USPNF发补内容.docx

1、USPNF发补内容First supplement, USP-NF 发补1，USP-NFSoybean-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:7.30.2 灭菌后pH值：7.30.2Dissolve the solids in the purified water, heating slightly to effect a s

2、olution. Cool the solution to room temperature, and adjust the pH within 1N sodium hydroxide so that, after sterilization, it will have a PH of 7.30.2. Filter, if necessary to clarify, dispense into suitable containers, and sterilize using a validated procedure. Store at a temperature between 2 and

3、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。S

4、oybean-Casein Digest Medium is to be incubated at 22.52.5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 t

5、he preparation of Fluid Thioglycollate Medium and the SoybeanCasein Digest Medium as follows. To the containers of each medium, transfer aseptically a quantity of-lactamase sufficient to inactivate the amount of antibiotic in the specimen under test. Determine the quantity of-lactamase required to i

6、nactivate the antibiotic by using a-lactamase preparation that has been assayed previously for its penicillin- or cephalosporin-inactivating power. NOTESupplemented -lactamase 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

7、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 separate from that used for sterility testing), confirm that an appropriate amount of -lactamase is incorporated into the medium, following

8、 either method under .Method suitability Test, using less than 100 colony-forming units (cfu) of Staphylococcus aureus (see Table 1) as the challenge. Typical microbial growth of the inoculated culture must be observed as a confirmation that the -lactamase concentration is appropriate. 或者（在与无菌试验所用场所

9、彻底隔离的区域中），按照适应性试验方法项下的任意一种方法，使用少于100个菌落（cfu）的金黄色葡萄球菌（见表1）作为挑战，来确认适当数量的 -内酰胺酶已经被整合到该培养基中。必须观测到接种后培养物中出现典型微生物生长，才能确认 -内酰胺酶浓度是适当的。Table 1. Strains of the Test Microorganisms Suitable for Use in the Growth Promotion Test and theValidation Test 表1 适合用于生长促进试验和验证试验中的试验微生物的菌株Staphylococcus aureus 1 金黄色葡萄球菌A

10、TCC 6538, CIP 4.83, NCTC 10788, NCIMB 9518Bacillus subtilis枯草芽孢杆菌ATCC 6633, CIP 52.62, NCIMB 8054,NBRC3134Pseudomonas aeruginosa 2 绿脓杆菌ATCC 9027, NCIMB 8626, CIP 82.118,NBRC13275Anaerobic bacterium厌氧菌Clostridium sporogenes 3 产芽胞梭状芽胞杆菌ATCC 19404, CIP 79.3, NCTC 532 or ATCC 11437,NBRC14293Fungi霉菌Candi

11、da albicans白色念珠菌ATCC 10231, IP 48.72, NCPF 3179,NBRC 1594Aspergillus niger黑曲霉ATCC 16404, IP 1431.83, IMI 149007,NBRC 9455The media used comply with the following tests, carried out before, or in parallel, with the test on the product to be examined.所使用的培养基须符合下列试验，这些试验应在检验供试产品之前或者同时进行。Microbiological

12、 test 微生物检测 Sterility tests: 无菌试验STERILITY 无菌状态Incubate portions of the media for 14 days. No growth of microorganisms occurs.将一部分培养基培养14天，不得出现微生物生长。GROWTH PROMOTION TEST OF AEROBES, ANAEROBES, and FUNGI 好氧菌、厌氧菌、霉菌的生长促进试验Test each lot of ready-prepared medium and each batch of medium prepared either

13、 from dehydrated medium or from ingredients 1 . Suitable strains of microorganisms are indicated in Table 1.检查每一批已经配制好的培养基和每一批用脱水培养基或配料制备的培养基 1 。适当微生物菌株见表1。Inoculate portions of Fluid Thioglycollate Medium with a small number (not more than 100 cfu) of the following microorganisms, using a separate

14、portion of medium for each of the following species of microorganism: Clostridium sporogenes, Pseudomonas aeruginosa, and Staphylococcus aureus. Inoculate portions of Alternative thioglycollate medium with a small number (not more than 100 cfu) of Clostridium sporogenes. Inoculate portions of Soybea

15、nCasein Digest Medium with a small number (not more than 100 cfu) of the following microorganisms, using a separate portion of medium for each of the following species of microorganism: Aspergillus niger, Bacillus subtilis, and Candida albicans. Incubate for not more than 3 days in the case of bacte

16、ria and not more than 5 days in the case of fungi.在部分巯基醋酸盐液体培养基上接种少量（不超过100cfu）下列微生物，每一种微生物均使用单独一部分培养基：产芽胞梭状芽胞杆菌、绿脓杆菌、金黄色葡萄球菌。 在部分替代巯基醋酸盐液体培养基上接种少量（不超过100cfu）产芽胞梭状芽胞杆菌。 在部分大豆-酪蛋白消化物培养基上接种少量（不超过100cfu）下列微生物，每一种微生物均使用单独一部分的培养基：黑曲霉、枯草芽孢杆菌、白色念珠菌。细菌培养时间不超过3天，霉菌培养时间不超过5天。The media are suitable if a clearl

17、y visible growth of the microorganisms occurs.如果出现清晰可见的微生物生长，则该培养基是适合的。Change to read: 方法适应试验Carry out a test as described below under Test for Sterility of the Product to be Examined using exactly the same methods, except for the following modifications.按照下面供试产品无菌检查项下的描述，使用除了下面变更之外完全相同的方法，进行试验。Memb

