usp-51抗菌效力測(cè)試

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

2、gsubsequenttothemanufacturingprocess.Inthecaseofsterilearticlespackagedinmultipledosecontainersantimicrobialpreservativesareaddedtoinhibitthegrowthofmicroganismsthatmaybeintroducedfromrepeatedlywithdrawingindividualdoses

3、.抗菌防腐劑是實(shí)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(zhǎng)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(zhǎng)。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(gè)有菌產(chǎn)品的微生物群數(shù)量，或是在生產(chǎn)時(shí)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(huì)處在一個(gè)可能對(duì)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(gè)最小的濃度，如果配方的活性成分具有一個(gè)固定的抗菌力?？咕男Я?，不管是產(chǎn)品里固有的或者是生產(chǎn)中usp51抗菌效力測(cè)試.doc第3頁，共8頁TESTGANISMS測(cè)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(cè)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(cè)試的目的，「移轉(zhuǎn)」的定義是從一個(gè)已確定的培養(yǎng)基移到一個(gè)新鮮的媒介里。所有的移轉(zhuǎn)均應(yīng)被計(jì)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(shí)，每個(gè)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(chǔ)技術(shù)將會(huì)被使用到培養(yǎng)的長(zhǎng)期存儲(chǔ)中。從ATCC得到的培養(yǎng)基將會(huì)依

15、照操作方向蘇醒。如果在液體培養(yǎng)基里生長(zhǎng)，細(xì)胞會(huì)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(gè)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(zhǎng)。分配小部分的懸浮液到無菌的小瓶里。Stethevialsinliquidnitrogeninamechanicalfreezeratnomethan50.Whenafreshseedstockvialisreq