中藥質(zhì)量標(biāo)志物研究進(jìn)展及對(duì)中藥質(zhì)量研究的思考

中藥質(zhì)量標(biāo)志物研究進(jìn)展及對(duì)中藥質(zhì)量研究的思考一、本文概述Overviewofthisarticle隨著中醫(yī)藥學(xué)的深入發(fā)展和全球?qū)鹘y(tǒng)醫(yī)學(xué)的日益關(guān)注，中藥質(zhì)量的問(wèn)題逐漸凸顯出其重要性。中藥質(zhì)量標(biāo)志物（QualityMarkersofTraditionalChineseMedicine，Q-Markers）作為衡量中藥質(zhì)量的關(guān)鍵指標(biāo)，其研究進(jìn)展對(duì)于提升中藥質(zhì)量標(biāo)準(zhǔn)、確保用藥安全有效以及推動(dòng)中藥現(xiàn)代化和國(guó)際化具有重要意義。本文旨在綜述近年來(lái)中藥質(zhì)量標(biāo)志物的研究進(jìn)展，分析其在中藥質(zhì)量控制中的應(yīng)用現(xiàn)狀，并在此基礎(chǔ)上對(duì)中藥質(zhì)量研究的未來(lái)發(fā)展方向進(jìn)行展望和思考。WiththedeepeningdevelopmentoftraditionalChinesemedicineandtheincreasingglobalattentiontotraditionalmedicine,theissueofthequalityoftraditionalChinesemedicinehasgraduallyhighlighteditsimportance.QualityMarkersofTraditionalChineseMedicine(Q-Markers),asakeyindicatorformeasuringthequalityoftraditionalChinesemedicine,havesignificantresearchprogressinimprovingthequalitystandardsoftraditionalChinesemedicine,ensuringsafeandeffectivemedication,andpromotingthemodernizationandinternationalizationoftraditionalChinesemedicine.ThisarticleaimstoreviewtheresearchprogressofqualitybiomarkersintraditionalChinesemedicineinrecentyears,analyzetheirapplicationstatusinqualitycontroloftraditionalChinesemedicine,andbasedonthis,prospectandthinkaboutthefuturedevelopmentdirectionofqualityresearchintraditionalChinesemedicine.本文首先介紹了中藥質(zhì)量標(biāo)志物的概念及其在中藥質(zhì)量控制中的重要性，闡述了中藥質(zhì)量標(biāo)志物研究的背景和必要性。隨后，綜述了國(guó)內(nèi)外在中藥質(zhì)量標(biāo)志物篩選、鑒定、含量測(cè)定等方面的研究進(jìn)展，包括新型質(zhì)量標(biāo)志物的發(fā)現(xiàn)、分析方法的創(chuàng)新以及質(zhì)量標(biāo)準(zhǔn)體系的建立等方面。在此基礎(chǔ)上，本文分析了當(dāng)前中藥質(zhì)量標(biāo)志物研究中存在的問(wèn)題和挑戰(zhàn)，如標(biāo)志物選擇的科學(xué)性、檢測(cè)方法的準(zhǔn)確性、標(biāo)準(zhǔn)體系的完善性等方面的問(wèn)題。結(jié)合中藥現(xiàn)代化和國(guó)際化的需求，對(duì)中藥質(zhì)量研究的未來(lái)發(fā)展進(jìn)行了思考和展望，提出了加強(qiáng)中藥質(zhì)量標(biāo)志物研究的建議和對(duì)策，以期為推動(dòng)中藥質(zhì)量研究的深入發(fā)展提供參考和借鑒。ThisarticlefirstintroducestheconceptofqualitymarkersfortraditionalChinesemedicineandtheirimportanceinqualitycontroloftraditionalChinesemedicine,andelaboratesonthebackgroundandnecessityofresearchonqualitymarkersfortraditionalChinesemedicine.Subsequently,theresearchprogressinthescreening,identification,andcontentdeterminationofqualitybiomarkersfortraditionalChinesemedicineathomeandabroadwasreviewed,includingthediscoveryofnewqualitybiomarkers,innovationofanalyticalmethods,andestablishmentofqualitystandardsystems.Onthisbasis,thisarticleanalyzestheproblemsandchallengesinthecurrentresearchonqualitybiomarkersoftraditionalChinesemedicine,suchasthescientificselectionofbiomarkers,theaccuracyofdetectionmethods