欧洲药典EP8.0-2.6.1无菌检验-sterility中英文翻译.doc

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1、2.6.1.STERILITY2.6.1无菌检查法Thetestisappliedtosubstances,preparationsorarticleswhich,accordingtothePharmacopoeia,arerequiredtobesterile.However,asatisfactoryresultonlyindicatesthatnocontaminatingmicro-organismhasbeenfoundinthesampleexaminedintheconditionsofthetest.本检查方法适用于按照药典要求

2、应当无菌的原料、制剂或其他物质。但是，如果按照本无菌检查法的结果符合要求，仅表明在该检查条件下未发现微生物污染。PRECAUTIONSAGAINSTMICROBIALCONTAMINATION微生物污染防范Thetestforsterilityiscarriedoutunderasepticconditions.Inordertoachievesuchconditions,thetestenvironmenthastobeadaptedtothewayinwhichthesterilitytestisperformed.Theprecaution

3、stakentoavoidcontaminationaresuchthattheydonotaffectanymicro-organismswhicharetoberevealedinthetest.Theworkingconditionsinwhichthetestsareperformedaremonitoredregularlybyappropriatesamplingoftheworkingareaandbycarryingoutappropriatecontrols.无菌检测试验应在无菌的条件下进行。为了达到这样的条件，检测环境应当与无

4、菌检测的操作要求相适应。避免污染的防范措施应当不对本检查方法进行检测的微生物造成影响（应并不影响用本检查法检测的微生物）。通过对工作区域的适当取样以及进行适当的控制来对无菌检查的工作环境进行例行监测。CULTUREMEDIAANDINCUBATIONTEMPERATURES培养基和培养温度Mediaforthetestmaybepreparedasdescribedbelow,orequivalentcommercialmediamaybeusedprovidedthattheycomplywiththegrowthpromotiontest.应

5、按下面描述的方法制备无菌检查的培养介质，如果满足生长促进试验要求，与本处所述培养基相当的商业化培养基也可以采用（也可采用与本处……）。Thefollowingculturemediahavebeenfoundtobesuitableforthetestforsterility.Fluidthioglycollatemediumisprimarilyintendedforthecultureofanaerobicbacteria;however,itwillalsodetectaerobicbacteria.Soya-beancaseindiges

6、tmediumissuitableforthecultureofbothfungiandaerobicbacteria.下述的培养基已被证明（经证明）适用于无菌检查。硫乙醇酸盐流体培养基主要用于厌氧菌培养，但是，也适用于需氧菌检测。大豆酪蛋白消化物培养基适用于真菌和需氧菌培养。Fluidthioglycollatemedium硫乙醇酸盐流体培养基L-Cystine0.5gL-胱氨酸0.5gAgar0.75g琼脂0.75gSodiumchloride2.5g氯化钠2.5gGlucosemonohydrate/anhydrous5.5g/5.0g葡萄

7、糖一水合物/无水葡萄糖5.5g/5.0gYeastextract(water-soluble)5.0g酵母提取物（水溶性）5.0gPancreaticdigestofcasein15.0g酪蛋白胰酶消化物15.0gSodiumthioglycollateor0.5g硫乙醇酸钠0.5gThioglycollicacid0.3mL硫乙醇酸0.3mlResazurinsodiumsolution(1g/Lofresazurin1.0mLsodium),freshlyprepared刃天青钠溶液（刃天青钠1g/L），新鲜配制WaterR1000mL水R1

8、000mlpHaftersterilisation7.1±0.2灭菌后的pH7.1±0.2MixtheL-cystine,agar,so