《制藥工程》PPT電子課件
《制藥工程》PPT電子課件,制藥工程,制藥,工程,PPT,電子,課件
第一章第一章緒論緒論Chapter1Introduction為什么要進行新藥研發(fā)為什么要進行新藥研發(fā)n n雞尾酒療法治療艾滋?。R多夫定、雞尾酒療法治療艾滋?。R多夫定、雞尾酒療法治療艾滋?。R多夫定、雞尾酒療法治療艾滋?。R多夫定、拉米夫定拉米夫定拉米夫定拉米夫定和依非韋倫和依非韋倫和依非韋倫和依非韋倫)n n中國批準:中國批準:中國批準:中國批準:齊多夫定齊多夫定齊多夫定齊多夫定、去羥肌苷、司他夫定、奈韋拉平、去羥肌苷、司他夫定、奈韋拉平、去羥肌苷、司他夫定、奈韋拉平、去羥肌苷、司他夫定、奈韋拉平 n n政府發(fā)放低成本藥物,但副作用大政府發(fā)放低成本藥物,但副作用大政府發(fā)放低成本藥物,但副作用大政府發(fā)放低成本藥物,但副作用大惡心、貧血、腎結(jié)石惡心、貧血、腎結(jié)石惡心、貧血、腎結(jié)石惡心、貧血、腎結(jié)石 n n最新的藥物,效果好,但價格高最新的藥物,效果好,但價格高最新的藥物,效果好,但價格高最新的藥物,效果好,但價格高n n成本高的主要原因是成本高的主要原因是成本高的主要原因是成本高的主要原因是進口進口進口進口藥物藥物藥物藥物Whyweshoulddevelopthenewdrugsn nCocktailtherapyforHIVCocktailtherapyforHIV(Zidovudine,lamivudineandZidovudine,lamivudineandefavirenzefavirenz)n nChinaapprovedChinaapproved:Zidovudine,didanosine,stavudine,Zidovudine,didanosine,stavudine,nevirapinenevirapinen nGovernmentissuesGovernmentissueslow-costdrugs,butlow-costdrugs,buttherearethetherearethesideeffectssideeffectssuchasnauseasuchasnausea,anemia,kidneystones,anemia,kidneystones n nThelatestdrugs,theeffectisgood,butthepriceishighThelatestdrugs,theeffectisgood,butthepriceishighn nThemainThemainreasonofthehighcostreasonofthehighcostisisthatthesedrugsarethatthesedrugsareimported.imported.為什么要進行新藥研發(fā)為什么要進行新藥研發(fā)n n最近幾年發(fā)生的最近幾年發(fā)生的天價醫(yī)療費天價醫(yī)療費事件事件n n老百姓普遍反映的看病老百姓普遍反映的看病貴貴、難難等問題等問題n n“自費藥自費藥”等等Whyweshoulddevelopthenewdrugsn nAstronomicalmedicalexpensesincidentoccurredinrecentyearsn nPeoplegenerallyreflecttheexpensive,difficultissuesofseeingadoctorn nPocketmedicine,etc.政府高度重視政府高度重視新藥創(chuàng)制基金2008年下拔45億人民幣20112015年,500億ThegovernmentgivesmoreattentionDrugDiscoveryFund2008,4.5billionyuan2011-2015,50billionyuan制藥工程的起源及發(fā)展制藥工程的起源及發(fā)展n n1植物藥起源于植物藥起源于5000年之前年之前n n2植物藥有效成分的發(fā)現(xiàn)推動了化學植物藥有效成分的發(fā)現(xiàn)推動了化學制藥的發(fā)展制藥的發(fā)展n n3人類對健康的追求推動了生物技術人類對健康的追求推動了生物技術的發(fā)展,生物技術的發(fā)展推動了生物制的發(fā)展,生物技術的發(fā)展推動了生物制藥的發(fā)展藥的發(fā)展OriginandDevelopmentofPharmaceuticalEngineeringn n1 1BotanicalsoriginatedBotanicalsoriginated50005000yearsagoyearsagon n22ActiveActiveingredientsfoundinherbalingredientsfoundinherbalpromotethedevelopmentofpharmaceuticalpromotethedevelopmentofpharmaceuticalchemistrychemistryn n33PeoplepursuinghealthpromotesPeoplepursuinghealthpromotesthethedevelopmentofbiotechnology,developmentofbiotechnology,whilethewhilethedevelopmentofbiotechnologydevelopmentofbiotechnologypromotespromotesthethedevelopmentofdevelopmentofbiopharmaceuticals.biopharmaceuticals.