Article(id=1291339061919216153, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291339021272211834, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.02.028, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1723651200000, receivedDateStr=2024-08-15, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785808824253, onlineDateStr=2026-08-04, pubDate=1737993600000, pubDateStr=2025-01-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785808824253, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785808824253, creator=13041195026, updateTime=1785808824253, updator=13041195026, issue=Issue{id=1291339021272211834, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='2', pageStart='151', pageEnd='300', issueExtLink='null', onlineDate='null', pubDate='1737993600000', pubDateStr='2025-01-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785808814590, creator='13041195026', updateTime=1785808814590, updator='13041195026', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=290, endPage=295, ext={EN=ArticleExt(id=1291339063894733338, articleId=1291339061919216153, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Discussion on the pharmaceutical research of generic drugs of sacubitril valsartan sodium tablets, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

Sacubitril valsartan sodium tablets are a novel supramolecular co-crystal drug that combines the dual effects of angiotensin receptor blockade and neprilysin inhibitor. It has shown broad application prospects in heart failure, hypertension, maintaining water sodium balance in the body, and protecting target organs, etc. It is a major breakthrough in cardiovascular treatment drugs in recent years. It is clinically used in China for chronic heart failure in adult patients with reduced ejection fraction and primary hypertension. In recent years, pharmaceutical co-crystals has become a hot topic in the research of crystalline drugs, and sacubitril valsartan sodium tablets, as a marketed co-crystal drug, have attracted industry attention. This article summarizes the characteristics of sacubitril valsartan sodium co-crystal drug, the application and approval cases through relevant literature investigation, and discussses pharmaceutical research of the formulation, in order to provide some references for the research and development of generic drugs.

, authors=Yun-chuan HAN, Xiao-hong XU, Fei LI, authorsList=Yun-chuan HAN, Xiao-hong XU, Fei LI, authorCompany=null, correspAuthors=Fei LI, 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=1291339064779731483, articleId=1291339061919216153, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=沙库巴曲缬沙坦钠片仿制药药学研究探讨, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=

沙库巴曲缬沙坦钠片是一种新型超分子共晶药物，兼具血管紧张素受体阻断药和脑啡肽酶抑制双重作用，在心力衰竭、高血压、维持体内水钠平衡及保护靶器官等方面显示出广阔的应用前景，是近些年心血管治疗药物的重大突破，国内临床上用于射血分数降低的慢性心力衰竭成年患者和原发性高血压的治疗。近年来，药物共晶作为晶型药物研究热点，而沙库巴曲缬沙坦钠片作为已上市共晶药物备受行业关注。本文通过相关文献调研，概述沙库巴曲缬沙坦钠共晶药物特性、国内外制剂批准上市情况，并对制剂的药学研究进行探讨，以期为仿制药研究开发提供一定参考。

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韩云川（1990-），男，主管药师，主要从事化学药品技术审评工作

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韩云川（1990-），男，主管药师，主要从事化学药品技术审评工作

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