Article(id=1236344970647490854, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236344966058931117, 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=1658764800000, acceptedDateStr=2022-07-26, onlineDate=1772697211181, onlineDateStr=2026-03-05, pubDate=1678809600000, pubDateStr=2023-03-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772697211181, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772697211181, creator=13701087609, updateTime=1772697211181, updator=13701087609, issue=Issue{id=1236344966058931117, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='5', pageStart='441', pageEnd='552', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772697210087, creator=13701087609, updateTime=1772697640190, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236346770087793082, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236344966058931117, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236346770087793083, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236344966058931117, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=522, endPage=530, ext={EN=ArticleExt(id=1236344970941092149, articleId=1236344970647490854, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Pharmacokinetics of two components of Jinzhen oral liquid in rats, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To evaluate the pharmacokinetic characteristics of Jinzhen oral liquid and compare the difference of the absorption and metabolism after single and multiple administrations in rats.
Methods: An ultra-high performance liquid chromatography coupled to triple-stage quadrupole mass spectrometer (UPLC-TSQ-MS) was applied to established the method for simultaneous determination of baicalin and wogonoside in rat plasma. Healthy rats were administered a single dose (3.228, 6.456, and 12.912 g·kg-1) and multiple dose (6.456 g·kg-1) of Jinzhen oral liquid (crude drug) by oral gavage. The content of target components in plasma at different time points was determined, and the pharmacokinetic parameters were calculated using the non-compartmental model.
Results: The two components in the plasma sample have good linear relation (r>0.99). RSDs of their extraction recovery rate and matrix effect are both <15%, the intra- and inter-batch precision and accuracy, and stability meet the requirements of biological sample analysis. After single administration of Jinzhen oral liquid, the areas under the concentration-time curve AUC(0-t) of baicalin and wogonoside show a good positive correlation with dose (R2>0.9), and their t1/2z and CLz/F have no significant difference at different doses. Compared with a single administration, their absorption and metabolism process are basically the same, and their AUC(0-t) and t1/2z have no significant difference after multiple administration.
Conclusion: A stable and reliable UPLC-TSQ-MS quantitative method for baicalin and wogonoside was established. And two components of Jinzhen oral liquid show linear dynamics characteristics in rats between 3.228 and 12.912 g·kg-1 (crude drug), and there is no accumulation after multiple administrations, revealing the rationality of the clinical dosage of the preparation.
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目的: 评估金振口服液单次和多次服用后药动学特征和吸收代谢差异。
方法: 运用超高效液相色谱-三重四级杆质谱联用(UPLC-TSQ-MS)技术,建立同时定量大鼠血浆中黄芩苷和汉黄芩苷的分析方法。将健康大鼠分别按3.228,6.456,12.912 g生药量·kg-1单次灌胃(ig)和按6.456 g生药量·kg-1多次ig金振口服液,测定不同时间血浆中待测成分含量,运用非房室模型计算药动学参数。
结果: 血浆样品中2种成分的线性关系良好(r>0.995),提取回收率和基质效应的RSD均<15%,批内、批间的精密度和准确度以及稳定性均符合生物样品分析要求。大鼠单次给药后,黄芩苷和汉黄芩苷的AUC0-t均与剂量呈良好的正相关性,且不同剂量下t1/2z和清除率(CLz/F)无显著变化;与单次给药相比,多次给药后大鼠的吸收代谢过程基本相同、AUC0-t和t1/2z差异无统计学意义。
结论: 本研究建立了稳定可靠的黄芩苷和汉黄芩苷UPLC-TSQ-MS定量方法,在3.228~12.912 g生药量·kg-1范围内金振口服液中2种成分在体内呈现线性动力学的特征,多次给药后无蓄积现象,揭示该制剂临床剂量的合理性。
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1江苏康缘药业股份有限公司,连云港 222001
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高霞,女,硕士,主要从事药物分析、药动学研究。E-mail: gaoxia0218@163.com。
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高霞,女,硕士,主要从事药物分析、药动学研究。E-mail: gaoxia0218@163.com。
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1Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China
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1江苏康缘药业股份有限公司,连云港 222001
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1Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China
2State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236344972421681540, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236344970647490854, authorId=1236344972178411901, language=CN, stringName=王佳佳, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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1江苏康缘药业股份有限公司,连云港 222001
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1Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China
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1江苏康缘药业股份有限公司,连云港 222001
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1, 2, address=
1Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China
2State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236344972954358175, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236344970647490854, authorId=1236344972794974616, language=CN, stringName=钱梦雨, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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