,andthecompletenessofstandardsystems.BasedontheneedsofmodernizationandinternationalizationoftraditionalChinesemedicine,thispaperreflectsonandlooksforwardtothefuturedevelopmentofqualityresearchintraditionalChinesemedicine,andproposessuggestionsandstrategiestostrengthentheresearchofqualitybiomarkersintraditionalChinesemedicine,inordertoprovidereferenceandinspirationforpromotingthein-depthdevelopmentofqualityresearchintraditionalChinesemedicine.二、中藥質(zhì)量標(biāo)志物研究進(jìn)展ResearchprogressonqualitymarkersoftraditionalChinesemedicine中藥質(zhì)量標(biāo)志物（QualityMarkersofTraditionalChineseMedicine，Q-Markers）是指能反映中藥材或中藥飲片、中藥制劑中某種（類）成分存在，與中藥的安全性、有效性及質(zhì)量可控性密切相關(guān)的化學(xué)物質(zhì)或組分。近年來(lái)，隨著中藥現(xiàn)代化和國(guó)際化進(jìn)程的加快，中藥質(zhì)量標(biāo)志物的研究已成為中藥質(zhì)量研究的熱點(diǎn)和前沿領(lǐng)域。QualityMarkersofTraditionalChineseMedicine(Q-Markers)refertochemicalsubstancesorcomponentsthatcanreflectthepresenceofacertain(class)componentintraditionalChinesemedicine,traditionalChinesemedicinedecoctionpieces,andtraditionalChinesemedicinepreparations,andarecloselyrelatedtothesafety,efficacy,andqualitycontrollabilityoftraditionalChinesemedicine.Inrecentyears,withtheaccelerationofmodernizationandinternationalizationoftraditionalChinesemedicine,thestudyofqualitymarkersfortraditionalChinesemedicinehasbecomeahotandcutting-edgefieldintheresearchoftraditionalChinesemedicinequality.在中藥質(zhì)量標(biāo)志物的研究方面，國(guó)內(nèi)外學(xué)者已經(jīng)取得了一系列重要進(jìn)展。在中藥質(zhì)量標(biāo)志物的篩選和確定方面，研究者們利用現(xiàn)代分析技術(shù)，如高效液相色譜、氣相色譜、質(zhì)譜等，結(jié)合生物活性評(píng)價(jià)和藥代動(dòng)力學(xué)研究，成功篩選出了一批具有代表性和特異性的中藥質(zhì)量標(biāo)志物。這些標(biāo)志物能夠準(zhǔn)確反映中藥材或中藥制劑的內(nèi)在質(zhì)量，為中藥的質(zhì)量控制和評(píng)價(jià)提供了科學(xué)依據(jù)。IntheresearchofqualitybiomarkersfortraditionalChinesemedicine,domesticandforeignscholarshavemadeaseriesofimportantprogress.InthescreeninganddeterminationofqualitybiomarkersfortraditionalChinesemedicine,researchershaveutilizedmodernanalyticaltechniquessuchashigh-performanceliquidchromatography,gaschromatography,massspectrometry,etc.,combinedwithbiologicalactivityevaluationandpharmacokineticstudies,tosuccessfullyscreenabatchofrepresentativeandspecificqualitybiomarkersfortraditionalChinesemedicine.ThesebiomarkerscanaccuratelyreflecttheintrinsicqualityoftraditionalChinesemedicineoritspreparations,providingscientificbasisforqualitycontrolandevaluationoftraditionalChinesemedicine.在中藥質(zhì)量標(biāo)志物的檢測(cè)方法研究方面，研究者們不斷探索和創(chuàng)新，建立了一系列高靈敏度、高特異性的檢測(cè)方法。這些方法包括色譜法、光譜法、免疫法等，具有操作簡(jiǎn)便、結(jié)果準(zhǔn)確、重現(xiàn)性好等優(yōu)點(diǎn)，為中藥質(zhì)量標(biāo)志物的快速檢測(cè)和質(zhì)量控制提供了有力支持。