Article(id=1236696516623134768, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236696515473895464, 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=1655568000000, acceptedDateStr=2022-06-19, onlineDate=1772781026273, onlineDateStr=2026-03-06, pubDate=1673712000000, pubDateStr=2023-01-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772781026273, onlineIssueDateStr=2026-03-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772781026273, creator=13701087609, updateTime=1772781026273, updator=13701087609, issue=Issue{id=1236696515473895464, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='1', pageStart='1', pageEnd='109', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772781025999, creator=13701087609, updateTime=1772782685740, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236703476982542786, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236696515473895464, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236703476982542787, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236696515473895464, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=65, endPage=71, ext={EN=ArticleExt(id=1236696516837044280, articleId=1236696516623134768, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Analysis on the factors affecting the whiteness about pharmaceutical excipient talc, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Objective: To study the factors affecting the whiteness of talc and the relationship between them. Methods: The content of metal elements, particle size and particle size distribution, which affect the whiteness of talc, were measured, and the main factors were speculated by principal component analysis (PCA). The linear regression model was established by SPSS. Results: Using PCA analysis, it is speculated that the main factors are the content of impurity metal calcium and particle size D₉₀. The established linear regression model is: Whiteness=96.457+42.770×Calcium% -0.422×D₉₀, with R² of 0.944 and Adjusted R² of 0.934 (P<0.05). The model was successfully constructed. Conclusion: The whiteness of pharmaceutical excipient talc is affected by its impurity metal calcium content and particle size D₉₀. The established whiteness correlation regression model provides a theoretical basis for whiteness as a visual quantity to control the particle size and impurity metal calcium content in talc production process and preparation. This study also provides a new idea for the study of the characteristics and quality attributes of pharmaceutical excipient talc.

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目的：研究影响药用辅料滑石粉白度的因素及其之间的关系分析。方法：首先对可能影响药用辅料滑石粉白度的因素（金属元素含量、粒度和粒度分布）进行测定，随后对测定结果进行主成分分析（PCA）推测主要因素，最后通过SPSS建立线性回归模型进行验证。结果：经PCA分析推测主要因素为杂质金属钙含量以及粒度D₉₀；建立的线性回归模型为：白度=96.457+42.770×钙%-0.422×D₉₀。其中R²为0.944，调整R2为0.934，P<0.05，模型构建有意义。结论：药用辅料滑石粉的白度由自身的杂质金属钙含量与粒度D₉₀共同影响，建立白度相关回归模型，为白度作为可视化量值用来控制滑石粉生产工艺与制剂中的粒度及杂质金属钙含量提供理论依据，也为药用辅料滑石粉的特性质量属性研究提供一种新思路。

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²National Institutes for Food and Drug Control, Beijing 100050, China
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²中国食品药品检定研究院，北京 100050
³北华大学药学院，吉林 132013, bio={"content":"

王会娟，女，硕士研究生，研究方向：药物化学和药用辅料质量控制。E-mail: huijuanW1205@163.com。

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王会娟，女，硕士研究生，研究方向：药物化学和药用辅料质量控制。E-mail: huijuanW1205@163.com。

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杨锐，男，副研究员，研究方向：药用辅料质量控制。E-mail: yangruiinchina@126.com。

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杨锐，男，副研究员，研究方向：药用辅料质量控制。E-mail: yangruiinchina@126.com。

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