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Article(id=1321425601756508823, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.07.012, 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=1762963200000, acceptedDateStr=2025-11-13, onlineDate=1792982014358, onlineDateStr=2026-10-26, pubDate=1776182400000, pubDateStr=2026-04-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982014358, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982014358, creator=13701087609, updateTime=1792982014358, updator=13701087609, issue=Issue{id=1321425569611362746, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='7', pageStart='673', pageEnd='784', issueExtLink='null', onlineDate='null', pubDate='1776182400000', pubDateStr='2026-04-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982006695, creator='13701087609', updateTime=1792983136833, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321430309837587328, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321430309837587329, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=754, endPage=763, ext={EN=ArticleExt(id=1321425601966224025, articleId=1321425601756508823, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Bioavailability study of five components of Yinqiao Qingre tablets in rats, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To evaluate the in vivo dynamic change patterns and bioavailability of 5 main components in Yinqiao Qingre tablets in rat plasma.

Methods:

A UPLC-TQ-MS method was established and validated for the simultaneous quantification of the 5 components in plasma. Rats were randomly divided into three groups: Group 1 was given Yinqiao Qingre tablets by intragastric administration (ig) at a dose of 0.153 7 g·kg-1 crude drug; Group 2 was given a mixed solution of the 5 components at the same concentration as that in the first group via ig; gGroup 3 was intravenously injected (via tail vein) with the mixed solution of the 5 components at a dose of 1 mg·kg-1. Plasma concentrations of the 5 components at different time points were determined. Pharmacokinetic parameters were calculated using a non-compartmental model, and absolute and relative bioavailability values were further computed.

Results:

The specificity of the 5 components analysis methods in plasma was good, the linear relationship was good (r>0.99), the extraction recovery and matrix effect RSD were less than 15%, and the precision, accuracy and stability within and between batches met the requirements. The average peak time (Tmax) of the five components was 0.083~1.35 h, and the terminal elimination half-life (t1/2) was less than 4 h. Moreover, the compound preparation could prolong the elimination half-life and in vivo residence time of the components. The absolute bioavailabilities of chlorogenic acid, puerarin, isoferulic acid, caffeic acid, and ferulic acid were 0.84%, 1.50%, 45.17%, 23.82%, and 32.97%, respectively, while their relative bioavailabilities were all relatively high (ranging from 82% to 94%).

Conclusion:

The established analytical method for plasma samples is rapid, stable, and accurate. Yinqiao Qingre tablets can be rapidly absorbed into the blood after oral administration, with isoferulic acid showing the highest plasma exposure and absolute bioavailability. The compatibility of the compound preparation is beneficial for the full exertion of therapeutic effects, and has little impact on the absolute bioavailability of the 5 components.

, authors=Yu-rong TAN1, 2, Ming-ke YIN1, 2, Jian FENG1, 2, Xia-lin CHEN1, 2, Dong-hui WANG1, 2, Jia-jia WANG1, 2, Liang CAO1, 2, Zhen-zhong WANG1, 2, Wei XIAO1, 2, *, Xia GAO1, 2, *, authorsList=Yu-rong TAN, Ming-ke YIN, Jian FENG, Xia-lin CHEN, Dong-hui WANG, Jia-jia WANG, Liang CAO, Zhen-zhong WANG, Wei XIAO, Xia GAO, authorCompany=null, correspAuthors=Wei XIAO, Xia GAO, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1321425602276602522, articleId=1321425601756508823, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=银翘清热片中5种成分在大鼠体内的生物利用度研究, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的：

评估银翘清热片中5种主要成分在大鼠血浆中动态变化规律与生物利用度。

方法：

应用超高效液相色谱-三重四极杆质谱联用法（UPLC-TQ-MS）建立并验证血浆中5种成分同时定量的分析方法。大鼠随机分为3组，第1组按0.153 7 g生药量·kg-1 ig给予银翘清热片，第2组ig给予与第1组等浓度的5种成分混合溶液，第3组按照1 mg·kg-1于尾iv 5种成分混合溶液，测定不同时间点大鼠血浆中5种成分的浓度，运用非房室模型计算药动学参数并计算绝对生物利用度与相对生物利用度。

结果：

血浆中5种成分分析方法专属性良好，线性关系良好（r>0.99），提取回收率与基质效应RSD<15%，批内、批间精密度和准确度以及稳定性均符合要求。复方给药后5种成分平均达峰时间为0.083~1.35 h，消除半衰期均小于4 h，且复方能够延长成分的消除半衰期和体内驻留时间。绿原酸、葛根素、异阿魏酸、咖啡酸、阿魏酸的绝对生物利用度分别为0.84%、1.50%、45.17%、23.82%、32.97%，相对生物利用度均较高（82%~94%）。