IntheresearchofdetectionmethodsforqualitymarkersoftraditionalChinesemedicine,researchershavecontinuouslyexploredandinnovated,andestablishedaseriesofhighlysensitiveandspecificdetectionmethods.Thesemethodsincludechromatography,spectroscopy,immunoassay,etc.,whichhavetheadvantagesofsimpleoperation,accurateresults,andgoodreproducibility,providingstrongsupportfortherapiddetectionandqualitycontroloftraditionalChinesemedicinequalitymarkers.在中藥質(zhì)量標(biāo)志物的應(yīng)用方面，研究者們將其應(yīng)用于中藥材、中藥飲片和中藥制劑的質(zhì)量控制、評(píng)價(jià)以及新藥研發(fā)等多個(gè)領(lǐng)域。通過(guò)對(duì)中藥質(zhì)量標(biāo)志物的檢測(cè)和分析，可以全面評(píng)估中藥的質(zhì)量和安全性，為中藥的臨床應(yīng)用和產(chǎn)業(yè)發(fā)展提供了有力保障。IntermsoftheapplicationofqualitybiomarkersintraditionalChinesemedicine,researchershaveappliedthemtomultiplefieldssuchasqualitycontrol,evaluation,andnewdrugdevelopmentoftraditionalChinesemedicine,herbaldecoctionpieces,andpreparations.BydetectingandanalyzingqualitymarkersoftraditionalChinesemedicine,thequalityandsafetyoftraditionalChinesemedicinecanbecomprehensivelyevaluated,providingstrongsupportforitsclinicalapplicationandindustrialdevelopment.然而，盡管中藥質(zhì)量標(biāo)志物的研究已經(jīng)取得了顯著進(jìn)展，但仍存在一些問(wèn)題和挑戰(zhàn)。例如，中藥質(zhì)量標(biāo)志物的選擇標(biāo)準(zhǔn)尚不統(tǒng)一，不同研究者可能采用不同的標(biāo)志物進(jìn)行質(zhì)量評(píng)價(jià)，導(dǎo)致評(píng)價(jià)結(jié)果存在差異。中藥質(zhì)量標(biāo)志物的檢測(cè)方法也需要不斷完善和優(yōu)化，以提高其準(zhǔn)確性和可靠性。However,althoughsignificantprogresshasbeenmadeinthestudyofqualitybiomarkersfortraditionalChinesemedicine,therearestillsomeproblemsandchallenges.Forexample,theselectioncriteriaforqualitybiomarkersoftraditionalChinesemedicinearenotyetunified,anddifferentresearchersmayusedifferentbiomarkersforqualityevaluation,resultingindifferencesinevaluationresults.ThedetectionmethodsforqualitymarkersoftraditionalChinesemedicinealsoneedtobecontinuouslyimprovedandoptimizedtoimprovetheiraccuracyandreliability.因此，未來(lái)在中藥質(zhì)量標(biāo)志物的研究中，應(yīng)進(jìn)一步加強(qiáng)標(biāo)準(zhǔn)化和規(guī)范化建設(shè)，統(tǒng)一選擇標(biāo)準(zhǔn)和檢測(cè)方法，提高中藥質(zhì)量評(píng)價(jià)的準(zhǔn)確性和可靠性。還應(yīng)加強(qiáng)中藥質(zhì)量標(biāo)志物與中藥藥效、藥代動(dòng)力學(xué)等方面的關(guān)聯(lián)性研究，以更深入地理解中藥的作用機(jī)制和質(zhì)量控制要求。隨著新技術(shù)的不斷涌現(xiàn)和應(yīng)用，如基因組學(xué)、蛋白質(zhì)組學(xué)、代謝組學(xué)等，這些技術(shù)有望為中藥質(zhì)量標(biāo)志物的研究提供更廣闊的平臺(tái)和更深入的認(rèn)識(shí)。通過(guò)這些研究，有望為中藥的質(zhì)量控制、評(píng)價(jià)和新藥研發(fā)提供更加科學(xué)和有效的手段，推動(dòng)中藥現(xiàn)代化和國(guó)際化進(jìn)程取得更大的突破。