生物制藥是增長速度最快的制生物制藥是增長速度最快的制藥行業(yè)藥行業(yè)n n微生物制藥微生物制藥n n疫苗疫苗n n干細胞干細胞n n基因治療基因治療Biopharmaceuticalsisthefastestgrowingpharmaceuticalindustryn nMicrobialdrugn nVaccinen nStemCellsn nGeneTherapyn第一章第一章緒論緒論nChapter1Introduction主要內(nèi)容主要內(nèi)容n n1.1制藥工程的概念制藥工程的概念n n1.2制藥工程技術的構(gòu)成制藥工程技術的構(gòu)成n n1.3制藥分離技術制藥分離技術Maincontentn n1.1TheconceptofPharmaceuticalEngineeringn n1.2Pharmaceuticalengineeringtechnologyn n1.3PharmaceuticalSeparationTechnology藥物生產(chǎn)的核心問題藥物生產(chǎn)的核心問題1.工藝問題生產(chǎn)同一化合物,工藝是否唯一2.工程問題同一工藝,所選設備是否唯一Thecoreproblemofdrugproduction1.ProcessissuesToproducethesamecompound,whethertheprocessisunique2.EngineeringproblemsForthesameprocess,whethertheselecteddeviceisunique.例子:鞣花酸的生產(chǎn)例子:鞣花酸的生產(chǎn)抗癌抗癌/抗突變性能抗突變性能抗抗HIV抗氧化抗氧化在美國抗癌物質(zhì)排行榜上名列第二在美國抗癌物質(zhì)排行榜上名列第二Examples:EllagicacidproductionAnti-cancer/anti-mutagenicpropertiesAnti-HIVAntioxidantRankedsecondinanti-cancersubstancesininUSA.25鞣花酸及安石榴甙生產(chǎn)工藝研究現(xiàn)狀鞣花酸及安石榴甙生產(chǎn)工藝研究現(xiàn)狀 n n鞣花酸生產(chǎn)工藝植物組織提取植物組織提取由沒食子酸或沒食子由沒食子酸或沒食子酸酯通過氧化聚合作酸酯通過氧化聚合作用制備用制備從含沒食子酸基的單從含沒食子酸基的單寧通過空氣氧化制取寧通過空氣氧化制取原料成本較高原料成本較高 產(chǎn)品的分離純化困難產(chǎn)品的分離純化困難動物蟲癭,動物來源,動物蟲癭,動物來源,存在安全問題存在安全問題工藝方法工藝方法缺點缺點26Research Status of production process of ellagic acid and pomegranate glycosidesn nEllagicacidproductionprocessPlant tissue extractsProduced from the gallic acid or gallate prepared through oxidative polymerizationProduced from tannics through the air oxidationHigher costs for raw materialDifficult in product separation and purificationAnimal galls,animal sources,there are security issuesProcessDisadvantage石榴的應用現(xiàn)狀石榴的應用現(xiàn)狀石榴果汁果汁果酒果酒果醬果醬少部分作為少部分作為中藥材中藥材大部分被大部分被廢棄廢棄少部分作為少部分作為茶飲用茶飲用大部分被大部分被廢棄廢棄僅作為僅作為種子種子大部分被大部分被廢棄廢棄目前石榴是國內(nèi)重點發(fā)展的水果之一,2004年國內(nèi)產(chǎn)量32萬噸。每棵樹約每棵樹約產(chǎn)產(chǎn)3公斤公斤石榴葉石榴葉(干)干)石榴皮占石榴皮占果實重量果實重量的的20-30%石榴籽石榴籽約占果約占果實重量實重量的的10%石榴果汁果汁果酒果酒果醬果醬少部分作為少部分作為中藥材中藥材大部分被大部分被廢棄廢棄少部分作為少部分作為茶飲用茶飲用大部分被大部分被廢棄廢棄僅作為僅作為種子種子大部分被大部分被廢棄廢棄目前石榴是國內(nèi)重點發(fā)展的水果之一,2004年國內(nèi)產(chǎn)量32萬噸。Pomegranate application status石榴JuiceWineJamSmallpartasChineseherbalmedicineAsmallpartasteaMostwereabandonedOnlyasaeeds大部分被大部分被廢棄廢棄10000tonsperyearPomegranateisoneoftheimportantfruitsinChina.Domesticproductionis320,000tonsin2004.3kg/tree20000tonsperyearMostwereabandonedMostwereabandoned酶轉(zhuǎn)化法制備鞣花酸酶轉(zhuǎn)化法制備鞣花酸闡明了含有闡明了含有HHDPHHDP基團的石榴單寧水解后基團的石榴單寧水解后生產(chǎn)鞣花酸的轉(zhuǎn)化機制;生產(chǎn)鞣花酸的轉(zhuǎn)化機制;發(fā)現(xiàn)可轉(zhuǎn)化該類單寧的酶系,提出通過發(fā)現(xiàn)可轉(zhuǎn)化該類單寧的酶系,提出通過前體化轉(zhuǎn)化以制備鞣花酸的構(gòu)想;前體化轉(zhuǎn)化以制備鞣花酸的構(gòu)想;發(fā)明了石榴皮中前體物轉(zhuǎn)化法制備鞣花發(fā)明了石榴皮中前體物轉(zhuǎn)化法制備鞣花酸的新工藝,鞣花酸的得率由轉(zhuǎn)化前的酸的新工藝,鞣花酸的得率由轉(zhuǎn)化前的1%1%提高至提高至9.75%9.75%。