结论：

本研究建立的血浆样品分析方法快速、稳定、准确。银翘清热片口服后可快速吸收入血，异阿魏酸的血浆暴露量与绝对生物利用度最大。其复方配伍有利于疗效充分发挥，对5种成分的绝对生物利用度影响较小。

, authors=谭玉蓉1, 2, 尹铭钶1, 2, 冯健1, 2, 陈夏霖1, 2, 王冬慧1, 2, 王佳佳1, 2, 曹亮1, 2, 王振中1, 2, 肖伟1, 2, *, 高霞1, 2, *, authorsList=谭玉蓉, 尹铭钶, 冯健, 陈夏霖, 王冬慧, 王佳佳, 曹亮, 王振中, 肖伟, 高霞, authorCompany=null, correspAuthors=肖伟, 高霞, authorNote=

谭玉蓉，女，硕士，主要从事药物分析研究。E-mail: 。

, correspAuthorsNote=
* 肖伟，男，教授，博士生导师，主要从事中药新药研发及过程质量控制研究。联系电话：（0518）81522367，E-mail: 。
* 高霞，女，硕士，副主任药师，主要从事中药化学成分和药动学研究。E-mail: 。
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谭玉蓉，女，硕士，主要从事药物分析研究。E-mail: 。

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银翘清热片中5种成分在大鼠体内的生物利用度研究
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谭玉蓉 1, 2 , 尹铭钶 1, 2 , 冯健 1, 2 , 陈夏霖 1, 2 , 王冬慧 1, 2 , 王佳佳 1, 2 , 曹亮 1, 2 , 王振中 1, 2 , 肖伟 1, 2, * , 高霞 1, 2, *
中国新药杂志 | 实验研究 2026,35(7): 754-763
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中国新药杂志 |实验研究 2026 , 35 (7) : 754 -763
银翘清热片中5种成分在大鼠体内的生物利用度研究
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谭玉蓉1, 2 , 尹铭钶1, 2, 冯健1, 2, 陈夏霖1, 2, 王冬慧1, 2, 王佳佳1, 2, 曹亮1, 2, 王振中1, 2, 肖伟1, 2, * , 高霞1, 2, *
作者信息
  • 1江苏康缘药业股份有限公司/南京中医药大学中药制药过程控制与智能制造技术全国重点实验室，南京 211112
  • 2江苏康缘药业股份有限公司，连云港 222001
通讯作者:
* 肖伟，男，教授，博士生导师，主要从事中药新药研发及过程质量控制研究。联系电话：（0518）81522367，E-mail: 。
* 高霞，女，硕士，副主任药师，主要从事中药化学成分和药动学研究。E-mail: 。
作者简介:

谭玉蓉，女，硕士，主要从事药物分析研究。E-mail: 。

Bioavailability study of five components of Yinqiao Qingre tablets in rats
Yu-rong TAN1, 2 , Ming-ke YIN1, 2, Jian FENG1, 2, Xia-lin CHEN1, 2, Dong-hui WANG1, 2, Jia-jia WANG1, 2, Liang CAO1, 2, Zhen-zhong WANG1, 2, Wei XIAO1, 2, * , Xia GAO1, 2, *
Affiliations
  • 1State Key Laboratory of Technologies for Chinese Medicine Pharmaceutical Process Control and Intelligent Manufacture, Jiangsu Kanion Pharmaceutical Co., Ltd. & Nanjing University of Chinese Medicine, Nanjing 211112, China
  • 2Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China
出版时间: 2026-04-15 doi: 10.20251/j.cnki.1003-3734.2026.07.012
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摘要
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目的：

评估银翘清热片中5种主要成分在大鼠血浆中动态变化规律与生物利用度。

方法：

应用超高效液相色谱-三重四极杆质谱联用法（UPLC-TQ-MS）建立并验证血浆中5种成分同时定量的分析方法。大鼠随机分为3组，第1组按0.153 7 g生药量·kg-1 ig给予银翘清热片，第2组ig给予与第1组等浓度的5种成分混合溶液，第3组按照1 mg·kg-1于尾iv 5种成分混合溶液，测定不同时间点大鼠血浆中5种成分的浓度，运用非房室模型计算药动学参数并计算绝对生物利用度与相对生物利用度。

结果：

血浆中5种成分分析方法专属性良好，线性关系良好（r>0.99），提取回收率与基质效应RSD<15%，批内、批间精密度和准确度以及稳定性均符合要求。复方给药后5种成分平均达峰时间为0.083~1.35 h，消除半衰期均小于4 h，且复方能够延长成分的消除半衰期和体内驻留时间。绿原酸、葛根素、异阿魏酸、咖啡酸、阿魏酸的绝对生物利用度分别为0.84%、1.50%、45.17%、23.82%、32.97%，相对生物利用度均较高（82%~94%）。

结论：

本研究建立的血浆样品分析方法快速、稳定、准确。银翘清热片口服后可快速吸收入血，异阿魏酸的血浆暴露量与绝对生物利用度最大。其复方配伍有利于疗效充分发挥，对5种成分的绝对生物利用度影响较小。

银翘清热片  /  超高效液相色谱-三重四极杆质谱联用法  /  生物利用度  /  血浆暴露量  /  药动学
Objective:

To evaluate the in vivo dynamic change patterns and bioavailability of 5 main components in Yinqiao Qingre tablets in rat plasma.

