杂志, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1788948968404, updatedTime=1788948968404, createdBy=13041195026, updatedBy=13041195026, submissionGuidelinesUrl=, submissionAuthorUrl=http://draft.newdrug.cn/journalx_zgxy/authorLogOn.action, submissionEditorUrl=http://draft.newdrug.cn/journalx_zgxy/editorLogOn.action, submissionReviewUrl=http://draft.newdrug.cn/journalx_zgxy/expertLogOn.action, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""}), JournalExt(id=1304509781025255688, language=EN, name=Chinese Journal of New Drugs, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1788948968416, updatedTime=1788948968416, createdBy=13041195026, updatedBy=13041195026, submissionGuidelinesUrl=, submissionAuthorUrl=http://draft.newdrug.cn/journalx_zgxy/authorLogOn.action, submissionEditorUrl=http://draft.newdrug.cn/journalx_zgxy/editorLogOn.action, submissionReviewUrl=http://draft.newdrug.cn/journalx_zgxy/expertLogOn.action, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""})], databaseList=null, tenantJournalId=1235980733773295621, websiteList=[Website(id=1235982099191222761, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1235980733773295621, 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/zgxyzz/CN, language=CN, createTime=1772610695884, createBy=18614031015, updateTime=1772610860397, updateBy=18614031015, name=中国新药杂志-中文, tplId=1146099689490845704, title=中国新药杂志, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1235983918629966444, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=articleTextType, value=kx, createTime=1772611129672, updateTime=1772611129672, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918604800617, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=banner, value=null, createTime=1772611129666, updateTime=1772611129666, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918655132271, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=grayFlag, value=0, createTime=1772611129678, updateTime=1772611129678, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918596412008, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=logo, value=https://castjournals.cast.org.cn/joweb/zgxyzz/CN/file/pic?fileId=W567vm71kFC7UhK9TSU6xw==, createTime=1772611129664, updateTime=1772611129664, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918667715185, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=minRunFlag, value=0, createTime=1772611129681, updateTime=1772611129681, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918617383531, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/zgxyzz/CN/file/pic, createTime=1772611129669, updateTime=1772611129669, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918659326576, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=silenceFlag, value=0, createTime=1772611129679, updateTime=1772611129679, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918613189226, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_cn_619/, createTime=1772611129668, updateTime=1772611129668, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918634160749, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=themeColor, value=null, createTime=1772611129673, updateTime=1772611129673, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918646743662, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=themeStyle, value=null, createTime=1772611129676, updateTime=1772611129676, creator=18614031015, updator=18614031015)]), Website(id=1235982099270914542, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1235980733773295621, 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/zgxyzz/EN, language=EN, createTime=1772610695903, createBy=18614031015, updateTime=1772610875891, updateBy=18614031015, name=中国新药杂志-英文, tplId=1146101810881728533, title=Chinese Journal of New Drugs, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1235983955829248630, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=articleTextType, value=kx, createTime=1772611138541, updateTime=1772611138541, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955804082803, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=banner, value=null, createTime=1772611138535, updateTime=1772611138535, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955854414457, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=grayFlag, value=0, createTime=1772611138547, updateTime=1772611138547, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955795694194, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=logo, value=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/file/pic?fileId=W567vm71kFC7UhK9TSU6xw==, createTime=1772611138533, updateTime=1772611138533, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955866997371, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=minRunFlag, value=0, createTime=1772611138550, updateTime=1772611138550, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955820860021, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/file/pic, createTime=1772611138539, updateTime=1772611138539, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955862803066, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=silenceFlag, value=0, createTime=1772611138549, updateTime=1772611138549, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955812471412, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_en_623/, createTime=1772611138537, updateTime=1772611138537, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955837637239, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=themeColor, value=null, createTime=1772611138543, updateTime=1772611138543, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955846025848, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=themeStyle, value=null, createTime=1772611138545, updateTime=1772611138545, creator=18614031015, updator=18614031015)])], journalTitle=中国新药杂志, weixinUrl=null, journalUrl=http://www.newdrug.cn/, iacademicId=null, status=1, seqNo=null, journalTitleEn=Chinese Journal of New Drugs, journalPhotoCn=ohPEEN//Vz1tDT3ZBNTp4Q==, journalPhotoEn=f9WK9bvTM4guTmS/iGhOMg==, journalFirstLetter=Z, journalRecommend=null, journalNew=null, journalCollection=null, jcrJf=null, cjcrJf=null, 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=, provinceCode=null, provinceName=null, collectFlag=false, interPubPlatform=, interPubPlatformUrl=null), detailUrlCn=https://castjournals.cast.org.cn/joweb/zgxyzz/CN/Y2021/V30/I5/399, detailUrlEn=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/Y2021/V30/I5/399, pdfUrlCn=https://castjournals.cast.org.cn/joweb/zgxyzz/CN/PDF/Y2021/V30/I5/399, pdfUrlEn=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/PDF/Y2021/V30/I5/399, aliStartDate=0, aliEndDate=0, collectionFlag=false, citedCount=null, citedUrl=null, previewStatus=0, delFlag=0, hasFullText=0, orderTime=1615737600000, fullTextJson=null, articleText=null, reference=null)
全屏
文章导航
PDF下载
8
2
关闭全屏
北京市海淀区学院南路86号
010-62662699（运营及技术支持）
qkjq@cast.org.cn