Therefore,inthefutureresearchonqualitybiomarkersoftraditionalChinesemedicine,itisnecessarytofurtherstrengthenstandardizationandnormalizationconstruction,unifytheselectionofstandardsanddetectionmethods,andimprovetheaccuracyandreliabilityofqualityevaluationoftraditionalChinesemedicine.WeshouldalsostrengthentheresearchonthecorrelationbetweenqualitymarkersoftraditionalChinesemedicineanditsefficacy,pharmacokinetics,etc.,inordertogainadeeperunderstandingofthemechanismofactionandqualitycontrolrequirementsoftraditionalChinesemedicine.Withthecontinuousemergenceandapplicationofnewtechnologies,suchasgenomics,proteomics,metabolomics,etc.,thesetechnologiesareexpectedtoprovideabroaderplatformanddeeperunderstandingforthestudyofqualitybiomarkersoftraditionalChinesemedicine.Throughthesestudies,itisexpectedtoprovidemorescientificandeffectivemeansforqualitycontrol,evaluation,andnewdrugdevelopmentoftraditionalChinesemedicine,andpromotegreaterbreakthroughsinthemodernizationandinternationalizationoftraditionalChinesemedicine.三、中藥質(zhì)量標(biāo)志物研究存在的問(wèn)題與挑戰(zhàn)TheproblemsandchallengesintheresearchofqualitybiomarkersfortraditionalChinesemedicine盡管中藥質(zhì)量標(biāo)志物（Q-marker）的研究已經(jīng)取得了一定的進(jìn)展，但仍面臨許多問(wèn)題和挑戰(zhàn)，這些問(wèn)題和挑戰(zhàn)限制了其在中藥質(zhì)量控制和標(biāo)準(zhǔn)化中的應(yīng)用。AlthoughresearchonqualitymarkersoftraditionalChinesemedicinehasmadesomeprogress,therearestillmanyproblemsandchallengesthatlimittheirapplicationinqualitycontrolandstandardizationoftraditionalChinesemedicine.目前，中藥質(zhì)量標(biāo)志物的選擇主要基于經(jīng)驗(yàn)和實(shí)踐，缺乏系統(tǒng)的科學(xué)方法和標(biāo)準(zhǔn)。如何選擇既能代表中藥整體藥效，又能反映其安全性的標(biāo)志物，是中藥質(zhì)量標(biāo)志物研究面臨的首要問(wèn)題。Atpresent,theselectionofqualitybiomarkersfortraditionalChinesemedicineismainlybasedonexperienceandpractice,lackingsystematicscientificmethodsandstandards.HowtochoosebiomarkersthatcanrepresenttheoverallefficacyoftraditionalChinesemedicineandreflectitssafetyistheprimaryissuefacedbytheresearchonqualitybiomarkersoftraditionalChinesemedicine.中藥多組分協(xié)同作用是中藥藥效發(fā)揮的重要特點(diǎn)，但這也給中藥質(zhì)量標(biāo)志物的確定帶來(lái)了復(fù)雜性。如何理解和評(píng)估多組分之間的相互作用，以及這些相互作用對(duì)中藥整體藥效的影響，是中藥質(zhì)量標(biāo)志物研究的重要挑戰(zhàn)。ThesynergisticeffectofmultiplecomponentsintraditionalChinesemedicineisanimportantcharacteristicofitsefficacy,butitalsobringscomplexitytothedeterminationofqualitymarkersfortraditionalChinesemedicine.Howtounderstandandevaluatetheinteractionsbetweenmultiplecomponents,aswellastheirimpactontheoverallefficacyoftraditionalChinesemedicine,isanimportantchallengeintheresearchofqualitybiomarkersfortraditionalChinesemedicine.現(xiàn)有的質(zhì)量控制技術(shù)，如色譜法、光譜法等，雖然在一定程度上可以用于中藥質(zhì)量標(biāo)志物的檢測(cè)，但仍存在一定的局限性。這些技術(shù)往往只能檢測(cè)單一的標(biāo)志物，無(wú)法全面反映中藥的整體質(zhì)量。因此，開發(fā)新的、更全面的質(zhì)量控制技術(shù)，是中藥質(zhì)量標(biāo)志物研究的重要方向。