本文引用：龙世玉，刘，秀，秦杰峰，王玲兰，任超，刘文龙。利格列汀片的制备及体内外评价[JI.湖南中医药大学学报，2025，45(5)：856-861.

    [关键词]利格列汀片；溶出曲线；原研制剂；生物等效；高效液相色谱法 [中图分类号]R927 [文献标志码]A [文章编号]doi：10.3969/j.issn.1674-070X.2025.05.010

    [Abstract]Objective To developa generic linagliptintablet with consistentin vitro dissolutionandinvivo bioequivalence tothereferencepreparationMethodsLinagliptintabletswereprepared.Ahighperformanceliquidchromatography(HPLC)-based invitrodisslution testingmethodwasestablishedtodeterminethecumulativedisolutionofboththetestandthereference preparationsinfourmedia：pH1Ohydrochloricacidsolution，pH4.5sodiumacetatebufer，pH6.8potassiumdihydrogen phosphatebuffr，andwater.Thedissolutionsimilaritybetweenthepreparationswasassessedusingthemodel-independent approach ( I₂ similarity factor).Concurrentlyasingle-dose，two-preparation，two-sequence，two-periodcrossverpharmacokinetic studywasconductedinhealthyadultsubjects，withbloodconcentrationsoflinagliptinmeasuredunderfastingandhighfatpostmeal conditions.Pharmacokineticparameters werecalculatedResultsThecumulativedisolutionprofilesofthetestandreference preparationsweresimilarinallfourdissolutionmediaPharmacokineticanalysisrevealedthatunderbothfastingandfed conditions ......