美國(guó)藥典usp31-nf26無(wú)菌檢查法(編輯修改稿)

　

【文章內(nèi)容簡(jiǎn)介】 suitable if a clearly visible growth of the microorganisms occurs.如果出現(xiàn)清晰可見(jiàn)的微生物生長(zhǎng)，則該培養(yǎng)基是適合的。STORAGE 保存If prepared media are stored in unsealed containers, they can be used for 1 month, provided that they are tested for growth promotion within 2 weeks of the time of use and that color indicator requirements are met. If stored in tight containers, the media can be used for 1 year, provided that they are tested for growth promotion within 3 months of the time of use and that the color indicator requirements are met. 如果配制好的培養(yǎng)基保存于未密閉的容器中，只要在使用時(shí)間的2周內(nèi)對(duì)其進(jìn)行了生長(zhǎng)促進(jìn)試驗(yàn)并且符合顏色指示劑的要求，它們就可以使用1個(gè)月。如果保存在密閉的容器中，只要在使用時(shí)間的3個(gè)月內(nèi)對(duì)其進(jìn)行了生長(zhǎng)促進(jìn)試驗(yàn)并且符合顏色指示劑的要求，則該培養(yǎng)基可以使用1年。DILUTING AND RINSING FLUIDS FOR MEMBRANE FILTRATION 用于膜過(guò)濾的稀釋和沖洗液Fluid A 液體APREPARATION 配制品Dissolve 1 g of peptic digest of animal tissue in water to make 1 L, filter or centrifuge to clarify, if necessary, and adjust to a pH of 177。 . Dispense into containers, and sterilize using a validated process.將1g動(dòng)物組織胃蛋白酶消化物溶于1L水中，如果需要?jiǎng)t通過(guò)濾或離心使其澄清， 177。 。分裝入容器中，并用經(jīng)過(guò)驗(yàn)證的工藝滅菌。PREPARATION FOR PENICILLINS OR CEPHALOSPORINS用于青霉素或頭孢菌素的配制品Aseptically add to the above Preparation, if necessary, a quantity of sterile lactamase sufficient to inactivate any residual antibiotic activity on the membranes after the solution of the test specimen has been filtered (see Media for Penicillins or Cephalosporins).在供試樣品溶液已經(jīng)過(guò)濾（見(jiàn)用于青霉素或頭孢菌素的培養(yǎng)基）之后，如果需要，向上述配制品中，以無(wú)菌操作加入數(shù)量足夠滅活濾膜上殘余抗生素活性的 內(nèi)酰胺酶。Fluid D 液體DTo each L of Fluid A add 1 mL of polysorbate 80, adjust to a pH of 177。 , dispense into containers, and sterilize using a validated process. Use this fluid for articles containing lecithin or oil, or for devices labeled as “sterile pathway.”向每升液體A中，加入1mL聚山梨酯80， 177。 ，分裝入容器中，并使用經(jīng)過(guò)驗(yàn)證的工藝滅菌。此液體用于含有卵磷脂或油脂的物品，或用于標(biāo)為 “無(wú)菌通道”的設(shè)備。Fluid K 液體KDissolve g of peptic digest of animal tissue, g of beef extract, and g of polysorbate 80 in water to make 1 L. Adjust the pH to obtain, after sterilization, a pH of 177。 . Dispense into containers, and sterilize using a validated process. 、。調(diào)節(jié)pH值， 177。 。分裝入容器中，并使用經(jīng)過(guò)驗(yàn)證的工藝滅菌。VALIDATION TEST 驗(yàn)證試驗(yàn)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.按照下面供試產(chǎn)品無(wú)菌檢查項(xiàng)下的描述，使用除了下面變更之外完全相同的方法，進(jìn)行試驗(yàn)。Membrane Filtration 膜過(guò)濾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.在將一個(gè)或多個(gè)供試容器中的內(nèi)容物轉(zhuǎn)移到濾膜之后，在最后一次的沖洗液中加入少量（不超過(guò)100cfu）試驗(yàn)菌.Direct Inoculation 直接接種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.