Article(id=1236331825379987584, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331822909550881, 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=1690560000000, acceptedDateStr=2023-07-29, onlineDate=1772694077104, onlineDateStr=2026-03-05, pubDate=1701273600000, pubDateStr=2023-11-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772694077104, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772694077104, creator=13701087609, updateTime=1772694077104, updator=13701087609, issue=Issue{id=1236331822909550881, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='22', pageStart='2225', pageEnd='2328', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772694076516, creator=13701087609, updateTime=1772696919965, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236343749253591892, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331822909550881, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236343749253591893, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331822909550881, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=2317, endPage=2323, ext={EN=ArticleExt(id=1236331825610674305, articleId=1236331825379987584, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Correlation analysis of the structure and water swellability of carboxymethyl starch sodium, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: Carboxymethyl starch sodium is the most commonly used superdisintegrant, and the degree of substitution and crosslinking density are the important quality attributes that affect its water swellability and disintegration performance. By exploring the correlation between degree of substitution, crosslinking density, and water swellability, this study aims to provide a theoretical reference for the production of disintegrant with excellent performance.
Methods: Seventeen batches of carboxymethyl starch sodium were collected. Low-field nuclear magnetic resonance technique was used to determine the crosslink density values. And the degree of substitution and water swellability value were determined by physical-chemical method. The correlation between crosslinking density, degree of substitution and water swellability was investigated by Pearson correlation.
Results: There were significant differences in the attribute values of products from different sources. The crosslinking density was significantly negatively correlated with the degree of substitution and water swellability, and the correlation coefficients were -0.814 and -0.854. The degree of substitution was significantly positively correlated with the water swellability, and the correlation coefficient was 0.823.
Conclusion: The crosslinking density and the degree of substitution are the critical quality attributes that affect the disintegration of carboxymethyl starch sodium. Understanding the disintegration behavior of disintegrants is of great significance for the development of pharmaceutical solid preparations. Clarifying the relationship between the disintegration characteristics of carboxymethyl starch sodium and crosslinking density and degree of substitution will help to select the correct disintegrant for a given formulation.
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目的： 羧甲淀粉钠作为最常用的超级崩解剂，取代度和交联密度是影响其吸水膨胀性即崩解特性的重要质量属性。通过探索取代度、交联密度与吸水膨胀性能之间的相关性，旨在为生产出性能优良的崩解产品及仿制药提供理论参考。
方法： 本文收集了17个不同企业和批次羧甲淀粉钠产品，采用低场核磁共振技术测定其交联密度值，采用物理化学方法测定其取代度和吸水膨胀性值。同时利用皮尔逊相关分析方法考察了交联密度、取代度与吸水膨胀性之间的相关关系。
结果： 不同来源产品的取代度、吸水膨胀性及交联密度值存在显著差异。交联密度与取代度、吸水膨胀性呈显著负相关性，相关系数分别为-0.814和-0.854。取代度与吸水膨胀性呈显著正相关，相关系数为0.823。
结论： 交联密度和取代度是影响羧甲淀粉钠崩解性的关键质量属性。了解崩解剂的崩解行为对药物固体制剂的开发具有重要意义。明确羧甲淀粉钠崩解特性与交联密度和取代度的关系，有助于为既定的处方选择正确的崩解剂。
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孙会敏，男，博士，研究员，主要从事药用辅料及药品包装材料质量控制及安全性评价研究。联系电话：(010)53852486，E-mail:
sunhm@126.com。
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1National Institutes for Food and Drug Control, Beijing 102629, China
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1中国食品药品检定研究院，北京 102629
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武美芹，女，硕士研究生，专业方向：药学。联系电话：(010)53852039，E-mail: wmq0406@163.com。
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武美芹，女，硕士研究生，专业方向：药学。联系电话：(010)53852039，E-mail: wmq0406@163.com。
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