Article(id=1236334170335670346, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236334167978472434, 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=1671638400000, acceptedDateStr=2022-12-22, onlineDate=1772694636185, onlineDateStr=2026-03-05, pubDate=1689350400000, pubDateStr=2023-07-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772694636185, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772694636185, creator=13701087609, updateTime=1772694636185, updator=13701087609, issue=Issue{id=1236334167978472434, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='13', pageStart='1281', pageEnd='1384', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=0, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772694635624, creator=13701087609, updateTime=1772696111905, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236340360004292707, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236334167978472434, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236340360004292708, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236334167978472434, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1315, endPage=1324, ext={EN=ArticleExt(id=1236334171010953339, articleId=1236334170335670346, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Comparison of the dissolution profiles of quetiapine fumarate tablets from different manufacturers in five dissolution medias, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To compare the in vitro dissolution profiles of quetiapine fumarate tablets from different sources, in order to provide reference for the evaluation of quality consistency.
Methods: The solvents used in this study were 0.01 mol·L-1 hydrochloric acid, 0.1 mol·L-1 hydrochloric acid, pH 4.5 acetate buffer, pH 6.8 phosphate buffer and water, respectively, with the volume of 900 mL. The paddle method was applied at the rotation speed of 50 r·min-1. The content of quetiapine fumarate was determined by HPLC. The cumulative dissolution was calculated and the dissolution curves were obtained. Similarity factor (f2) method was used to evaluate the similarity of dissolution profiles.
Results: Among the reference preparations from 5 different sources, the cumulative dissolutions in 15 min were all above 85% or the similarity factors (f2) greater than 50. The dissolution curves were similar and the dissolution behaviors were consistent. Among the domestic generic preparations from 5 different sources, product from manufacturer B in 0.1 mol·L-1 hydrochloric acid, products of 100 mg and 200 mg from manufacturer A in pH 6.8 phosphate buffer, the f2 were less than 50, which are not similar to the reference. The other batches have similar dissolution profiles to the reference preparations, thus their dissolution behavior are consistent.
Conclusion: The dissolution profiles of reference preparations from different sources are similar, and the dissolution behaviors are consistent. However, in a dissolution medium not specified in the pharmacopoeia of quetiapine fumarate tablets, a few domestic generic preparations from different sources have dissimilar dissolution profiles and inconsistent dissolution behaviors. In order to make a comprehensive assessment of the consistency of quetiapine fumarate tablets, the specific bioequivalence experiments and other indicators of pharmacy still needs to be integrated for the reference and domestic generic preparations from different sources.
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目的： 通过比较不同来源的富马酸喹硫平片的体外溶出曲线，为其质量一致性评价提供参考。
方法： 以0.01 mol·L-1盐酸、0.1 mol·L-1盐酸、pH 4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液和水分别作为溶出介质，体积为900 mL，采用桨法，转速为50 r·min-1，进行富马酸喹硫平片的溶出考察，采用HPLC法测定富马酸喹硫平的含量，并计算累积溶出量，绘制溶出曲线，采用相似因子（f2）法评价溶出曲线的相似性。
结果： 不同来源参比制剂在5种溶出介质中，15 min累积溶出量均≥85%或f2均>50，溶出曲线相似，溶出行为一致。不同来源国产仿制制剂在5种溶出介质中，厂家B在0.1 mol·L-1盐酸介质中、厂家A生产的100和200 mg规格在pH 6.8磷酸盐缓冲液介质中，与原研进口参比制剂相比， f2<50，溶出曲线存在不相似的情况。其余批次溶出曲线相似，溶出行为一致。
结论： 不同来源的参比制剂溶出曲线相似，溶出行为均一致；少数国产仿制制剂与原研进口参比制剂在非药典溶出度检查项目规定的溶出介质中存在溶出行为不完全一致的情况，仍需结合具体的生物等效性试验以及其他药学指标进行一致性的全面评估。
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1National Institute for Food and Drug Control, Beijing 100050, China
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1中国食品药品检定研究院，北京 100050
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汪路楠，女，硕士研究生，主要从事药物质量与过程控制方向的研究。E-mail: wwwanglunan@163.com。
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马玲云，女，副研究员，主要从事药品质量研究。联系电话：(010)67095875，E-mail: mlyun@nifdc.org.cn。
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马玲云，女，副研究员，主要从事药品质量研究。联系电话：(010)67095875，E-mail: mlyun@nifdc.org.cn。
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