USP微生物限度及无菌检验方法2.doc

USP微生物限度及无菌检验方法1 First supplement, USP-NF 发补1，USP-NF Soybean-casein digest medium (continued) 大豆蛋白消化酶（继续） Dibasic Potassium Phosphate二盐基亚磷酸钾Dextrose Monohydrate/Anhydrous葡萄糖一水/无水Purified water纯化水pH after sterilization:7.3±0.2 灭菌后pH值7.3±0.2 Dissolve the solids in the purified water, heating slightly to effect a solution. Cool the solution to room temperature, and adjust the pH within 1N sodium hydroxide so that, after sterilization, it will have a PH of 7.3±0.2. Filter, if necessary to clarify, dispense into suitable containers, and sterilize using a validated procedure. Store at a temperature between 2° and 25° in a sterile well-closed container, unless it is intended for immediate use. Do not use the medium for a longer storage period than has been validated. 将固体物质溶解于纯净水，轻微加热以实现溶解。放凉溶液至室温，并用1N氢氧化钠调整pH值，以便在灭菌后其pH值呈7.3 ± 0.2。过滤，如需要则使之澄清，分装入适合的容器，并用经过验证的程序消毒。如果不立刻使用，则在2 到25 度之间以无菌且密闭良好的容器保存。不要使用储存器超过验证期的酶。 Soybean-Casein Digest Medium is to be incubated at 22.5±2.5°大豆-酪蛋白消化物培养基将在22.5 ± 2.5 条件下培养Media for Penicillins or Cephalosporins 用于青霉素和头孢菌素的培养基Where sterility test media are to be used in the Direct Inoculation of the Culture Medium method under Test for Sterility of the Product to be Examined, modify the preparation of Fluid Thioglycollate Medium and the Soybean–Casein Digest Medium as follows. To the containers of each medium, transfer aseptically a quantity ofβ-lactamase sufficient to inactivate the amount of antibiotic in the specimen under test. Determine the quantity ofβ-lactamase required to inactivate the antibiotic by using aβ-lactamase preparation that has been assayed previously for its penicillin- or cephalosporin-inactivating power. [NOTE—Supplemented -βlactamase media can also be used in the membrane filtration test.] 当无菌检查培养基用于供试产品无菌检查项下的培养基直接接种法时，按如下内容变更巯基醋酸盐液体培养基和大豆-酪蛋白消化物培养基的制备方法。向每一种培养基的容器中，以无菌操作转移足够灭活供试样品中所存在抗生素的 -内酰胺酶。使用此前已经对其青霉素或头孢菌素灭活能力进行了测定的 -内酰胺酶配制品，来测定灭活该抗生素所必需的 -内酰胺酶数量。[注意：补充的 -内酰胺酶培养基也可以用于膜过滤试验]Alternatively (in an area completely sep