生物评价在中药质量标准化中的研究与应用-肖小河

—★〔WorldScienceandTechnology/ModernizationofTraditionalChineseMedicineandMateriaMedica〕收稿日期：2014-02-21修回日期：2014-03-18＊国家自然科学基金委面上项目（81274026）：“道地指数”的构建及其在中药材品质评控中的应用研究，负责人：肖小河；国家自然科学基金委青年科学项目（81322052）：中药质量评价，负责人：鄢丹。＊＊通讯作者：肖小河，本刊编委，博士生导师，主要研究方向：面向临床的中药标准化。肖小河＊＊，王伽伯，鄢丹302/100039生物评价是中药质量标准与临床功效和安全性评价的重要手段和途径，已成为中药质量标准化发展的重要方向之一。本文论述了中药质量生物评价研究的必要性、可行性和已取得的主要研究进展，同时探讨了目前中药质量生物评价研究与应用中存在的主要问题，以供同行参考与商榷。：中药质量标准化生物评价研究进展doi:10.11842/wst.2014.03.011中图分类号：R284.1文献标识码：A。、。、。、、。1DNARAPD、DNA。[1]。、、、[2~4]。。。、、[5]。“”“”。、。、、。、、。2010《》“”[6]2015《》、。5142014★Vol.16No.3〔WorldScienceandTechnology/ModernizationofTraditionalChineseMedicineandMateriaMedica〕2、。、、、。。Bio-responsePro－fileBio-activityFingerprint[7,8]。。。、、、、、、、[9]。3、。。3.1药效物质不清的中药质量评控、[10,11][12][13][14]“”。3.2“有毒”中药的质量与安全性控制[15]。3、。、、。、[16]。3.3中药材道地性与商品规格等级的生物评价“”。、。3[17][18]。。3.4名贵中药的质量评控与代用品开发、、、[19~21]COX-2。、、/。、、[22,23]515—★〔WorldScienceandTechnology/ModernizationofTraditionalChineseMedicineandMateriaMedica〕、、。3.5中药注射剂质量评控与临床合理用药的应用3.5.1中药注射剂质量一致性与稳定性的生物监测、、[24]。。3.5.2基于生物热动力学表征的中西药注射剂无菌快速检测、、。。[25]14~1724h1CFU。3.5.3基于化学热动力学表征的中西药注射剂无菌快速检测。。[26]、[27][28]。4[9]4.1忽视中药质量生物评价方法与化学和常规检验方法的有机结合。“”。、。4.2忽视中药质量生物评价的药物分析属性，将中药质量生物评价等同于药理药效评价。2.2.15。2.2.152.2.152.2.15。4.3忽视生物评价自身的方法学特点，以理化检定的方法学质量苛求中药生物评价方法、、、、。4.3.1关于指标的专属性。。。4.3.2关于指标的代表性5162014★Vol.16No.3〔WorldScienceandTechnology/ModernizationofTraditionalChineseMedicineandMateriaMedica〕、。。。1~2、。4.3.3关于检验误差±5%±30%。。。。。、、--。、。5“”。。IntegrativeQualityConcept[29]--Con－trolofQuality-effect-quantityIntegrationforCHM[30]Effect-constituteIndexofCHMECI[31]、DaodiQualityIndexDQI[32]“”[33]。1,,,.DNA.-,2011,13(5)∶747~754.2..:,2005∶11.3..,2001,17(1)∶1~2.4,,.“”.,2010,26(5)∶158~161.5,,,..,2007,32(14)∶1377~1382.6.().:,2010.7LiJX,YanD,MaLN,etal.AqualityevaluationstrategyforRhizomacoptidisfromavarietyofdifferentsourcesusingchromato－graphicfingerprintingcombinedwithbiologicalfingerprinting.ChinSciBull,2013,58(33)∶4092~4100.8RobertT,AnthonyAP,GuanJQ,etal.Acomprehensiveplatformforqualitycontrolofbotanicaldrugs(PhytomicsQC):acasestudyofHuangqinTang(HQT)andPHY906.ChinMed,2010,5(1)∶30~45.9,,,..517—★〔WorldScienceandTechnology/ModernizationofTraditionalChineseMedicineandMateriaMedica〕-,2009,11(4)∶504~508.10,,,..,2009,44(2)∶162~166.11,,,..,2009,29(4)∶908~912.12,,,..,2010,45(4)∶479~483.13WeiL,JinC,LiY,etal.MethodologicalresearchonthequalityevaluationofRadixIsatidisbasedonantibacterialpotency.WorldScienceandTechnology,2008,10(2)∶33~36.14,,,..,2011,46(4)∶438~442.15,,旸,..CN103352069A,2013-07-03.16,,,..,2009,44(5)∶500~505.17,,,..,2011,42(9)∶1779~1782.18YanD,HanYM,etal.ForensicDNAbarcodingandbio-re－sponsestudiesofanimalhornproductsusedintraditionalmedicine.PLoSOne,2013,8(2)∶e55854.19KongWJ,WangJB,ZangQC,etal.Anovel“targetcon－stituentknock-out”strategycoupledwithTLC,UPLC-ELSDandmicrocalorimetryforpreliminaryscreeningofantibacterialcon－stituentsinCalculusbovis.JChromatogrBAnalytTechnolBiomedLiftSci,2011,879(30)∶3565~3573.20,,,..,2009,44(6)∶640~644.21,,,..,2006,26(7)∶628.22LuoJY,YanD,SongJY,etal.Astrategyfortrademonitoringandsubstitutionoftheorgansofthreatenedanimals.ScientificReports,2013,3∶3108.23QinY,WangJB,ZhaoYL,etal.EstablishmentofabioassayforthetoxicityevaluationandqualitycontrolofAconitumherbs.JHazardMater,2012,199(15)∶350~357.24RenYS,ZhangP,YanD,etal.AstrategyforthedetectionofqualityfluctuationofaChineseherbalinjectionbasedonchemicalfingerprintingcombinedwithbiologicalfingerprinting.JPharmBiomedAnal,2011,56(2)∶436~442.25TanMR,RenYS,YanD,etal.Detectionofmicroorganismsindifferentgrowthstatesbasedonmicrocalorimetry.JThermAnalCalorim,2012,109(2)∶1069~1075.26,,,.,2008,24(3)∶63~65.27,,,.()—、.,2002,25(6)∶409~411.28,,,..,2005,11(10)∶782~784.29,,,..,2010,41(4)∶505~508.30,,,..-,2010,12(4)∶617~622.31,,,.:.,2014,45(1)∶1~7.32,,,.“”.,2012,37(11)∶1513~1516.33,,,.:.,2012,43(1)∶1~8.StudiesandApplicationofBiologicalEvaluationintheQualityStandardizationofChineseMedicinesXiaoXiaohe,WangJiabo,YanDan(MilitaryInstituteofChineseMateriaMedica,302MilitaryHospitalofChina,Beijing100039,China)Abstract:BiologicalevaluationisacriticalapproachbywhichthequalitystandardizationoftraditionalChinesemedicinescanbelinkedtotheclinicalefficacyandsafety,whichhasbecomeanimportantaspectinthedevelop-mentofqualitystandardizationofChinesemedicines.Inthisarticle,thenecessityandfeasibilityofthebiologicale-valuationresearchwereanalyzed.Further,themainprogressachievedaswellasthemajorproblemsaboutthere-searchandapplicationsofthebiologicalevaluationoftraditionalChinesemedicineswerediscussed,tobringforwardapointforconsiderationordiscussion.Keywords:Chinesemedicines,qualitystandardization,biologicalevaluation,researchprogress（责任编辑：叶丽萍张志华，责任译审：王）518