Article(id=1236346466134978639, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236346464578891843, 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=1655654400000, acceptedDateStr=2022-06-20, onlineDate=1772697567732, onlineDateStr=2026-03-05, pubDate=1684080000000, pubDateStr=2023-05-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772697567732, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772697567732, creator=13701087609, updateTime=1772697567732, updator=13701087609, issue=Issue{id=1236346464578891843, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='9', pageStart='865', pageEnd='968', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772697567361, creator=13701087609, updateTime=1772697682369, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236346947028701631, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236346464578891843, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236346947028701632, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236346464578891843, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=955, endPage=960, ext={EN=ArticleExt(id=1236346466407608409, articleId=1236346466134978639, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Study on quality standard of Xianqian Granules, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To establish the quality standard of Xianqian Granules.
Methods: According to the relevant methods presented in the fourth general rules of Pharmacopoeia of the People's Republic of China (2020), TLC method for identifying 4 Chinese medicinal materials in Xianqian Granules, including Agrimoniae Herba, Rubiae Radix et Rhizoma, Paeoniae Radix Rubra, and Notoginseng Radix et Rhizoma, was established, as well as the HPLC method for determining the index components of purpurin and paeoniflorin in Xianqian Granules.
Results: The TLC method was specific to identify the 4 medicinal materials effectively. In the quantitative analysis method, the mass concentrations of purpurin and paeoniflorin were linear in the ranges of 2.47~53.00 μg·mL-1 and 18.29~392.0 μg·mL-1, respectively. The average recoveries were 97.37% (RSD 1.44%) and 99.04% (RSD 0.82%), respectively.
Conclusion: The established methods for quality evaluation of Xianqian Granules are simple, accurate, and specific, which can be used for the quality control for Xianqian Granules.
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方法: 参照《中华人民共和国药典》2020年版四部通则相关方法,建立鉴别仙茜颗粒中仙鹤草、茜草、赤芍、三七4味饮片的TLC法;建立分析仙茜颗粒中羟基茜草素和芍药苷含量的HPLC法。
结果: TLC法能有效鉴别方中4味饮片;定量分析方法中,羟基茜草素、芍药苷质量浓度分别在2.47~53.00,18.29~392.0 μg·mL-1范围内线性关系良好,平均加样回收率分别为97.37%(RSD为1.44%)、99.04%(RSD为0.82%)。
结论: 建立的质量标准简便准确、专属性强,可用于仙茜颗粒的质量控制。
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