酶酶鞣花單寧鞣花單寧鞣花酸鞣花酸HHDPHHDP基團基團PreparationofellagicacidusingenzymaticconversionClarify transformation mechanism of production of ellagic acid after the pomegranate tannins with hydrolysis HHDP groups;discover enzyme systems which are used for transformation of these tannins;propose the idea of production of ellagic acid through conversion of the precursor;invent the new technology of ellagic acid production by conversion of pomegranate rind;Ellagic acid conversion rate was increased from 1%to 9.75%.EnzymeEllagitanninEllagic acidHHDPgHHDPggroupgroup工藝選擇工藝選擇五倍子工藝五倍子工藝:原料6萬/噸,3噸原料/噸產(chǎn)品,原料成本18萬/噸產(chǎn)品。石榴皮工藝石榴皮工藝:原料0.28萬/噸,20噸原料/噸產(chǎn)品,原料成本5.6萬/噸產(chǎn)品。?選哪一個ProcessselectionGallic process:Materials 60,000/ton,three tons of raw materials/ton of product,raw material costs 180,000/ton product。Granatum process:raw materials 2,800/ton,20 tons of raw materials/ton of product,raw material costs 56,000/ton of product?Which one to be chosen工藝選擇工藝選擇五倍子工藝過程簡單五倍子工藝過程簡單:氧化、過濾、堿溶、:氧化、過濾、堿溶、酸沉、水洗、產(chǎn)品酸沉、水洗、產(chǎn)品石榴工藝過程復雜石榴工藝過程復雜:酶解或酸解、水洗、:酶解或酸解、水洗、堿溶、離心除雜、酸沉除雜、堿溶、離心除雜、酸沉除雜、堿溶、酸堿溶、酸沉、水洗、產(chǎn)品沉、水洗、產(chǎn)品投資估算投資估算年產(chǎn)年產(chǎn)100100噸鞣花酸計,噸鞣花酸計,五倍子工藝投資:五倍子工藝投資:設備:設備:3030噸氧化罐噸氧化罐3636萬萬3535噸堿溶罐噸堿溶罐4242萬萬3030噸水洗罐噸水洗罐4848萬萬板框過濾:板框過濾:4040平方米平方米2 2臺,臺,4242萬萬.蝶片式離心機蝶片式離心機6060萬萬.閃蒸干燥閃蒸干燥2020萬萬合計:合計:248248萬。萬。廠房:廠房:600600平方米,平方米,12001200元元/平方米。平方米。7272萬萬公用工程:公用工程:純凈水:純凈水:4 4噸噸/小時,小時,4040萬。電:萬。電:100KW100KW,2020萬。萬。合計:合計:380380萬。萬。InvestmentEstimationAnannualoutputof100tonsofellagicAnannualoutputof100tonsofellagicacid:acid:Gallictechnologyinvestments:Gallictechnologyinvestments:Equipment:Equipment:30-ton30-tonoxidationtank360000oxidationtank36000035-ton35-tonalkali-solubletank420000alkali-solubletank42000030-ton30-tonwashingtank480000washingtank480000Framefilter:40squaremeters2,420,000.Framefilter:40squaremeters2,420,000.Butterflypiececentrifuge600,000.Butterflypiececentrifuge600,000.Flashdrying200,000Flashdrying200,000Total:2,480,000.Total:2,480,000.Plant:600Plant:600squremeterssquremeters,1,200yuan/squaremeter.720000,1,200yuan/squaremeter.720000PublicWorks:Purifiedwater:4tons/hour,400,000.Power:PublicWorks:Purifiedwater:4tons/hour,400,000.Power:100KW,20thousand.100KW,20thousand.Total:3,800,000Total:3,800,000.