Article(id=1291404338497314965, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404284806030089, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.04.018, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1721923200000, receivedDateStr=2024-07-26, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824387429, onlineDateStr=2026-08-04, pubDate=1740672000000, pubDateStr=2025-02-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824387429, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824387429, creator=13701087609, updateTime=1785824387429, updator=13701087609, issue=Issue{id=1291404284806030089, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='4', pageStart='451', pageEnd='600', issueExtLink='null', onlineDate='null', pubDate='1740672000000', pubDateStr='2025-02-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824374629, creator='13701087609', updateTime=1785897184019, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291709669605663367, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404284806030089, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291709669605663368, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404284806030089, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=538, endPage=542, ext={EN=ArticleExt(id=1291404338665087126, articleId=1291404338497314965, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Bioequivalence study of bromhexine hydrochloride granules and fine granules in healthy Chinese subjects, columnId=1246531407389020354, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Pharmacokinetics and Bioequivalence Study, runingTitle=null, highlight=null, articleAbstract=
Objective To evaluate the bioequivalence of domestic bromhexine hydrochloride granules and imported bromhexine hydrochloride fine granules in Chinese healthy subjects under fasting and fed states.
Methods A single-center, randomized, open-label, fasting and fed single-dose, two-preparation, two-sequence, and two-period crossover study design was used. Forty-eight Chinese healthy subjects were enrolled in fasting and fed trial, respectively. A random crossover, single-dose of bromhexine hydrochloride granules 0.4 g(containing 8 mg bromhexine) or bromhexine hydrochloride fine granules 0.4 g (containing 8 mg bromhexine) were orally given to subjects. Blood samples were collected at different time points, and plasma concentrations of bromhexine were measured by high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Phoenix WinNonlin 8.3 software was used for data analysis.
Results In the fasting group, the main pharmacokinetic parameters of bromhexine in plasma after taking the test and reference preparations: Cmax were (18.29±7.80) and (19.92±10.23) ng·mL-1, AUC0-t were (31.52±12.23) and (32.22±12.32) ng·h·mL-1, AUC0-∞ were (34.43±13.60) and (34.84±13.36) ng·h·mL-1, respectively. In the fed group, the main pharmacokinetic parameters of bromhexine in plasma after taking the test and reference preparations: Cmax were (12.55±6.27) and (12.64±6.51) ng·mL-1, AUC0-t were (58.86±24.38) and (60.60±26.44) ng·h·mL-1, AUC0-∞ were (68.27±30.76) and (94.01±113.13) ng·h·mL-1, respectively. The 90% confidence intervals of the geometric mean ratio of the two preparations in fasting group: Cmax was 88.79%-101.49%, AUC0-t was 93.69%-102.15%, AUC0-∞ was 94.59%-102.95%; in fed group: Cmax was 93.08%-106.82%, AUC0-t was 94.30%-102.80%, AUC0-∞ was 92.97%-103.89%.
Conclusions In this study, the test preparation bromhexine hydrochloride granules and the reference preparation bromhexine hydrochloride fine granules were bioequivalent in healthy Chinese subjects.
, authors=Feng-li ZHAO
1, Pan-pan SHI
1, Xiao-jue LIU
1, Lin YANG
1, Song ZHANG
2, Dui-liang ZHANG
2, Wei-guo XU
2, Wen-chao ZHOU
2, authorsList=Feng-li ZHAO, Pan-pan SHI, Xiao-jue LIU, Lin YANG, Song ZHANG, Dui-liang ZHANG, Wei-guo XU, Wen-chao ZHOU, authorCompany=null, correspAuthors=Feng-li ZHAO, 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=1291404338983854231, articleId=1291404338497314965, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=盐酸溴己新颗粒与盐酸溴己新细粒在中国健康受试者中的生物等效性研究, 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 评价国产盐酸溴己新颗粒剂和进口盐酸溴己新细粒剂在中国健康受试者中空腹和餐后状态下的生物等效性。
方法 用单中心、随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉研究设计，空腹与餐后试验各纳入中国健康受试者48例，随机交叉单次口服盐酸溴己新颗粒0.4 g（含溴己新8 mg）或盐酸溴己新细粒0.4 g（含溴己新8 mg），按时间点采血后，用高效液相色谱-质谱联用（HPLC-MS/MS）法进行血药浓度检测，用Phoenix WinNonlin 8.3进行数据分析，评价生物等效性。
结果 空腹组受试者服用受试制剂和参比制剂后，血浆中溴己新主要药代动力学参数：Cmax分别为（18.29±7.80）和（19.92±10.23）ng·mL-1，AUC0-t分别为（31.52±12.23）和（32.22±12.32）ng·h·mL-1，AUC0-∞分别为（34.43±13.60）和（34.84±13.36）ng·h·mL-1。餐后组受试者服用受试制剂和参比制剂后，血浆中溴己新主要药代动力学参数：Cmax分别为（12.55±6.27）和（12.64±6.51）ng·mL-1，AUC0-t分别为（58.86±24.38）和（60.60±26.44）ng·h·mL-1，AUC0-∞分别为（68.27±30.76）和（94.01±113.13）ng·h·mL-1。空腹组受试制剂与参比制剂Cmax、AUC0-t、AUC0-∞的几何均值比的90%置信区间分别为88.79%~101.49%、93.69%~102.15%、94.59%~102.95%；餐后组分别为93.08%~106.82%、94.30%~102.80%、92.97%~103.89%。
结论 本研究中受试制剂盐酸溴己新颗粒和参比制剂盐酸溴己新细粒在中国健康受试者中具有生物等效性。
, authors=赵丰丽
1, 石盼盼
1, 刘晓珏
1, 杨琳
1, 张嵩
2, 张对良
2, 徐卫国
2, 周文超
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赵丰丽（1985-），女，副主任医师，主要从事仿制药生物等效性研究和新药I期临床试验
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