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Article(id=1292126502213149582, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.02.011, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1758988800000, receivedDateStr=2025-09-28, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996564676, onlineDateStr=2026-08-06, pubDate=1769529600000, pubDateStr=2026-01-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996564676, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996564676, creator=13701087609, updateTime=1785996564676, updator=13701087609, issue=Issue{id=1292126409196064779, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='2', pageStart='151', pageEnd='300', issueExtLink='null', onlineDate='null', pubDate='1769529600000', pubDateStr='2026-01-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996542500, creator='13701087609', updateTime=1786014671444, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292202447569707674, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292202447569707675, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=219, endPage=223, ext={EN=ArticleExt(id=1292126502401893263, articleId=1292126502213149582, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Population pharmacokinetic study of amoxicillin and clavulanate potassium tablets in healthy Chinese subjects, columnId=1246531407389020354, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Pharmacokinetics and Bioequivalence Study, runingTitle=null, highlight=null, articleAbstract=
Objective

To establish a population pharmacokinetic model of amoxicillin and clavulanate potassium tablets in healthy Chinese subjects under fasting condition.

Methods

Based on the previously confirmed bioequivalence results, this study retrospectively collected the plasma concentration data of 18 subjects who received the test preparation and 17 subjects who received the reference preparation. The population pharmacokinetic model of amoxicillin was constructed using Phoenix NLME software. The effects of covariates such as gender, age, albumin, serum creatinine, creatine kinase, fasting blood glucose, and total cholesterol on pharmacokinetics were evaluated by forward inclusion and backward elimination methods. Model validation included goodness-of-fit plots, bootstrap method, and visual predictive check (VPC).

Results

The population pharmacokinetic model of amoxicillin in healthy subjects conformed to a two-compartment model with first-order elimination kinetics and lag time, which could well describe the data. Serum creatinine and body mass index (BMI) were significant covariates. The parameters of the final model were as follows: central volume of distribution (V)=51.56 L, peripheral volume of distribution (V2)=7.65 L; clearance (CL)=39.99 L·h-1, intercompartmental clearance (CL2)=1.78 L·h-1, absorption rate constant (Ka)=1.45 h-1. Serum creatinine had an impact on CL2 and Ka, while BMI affected V.

Conclusion

The two-compartment model with first-order elimination kinetics and lag time can better describe the in vivo absorption characteristics of amoxicillin after oral administration of amoxicillin and clavulanate potassium tablets in healthy subjects.

, authors=Wei-ya HUO1, 2, Shuo SHI1, 2, Xin XU3, Wan-jun BAI1, 2, authorsList=Wei-ya HUO, Shuo SHI, Xin XU, Wan-jun BAI, authorCompany=null, correspAuthors=Wan-jun BAI, 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=1292126502674523024, articleId=1292126502213149582, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=阿莫西林克拉维酸钾片在中国健康人体中群体药代动力学研究, columnId=1246531407988805834, journalTitle=中国临床药理学杂志, columnName=药代动力学与生物等效性研究, runingTitle=null, highlight=null, articleAbstract=
目的

构建阿莫西林克拉维酸钾片（amoxicillin and clavulanate potassium tablets）在中国健康人群中空腹状态下的群体药代动力学模型。

方法

本研究基于前期已证实的生物等效性结论，通过回顾性收集18例服用受试制剂和17例服用参比制剂患者的血药浓度数据，借助Phoenix NLME软件构建阿莫西林的群体药代动力学模型，通过向前纳入法和向后剔除法，考察性别、年龄、白蛋白、血清肌酐、肌酸激酶、空腹血糖、总胆固醇等指标对药代动力学的影响。模型验证包括拟合优度图、自举法、可视化检验（VPC）。

结果

阿莫西林在健康人群中的群体药动学数据可以较好地被具有吸收滞后时间的一级消除动力学二房室模型描述，血清肌酐、BMI值是显著的协变量。最终模型中心室分布容积（V）值为51.56 L，周边室分布容积（V2）为7.65 L；CL值为39.99 L·h-1，CL2值为1.78 L·h-1，Ka值为1.45 h-1，高血清肌酐的患者CL2更低，而高血清肌酐的患者Ka更高，高BMI患者V则更高。

结论

具有滞后时间的一级消除动力学二房室模型，更好地描述了健康人体口服阿莫西林克拉维酸钾片的体内吸收特征。

, authors=霍卫亚1, 2, 石硕1, 2, 徐馨3, 白万军1, 2, authorsList=霍卫亚, 石硕, 徐馨, 白万军, authorCompany=null, correspAuthors=白万军, authorNote=

霍卫亚（1990-），女，硕士研究生，从事临床药学研究

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白万军，副主任药师，硕士生导师 MP: 15833997197 E-mail:
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霍卫亚（1990-），女，硕士研究生，从事临床药学研究

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阿莫西林克拉维酸钾片在中国健康人体中群体药代动力学研究
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霍卫亚 1, 2 , 石硕 1, 2 , 徐馨 3 , 白万军 1, 2
中国临床药理学杂志 | 药代动力学与生物等效性研究 2026,42(2): 219-223
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中国临床药理学杂志 |药代动力学与生物等效性研究 2026 , 42 (2) : 219 -223
阿莫西林克拉维酸钾片在中国健康人体中群体药代动力学研究
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霍卫亚1, 2, 石硕1, 2, 徐馨3, 白万军1, 2
作者信息
  • 1.河北医科大学 药学院，河北 石家庄 050017
  • 2.河北省人民医院 药学部，河北省临床药学重点实验室，河北 石家庄 050051
  • 3.河北省人民医院，河北 石家庄 050051
通讯作者:
白万军，副主任药师，硕士生导师 MP: 15833997197 E-mail:
作者简介:

霍卫亚（1990-），女，硕士研究生，从事临床药学研究

Population pharmacokinetic study of amoxicillin and clavulanate potassium tablets in healthy Chinese subjects
Wei-ya HUO1, 2, Shuo SHI1, 2, Xin XU3, Wan-jun BAI1, 2
Affiliations
  • 1.School of Pharmacy, Hebei Medical University, Shijiazhuang 050017, Hebei Province, China
  • 2.Department of Pharmacy, Hebei General Hospital; Hebei Key Laboratory of Clinical Pharmacy, Shijiazhuang 050051, Hebei Province, China
  • 3.School of Medicine, Hexi University, Zhangye 734000, Gansu Province, China
出版时间: 2026-01-28 doi: 10.13699/j.cnki.1001-6821.2026.02.011
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摘要
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目的

构建阿莫西林克拉维酸钾片（amoxicillin and clavulanate potassium tablets）在中国健康人群中空腹状态下的群体药代动力学模型。

方法

本研究基于前期已证实的生物等效性结论，通过回顾性收集18例服用受试制剂和17例服用参比制剂患者的血药浓度数据，借助Phoenix NLME软件构建阿莫西林的群体药代动力学模型，通过向前纳入法和向后剔除法，考察性别、年龄、白蛋白、血清肌酐、肌酸激酶、空腹血糖、总胆固醇等指标对药代动力学的影响。模型验证包括拟合优度图、自举法、可视化检验（VPC）。

结果

阿莫西林在健康人群中的群体药动学数据可以较好地被具有吸收滞后时间的一级消除动力学二房室模型描述，血清肌酐、BMI值是显著的协变量。最终模型中心室分布容积（V）值为51.56 L，周边室分布容积（V2）为7.65 L；CL值为39.99 L·h-1，CL2值为1.78 L·h-1，Ka值为1.45 h-1，高血清肌酐的患者CL2更低，而高血清肌酐的患者Ka更高，高BMI患者V则更高。

结论

具有滞后时间的一级消除动力学二房室模型，更好地描述了健康人体口服阿莫西林克拉维酸钾片的体内吸收特征。

阿莫西林克拉维酸钾  /  群体药代动力学模型  /  协变量  /  血清肌酐
Objective

To establish a population pharmacokinetic model of amoxicillin and clavulanate potassium tablets in healthy Chinese subjects under fasting condition.

Methods

Based on the previously confirmed bioequivalence results, this study retrospectively collected the plasma concentration data of 18 subjects who received the test preparation and 17 subjects who received the reference preparation. The population pharmacokinetic model of amoxicillin was constructed using Phoenix NLME software. The effects of covariates such as gender, age, albumin, serum creatinine, creatine kinase, fasting blood glucose, and total cholesterol on pharmacokinetics were evaluated by forward inclusion and backward elimination methods. Model validation included goodness-of-fit plots, bootstrap method, and visual predictive check (VPC).

Results

The population pharmacokinetic model of amoxicillin in healthy subjects conformed to a two-compartment model with first-order elimination kinetics and lag time, which could well describe the data. Serum creatinine and body mass index (BMI) were significant covariates. The parameters of the final model were as follows: central volume of distribution (V)=51.56 L, peripheral volume of distribution (V2)=7.65 L; clearance (CL)=39.99 L·h-1, intercompartmental clearance (CL2)=1.78 L·h-1, absorption rate constant (Ka)=1.45 h-1. Serum creatinine had an impact on CL2 and Ka, while BMI affected V.

Conclusion

The two-compartment model with first-order elimination kinetics and lag time can better describe the in vivo absorption characteristics of amoxicillin after oral administration of amoxicillin and clavulanate potassium tablets in healthy subjects.

amoxicillin and clavulanate potassium  /  population pharmacokinetic model  /  covariate  /  serum creatinine
霍卫亚, 石硕, 徐馨, 白万军. 阿莫西林克拉维酸钾片在中国健康人体中群体药代动力学研究. 中国临床药理学杂志, 2026 , 42 (2) : 219 -223 . DOI: 10.13699/j.cnki.1001-6821.2026.02.011
Wei-ya HUO, Shuo SHI, Xin XU, Wan-jun BAI. Population pharmacokinetic study of amoxicillin and clavulanate potassium tablets in healthy Chinese subjects[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (2) : 219 -223 . DOI: 10.13699/j.cnki.1001-6821.2026.02.011
基金
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  • 政府资助临床医学优秀人才培养项目(202218)
  • 河北省医学适用技术跟踪项目(GZ2022007)
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2026年第42卷第2期
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doi: 10.13699/j.cnki.1001-6821.2026.02.011
  • 接收时间：2025-09-28
  • 首发时间：2026-08-06
  • 出版时间：2026-01-28
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出版历史
  • 收稿日期：2025-09-28
基金
政府资助临床医学优秀人才培养项目(202218)
河北省医学适用技术跟踪项目(GZ2022007)
作者信息
    1.河北医科大学 药学院，河北 石家庄 050017
    2.河北省人民医院 药学部，河北省临床药学重点实验室，河北 石家庄 050051
    3.河北省人民医院，河北 石家庄 050051

通讯作者:

白万军，副主任药师，硕士生导师 MP: 15833997197 E-mail:
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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2026.02.011
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2种不同金属材料的力学参数
科
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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