投資估算投資估算石榴皮工藝投資:石榴皮工藝投資:石榴皮工藝投資:石榴皮工藝投資:設備:設備:設備:設備:固態(tài)發(fā)酵池:固態(tài)發(fā)酵池:固態(tài)發(fā)酵池:固態(tài)發(fā)酵池:3030噸,噸,噸,噸,3030萬萬萬萬水洗罐:水洗罐:水洗罐:水洗罐:5050噸,噸,噸,噸,6060萬萬萬萬一次堿溶罐:一次堿溶罐:一次堿溶罐:一次堿溶罐:5050噸,噸,噸,噸,6060萬萬萬萬一次酸沉罐:一次酸沉罐:一次酸沉罐:一次酸沉罐:5050噸,噸,噸,噸,8080萬萬萬萬二次堿溶罐:二次堿溶罐:二次堿溶罐:二次堿溶罐:3030噸,噸,噸,噸,3636萬萬萬萬二次酸沉罐:二次酸沉罐:二次酸沉罐:二次酸沉罐:3030噸,噸,噸,噸,4848萬萬萬萬板框過濾板框過濾板框過濾板框過濾8080平平平平1,401,40平平平平158158萬萬萬萬蝶式離心機蝶式離心機蝶式離心機蝶式離心機6 6臺臺臺臺180180萬萬萬萬閃蒸干燥閃蒸干燥閃蒸干燥閃蒸干燥2020萬萬萬萬合計:合計:合計:合計:572572萬萬萬萬廠房:廠房:廠房:廠房:12001200平,平,平,平,12001200元元元元/平,平,平,平,144144萬萬萬萬公用工程:公用工程:公用工程:公用工程:水:水:水:水:6 6噸噸噸噸/小時,小時,小時,小時,6060萬。電:萬。電:萬。電:萬。電:200KW200KW,4040萬萬萬萬 合計:合計:合計:合計:816816萬萬萬萬InvestmentEstimationGranatumtechnologyinvestments:Granatumtechnologyinvestments:Equipment:solid-statefermentationtank:30tons,300,000Equipment:solid-statefermentationtank:30tons,300,000Washingtank:50tons,600,000Washingtank:50tons,600,000Ameltingpotbase:50tons,600,000Ameltingpotbase:50tons,600,000Onceacidprecipitationtank:50tons,800,000Onceacidprecipitationtank:50tons,800,000Secondaryalkali-solubletank:30tons,360,000Secondaryalkali-solubletank:30tons,360,000Secondaryacidprecipitationtank:30tons,480,000Secondaryacidprecipitationtank:30tons,480,000Framefilter:80squaremeter,1;40squaremeter,1;1Framefilter:80squaremeter,1;40squaremeter,1;1580000580000Butterflycentrifugesix1800000Butterflycentrifugesix1800000Flashdrying200,000Flashdrying200,000Total:5,720,000Total:5,720,000Plant:1200Plant:1200squaremeter,squaremeter,1,200yuan/1,200yuan/squaremeter,squaremeter,14400001440000PublicWorks:Water:6tons/hour,600,000.Power:200KW,PublicWorks:Water:6tons/hour,600,000.Power:200KW,400000400000Total:Total:8,160,0008,160,000年消耗:年消耗:五倍子工藝:五倍子工藝:原、輔料:原、輔料:20002000萬萬水、電、工資:水、電、工資:600600萬萬合計:合計:26002600萬萬石榴工藝:石榴工藝:原、輔料:原、輔料:710710萬萬 水、電、工資:水、電、工資:820820萬萬 合計:合計:15301530萬萬1 1年節(jié)省年節(jié)省10701070萬。萬。AnnualconsumptionGallicprocess:Gallicprocess:Rawmaterials,auxiliarymaterials:20,000,000Rawmaterials,auxiliarymaterials:20,000,000Water,electricity,wages:6000000Water,electricity,wages:6000000Total:26,000,000Total:26,000,000Pomegranateprocess:Pomegranateprocess:Rawmaterials,auxiliarymaterials:7100000Rawmaterials,auxiliarymaterials:7100000Water,electricity,wages:8200000Water,electricity,wages:8200000Total:15.3millionTotal:15.3millionAnannualsavingsof10.7millionAnannualsavingsof10.7million.工藝確定工藝確定選石榴工藝DeterminationofprocessSelectPomegranateprocess工程問題工程問題在五倍子工藝中:在五倍子工藝中:在五倍子工藝中:在五倍子工藝中:關鍵設備:關鍵設備:關鍵設備:關鍵設備:氧化反應釜關鍵參數(shù):氧化反應釜關鍵參數(shù):高徑比高徑比攪拌漿形式及轉(zhuǎn)速攪拌漿形式及轉(zhuǎn)速通氣管通氣管電機功率電機功率 材質(zhì):材質(zhì):304304不銹鋼不銹鋼檢測:溫度檢測:溫度EngineeringproblemsInIngallicprocess:gallicprocess:Keyequipment:Keyequipment:KeyparametersoftheKeyparametersoftheoxidationreactor:oxidationreactor:HeighttodiameterratioHeighttodiameterratioTheTheformandspeedformandspeedofofstirrerstirrerSnorkelSnorkelMotorPowerMotorPowerMaterial:304stainlessMaterial:304stainlesssteelsteelDetection:Detection:TemperatureTemperature工程問題工程問題堿溶罐關鍵參數(shù):堿溶罐關鍵參數(shù):攪拌漿形式及轉(zhuǎn)速攪拌漿形式及轉(zhuǎn)速電機功率電機功率高徑比高徑比材質(zhì):材質(zhì):304不銹鋼不銹鋼檢測:溫度檢測:溫度EngineeringproblemsKey parameters of alkali-soluble tank:Stirring The form and speed of stirrerMotor Power Height to diameter ratio Material:304 stainless steel Detection:Temperature工程問題工程問題酸沉罐關鍵參數(shù):酸沉罐關鍵參數(shù):攪拌漿形式及轉(zhuǎn)速攪拌漿形式及轉(zhuǎn)速電機功率電機功率高徑比高徑比材質(zhì):材質(zhì):316L不銹鋼不銹鋼檢測:檢測:pHEngineeringproblemsKeyparametersofacidprecipitationtank:TheformandspeedofstirrerMotorPowerHeighttodiameterratioMaterial:316LstainlesssteelDetection:pH工程問題工程問題板框過濾:板框過濾:板框過濾:板框過濾:過濾面積過濾面積過濾面積過濾面積材質(zhì)材質(zhì)材質(zhì)材質(zhì)泵的流量、壓力泵的流量、壓力泵的流量、壓力泵的流量、壓力EngineeringproblemsFramefilter:Framefilter:FilterareaFilterareaMaterialMaterialPumpflow,Pumpflow,pressurepressure工程問題工程問題n n蝶片式離心機選型蝶片式離心機選型n n主要參數(shù):主要參數(shù):n n處理量處理量n n分離因數(shù)分離因數(shù)蝶片式離心機主要參數(shù)蝶片式離心機主要參數(shù)n n實際生產(chǎn)能力實際生產(chǎn)能力n n水通量水通量n n轉(zhuǎn)鼓轉(zhuǎn)速轉(zhuǎn)鼓轉(zhuǎn)速n n實際分離因素實際分離因素n n排渣時間及間隔時間排渣時間及間隔時間n n電機轉(zhuǎn)速電機轉(zhuǎn)速n n電機型號及裝機功率電機型號及裝機功率n n啟動時間停機時間(不采用啟動時間停機時間(不采用剎車裝置)剎車裝置)n n料進口壓力料進口壓力n n料出口壓力料出口壓力n n操作水壓力操作水壓力n n噪音水平噪音水平n n最大振動水平最大振動水平n n整機重量整機重量n n整機外型尺寸:整機外型尺寸:(長長 寬寬 高高)1000L/h15000L/h6700rpm11926根據(jù)原料的品質(zhì),排渣時間從0.1秒0.9秒、排渣周期從1分鐘240分鐘,任意可調(diào)1460rpmY160L-4-B515kw610minute,40minute00.1mpa00.3mpa0.2mPap0.45mPa73dB1.5mm/s1760kg177214731855Keyparametersofbutterflychipcentrifugen nActualproductioncapacityActualproductioncapacityn nWaterfluxWaterfluxn nDrumspeedDrumspeedn nTheactualseparationfactorTheactualseparationfactorn nSlagSlagtimeandtimeandthethetimeintervalstimeintervalsn nMotorspeedMotorspeedn nMotormodelandinstalledpowerMotormodelandinstalledpowern nDowntimeDowntimeandstartandstarttime(donotusetime(donotusebrakes)brakes)n nFeedinletpressureFeedinletpressuren nMaterialoutletpressureMaterialoutletpressuren nOperatingwaterpressureOperatingwaterpressuren nNoiselevelNoiseleveln nMaximumvibrationlevelsMaximumvibrationlevelsn nTotalWeightTotalWeightn nMachineDimensions:(LWHMachineDimensions:(LWH)1000L/h15000L/h6700rpm11926根據(jù)原料的品質(zhì),排渣時間從0.1秒0.9秒、排渣周期從1分鐘240分鐘,任意可調(diào)1460rpmY160L-4-B515kw610minute,40minute00.1mpa00.3mpa0.2mPap0.45mPa73dB1.5mm/s1760kg177214731855蝶片式離心機外形及基礎圖蝶片式離心機外形及基礎圖Shapesandbasedrawingofbutterfly-chipcentrifuge閃蒸干燥設備閃蒸干燥設備n n原理:原理:原理:原理:熱空氣由入口管以適宜的噴動速度從熱空氣由入口管以適宜的噴動速度從熱空氣由入口管以適宜的噴動速度從熱空氣由入口管以適宜的噴動速度從干燥機底部進入攪拌粉碎干燥室干燥機底部進入攪拌粉碎干燥室干燥機底部進入攪拌粉碎干燥室干燥機底部進入攪拌粉碎干燥室,對物,對物,對物,對物料產(chǎn)生強烈的剪切、吹浮、旋轉(zhuǎn)作用,料產(chǎn)生強烈的剪切、吹浮、旋轉(zhuǎn)作用,料產(chǎn)生強烈的剪切、吹浮、旋轉(zhuǎn)作用,料產(chǎn)生強烈的剪切、吹浮、旋轉(zhuǎn)作用,于是物料受到于是物料受到于是物料受到于是物料受到離心、剪切、碰撞、摩擦離心、剪切、碰撞、摩擦離心、剪切、碰撞、摩擦離心、剪切、碰撞、摩擦而被除數(shù)微?;?,強化了傳質(zhì)傳熱。而被除數(shù)微?;瑥娀藗髻|(zhì)傳熱。而被除數(shù)微?;?,強化了傳質(zhì)傳熱。而被除數(shù)微粒化,強化了傳質(zhì)傳熱。n n在干燥機底部,較大較濕的顆粒團在攪拌在干燥機底部,較大較濕的顆粒團在攪拌在干燥機底部,較大較濕的顆粒團在攪拌在干燥機底部,較大較濕的顆粒團在攪拌器的作用下被機械破碎,濕含量較低、器的作用下被機械破碎,濕含量較低、器的作用下被機械破碎,濕含量較低、器的作用下被機械破碎,濕含量較低、顆粒度較小的顆粒被旋轉(zhuǎn)氣流夾帶上升,顆粒度較小的顆粒被旋轉(zhuǎn)氣流夾帶上升,顆粒度較小的顆粒被旋轉(zhuǎn)氣流夾帶上升,顆粒度較小的顆粒被旋轉(zhuǎn)氣流夾帶上升,在上升過程中進一步干燥。在上升過程中進一步干燥。在上升過程中進一步干燥。在上升過程中進一步干燥。n n由于氣固兩相作旋轉(zhuǎn)流動,固相慣性大于由于氣固兩相作旋轉(zhuǎn)流動,固相慣性大于由于氣固兩相作旋轉(zhuǎn)流動,固相慣性大于由于氣固兩相作旋轉(zhuǎn)流動,固相慣性大于氣相,固氣兩相間的相對速度較大,強氣相,固氣兩相間的相對速度較大,強氣相,固氣兩相間的相對速度較大,強氣相,固氣兩相間的相對速度較大,強化兩相間的傳質(zhì)傳熱,所以該機生產(chǎn)強化兩相間的傳質(zhì)傳熱,所以該機生產(chǎn)強化兩相間的傳質(zhì)傳熱,所以該機生產(chǎn)強化兩相間的傳質(zhì)傳熱,所以該機生產(chǎn)強度高。度高。度高。度高。型號型號主機內(nèi)經(jīng)主機內(nèi)經(jīng)(mm)處理風量處理風量(m3/h)蒸發(fā)水量蒸發(fā)水量(kg/h)最大裝機容量最大裝機容量(KW)最大高度最大高度(m)占用平面占用平面(m2)XSG-44001150-230058-7321.44.627Flashdryingequipmentn nPrinciplePrinciple:HotairHotairatattheappropriatespeedtheappropriatespeedgoesgoesintointothestirringandcrushinganddryingthestirringandcrushinganddryingchamberfromthebottomofthedryerchamberfromthebottomofthedryerviaviainletinlettube.Ittube.Itexertsstrongshearing,blowing,exertsstrongshearing,blowing,floatingandrotatingfloatingandrotatingeffectonthematerial.effectonthematerial.Thus,Thus,thethematerialismicronizedbymaterialismicronizedbycentrifugation,shear,centrifugation,shear,collisionandfrictionandcollisionandfrictionandthenitenhancesthenitenhancesheatandmasstransfer.heatandmasstransfer.n nAtAtthebottomofthedryer,wetthebottomofthedryer,wetandlargerandlargergranulesaremechanicallycrushedbytheactiongranulesaremechanicallycrushedbytheactionoftheagitator.Theparticleswiththeoftheagitator.Theparticleswiththelowerthelowerthemoisturemoisturecontentandsmallerparticlecontentandsmallerparticlesizesizeareareentrainedentrainedtoincreasebytoincreasebytherotatingtherotatingairflow,airflow,andfurtherdriedintherisingprocess.andfurtherdriedintherisingprocess.n