2011年2月ChineseJournalofExperimentalTraditionalMedicalFormulaeFeb.,2011·文献研究·中药配方颗粒研究进展(Ⅱ———中药单煎与合煎对比研究概况崔景朝*,赵自明(广东省中医研究所,广州510095[摘要]目的:概述中药单煎与合煎对比研究的现况。方法:检索万方数据、维普资讯和中国知网(CNKI三大全文数据库,对去重后的中药单煎与合煎文献进行系统分析。结果:中药单合煎对比研究主要包括化学成分、药效和临床疗效3个方面,涉及单味中药、药对和复方,一种或多种指标性成分或有效成分,一种或多种药理效应和疾病种类,单合煎化学成分各有增减、效应各有强弱,临床效应各有大小,单合煎化学成分差异的机制十分复杂、影响因素众多,在药物代谢、药效和临床应用上有所异同。结论:以若干有效成分、药理效应指标或疾病的疗效为指标进行中药单合煎对比研究,不能全面反映中药单合煎的优劣,单合煎有效成分(尤其是指标性成分种类与数量上的差异,无法推论出药效的强弱和适应症的差异,需进行中药单合煎化学-药动-药效/毒理-临床联合研究;中药单合煎对比研究方法在传统汤剂和配方颗粒优劣性的应用缺乏论证依据,不同剂型药物应进行药理等效性、生物等效性或临床非劣/优效性研究,现有文献体现了上述发展趋势。[关键词]单煎;合煎;中药;对比;进展[中图分类号]R24[文献标识码]A[文章编号]1005-9903(201104-0240-06ProgressofChineseMedicinalDispensingGranule(Ⅱ———SurveyonComparativeStudiesbetweenSingle-decoctionandMixed-decoctionofChineseMedicineCUIJing-chao,ZHAOZi-ming(GuangdongProvincialInstituteofTraditionalChineseMedicine,Guangzhou510095,China[Abstract]Objective:Tooverviewthecomparativestudiesbetweensingle-decoctionandmixed-decoctionofChinesemedicine.Method:Theliteratureswhichcomparativestudiedthesimilaritiesanddifferencesbetweensin-gle-andmixed-decoctionofthechinesemedicinecollectedbyWangfangdata,VIPinformationandCNKIin2001-2010wereanalized.Result:Thecomparativestudiesbetweensingle-andmixed-decoctionofChineseMedicinere-latedmainlytofiveareas:chemicalcomposition,pharmacokinetics,pharmacodynamicsandclinicalefficacy,themedicineincludingsingleherbs,drugpairsandcompounds,therelatedchemicalcompositionincludedtheindexcomponentsandtheeffectivecomponents,oneormorepharmacologicaleffectsandthediseaseswereobserved;andthechemicalcompositions,effectsandclinicaleffectincreasedanddecreasedbothinsingle-andmixed-decoction,themechanismsandrelatedfactorsofthedifferentchemicalcompositionsinsingle-andmixed-decoctionareverycomplicated,drugmetabolism,efficacyandclinicalapplicationshowbothsimilaritiesanddifferencestoo.Conclu-sion:Usingsomequantitativeactiveingredients,pharmacologicaleffectsorefficacyfortreatingdiseases,thecom-parativeevaluationbetweensingle-andmixed-decoctionisinsufficient.Thecomparativestudiesonsingle-andmixed-decoctionofChinesemedicineisnotsuitableforevaluationthetraditionaldecoctionandtheChinesemedicinedispensinggranule.Thedifferentformulationsofdrugsshouldbeevaluatedbythepharmacologicalequivalence,[收稿日期]2010-09-06[通讯作者]*崔景朝,主任中药师,研究方向:中药药理,Tel:020-********,E-mail:zzm740103@163.combioequivalenceorclinicalnon-inferiority/superiorityresearches,thecurrentresearchreflectsthesetrends.[Keywords]single-decoction;mixed-decoction;Chinesemedicine;comparation;progress近年来,中药配方颗粒生产所引发的中药单煎与合煎的争议一直持续不断,而中药单煎与合煎间的异同性研究则成为共同关注的核心问题,并针对这个问题进行了大量的研究工作,本文就中药单煎与合煎化学、药效与临床方面的研究进行综述、分析与讨论。1中药单煎与合煎化学成分对比研究1.1指标性成分或有效性成分含量对比研究此方面研究较多,在成分数量(单一成分...