Methods:

A UPLC-TQ-MS method was established and validated for the simultaneous quantification of the 5 components in plasma. Rats were randomly divided into three groups: Group 1 was given Yinqiao Qingre tablets by intragastric administration (ig) at a dose of 0.153 7 g·kg-1 crude drug; Group 2 was given a mixed solution of the 5 components at the same concentration as that in the first group via ig; gGroup 3 was intravenously injected (via tail vein) with the mixed solution of the 5 components at a dose of 1 mg·kg-1. Plasma concentrations of the 5 components at different time points were determined. Pharmacokinetic parameters were calculated using a non-compartmental model, and absolute and relative bioavailability values were further computed.

Results:

The specificity of the 5 components analysis methods in plasma was good, the linear relationship was good (r>0.99), the extraction recovery and matrix effect RSD were less than 15%, and the precision, accuracy and stability within and between batches met the requirements. The average peak time (Tmax) of the five components was 0.083~1.35 h, and the terminal elimination half-life (t1/2) was less than 4 h. Moreover, the compound preparation could prolong the elimination half-life and in vivo residence time of the components. The absolute bioavailabilities of chlorogenic acid, puerarin, isoferulic acid, caffeic acid, and ferulic acid were 0.84%, 1.50%, 45.17%, 23.82%, and 32.97%, respectively, while their relative bioavailabilities were all relatively high (ranging from 82% to 94%).

Conclusion:

The established analytical method for plasma samples is rapid, stable, and accurate. Yinqiao Qingre tablets can be rapidly absorbed into the blood after oral administration, with isoferulic acid showing the highest plasma exposure and absolute bioavailability. The compatibility of the compound preparation is beneficial for the full exertion of therapeutic effects, and has little impact on the absolute bioavailability of the 5 components.

Yinqiao Qingre tablets  /  UPLC-TQ-MS  /  bioavailability  /  plasma exposure  /  pharmacokinetics
谭玉蓉, 尹铭钶, 冯健, 陈夏霖, 王冬慧, 王佳佳, 曹亮, 王振中, 肖伟, 高霞. 银翘清热片中5种成分在大鼠体内的生物利用度研究. 中国新药杂志, 2026 , 35 (7) : 754 -763 . DOI: 10.20251/j.cnki.1003-3734.2026.07.012
Yu-rong TAN, Ming-ke YIN, Jian FENG, Xia-lin CHEN, Dong-hui WANG, Jia-jia WANG, Liang CAO, Zhen-zhong WANG, Wei XIAO, Xia GAO. Bioavailability study of five components of Yinqiao Qingre tablets in rats[J]. Chinese Journal of New Drugs, 2026 , 35 (7) : 754 -763 . DOI: 10.20251/j.cnki.1003-3734.2026.07.012
基金
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  • 江苏省基础研究计划自然科学基金——前沿引领技术基础研究专项资助项目(BK20232014)
  • 中药制药过程控制与智能制造技术全国重点实验室定向课题资助项目(SKL2023D01003)
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2026年第35卷第7期
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doi: 10.20251/j.cnki.1003-3734.2026.07.012
  • 首发时间：2026-10-26
  • 出版时间：2026-04-15
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  • 录用日期：2025-11-13
基金
江苏省基础研究计划自然科学基金——前沿引领技术基础研究专项资助项目(BK20232014)
中药制药过程控制与智能制造技术全国重点实验室定向课题资助项目(SKL2023D01003)
作者信息
    1江苏康缘药业股份有限公司/南京中医药大学中药制药过程控制与智能制造技术全国重点实验室，南京 211112
    2江苏康缘药业股份有限公司，连云港 222001

通讯作者:

* 肖伟，男，教授，博士生导师，主要从事中药新药研发及过程质量控制研究。联系电话：（0518）81522367，E-mail: 。
* 高霞，女，硕士，副主任药师，主要从事中药化学成分和药动学研究。E-mail: 。
参考文献
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https://castjournals.cast.org.cn/joweb/zgxyzz/CN/10.20251/j.cnki.1003-3734.2026.07.012
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2种不同金属材料的力学参数
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Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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