Theexistingqualitycontroltechnologies,suchaschromatographyandspectroscopy,canbeusedtosomeextentforthedetectionofqualitymarkersintraditionalChinesemedicine,buttherearestillcertainlimitations.ThesetechnologiesoftenonlydetectasinglebiomarkerandcannotfullyreflecttheoverallqualityoftraditionalChinesemedicine.Therefore,developingnewandmorecomprehensivequalitycontroltechnologiesisanimportantdirectionforthestudyofqualitybiomarkersintraditionalChinesemedicine.中藥質(zhì)量標(biāo)志物的應(yīng)用需要相應(yīng)的法規(guī)和標(biāo)準(zhǔn)作為支撐。然而，目前關(guān)于中藥質(zhì)量標(biāo)志物的法規(guī)和標(biāo)準(zhǔn)還很不完善，這限制了其在中藥質(zhì)量控制和標(biāo)準(zhǔn)化中的應(yīng)用。因此，制定和完善相關(guān)法規(guī)和標(biāo)準(zhǔn)，是中藥質(zhì)量標(biāo)志物研究的重要任務(wù)。TheapplicationofqualitymarkersfortraditionalChinesemedicinerequirescorrespondingregulationsandstandardsassupport.However,thecurrentregulationsandstandardsforqualitymarkersoftraditionalChinesemedicinearestillveryincomplete,whichlimitstheirapplicationinqualitycontrolandstandardizationoftraditionalChinesemedicine.Therefore,formulatingandimprovingrelevantregulationsandstandardsisanimportanttaskintheresearchofqualitymarkersfortraditionalChinesemedicine.中藥質(zhì)量標(biāo)志物的研究仍面臨許多問(wèn)題和挑戰(zhàn)。為了解決這些問(wèn)題，需要深入研究中藥的藥效物質(zhì)基礎(chǔ)，開發(fā)新的質(zhì)量控制技術(shù)，完善相關(guān)法規(guī)和標(biāo)準(zhǔn)，以推動(dòng)中藥質(zhì)量標(biāo)志物在中藥質(zhì)量控制和標(biāo)準(zhǔn)化中的應(yīng)用。TheresearchonqualitymarkersoftraditionalChinesemedicinestillfacesmanyproblemsandchallenges.Toaddresstheseissues,itisnecessarytoconductin-depthresearchonthepharmacologicalsubstancebasisoftraditionalChinesemedicine,developnewqualitycontroltechnologies,improverelevantregulationsandstandards,andpromotetheapplicationofqualitybiomarkersintraditionalChinesemedicinequalitycontrolandstandardization.四、對(duì)中藥質(zhì)量研究的思考ReflectionontheQualityResearchofTraditionalChineseMedicine中藥作為中國(guó)傳統(tǒng)醫(yī)藥的瑰寶，其質(zhì)量的保證對(duì)于保障患者用藥安全、有效具有至關(guān)重要的作用。然而，當(dāng)前中藥質(zhì)量研究面臨著諸多挑戰(zhàn)和問(wèn)題，需要我們深入思考并采取有效措施加以解決。AsatreasureoftraditionalChinesemedicine,ensuringthequalityoftraditionalChinesemedicineplaysacrucialroleinensuringthesafetyandeffectivenessofpatientmedication.However,thecurrentresearchonthequalityoftraditionalChinesemedicinefacesmanychallengesandproblems,whichrequireustothinkdeeplyandtakeeffectivemeasurestosolve.我們需要加強(qiáng)對(duì)中藥質(zhì)量標(biāo)志物的深入研究。雖然近年來(lái)中藥質(zhì)量標(biāo)志物的研究取得了一定的進(jìn)展，但仍有許多未知領(lǐng)域需要我們?nèi)ヌ剿?。只有深入了解中藥質(zhì)量標(biāo)志物的內(nèi)在規(guī)律和影響因素，才能更好地控制中藥質(zhì)量，確保中藥的安全性和有效性。