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1、復(fù)方五仁醇膠囊保肝作用實(shí)驗(yàn)及臨床探究作者:朱浩然竇志華羅琳張兵李民達(dá)坤林【摘要】目的考察復(fù)方五仁醇膠囊對(duì)損傷肝細(xì)胞的保護(hù)作用及對(duì)慢性肝炎的治療效果。方法以SD大鼠為供體制備復(fù)方五仁醇膠囊含藥血清,CC14誘導(dǎo)大鼠原代培養(yǎng)肝細(xì)胞損傷模型,采用血清藥理學(xué)方法考察含藥血清對(duì)損傷肝細(xì)胞增值(MTT法)和培養(yǎng)上清液中丙氨酸氨基轉(zhuǎn)移酶(ALT)的影響;將446例慢性乙型肝炎患者隨機(jī)分成治療組和對(duì)照組,以臨床癥狀、體征、肝功能為主要指標(biāo),考察復(fù)方五仁醇膠囊的治療效果。結(jié)果與模型組比較,含藥血清組MTT值明顯升高,上清液中ALT均顯著下降,體系中加入10%含藥血
2、清效果最佳;治療組、對(duì)照組臨床癥狀、體征及肝功能指標(biāo)均明顯得到改善,復(fù)方五仁醇膠囊的療效優(yōu)于陽(yáng)性對(duì)照藥護(hù)肝片。結(jié)論復(fù)方五仁醇膠囊對(duì)肝細(xì)胞損傷具有明顯保護(hù)作用,對(duì)慢性肝炎有較好治療作用?!娟P(guān)鍵詞】復(fù)方五仁醇膠囊;保肝作用;血清藥理學(xué);臨床觀察Abstroct:ObjectiveToinvestigatetheprotectiveeffectoftheCompoundWurenchunCapsula(CWC)oninjuredhepatocytepatientswithchronichepatitis.MethodsHepatocyteinjurym
3、odelwasinducedbyCC14andtheinjuredhepatocyteswereincubatedwithratserumobtainedafteroraladministrationofCWC?Thehepatocyteproliferationrate(MTT)andalanineaminotransferase(ALT)concentrationincellculturemediumweredetermined.446patientswithchronichepatitisweredividedintoexperimenta
4、lgroup(treatedbyCWC)andcontrolgroup(treatedbyHuGanTablets,HGT)randomly.Withphysicalsign,symptomandhepaticfunctionasmainindices,thetherapeuticeffectofCWConpatientswithchronichepatitiswasevaluated.ResuItsSerumcontainingdrugcouldelevateMTTincrementanddepressALTsignificantly,with
5、thebesteffectataconcentrationof10%?Physicalsign,symptomandliverfunctionofpatientsinexperimentalandcontrolgroupswereallimprovedaftertreatment,andthetherapeuticeffectofCWCwassurpassedtheoneofHGT.ConclusionCWChasanobviousprotectiveeffectoninjuredhepatocyteandpossessesanexactlyth
6、erapeuticeffectforchronichepatitis.Keywords:CompoundWurenchunCapsula(CWC);Liver-protectiveeffect;Serumpharmacology;Clinicalobservation復(fù)方五仁醇膠囊是我院經(jīng)過(guò)長(zhǎng)期臨床實(shí)踐總結(jié)而研制的科研制劑(批準(zhǔn)文號(hào):蘇藥制字Z04001984),處方由五味子、柴胡、葉下珠、三七4味中藥組成,具有清熱解毒、疏肝活血、補(bǔ)益肝腎作用[1]。初步研究結(jié)果表明,該制劑能改善慢性肝炎患者癥狀和體征、降低血清轉(zhuǎn)氨酶[2]o為了進(jìn)一步深化開(kāi)發(fā)和
7、推廣應(yīng)用,近年來(lái)我們?cè)谑∈卸囗?xiàng)科研計(jì)劃的資助下對(duì)復(fù)方五仁醇膠囊進(jìn)行了藥效物質(zhì)基礎(chǔ)、作用機(jī)理、質(zhì)量控制標(biāo)準(zhǔn)等較為全面的研究[3?8]?,F(xiàn)將有關(guān)藥效及臨床擴(kuò)大研究的結(jié)果報(bào)道如下。1資料與方法1.1實(shí)驗(yàn)研究1.1.1材料SD大鼠[SPF級(jí),體重(230±19.8)g,早乞兼用,南通大學(xué)實(shí)驗(yàn)動(dòng)物中心提供,許可證號(hào)SYKXC蘇)2002-0022];釋乙基哌嗪乙磺酸(HEPES,香港FARC0公司,批號(hào)L0024LJ0101M21);乙二醇雙(2-氨基乙瞇)四乙酸(EGTA,美國(guó)AMRESC0公司分裝,批號(hào)0732);膠原酶IV(美國(guó)Sigma公司分裝,批
8、號(hào)0406);胰蛋白酶(美國(guó)Sigma公司分裝,批號(hào)030702);DMEM培養(yǎng)基(美國(guó)GIBC0公司,批號(hào)1255136);新西蘭新生