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1、欧洲药典无菌检验-sterility中英文翻译261. STERILITY261无菌检查法The test is applied to substa nces, preparati ons or articles which, accord ing to the Pharmacopoeia, are required to be sterile. However, a satisfactory result only in dicates that no con tam in ati ng micro-orga nism has bee n found in the sample exam i
2、ned in the con diti ons of the test.本检查方法适用于按照药典要求应当无菌的原料、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。PRECAUTIONS AGAINST MICROBIAL CONTAMINATION微生物污染防范The test for sterility is carried out under aseptic conditions. In order to achieve such con diti ons, the test en vir onment has to be adapte
3、d to the way in which the sterility test is performed. The precautions taken to avoid con tam in ati on are such that they do not affect any micro-orga ni sms which are to be revealed in the test. The working conditions in which the tests are performed are moni tored regularly by appropriate sampli
4、ng of the worki ng area and by carry ing out appropriate con trols.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。CULTURE MEDIA AND INCUBATION TEMPERATURES培养基和培养温度Media for the test may be prepared as describ
5、ed below, or equivale nt commercial media may be used provided that they comply with the growth promoti on test.应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）The follow ing culture media have bee n found to be suitable for the test for sterility. Fluid thioglycollate medium is pr
6、imarily in ten ded for the culture of an aerobic bacteria; however, it will also detect aerobic bacteria. Soya -bea n case in digest medium is suitable for the culture of both fungi and aerobic bacteria.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。Fluid thioglycol
7、late medium硫乙醇酸盐流体培养基L-Cysti ne0.5 gL-胱氨酸0.5gAgar 0.75 g琼脂0.75gSodium chloride 2.5 g 氯化钠2.5gGlucose mon ohydrate/a nhydrous5.5 g/5.0 g葡萄糖一水合物/无水葡萄糖5.5 g/5.0 gYeast extract （water-soluble） 5.0 g酵母提取物（水溶性）5.0gPan creatic digest of case in 15.0 g酪蛋白胰酶消化物15.0gSodium thioglycollate or 0.5 g硫乙醇酸钠0.5gThiog
8、lycollic acid 0.3 mL硫乙醇酸0.3mlResazurin sodium solution （1 g/L of resazurin1.0 mLsodium）, freshly prepared刃天青钠溶液（刃天青钠1 g/L），新鲜配制Water R 1000 mL水 R 1000mlpH after sterilisation 7.1 0.2灭菌后的pH 7.1 0.2Mix the L-cystine, agar, sodium chloride, glucose, water-soluble yeast extract and pan creatic digest of
9、 case in with the water R and heat un til soluti on is effected. Dissolve the sodium thioglycollate or thioglycollic acid in the soluti on and, if necessary, add 1 M sodium hydroxide so that, after sterilisation, the solution will have a pH of 7.10.2. If fiation is necessary, heat the solutionagain
10、without boiling and filter while hot through moistened filter paper. Add the resazurin sodium solution, mix and place the medium in suitable vessels which provide a ratio of surface to depth of medium such that not more than the upper half of the medium has un dergo n e a colour change indicative of
11、 oxygen uptake at the end of the incubation period. Sterilise using a validated process. If the medium is stored, store at a temperature betwee n 2C and 25C in a sterile, airtight contain er. If morethan the upper on e-third of the medium has acquired a pink colour, the medium may be restored once b
12、y heati ng the containers in a water-bath or in free-flow ing steam un til the pink colour disappears and cooli ng quickly, tak ing care to prevent the introduction of non -sterile air into the container.Do not use the medium for a Ion ger storage period tha n has bee n validated.将L-胱氨酸、琼脂、氯化钠、葡萄糖、水
13、溶性酵母提取物以及酪蛋白胰酶 消化物与水R混合，加热至溶解。将硫乙醇酸钠或硫乙醇酸用上述溶液溶解， 必要时用1M氢氧化钠调节pH值，使灭菌后培养基溶液的pH值为7.1 0.2。 如需要过滤处理，将溶液在此加热（加热此溶液），但不得煮到沸腾，乘热采 用经润湿的滤纸进行过滤。加入刃天青钠溶液，混合均匀，将制备的培养基装 入合适的容器中。在该容器中，培养基的表面和高度应具有恰当的比例，以便 在灭菌结束后指示氧气摄入的颜色变化不超过培养基的上半部分。采用经验证 的工艺灭菌。如果需要保存，将培养基装入无菌、气密容器并在2-25 C 之间储存。如果培养基的上面超过1/3的部分已经出现粉红色，将装有培养基的
14、容器 采用水浴或自由流动蒸气加热，直到粉红颜色消失，之后快速冷却，注意预防 非无菌的气体被引入装培养基的容器，以此进行培养基再生处理。如果培养基 保存的时间超过经验证的保存期限，不得使用。（禁止使用超过验证储存期限 的培养基）Fluid thioglycollate medium is to be in cubated at 30-35 C. For products containing a mercurial preservative that cannot be tested by themembra ne-filtratio n method, fluid thioglycollate
15、 medium in cubated at 20-25 C may be used in stead of soya-bea n case in digest medium provided that it has bee n validated as described in growth promoti on test.硫乙醇酸盐流体培养基用于（应）在30-35 C条件下培养。对于含有汞类防腐剂无法采用薄膜过滤法进行检查的产品，如果已按照生长促进试验所述方 法验证，硫乙醇酸盐流体培养基可代替替代重复大豆酪蛋白消化物培养基在 20-25 C条件下进行培养。Where prescribed o
16、r justified and authorised, the follow ing alter native thioglycollate medium may be used. Prepare a mixture having the same composition as that of the fluid thioglycollate medium, but omitting the agar and the resazuri n sodium soluti on, sterilise as directed above. The pH after sterilisation is 7.10.2. Het in a water-bath prior to use and incubate at30-35 C un der an