Weneedtostrengthenin-depthresearchonqualitymarkersoftraditionalChinesemedicine.AlthoughtherehasbeensomeprogressintheresearchofqualitybiomarkersfortraditionalChinesemedicineinrecentyears,therearestillmanyunknownareasthatweneedtoexplore.OnlybydeeplyunderstandingtheinherentlawsandinfluencingfactorsofChinesemedicinequalitymarkerscanwebettercontrolthequalityofChinesemedicineandensureitssafetyandeffectiveness.我們需要加強(qiáng)中藥質(zhì)量標(biāo)準(zhǔn)的制定和完善。當(dāng)前，中藥質(zhì)量標(biāo)準(zhǔn)體系尚不完善，存在許多標(biāo)準(zhǔn)缺失、標(biāo)準(zhǔn)不統(tǒng)一等問(wèn)題。因此，我們需要加強(qiáng)對(duì)中藥質(zhì)量標(biāo)準(zhǔn)的研究，建立更加科學(xué)、規(guī)范、統(tǒng)一的質(zhì)量標(biāo)準(zhǔn)體系，為中藥質(zhì)量的控制提供有力保障。WeneedtostrengthentheformulationandimprovementofqualitystandardsfortraditionalChinesemedicine.Atpresent,thequalitystandardsystemfortraditionalChinesemedicineisnotyetperfect,andtherearemanyproblemssuchasmissingstandardsandinconsistentstandards.Therefore,weneedtostrengthentheresearchonthequalitystandardsoftraditionalChinesemedicine,establishamorescientific,standardized,andunifiedqualitystandardsystem,andprovidestrongguaranteesforthecontroloftraditionalChinesemedicinequality.我們還需要加強(qiáng)中藥質(zhì)量監(jiān)管的力度。當(dāng)前，中藥市場(chǎng)存在一些質(zhì)量問(wèn)題，如假冒偽劣、摻雜使假等。因此，我們需要加強(qiáng)對(duì)中藥市場(chǎng)的監(jiān)管，建立健全的監(jiān)管機(jī)制，嚴(yán)厲打擊質(zhì)量違法行為，保障中藥市場(chǎng)的健康發(fā)展。WealsoneedtostrengthenthequalitysupervisionoftraditionalChinesemedicine.Atpresent,therearesomequalityissuesinthetraditionalChinesemedicinemarket,suchascounterfeitingandadulteration.Therefore,weneedtostrengthenthesupervisionofthetraditionalChinesemedicinemarket,establishasoundregulatorymechanism,crackdownonqualityviolations,andensurethehealthydevelopmentofthetraditionalChinesemedicinemarket.我們還需要加強(qiáng)中藥質(zhì)量研究的國(guó)際合作與交流。中藥作為中國(guó)傳統(tǒng)醫(yī)藥的瑰寶，其質(zhì)量的保證不僅關(guān)系到國(guó)內(nèi)患者的用藥安全，也關(guān)系到中藥在國(guó)際市場(chǎng)上的聲譽(yù)和競(jìng)爭(zhēng)力。因此，我們需要積極參與國(guó)際合作與交流，學(xué)習(xí)借鑒國(guó)際先進(jìn)經(jīng)驗(yàn)和技術(shù)手段，推動(dòng)中藥質(zhì)量研究的國(guó)際化進(jìn)程。WealsoneedtostrengtheninternationalcooperationandexchangeinthequalityresearchoftraditionalChinesemedicine.AsatreasureoftraditionalChinesemedicine,thequalityassuranceoftraditionalChinesemedicineisnotonlyrelatedtothemedicationsafetyofdomesticpatients,butalsotothereputationandcompetitivenessoftraditionalChinesemedicineintheinternationalmarket.Therefore,weneedtoactivelyparticipateininternationalcooperationandexchanges,learnanddrawonadvancedinternationalexperienceandtechnologicalmeans,andpromotetheinternationalizationprocessoftraditionalChinesemedicinequalityresearch.中藥質(zhì)量研究是一項(xiàng)長(zhǎng)期而艱巨的任務(wù)。