在將一個(gè)或多個(gè)供試容器（對(duì)于獸醫(yī)的腸線(xiàn)和其他外科縫合用線(xiàn)：若干股線(xiàn)）中的內(nèi)容物轉(zhuǎn)移至培養(yǎng)基之后，將少量試驗(yàn)菌（不超過(guò)100cfu）加入至培養(yǎng)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 medium for not more than 5 days.在這兩種情況中，均按照上述好氧菌、厭氧菌、霉菌生長(zhǎng)促進(jìn)試驗(yàn)項(xiàng)下的描述，使用同樣的微生物。進(jìn)行一個(gè)生長(zhǎng)促進(jìn)試驗(yàn)作為陽(yáng)性對(duì)照。培養(yǎng)所有含有培養(yǎng)基的容器，培養(yǎng)時(shí)間不超過(guò)5天。If clearly visible growth of microorganisms is obtained after the incubation, visually parable to that in the control vessel without product, either the product possesses no antimicrobial 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.如果在培養(yǎng)后得到清晰可見(jiàn)的微生物生長(zhǎng)，看起來(lái)與沒(méi)有產(chǎn)品的對(duì)照容器中的生長(zhǎng)類(lèi)似，則該產(chǎn)品在此試驗(yàn)條件下沒(méi)有任何抗微生物活性，或者此活性已經(jīng)被令人滿(mǎn)意地消除了。然后，無(wú)菌試驗(yàn)可以進(jìn)行，而無(wú)需進(jìn)一步的變更。If clearly visible growth is not obtained in the presence of the product to be tested, visually parable 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 antimicrobial activity, and repeat the validation test.如果用肉眼與沒(méi)有產(chǎn)品的對(duì)照容器比較，無(wú)法在存在供試產(chǎn)品的情況下得到清晰可見(jiàn)的生長(zhǎng)，則該產(chǎn)品在試驗(yàn)條件下所具有的抗微生物活性尚未令人滿(mǎn)意地消除。變更條件以便消除抗微生物活性，并重復(fù)驗(yàn)證試驗(yàn)。This validation is performed (a) when the test for sterility has to be carried out on a new product。 and (b) whenever there is a change in the experimental conditions of the test. The validation may be performed simultaneously with the Test for Sterility of the Product to be Examined.當(dāng)(a)一個(gè)新產(chǎn)品必須進(jìn)行無(wú)菌試驗(yàn)時(shí)，和(b)無(wú)論何時(shí)該試驗(yàn)的試驗(yàn)條件發(fā)生改變時(shí)，則需進(jìn)行此驗(yàn)證試驗(yàn)。該驗(yàn)證可以與供試產(chǎn)品的無(wú)菌試驗(yàn)同時(shí)進(jìn)行。TEST FOR STERILITY OF THE PRODUCT TO BE EXAMINED 供試產(chǎn)品的無(wú)菌檢查Number of Articles to Be Tested 供試物品數(shù)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 portions are added to each of the specified media. [NOTE—Perform 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. 除非在此章節(jié)的其他位置或在具體的各論中另有規(guī)定，供試物品的數(shù)量遵照表3中的規(guī)定。如果每個(gè)物品的內(nèi)容物有足夠數(shù)量（見(jiàn)表2），可以將其分成若干等份，將適當(dāng)?shù)牡确菁尤氲矫總€(gè)指定的培養(yǎng)基。[注意：使用兩個(gè)或更多指定培養(yǎng)基，來(lái)進(jìn)行無(wú)菌試驗(yàn)。]如果每個(gè)物品內(nèi)容物的數(shù)量不夠每個(gè)培養(yǎng)基的用量，使用表3中所規(guī)定物品數(shù)量的2倍。Table 2. Minimum Quantity to be Used for Each Medium 表2：用于每個(gè)培養(yǎng)基的最小數(shù)量Quantity per Container每個(gè)容器中的數(shù)量Minimum Quantity to be Used (unless otherwise justified and authorized)最小使用數(shù)量(除非另有依據(jù)和授權(quán))Liquids (other than anitbiotics)液體(除了抗生素)Less than 1 mL少于1mLThe whole contents of each container每個(gè)容器的總內(nèi)容物1–40 mLHalf the contents of each container, but not less than 1 mL每個(gè)容器中內(nèi)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100mL20 mLGreater than 100 mL大于100mL10% of the contents of the container, but not less than 20 mL