18、rane Filtration 膜过滤After transferring the content of the container or containers to be tested to the membrane, add an inoculum of a small number of viable microorganisms (not more than 100 cfu) to the final portion of sterile diluent used to rinse the filter.在将一个或多个供试容器中的内容物转移到滤膜之后，在最后一次的冲洗液中加入少量（不超

19、过100cfu）试验菌.Direct Inoculation 直接接种After transferring the contents of the container or containers to be tested (for catgut and other surgical sutures for veterinary use: strands) to the culture medium, add an inoculum of a small number of viable microorganisms (not more than 100 cfu) to the medium.在

20、将一个或多个供试容器（对于兽医的肠线和其他外科缝合用线：若干股线）中的内容物转移至培养基之后，将少量试验菌（不超过100cfu）加入至培养基中。In both cases use the same microorganisms as those described above under Growth Promotion Test of Aerobes, Anaerobes, and Fungi. Perform a growth promotion test as a positive control. Incubate all the containers containing mediu

21、m for not more than 5 days.在这两种情况中，均按照上述好氧菌、厌氧菌、霉菌生长促进试验项下的描述，使用同样的微生物。进行一个生长促进试验作为阳性对照。培养所有含有培养基的容器，培养时间不超过5天。If clearly visible growth of microorganisms is obtained after the incubation, visually comparable to that in the control vessel without product, either the product possesses no antimicrobia

22、l activity under the conditions of the test or such activity has been satisfactorily eliminated. The test for sterility may then be carried out without further modification.如果在培养后得到清晰可见的微生物生长，看起来与没有产品的对照容器中的生长类似，则该产品在此试验条件下没有任何抗微生物活性，或者此活性已经被令人满意地消除了。然后，无菌试验可以进行，而无需进一步的变更。If clearly visible growth i

23、s not obtained in the presence of the product to be tested, visually comparable to that in the control vessels without product, the product possesses antimicrobial activity that has not been satisfactorily eliminated under the conditions of the test. Modify the conditions in order to eliminate the a

24、ntimicrobial activity, and repeat the method suitability test.如果用肉眼与没有产品的对照容器比较，无法在存在供试产品的情况下得到清晰可见的生长，则该产品在试验条件下所具有的抗微生物活性尚未令人满意地消除。变更条件以便消除抗微生物活性，并重复方法适应性试验。This method suitability is performed (a) when the test for sterility has to be carried out on a new product; and (b) whenever there is a chan

25、ge in the experimental conditions of the test. The method suitability may be performed simultaneously with the Test for Sterility of the Product to be Examined.当(a)一个新产品必须进行无菌试验时，和(b)无论何时该试验的试验条件发生改变时，则需进行此方法适应性。该方法适应性可以与供试产品的无菌试验同时进行。Change to read:TEST FOR STERILITY OF THE PRODUCT TO BE EXAMINED 供

26、试产品的无菌检查Number of Articles to Be Tested 供试物品数量Unless otherwise specified elsewhere in this chapter or in the individual monograph, test the number of articles specified in Table 3. If the contents of each article are of sufficient quantity (see Table 2), they may be divided so that equal appropriate

27、 portions are added to each of the specified media. NOTEPerform sterility testing employing two or more of the specified media. If each article does not contain sufficient quantities for each medium, use twice the number of articles indicated in Table 3. 除非在此章节的其他位置或在具体的各论中另有规定，供试物品的数量遵照表3中的规定。如果每个物

28、品的内容物有足够数量（见表2），可以将其分成若干等份，将适当的等份加入到每个指定的培养基。注意：使用两个或更多指定培养基，来进行无菌试验。如果每个物品内容物的数量不够每个培养基的用量，使用表3中所规定物品数量的2倍。The test may be carried out using the technique of Membrane Filtration or by Direct Inoculation of the Culture Medium with the product to be examined. Appropriate negative controls are include

29、d. The technique of membrane filtration is used whenever the nature of the product permits; that is, for filterable aqueous preparations, for alcoholic or oily preparations, and for preparations miscible with, or soluble in, aqueous or oily solvents, provided these solvents do not have an antimicrob

30、ial effect in the conditions of the test.此试验可以使用膜过滤法或培养基直接接种法进行。应包括多个适当的阴性对照。只要该产品的性质许可，就应使用膜过滤法；这些性质是，可过滤的水溶性配制品、酒精或油性配制品、易混合或溶解于水或油性溶剂的配制品，只要这些溶剂在试验条件下没有抗生素效果。Table 2. Minimum Quantity to be Used for Each Medium 表2：用于每个培养基的最小数量Quantity per Container每个容器中的数量Minimum Quantity to be Used (unless other

31、wise justified and authorized)最小使用数量(除非另有依据和授权)Liquids 液体Less than 1 mL少于1mLThe whole contents of each container每个容器的总内容物140 mLHalf the contents of each container, but not less than 1 mL每个容器中内容物的一半，但不得少于1mLGreater than 40 mL, and not greater than 100 mL大于40mL，但不大于100mLGreater than 100 mL大于100mL10% o

32、f the contents of the container, but not less than 20 mL该容器内容物的10%，但不得少于20mLAntibiotic liquids抗生素液体1 mLInsoluble preparations, creams, and ointments to be suspended or emulsified待悬浮或乳化的不溶性配制品、乳膏、油膏Use the contents of each container to provide not less than 200 mg使用每个容器的内容物，以提供不少于200mgSolids固体Less than 50 mg少于50mgThe whole contents of each container每个容器的全部内容物50 mg or more, but less than 300 mg50mg或者更多，但少于300mgHalf the content