Article(id=1261728973009110009, tenantId=1146029695717560320, journalId=1146119944283992078, issueId=1261728796072358112, 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=null, acceptedDateStr=null, onlineDate=1778749228956, onlineDateStr=2026-05-14, pubDate=1774195200000, pubDateStr=2026-03-23, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1778749228956, onlineIssueDateStr=2026-05-14, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1778749228956, creator=13701087609, updateTime=1778749228956, updator=13701087609, issue=Issue{id=1261728796072358112, tenantId=1146029695717560320, journalId=1146119944283992078, year='2026', volume='4', issue='6', pageStart='1', pageEnd='234', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=1, specialIssue=null, createTime=1778749186771, creator=13701087609, updateTime=1778750183088, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1261732975067148479, tenantId=1146029695717560320, journalId=1146119944283992078, issueId=1261728796072358112, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1261732975071342784, tenantId=1146029695717560320, journalId=1146119944283992078, issueId=1261728796072358112, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=161, endPage=163, ext={CN=ArticleExt(id=1261728974015741957, articleId=1261728973009110009, tenantId=1146029695717560320, journalId=1146119944283992078, language=CN, title=无水磷酸氢钙粒径对产品性能的影响及标准优化研究, columnId=1152194692738331642, journalTitle=实验室检测, columnName=聚焦话题, runingTitle=null, highlight=null, articleAbstract=
目的 探究无水磷酸氢钙粒径分布对其关键产品性能的影响规律，评估现有粒径检测标准的适用性并提出优化方向。
方法 采用激光衍射法与干湿法、筛分法并行测定不同批次样品的粒径分布参数（D10, D50, D90）；系统考察粒径对休止角（流动性）、粉末压缩成型抗压强度及模拟体液溶出速率的影响；通过多组独立实验（n≥3）获取重复性数据，采用单因素方差分析及Pearson相关性检验进行统计学处理。
结果 激光衍射法测得中位径（D50）为15~45 μm，筛分法显示>75 μm颗粒占比随工艺变化显著（P<0.001）；D50增大至45μm时，休止角由41.5°±1.2°显著降低至27.8°±0.9° （P<0.01），流动性提升约33%；D50减小至15 μm时，片剂抗压强度由（112.7±5.1） N提升至（152.4±6.3） N，增幅达35.2%（P<0.001）；两种粒径检测方法在D90以上区间差异显著（r2=0.83），激光衍射法对小粒径分辨率更优。
结论 粒径是影响无水磷酸氢钙功能特性的核心变量，需建立以D50为核心、兼顾粒度分布跨度（Span）的多维质量标准；推荐激光衍射法作为主检手段，辅以特定孔径筛分法监控粗颗粒；优化目标应平衡流动性与溶出需求，建议将D50控制在20~40 μm范围并限制超大颗粒（>100 μm）比例。
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