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《基于藥材基原-物質(zhì)基礎(chǔ)-質(zhì)量標(biāo)志物-質(zhì)控方法層級遞進(jìn)的中藥質(zhì)量標(biāo)準(zhǔn)模式研究》由會員上傳分享,免費(fèi)在線閱讀,更多相關(guān)內(nèi)容在學(xué)術(shù)論文-天天文庫。
1、屮草藥2016,23(47),4127-4133DOI:10.7501/j.issn.0253-2670.2016.23.001基于“藥材基原-物質(zhì)基礎(chǔ)-質(zhì)量標(biāo)志物-質(zhì)控方法”層級遞進(jìn)的中藥質(zhì)量標(biāo)準(zhǔn)模式研宄江振作王躍飛天津中醫(yī)藥大學(xué)天津市現(xiàn)代中藥重點(diǎn)實驗室天津國際生物醫(yī)藥聯(lián)合研宄院中藥新藥研發(fā)中心導(dǎo)出/參考文獻(xiàn)關(guān)注分享收藏打印摘要:中藥質(zhì)量控制是保證中藥臨床用藥安全性和有效性的重要措施,也是制約中藥現(xiàn)代化進(jìn)程的瓶頸。針對當(dāng)前中藥質(zhì)量標(biāo)準(zhǔn)評價模式,從中藥真?zhèn)舞b別和優(yōu)劣評價兩方面綜述現(xiàn)階段屮藥質(zhì)量控制方法的研宄策略,闡述屮藥質(zhì)量標(biāo)準(zhǔn)研究現(xiàn)狀,探討中藥質(zhì)量
2、標(biāo)準(zhǔn)的發(fā)展趨勢。提出以“藥材基原為基礎(chǔ)、物質(zhì)基礎(chǔ)研究為支撐,質(zhì)量標(biāo)志物(Q-markers)辨析為核心,質(zhì)控方法為手段”的中藥質(zhì)量控制新模式。基于正品藥材,深入研宄物質(zhì)基礎(chǔ),辨析Q-markers,構(gòu)建質(zhì)控方法,控制中藥質(zhì)量,制定符合屮藥特色的質(zhì)量控制標(biāo)準(zhǔn)。關(guān)鍵詞:中藥;質(zhì)量標(biāo)準(zhǔn);藥材基原;物質(zhì)基礎(chǔ);質(zhì)量標(biāo)忠物(Q-markers);質(zhì)控方法;作者簡介:江振作,碩士,主要從事中藥物質(zhì)基礎(chǔ)和質(zhì)量控制研究。Tel:(022)27386453E-mai1:zhenzuojiang@hotmai1.com作者簡介:王躍飛,副研究員,碩士生導(dǎo)師,主要從事中藥質(zhì)
3、量控制和腸道微生物研究。Tel:(022)27386453E~mai1:wangyuefei2006@hotmail.com收稿日期:2015-06-18基金:重大新藥創(chuàng)制科技重大專項(2014ZX09304307-001-005)ApatternofhierarchicalprogressionforqualitystandardofChinesemateriamedicabasedon“herbalorigin-materialbasis-qualitymarkers-qualitycontrolmethod”IANGZhen-zuoWANGYu
4、e-feiTianjinStateKeyLaboratoryofModernChineseMedicine,TianjinUniversityofTraditionalChineseMedicine;Abstract:QualitycontrolofChinesemateriamedica(CMM)isaneffectivemeasuretoensurethesafetyandeffectivenessofCMMinclinicalpractice,whichisalsoabottlenecktorestrictthemodernizationpro
5、cessofCMM.RegardingthecurrentqualityevaluationmodelofCMM,wereviewedtheresearchstrategicsofqualitycontrolforCMMatthepresentstagefromtheperspectivesof“discriminationofauthenticity”and“assessmentofsuperiority”tostatetheresearchstatusanddevelopmenttendencyofqualitystandardofCMM.Wha
6、t’smore,weputforwardanewqualitycontrolpatternofCMMbasedon“identificationofherbalorigin,studyonmaterialbasis,discriminationofqualitymarkers(Q-markers),anddevelopmentofqualitycontrolmethod”.Anin-depthstudyofmaterialbasisbasedonauthenticCMMwasimplementedtodiscriminate“Q-markers”,a
7、ndfurtherdevelopedaqualitycontrolmethodtocontrolthequalityofCMM.Finally,aqualitycontrolstandardhasbeenestablishedtomeetthecharacteristicofCMM.Keyword:Chinesemateriamedica;qualitystandard;herbalorigin;materialbasis;qualitymarkers(Q-markers):methodofqualitycontrol:Received:2015-0
8、6-18中藥的真假優(yōu)劣直接影響臨床用藥的安全性和有效性,其質(zhì)量控制和評價是中藥現(xiàn)代化發(fā)展的關(guān)鍵科學(xué)問題14^