浅淡生化药质量标准中的异常毒性等安全性检查

,,,,,,,2005,,,,[1],,.I:5.,1995.1:13-14李湛军　徐康森(100050)DiscussionaboutAbnormalToxicitySafetyTestintheQualityStandardsofBiochemicalDrugsLiZhan-jun,XuKang-sen(NationalInstitutefortheControlofPharmaceuticalandBiologicalProducts,Beijing100050),,3R(Reduction)(Replacement)(Re-finement),1(abnormaltoxicity)1.1,,1.21.3WHO1997[1],GMP,GMP,,,,,,WHO[2],,,,,,3R,[3](ChP)(BP),BP2004[4];(EP)(5th)47[5](30);(USP)(Safety)[6],4070(10)200542()[7]1.4,,,[5],:5mg(Fe),5103;(),BP2004(un-duetoxicity)[4];USP28(Acutetoxic-ity)[6]1.5BP20045,iv()0.5ml,1530,24h;ChP2005[8](),48h,45,30,,,,,;,17DrugStandardsofChina2006,vol.7No.5200675(337),;ChP2005BP200411两国药典异常毒性检查法比较ChP2005BP2004ChP2005BP2004g517204548h51722153024h521822,2503507d521722,2503507d1.6();,,EP(5th)abnor-maltoxicityUSP28Safetytest([6][6]),DNA,,(,),3R,2,,GMP,,[2]!,BP2004,200530()[7],,,,,;(2),(kg)2降压物质检查的生化药品种(60kg)%(kg)(6AA)ChP20059th[9]9th[9]9th[9]16th[10]1.5U/kg2mg/kg1ml/kg0.1mg/kg0.1ml/kg278U//80-100mg//,40mg//im250ml//100mg//4ml//im8-12ml//32%120%24%6%50%,,[1]..,1998,17(4):253-6[2]SponerG.Animalexperimentsinthecontextofqualitycontrolofpharmaceuticals.ReviewoftheEuropeanPharmacopoeia,4thedition,2002.ALTEX.2004;21(2):73-80[3]KramerB,NagelM,DuchowK,SchwanigM,CusslerK.Istheabnormaltoxicityteststillrelevantforthesafetyofvaccines,seraandimmunoglobulins?ALTEX.1996;13(1):7-16[4]BP.2004[5]EP.5thedition,2004[6]USP28.NF23[7],,,2005().,2005,6(1)30-33[8]2005[9](),,2002[10](),,200318200675(338)DrugStandardsofChina2006,vol.7No.5