血液制品生产工艺特点及生产车间平面规划设计

24320082GansuScienceandTechnologyVol.24No.3Feb.2008(,730000):GMP,,,:;;;GMP:TQ460.8,,,,GMP,,,11.1,[1],11DNAKDPI(mg/dL)1(Albumin)+++066.4584.74.8350055002(Polyvalentimmunoglobulin)++-05.87.312503(HyperimmuneIgS)+++05.87.312504FVIII(factorVIII)++++00.115FIX(factorIX)++++046.5480.10.76FVII(factorVII)++0-0.527FVIIa(factorVIIa)(++)++-8(Thrombin,TB)++009(Fibrinogen,Fg)++0020045010(Fibrinsealant)++0011FXI(factorXI)++--0.512FXIII(factorXIII)++001.54.713VWF(VonWillebrandfactor)++0-14(Prothrombincomplex,PCC)++--15(ActivatedPCC,APCC)++0-16C(ProteinC)++00620.40.517C(ActivatedProteinC,APC)+++-620.40.5181-(Alpha-1-antitrypsin,1-AT)++++514.815035019III(AntithrombinIII)++0+62675.1153020C1(C1-esteraseinhibitor,C1-INH)++0+23.53.021(Apotransferrin)+005.925043022(MannanbindingLectin)+0-23(ApolipoproteinA-1)+0-24(Fibronectin,Fn)+0-45029440725(Butyrylcholinesterase)00-26(Plasmin)0--272(2-Macroglobuin,2-M)++--7255.4220380281-(Alpha-1-acidglycoprotein,AAG)+--402.73.525200291-(Alpha-1-protease)+--30(ReconsitutedHDL,RHDL)+--360:++(++)+0DNA1,19,7,[2]FVIII,III,2(2-M)(HDL)FVIIFIX,(),,,,2.867.14,2,,2(ITIS)(g/a)/0.2//0.50.07,,,,,,,34,5,:,,,,,:32007()()/9755.84285.775%/91%4462.62864.12898.51032.142006()()/25740.2110978.4337%/25%4087.751266.15471.231443.295(BCC.Inc.2001)()(L)15002190000140%FVIII190027596FVIX200156001.2,,(Albumin)(Im2muneGlobulin),(PCC)FVIII,,,()()1998GMP,GMP,,,90,1996Octap2harma,,,,SFDA,2007,:902,:(PCC)7113:2.1,,,,,,-25-30()(),2.2,580ml25,,,,28GMP,PCC,,,2.3,,,,,,,,,;,,,,05,0-6812,-25-30,,2.4,PCCFVIIIFVIII,PCCIII,I()(),S/D;;,,,,,,2.5,FII+III,()(),pH();;(),,2.6,FV,81124(),,,,2.73728,3(1),,,;(2),,,CohnKistlerandNitschmann,;(3),(),;(4),,,;(5),,,;(6),;4GMP,,,,:[1]JanOver,Plasmaproteinproducts,opportunitiesforthefuture[M].AreportfromthethirdPlasmaProd2uctsBiotechnologymeeting,Ntherlands,April2226,2003.[2]..,2002.[3].(137)150kg120kg7,,8,4,,,,9,:,,,::65%60020%3000,,,,,,40%50072.2%80072%50060040%50040%80001000025%3000,1.8%150030005%1000010%25002.5%30009113: