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1、怡欣乐口服液安全性评价及升高外周血白细胞的实验研究作者：伍趣京，石世德，周民伟【摘要】目的研究中药制剂怡欣乐口服液(YXL)的安全性评价和升高外周白细胞的作用机制。方法按照新药审批办法有关规定，分别运用小鼠和大鼠进行了YXL急性和长期毒性实验;分别采用环磷酰胺、苯中毒及60Co-γ辐射等因素诱发小鼠外周血白细胞总数低下运动模型,观察YXL对模型小鼠外周血白细胞数的影响。结果以最大浓度、最大体积的YXL给小鼠口服灌胃,每天1次,最大耐受量为35.6g/kg。大鼠给药60天后,高剂量组白蛋白,高、中剂量组总胆红素明显下降,与对照组比较差异有显著性;高、中剂量组的总胆固醇有下降趋势,但
2、与对照组比较差异无显著性;停止给药15天,各项指标均在正常值范围内与对照组比较无差异;给予YXL3g/kg、2g/kg和1g/kg3个剂量的药物干预后,3个给药剂量均能提高以上3种诱因所致小鼠外周血白细胞总数低下。结论YXL以灌胃给药测得最大耐受量为35.6g/kg,接近临床剂量的200倍;长期毒性的各项指标均在正常值范围内与对照组比较无差异;YXL具有明显升高血白细胞作用。本实验YXL临床运用提供了安全性评价依据和药效学方面的实验依据。【关键词】怡欣乐口服液;安全性;白细胞;大鼠;小鼠11 [Abstract]ObjectiveToevaluatethesafetyofYXL
3、oralliquidandtostudyitsmechanisminincreasingtheWBCinperipheralblood.MethodAccordingtotheregulationfornewdrugapplication,miceandratswereappliedfortheacuteandlongtermtoxicexperiment;dynamiclowperipheralbloodWBCinmouseandratmodelwerebuildupbytoxictreatmentofcyclophosphamide,benzene,andthe60Co-γr
4、ayirradiation,thentheeffectonWBCinperipheralbloodwereobserved.ResultYXLoralliquidwasfeedtothemicebygastricperfusionwiththemaximumconcentrationandvolume,onceaday,maximallytolerateddoseis35.6g/kg.Thealbumininthehighdosagegroupandthetotalbilirubininthehighandmediumdosagedecreasedobviouslyinrataf
5、terthedrugwasfeedfor60days,whichhadobviousdifferencewiththecontrolgroup.Thetotalcholesterolinthehighandmediumhadthetrendofdecrease,butdidn’thaveobviousdifferencewiththecontrolgroup.Thetreatmentofallthreedifferentdosage,YXL3g/kg,2g/kgand1g/kgcouldimprovethelowWBCinperipheralbloodofthe3mousemod
6、els.ConclusionThemaximumtolerancedosageofYXLoralliquidbygastricperfusionis35.6g/kg,whichwasabout200timesthantheclinicaldosage.Alltheindexesforthelongtermtoxicityareinthenormalrangewhichhadnodifferencecompared11withthecontrolgroup.YXLhasanobviouseffectinincreasingtheamountofWBC.Thisresearchpro
7、videdexperimentalevidenceforthesafetyevaluationandpharmacodynamicsintheclinicalapplicationofYXL. [Keywords]Yixinleoralliquid;safety;whitebloodcell;rat;mouse YXL是由我们在补肾填精，养心安神治法指导下，选用西洋参、冬虫夏草、阿胶、何首乌等药物，采用现代制药技术研制而成的中药复方制剂。为了研究YXL在用药安全性评价和升高外
