usp-51抗菌效力測試

1、usp51抗菌效力測試.doc第1頁，共8頁?51?ANTIMICROBIALEFFECTIVENESSTESTING抗菌的效力測試Antimicrobialpreservativesaresubstancesaddedtononsteriledosagefmstoprotectthemfrommicrobiologicalgrowthfrommicroganismsthatareintroducedinadvertentlydurin

2、gsubsequenttothemanufacturingprocess.Inthecaseofsterilearticlespackagedinmultipledosecontainersantimicrobialpreservativesareaddedtoinhibitthegrowthofmicroganismsthatmaybeintroducedfromrepeatedlywithdrawingindividualdoses

3、.抗菌防腐劑是實際被添加到有菌的劑量配方里的物質(zhì)，使他們不受微生物滋長或是被無意中引進(jìn)到生產(chǎn)過程中的微生物侵害。在無菌包裝多劑量配方的容器里，抗菌防腐劑被添加用來抑制由重復(fù)添加單劑量所引進(jìn)的微生物的滋長。Antimicrobialpreservativesshouldnotbeusedasasubstitutefgoodmanufacturingpracticessolelytoreducetheviablemicrobialpopul

4、ationofanonsterileproductcontrolthepresterilizationbioburdenofmultidosefmulationsduringmanufacturing.AntimicrobialpreservativesincompendialdosagefmsmeettherequirementsfAddedSubstancesunderIngredientsProcessesintheGeneral

5、Notices.抗菌防腐劑不應(yīng)被作為在良好生產(chǎn)操作中的替代方式使用，或僅是用來減少一個有菌產(chǎn)品的微生物群數(shù)量，或是在生產(chǎn)時控制多劑量的微生物量。在劑量表里抗菌防腐劑與添加的要求必需符合規(guī)定。Allusefulantimicrobialagentsaretoxicsubstances.Fmaximumprotectionofpatientstheconcentrationofthepreservativeshowntobeeffectiv

6、einthefinalpackagedproductshouldbebelowalevelthatmaybetoxictohumanbeings.Theconcentrationofanaddedantimicrobialpreservativecanbekeptataminimumiftheactiveingredientsofthefmulationpossessanintrinsicantimicrobialactivity.An

7、timicrobialeffectivenesswhetherinherentintheproductwhetherproducedbecauseoftheadditionofanantimicrobialpreservativemustbedemonstratedfallinjectionspackagedinmultipledosecontainersfotherproductscontainingantimicrobialpres

8、ervatives.Antimicrobialeffectivenessmustbedemonstratedfmultipledosetopicalaldosagefmsfotherdosagefmssuchasophthalmicoticnasalirrigationdialysisfluids(seePharmaceuticalDosageFms(1151).所有有用的抗菌藥劑都是有毒物質(zhì)。為了最大的保護(hù)使用者，防腐劑的含量應(yīng)被有效

9、地顯示在產(chǎn)品的最終包裝上，并應(yīng)會處在一個可能對人體有毒的水平線下。添加的抗菌防腐劑含量能夠被保持在一個最小的濃度，如果配方的活性成分具有一個固定的抗菌力?？咕男ЯΓ还苁钱a(chǎn)品里固有的或者是生產(chǎn)中usp51抗菌效力測試.doc第3頁，共8頁TESTGANISMS測試生物體Useculturesofthefollowingmicroganisms1:Cidaalbicans(ATCCNo.10231)Aspergillusniger(AT

10、CCNo.16404)Escherichiacoli(ATCCNo.8739)Pseudomonasaeruginosa(ATCCNo.9027)Staphylococcusaureus(ATCCNo.6538).TheviablemicroganismsusedinthetestmustnotbemethanfivepassagesremovedfromtheiginalATCCculture.Fpurposesoftheteston

11、epassageisdefinedasthetransferofganismsfromanestablishedculturetofreshmedium.Alltransfersarecounted.Inthecaseofganismsmaintainedbyseedlottechniqueseachcycleoffreezingthawingrevivalinfreshmediumistakenasonetransfer.使用以下微生

12、物的培養(yǎng)基：白念珠菌（ATCCNO.10231）黑曲霉菌（ATCCNO.16404）大腸桿菌（ATCCNO.8739）綠膿桿菌(ATCCno.9027)和金黃色葡萄球菌(ATCCNO.6538).在測試中使用活的微生物從原始的培養(yǎng)基移轉(zhuǎn)次數(shù)不得超過五次。為了測試的目的，「移轉(zhuǎn)」的定義是從一個已確定的培養(yǎng)基移到一個新鮮的媒介里。所有的移轉(zhuǎn)均應(yīng)被計算在內(nèi)的。一旦有機(jī)體被以種子庫(seedlot)技術(shù)保存下來時，每個在新鮮媒介里冰凍的，融化的

13、和再生的循環(huán)周期被認(rèn)為是一次轉(zhuǎn)移。Aseedstocktechniqueshouldbeusedflongtermstageofcultures.CulturesreceivedfromtheATCCshouldberesuscitatedaccdingtodirections.Ifgrowninbroththecellsarepelletedbycentrifugation.Resuspendin120ththevolumeoffre

14、shmaintenancebrothaddanequalvolumeof20%(vvinwater)sterileglycerol.Cellsgrownonagarmaybescrapedfromthesurfaceintothe10%glycerolbroth.Dispensesmallaliquotsofthesuspensionintosterilevials.種子存儲技術(shù)將會被使用到培養(yǎng)的長期存儲中。從ATCC得到的培養(yǎng)基將會依

15、照操作方向蘇醒。如果在液體培養(yǎng)基里生長，細(xì)胞會通過離心法的方式被聚集成塊。懸浮在120容量的新鮮的液體培養(yǎng)基里，并添加一個同等容量的20%（VV水里）的無菌的甘油。從表面到10%的甘油液體培養(yǎng)基里可能得到在瓊膠培養(yǎng)基上的細(xì)胞生長。分配小部分的懸浮液到無菌的小瓶里。Stethevialsinliquidnitrogeninamechanicalfreezeratnomethan50.Whenafreshseedstockvialisreq