发布时间 : 星期二 文章美国药典USP31 71 无菌检查法 双语版更新完毕开始阅读ad54fea69b89680202d8250b
将一个或多个供试容器的内容物转移到滤膜，如需要可先使用选定的无菌稀释剂稀释至验证试验中所用体积，但须使用不少于表2和3中规定的供试产品数量。立即过滤。如果该产品具有抗微生物特性，冲洗滤膜不少于3次，每次均将验证试验中所使用的无菌稀释剂体积滤过该滤膜。即便验证中显示5次200mL的冲洗循环没有完全消除抗微生物活性，也不要超越这样一个循环。转移整个滤膜至培养基，或以无菌操作将其切开至相等的2部分，并将每一部分转移至适当的培养基中。每个培养基的体积与验证试验所用的一样。或者，将培养基转移至设备中的滤膜上。培养该培养基，不少于14天。
SOLUBLE SOLIDS (other than antibiotics) 可溶固体（非抗生素）
Use for each medium not less than the quantity prescribed in Tables 2 and 3 of the product dissolved in a suitable solvent, such as Fluid A (Diluting and Rinsing Fluids for Membrane
Filtration), and proceed with the test as described above for Aqueous Solutions using a membrane appropriate to the chosen solvent.
在每个培养基中，使用不少于表2和3规定的产品数量溶于适当溶剂，例如溶液A（用于膜过滤的稀释和冲洗液），并按照上述关于水性溶液的描述，使用适合所选溶剂的滤膜，继续进行该试验。
OILS and OILY SOLUTIONS 油和油性溶液
Use for each medium not less than the quantity of the product prescribed in Tables 2 and 3. Oils and oily solutions of sufficiently low viscosity may be filtered without dilution through a dry membrane. Viscous oils may be diluted as necessary with a suitable sterile diluent such as
isopropyl myristate shown not to have antimicrobial activity in the conditions of the test. Allow the oil to penetrate the membrane by its own weight, and then filter, applying the pressure or suction gradually. Wash the membrane at least three times by filtering through it each time about 100 mL of a suitable sterile solution such as Fluid A (see Diluting and Rinsing Fluids for Membrane Filtration) containing a suitable emulsifying agent at a concentration shown to be appropriate in the validation of the test, for example polysorbate 80 at a concentration of 10 g per L (Fluid K) . Transfer the membrane or membranes to the culture medium or media, or vice versa, as described above for Aqueous Solutions, and incubate at the same temperatures and for the same times.
在每个培养基中，使用不少于表2和3中 描述的产品用量。粘性足够低的油和油性溶液可能在不经稀释的情况下滤过干燥滤膜。如需要，粘稠油质可以用适合的无菌稀释剂进行稀释，例如已证实在该试验条 件下不具有抗微生物活性的豆蔻酸异丙酯。使该油质依靠其自身的重量穿过滤膜，然后逐渐应用压力或抽吸过滤。每次过滤约100mL适当的无菌溶液，例如液体A（见用于膜过滤的稀释和冲洗液），并含有适当乳化剂且其浓度已证实适用于该试验的验证，例如浓度为10克每升的聚山梨酯80（液体K）。将一个或多个滤膜转移到一个或多个培养基，或反之，如上面关于水性溶液的描述，并在相同温度下培养同样的时间。
OINTMENTS and CREAMS 油膏和乳膏
Use for each medium not less than the quantities of the product prescribed in Tables 2 and 3.
Ointments in a fatty base and emulsions of the water-in-oil type may be diluted to 1% in isopropyl myristate as described above, by heating, if necessary, to not more than 40 . In exceptional cases it may be necessary to heat to not more than 44 . Filter as rapidly as possible, and proceed as described above for Oils and Oily Solutions.
在每个培养基中，使用不少于表2和3中描述的产品用量。脂肪状的油膏和水在油中形态乳化剂可以按照上面所述，在豆蔻酸异丙酯中稀释至1%，如需要可加热至不高于40 。在特别情况下，其可能必须加热到不超过44 。尽可能迅速地过滤，并按照上面针对油和油性溶液所述内容继续操作。
PREFILLED SYRINGES 预装填的注射器
For prefilled syringes without attached sterile needles, expel the contents of each syringe into one or two separate membrane filter funnels or into separate pooling vessels prior to transfer. If a separate sterile needle is attached, directly expel the syringe contents as indicated above, and
proceed as directed for Aqueous Solutions. Test the sterility of the needle, using Direct Inoculation under Validation Test.
对于没有附无菌针头的预装填注射器，在转移之前，将每个注射器的内容物排出至一个或两个单独的膜过滤器漏斗，或至若干单独的合并容器。如果附了单独的灭菌针头，直接按照上面的规定将注射器内容物直接排出，并按照关于水性溶液的规定继续进行。使用验证试验项下的直接接种，检查针头的无菌情况。
SOLIDS FOR INJECTION OTHER THAN ANTIBIOTICS 除了抗生素之外的注射用固体 Constitute the test articles as directed on the label, and proceed as directed for Aqueous Solutions or Oils and Oily Solutions, whichever applies. [NOTE—If necessary, excess diluent can be added to aid in the constitution and filtration of the constituted test article.]