nAsAsthegas-solidthegas-solidflowsrotate,theinertiaflowsrotate,theinertiaoftheofthesolidphaseisgreaterthansolidphaseisgreaterthanthatofthethatofthegasgasphase.phase.TheTherelativevelocitybetweensolidandgasrelativevelocitybetweensolidandgasphasesbecomelarger.Inordertostrengthenphasesbecomelarger.Inordertostrengthenheatandmasstransferbetweenthetwophases,heatandmasstransferbetweenthetwophases,theequipmenthasthehigh-strengththeequipmenthasthehigh-strengthproduction.production.ModelInsidediameter(mm)Airvolume(m3/h)Evaporationofwater(kg/h)Themaximumcapacity(KW)Maximumheight(m)Occupancyarea(m2)XSG-44001150-230058-7321.44.627流程圖流程圖Flowchart立面圖立面圖Elevations平面圖平面圖Elevations工廠實物圖工廠實物圖Factoryphysicalmap不同工藝的鞣花酸產(chǎn)品不同工藝的鞣花酸產(chǎn)品五倍子鞣花酸五倍子鞣花酸 石榴皮鞣花酸石榴皮鞣花酸EllagicacidproductsfromdifferentprocessesEllagic acid by heating gallic acid Ellagic acid from pomegranate1.1制藥工程的概念制藥工程的概念n n廣義廣義:利用原料進行批量生產(chǎn)利用原料進行批量生產(chǎn),制造出可制造出可用于疾病治療的藥品的過程用于疾病治療的藥品的過程.n n分為分為:n n1、原料藥生產(chǎn)(過程工程)、原料藥生產(chǎn)(過程工程)n n2、GMP條件下的制劑生產(chǎn)(加工工業(yè))條件下的制劑生產(chǎn)(加工工業(yè))1.1TheconceptofPharmaceuticalEngineeringn nGeneralized:Generalized:TheprocessofproducingtheTheprocessofproducingthedrugsfordrugsfordiseasetreatmentdiseasetreatmentusingrawusingrawmaterialsmaterialsformassproductionformassproductionn nDividedDividedinto:into:n n1,rawmaterial1,rawmaterialfordrugfordrugproduction(Processproduction(ProcessEngineering)Engineering)n n2,preparationofproductionunderGMP2,preparationofproductionunderGMPconditions(processingindustryconditions(processingindustry)原料藥的生產(chǎn)原料藥的生產(chǎn)根椐藥品的來源,可以分成哪幾大類?根椐藥品的來源,可以分成哪幾大類?1.2.3.productionofRawmaterialdrugBasedonthesourceofdrugs,itcanbedividedintoseveralcategories?根椐藥品的來源,可以分根椐藥品的來源,可以分成哪幾大類?成哪幾大類?1.TCM(TraditionalChineseMedicine)2.ChemicalSynthesisMedicine3.Biomedicine過程工業(yè)與加工工業(yè)的區(qū)別過程工業(yè)與加工工業(yè)的區(qū)別項目項目項目項目過程工業(yè)過程工業(yè)過程工業(yè)過程工業(yè)加工工業(yè)加工工業(yè)加工工業(yè)加工工業(yè)物質(zhì)結(jié)構(gòu)和形態(tài)物質(zhì)結(jié)構(gòu)和形態(tài)物質(zhì)結(jié)構(gòu)和形態(tài)物質(zhì)結(jié)構(gòu)和形態(tài)實現(xiàn)方法實現(xiàn)方法實現(xiàn)方法實現(xiàn)方法設備設備設備設備產(chǎn)量計量產(chǎn)量計量產(chǎn)量計量產(chǎn)量計量變化變化變化變化反應分離過程反應分離過程反應分離過程反應分離過程釜、罐、塔、泵釜、罐、塔、泵釜、罐、塔、泵釜、罐、塔、泵千克、噸、升千克、噸、升千克、噸、升千克、噸、升不變化不變化不變化不變化加工工序加工工序加工工序加工工序制劑設備制劑設備制劑設備制劑設備片、支、粒片、支、粒片、支、粒片、支、粒ThedifferencebetweentheprocessindustryandprocessingindustryProjectProjectProcessingProcessingindustryindustryProcessProcessindustryindustryPhysicalstructureandPhysicalstructureandmorphologymorphologyImplementationImplementationEquipmentEquipmentMeasurementyieldsMeasurementyieldschangechangeReactionseparationReactionseparationprocessprocessKettle,pot,towers,Kettle,pot,towers,pumpspumpsKilograms,tons,upKilograms,tons,upNochangeNochangeProcessingoperationsProcessingoperationsPreparationequipmentPreparationequipmentTablets,sticks,tabletsTablets,sticks,tablets1.2制藥工程技術的構(gòu)成制藥工程技術的構(gòu)成n