论文70992双黄连颗粒剂制备工艺的研究2

双黄连颗粒剂制备工艺的研究摘要研究目的：研究双黄连颗粒剂制备的现代化工艺，并对其所制备的双黄连颗粒进行质量考察，以确定制备工艺的科学性和合理性。研究方法：在本文的研究中，首先确定双黄连颗粒制备的处方用药量（金银花260g,黄芪260g,连翘520g,三者的用药比例符合1:1:2)。再深入研究金银花、黄芪、连翘的提取工艺和浓缩工艺，从而得到药物清膏约为160g(相对密度为1.22-1.26）。双黄连颗粒剂所选用的辅料为糊精和蔗糖，分别选取药物（清膏）：蔗糖：糊精不同的浓度配比，通过颗粒剂的制备工艺制备不同的双黄连颗粒，通过颗粒的疏松性状、吸湿性、溶化性、口感进行评价，筛选合理的药物（清膏）：蔗糖：糊精的配比浓度。同时对颗粒剂采用不同温度的烘箱进行干燥，通过干燥时间和成粒状态两个指标，测定颗双黄连颗粒烘干的最佳温度。对制成的双黄连颗粒进行崩解时间和含水量的检测，和通过中试工艺进行验证批量生产的可行性。研究结果：1.3号颗粒（辅料配比为1:3.8:0.6）综合评定效果最为理想，颗粒性状疏松、而吸湿性在2天符合颗粒制剂的要求，溶化性为溶液澄清（药物的溶化性效果理想），口感为甜（符合矫味剂的特点）。2.60℃和70℃烘干后，整粒效果最为理想，颗粒都能达到疏松状态，可直接过筛，然而60℃的烘干时间为48h,时间过长，从大批量工艺生产和效率的角度考虑，选择70℃作为颗粒制备的最好烘干温度。3.3号颗粒和4号颗粒的含水量明显低于1号颗粒和2号颗粒，即3号颗粒和4号颗粒的防潮性明显强于1号颗粒和2号颗粒。而3号颗粒在崩解时间上为2.8分钟，明显强于4号颗粒的4.6min,因此，可以确定辅料配比（药物：蔗糖：糊精）为1:3.8:0.6。4.三批中试样品在水分、性状、溶化性、粒度和含量上都符合双黄连颗粒制剂的标准和规定。研究结论：1.双黄连颗粒制剂的合适辅料配比（药物：蔗糖：糊精）为1:3.8:0.6。2.从大批量工艺生产和效率的角度考虑，70℃作为双黄连颗粒制备的最好烘干温度。3.本文以1:3.8:0.6的辅料配比，制备的双黄连颗粒中试试验效果理想，性状稳定，工艺简单，符合大批量生产的需要。关键词：双黄连颗粒剂制备工艺质量考察AbstractObjective:ModernizationProcessofSHLgranulesprepared,andinspectthequalityoftheirpreparationShuanghuanglianparticlestodeterminethescientificandreasonablepreparationprocess.Methods:Inthisstudy,thefirsttodeterminetheamountofprescriptiondrugsShuanghuangliangranulesprepared(honeysuckle260g,Astragalus260g,forsythia520g,theproportionofthethreedrugsto1:1:2).Furtherin-depthstudyofhoneysuckle,astragalus,forsythiaextractionprocessandconcentrationprocesstoobtainthedrugclearpasteisabout160g(relativedensityof1.22-1.26).SHLgranuleschosenaccessoriesdextrinandsucrosewereselecteddrugs(clearcream):sucrose:dextrindifferentconcentrationratio,preparedbyadifferentprocessforthepreparationofgranulesShuanghuanglianparticlesbylooseparticlestraitshygroscopic,meltingresistance,tasteevaluation,rationaldrugscreening(clearpaste):sucrose:dextrinratioofconcentrations.WhilethegranuleswithdifferenttemperatureovendryingtimebydryingandgranulationstatetwoindicatorstodetermineanoptimumtemperaturedryingstarsShuanghuanglianparticles.Shuanghuangliangranulesweresubjectedtothedisintegrationtimeandmoisturetesting,andtoverifythefeasibilityofmassproductionthroughthepilotprocess.Results:ParticlesNo.13(materialsratioof1:3.8:0.6).Themostcomprehensiveassessmentoftheeffectofidealtraitslooseparticles,andhygroscopicgranularformulationintwodaysinlinewiththerequirementsofthesolutionwasclearmelting(meltingdrugsoftheresultsaresatisfactory),thetasteissweet(inlinewiththecharacteristicsofflavor).After2.60℃anddryat70℃,wholeeffectismostideal,particlescanreachtheloosestate,canbedirectlyscreened,butthedryingtime60℃for48h,toolong,high-volumeproductionprocessandefficiencyfrompointofview,thedryingtemperatureispreferably70℃selectparticlesasprepared.No.3.3particlesandmoisturecontentonthe4thparticlesissignificantlylowerthanthe1standthe2ndgranuleparticles,namelythe3rdparticlesandmoistureresistance4particleswasstrongerthanthe1standthe2ndgranuleparticles.AndNo.3inthedisintegrationtimeof2.8minutes,significantlystrongerthanthe4thparticles4.6min,itispossibletodeterminetheratioofmaterials(drug:sugar:dextrin)is1:3.8:0.6.4threebatchestestasampleonthewater,character,melting,particlesizeandcontentareconsistentwiththestandardsandregulationsofSHLgranularformulations.Conclusions:1ratioSHLgranularformulationofappropriatematerials.(Drug:sugar:dextrin)is1:3.8:0.6.2Fromhigh-volumeproductionprocessandefficiencypointofview,70℃granulespreparedasSHL.Thebestdryingtemperature.3.Inthispaper,1:3.8:0.6ratioofaccessories,idealShuanghuangliangranulespreparedpilottestresults,traitstability,simpleprocess,inlinewiththeneedsofhigh-volumeproduction.Keywords：SHL,granules,PreparationProcess,qualityinvestigation.目录1.绪论..............................................................51.1研究背景.....................................................52.实验材料与方法...................................................52.1实验材料.....................................................52.2实验仪器.....................................................52.3处方用药量..................................................52.4中药材提取工艺...............................................52.4.1金银花和连翘提取工艺.................................................................................52.4.2黄芪提取工艺...................................................................................................62.4.3浓缩工艺............................................................................................................62.5双黄连颗粒制剂工艺...........................................62.5.1辅料的选择和配比..........................................................................................62.5.2溶化性检测方法..............................................................................................62.5.3吸湿性检测方法..............................................................................................62.5.4口感测定方法...................................................................................................62.5.5烘干温度的选择..............................................................................................62.6质量考察方法.................................................62.6.1崩解时间和含水量的