按照其标签上的规定配制供试物品，并按照适用的关于水性溶液或油和油性溶液的规定继续进行。[注意：如需要，可以加入额外的稀释剂以帮助对已配制的供试物品进行再配制和过滤]
ANTIBIOTIC SOLIDS FOR INJECTION 用于注射的抗生素
Pharmacy Bulk Packages, < 5 g— From each of 20 containers, aseptically transfer about 300 mg of solids, into a sterile 500-mL conical flask, dissolve in about 200 mL of Fluid A (see Diluting and Rinsing Fluids for Membrane Filtration), and mix; or constitute, as directed in the labeling, each of 20 containers and transfer a quantity of liquid or suspension, equivalent to about 300 mg of solids, into a sterile 500-mL conical flask, dissolve in about 200 mL of Fluid A, and mix. Proceed as directed for Aqueous Solutions or Oils and Oily Solutions, whichever applies. 药房散装< 5 g：取20个容器，每个容器均以无菌操作将约300mg固体转移至一个无菌的500mL锥形烧瓶，溶解于约200mL液体A中（见用于膜过滤的稀释和冲洗液），并混匀；或取20个容器，每个容器均按照标签上的规定配制，并将相当于大约300mg固体的液体或悬浮液转移至一个无菌的500mL锥形烧瓶，溶解于约200mL液体A中，并混匀。按照适合的关于水性溶液或油和油性溶液的规定，继续操作。
Pharmacy Bulk Packages, 5 g— From each of 6 containers, aseptically transfer about 1 g of solids into a sterile 500-mL conical flask, dissolve in about 200 mL of Fluid A, and mix; or constitute, as directed in the labeling, each of 6 containers and transfer a quantity of liquid, equivalent to about 1 g of solids, into a sterile 500-mL conical flask, dissolve in about 200 mL of Fluid A, and mix. Proceed as directed for Aqueous Solutions.
药方散装 5 g：取6个容器，每个均以无菌操作将大约1克的固体转移至一个无菌的500mL锥形烧瓶，溶解于约200mL液体A中，并混匀；或取6个容器，每个均按照标签的规定配制，将相当于1g固体的液体转移至一个无菌的500mL锥形烧瓶，溶解于200mL液体A中，并混匀。按照关于水性溶液的规定，继续操作。
ANTIBIOTIC SOLIDS, BULKS, and BLENDS 抗生素固体、散装品、混合品
Aseptically remove a sufficient quantity of solids from the appropriate amount of containers (see Table 2), mix to obtain a composite, equivalent to about 6 g of solids, and transfer to a sterile 500-mL conical flask. Dissolve in about 200 mL of Fluid A, and mix. Proceed as directed for Aqueous Solutions.
以无菌操作从适当数量的容器中（见表2）取出足够数量的固体，混匀以获得等同于6g固体的混合物，转移至一个无菌的500mL锥形烧瓶。溶解于约200mL液体A中，并混匀。按照关于水性溶液的规定，继续进行。
STERILE AEROSOL PRODUCTS 无菌气(喷)雾剂产品
For fluid products in pressurized aerosol form, freeze the containers in an alcohol-dry ice mixture at least at –20 for about 1 hour. If feasible, allow the propellant to escape before aseptically
opening the container, and transfer the contents to a sterile pooling vessel. Add 100 mL of Fluid D to the pooling vessel, and mix gently. Proceed as directed for Aqueous Solutions or Oils and Oily Solutions, whichever applies.
对于以加压气(喷)雾剂形式存在的液体产品，在大约–20 的酒精－干冰混合物中冷冻容器约1小时。如果可行，在以无菌操作打开容器之前使推进剂散发掉，并将内容物转移至一个无菌的合并容器。加入100mL液体D至该合并容器，并轻轻混匀。按照适合的关于水性溶液或油和油性溶液的规定，继续进行。
DEVICES WITH PATHWAYS LABELED STERILE 具有导管的医疗器具供试品 Aseptically pass not less than 10 pathway volumes of Fluid D through each device tested. Collect the fluids in an appropriate sterile vessel, and proceed as directed for Aqueous Solutions or Oils and Oily Solutions, whichever applies.
以无菌操作用10个通道体积的液体D通过供试设备。在适当的无菌容器中收集冲洗液，并按照适合的关于水性溶液或油和油性溶液的规定，继续进行。
In the case of sterile, empty syringes, draw sterile diluent into the barrel through the sterile needle, if attached, or th, rough a sterile needle attached for the purpose of the test, and express the contents into a sterile pooling vessel. Proceed as directed above.
对于无菌的空注射器，如果附有无菌针头，通过其将无菌稀释剂吸取至管中，或者使用一个专为此试验准备的无菌针头，并将内容物压出至合并容器中。按照上述内容继续进行。
Direct Inoculation of the Culture Medium 培养基的直接接种
Transfer the quantity of the preparation to be examined prescribed in Tables 2 and 3 directly into the culture medium so that the volume of the product is not more than 10% of the volume of the medium, unless otherwise prescribed.
If the product to be examined has antimicrobial activity, carry out the test after neutralizing this with a suitable neutralizing substance or by dilution in a sufficient quantity of culture medium. When it is necessary to use a large volume of the product, it may be preferable to use a
concentrated culture medium prepared in such a way that it takes into account the subsequent dilution. Where appropriate, the concentrated medium may be added directly to the product in its container.
按照表2和3规定的供试配制品 的数量，将该配制品直接转移到培养基中，除非另有规定，产品体积不得超过该培养基体积的10%。如果该供试产品具有抗微生物活性，通过使用适