n兩個階段兩個階段:n n(1)反應反應或合成或合成(上游上游):n n(2)分離分離(下游下游):1.2Constitutepharmaceuticalengineeringtechnologyn nTwostages:n n(A)reactionorsynthesis(upstream):n n(2)separating(downstream):反應反應共性技術共性技術(1)確定合成工藝路線和步驟確定合成工藝路線和步驟(2)確定反應條件確定反應條件(3)設計或選用適當?shù)姆磻髟O計或選用適當?shù)姆磻?4)獲得目的產(chǎn)物獲得目的產(chǎn)物(含雜質(zhì)含雜質(zhì))Reaction-commontechnology(1)determinethesynthesisprocessand(1)determinethesynthesisprocessandstepssteps(2)(2)determinedeterminethereactionconditionsthereactionconditions(3)(3)designdesignororselectanselectanappropriateappropriatereactorreactor(4)(4)obtainobtainthedesiredproductthedesiredproduct(containingimpurities(containingimpurities)分離分離共性技術共性技術(1)確定工藝流程確定工藝流程(2)確定操作條件確定操作條件(3)設計或選用適當?shù)脑O備設計或選用適當?shù)脑O備(4)得到合格的原料得到合格的原料一般一般分離分離占占總成本總成本的的50-70%.抗生素、基因工程藥物占抗生素、基因工程藥物占80-90%SeperationCommontechnology(1)(1)determinedeterminetheprocesstheprocess(2)determinetheoperatingconditions(2)determinetheoperatingconditions(3)(3)designdesignororselectappropriateselectappropriateequipmentequipment(4)(4)obtainobtainqualifiedmaterialqualifiedmaterialGenerallyGenerallythecostofseparationisthecostofseparationis50-70%50-70%ofofthethetotaltotalcost.cost.Antibiotics,geneticengineeringdrugsAntibiotics,geneticengineeringdrugsaccountedforaccountedfor80-90%80-90%1.3 1.3 制藥分離技術制藥分離技術特殊性特殊性:1、含量低(、含量低(0.0001%-1%)2、穩(wěn)定性差、穩(wěn)定性差(光、熱等光、熱等)3、產(chǎn)品質(zhì)量要求高(雜質(zhì)含量少)、產(chǎn)品質(zhì)量要求高(雜質(zhì)含量少)1.3 Pharmaceutical Separation TechnologyParticularity:1,lowlevel(0.0001%to1%)2,poorstability(light,heat,etc.)3,highproductqualityrequirements(lowimpuritycontent)常用分離技術常用分離技術過濾、離心分離、萃取、吸附、超濾、過濾、離心分離、萃取、吸附、超濾、精餾精餾色譜分離、離子交換、結(jié)晶色譜分離、離子交換、結(jié)晶ConventionalseparationtechniquesFiltration,centrifugation,extraction,Filtration,centrifugation,extraction,adsorption,ultrafiltration,distillationadsorption,ultrafiltration,distillationChromatography,ionexchange,Chromatography,ionexchange,crystallizationcrystallization思考題思考題當前藥物研發(fā)的方向是什么當前藥物研發(fā)的方向是什么?對我們研究開發(fā)新藥有何啟示?對我們研究開發(fā)新藥有何啟示?QuestionsWhatisthedirectionofthecurrentdrugdevelopmentis?Whatinspirationisforourresearchanddevelopmentofnewdrugs?
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