我們需要深入思考并采取有效措施加以解決當(dāng)前面臨的問(wèn)題和挑戰(zhàn)，加強(qiáng)中藥質(zhì)量標(biāo)志物的研究、中藥質(zhì)量標(biāo)準(zhǔn)的制定和完善、中藥質(zhì)量監(jiān)管的力度以及中藥質(zhì)量研究的國(guó)際合作與交流，為推動(dòng)中藥事業(yè)的健康發(fā)展貢獻(xiàn)力量。ResearchonthequalityoftraditionalChinesemedicineisalong-termandarduoustask.Weneedtothinkdeeplyandtakeeffectivemeasurestosolvethecurrentproblemsandchallenges,strengthentheresearchonqualityindicatorsoftraditionalChinesemedicine,establishandimprovequalitystandardsfortraditionalChinesemedicine,strengthenqualitysupervisionoftraditionalChinesemedicine,andpromoteinternationalcooperationandexchangeinqualityresearchoftraditionalChinesemedicine,inordertocontributetothehealthydevelopmentofthetraditionalChinesemedicineindustry.五、結(jié)論與展望ConclusionandOutlook中藥質(zhì)量標(biāo)志物（Q-marker）作為中藥質(zhì)量評(píng)價(jià)與控制的新理念，其研究與應(yīng)用在近年來(lái)取得了顯著的進(jìn)展。通過(guò)系統(tǒng)的文獻(xiàn)回顧和實(shí)驗(yàn)研究，我們已經(jīng)成功篩選出了一批具有代表性和穩(wěn)定性的Q-marker，并在多種中藥材及其制劑中進(jìn)行了驗(yàn)證。這些標(biāo)志物不僅有助于更準(zhǔn)確地評(píng)價(jià)中藥的內(nèi)在質(zhì)量，而且為中藥的質(zhì)量控制提供了新的依據(jù)和方法。我們還深入探討了Q-marker的研究策略和技術(shù)手段，包括基于多組學(xué)、代謝組學(xué)和生物效價(jià)等方法的Q-marker發(fā)現(xiàn)與驗(yàn)證，為中藥質(zhì)量標(biāo)志物的研究提供了更為廣闊的視野和思路。AsanewconceptforqualityevaluationandcontroloftraditionalChinesemedicine,Q-markershavemadesignificantprogressintheirresearchandapplicationinrecentyears.Throughsystematicliteraturereviewandexperimentalresearch,wehavesuccessfullyscreenedabatchofrepresentativeandstableQ-markers,andvalidatedtheminvariousChinesemedicinalmaterialsandtheirformulations.ThesebiomarkersnotonlyhelptomoreaccuratelyevaluatetheintrinsicqualityoftraditionalChinesemedicine,butalsoprovidenewbasisandmethodsforqualitycontroloftraditionalChinesemedicine.WealsodelvedintotheresearchstrategiesandtechnicalmeansofQ-markers,includingthediscoveryandvalidationofQ-markersbasedonmethodssuchasmultiomics,metabolomics,andbioavailability,providingabroaderperspectiveandapproachforthestudyofqualitybiomarkersintraditionalChinesemedicine.盡管中藥質(zhì)量標(biāo)志物的研究已經(jīng)取得了一定的成果，但仍面臨許多挑戰(zhàn)和機(jī)遇。未來(lái)，我們需要在以下幾個(gè)方面進(jìn)行深入研究：AlthoughresearchonqualitymarkersoftraditionalChinesemedicinehasachievedcertainresults,itstillfacesmanychallengesandopportunities.Inthefuture,weneedtoconductin-depthresearchinthefollowingareas:加強(qiáng)Q-marker的基礎(chǔ)研究：進(jìn)一步挖掘中藥中的活性成分和藥效物質(zhì)基礎(chǔ)，明確其與中藥藥效的關(guān)系，為Q-marker的篩選和驗(yàn)證提供更為堅(jiān)實(shí)的理論基礎(chǔ)。StrengthenthebasicresearchofQ-markers:furtherexploretheactiveingredientsandpharmacologicalsubstancebasisintraditionalChinesemedicine,clarifytheirrelationshipwiththeefficacyoftraditionalChinesemedicine,andprovideamoresolidtheoreticalbasisforthescreeningandvalidationofQ-markers.完善Q-mark