翻译USP 51
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51ANTIMICROBIAL EFFECTIVENESS TESTING 抗菌的效力测试
Antimicrobial preservatives are substances added to nonsterile dosage forms
to protect them from microbiological growth or from microorganisms that are introduced inadvertently during or subsequent
to the manufacturing process. In the case of sterile articles packaged in multiple-dose containers, antimicrobial
preservatives are added to inhibit the growth of microorganisms that may be introduced from repeatedly withdrawing
individual doses.
抗菌防腐剂是实际被添加到有菌的剂量形式里，来使他们不受微生物滋长或微生物侵害，被无意地引进到生产的过程中。在无菌包装多剂量的容器里，抗菌的防腐剂被添加来抑制微生物的滋长，这可能从重复地抽出单个剂量来引进。
Antimicrobial preservatives should not be used as a substitute for good manufacturing practices or solely to reduce the
viable microbial population of a nonsterile product or control the presterilization bioburden of multidose formulations during
manufacturing. Antimicrobial preservatives in compendial dosage forms meet the requirements for Added
Substancesunder Ingredients and Processesin the General Notices. 抗菌的防腐剂将不会被作为一个替代在商品生产中使用，或唯一地来减少一个有菌产品的有用的微生物群或在生产时控制多剂量的微生物量。在剂量表里抗菌防腐剂与添加的要求相符。
All useful antimicrobial agents are toxic substances. For maximum protection of patients, the concentration of the
preservative shown to be effective in the final packaged product should be below a level that may be toxic to human beings.
The concentration of an added antimicrobial preservative can be kept at a minimum if the active ingredients of the
formulation possess an intrinsic antimicrobial activity. Antimicrobial effectiveness, whether inherent in the product or
whether produced because of the addition of an antimicrobial preservative, must be demonstrated for all injections
packaged in multiple-dose containers or for other products containing antimicrobial preservatives. Antimicrobial
effectiveness must be demonstrated for multiple-dose topical and oral dosage forms and for other dosage forms such as
ophthalmic, otic, nasal, irrigation, and dialysis fluids (see Pharmaceutical Dosage Forms 1151).
所有有用的抗菌的介质是有毒的物质。为了实现最大的保护值，防腐剂的含量会被有效地显示在产品的最终包装上。将会在一个可能对人类有毒的水平线下。添加的抗菌防腐剂含量能够被保持在一个最小的值，如果配方的活性成分具有一个固定的抗菌力。抗菌的效力，不管产品里固有的或者是否生产，由于添加的一个抗菌防腐剂，必须在所有注入包装的多剂量容器里或其它包含抗菌防腐剂的产品上显示。抗菌防腐剂必须被显示在多剂量和口头剂型和给其它剂型如眼药，耳药，鼻药，冲洗的和透析液。(看 Pharmaceutical Dosage Forms 1151).
This chapter provides tests to demonstrate the effectiveness of antimicrobial protection. Added antimicrobial preservatives
must be declared on the label. The tests and criteria for effectiveness apply to a product in the original, unopened container
in which it was distributed by the manufacturer.
这篇提供测试来显示抗菌保护的效力。添加的抗菌防腐剂必须显示在标签上。效力的测试和标准适用于一个产品在原始的，没打开过的通过制造商销售的容器里。
PRODUCT CATEGORIES 产品分类
For the purpose of testing, compendial articles have been divided into four categories (see Table 1).The criteria of
antimicrobial effectiveness for these products are a function of the route of administration.
由于测试的目的，物品被分开为四个分类（看table 1）。抗菌效力的标准对于这些产品是一个执行路线的作用。
Table pendial Product Categories
Category Product Description
1 Injections, other parenterals including
emulsions, otic products, sterile nasal
products, and ophthalmic products made
with aqueous bases or vehicles.
2 Topically used products made with aqueous
bases or vehicles, nonsterile nasal products,
and emulsions, including those applied
to mucous membranes.
3 Oral products other than antacids, made with
aqueous bases or vehicles.
4 Antacids made with an aqueous base.
TEST ORGANISMS 测试有机体
Use cultures of the following microorganisms1:Candida albicans ( ATCC No.10231), Aspergillus niger(ATCC
No.16404),Escherichia coli(ATCC No.8739),Pseudomonas aeruginosa ( ATCC No.9027),and Staphylococcus aureus
( ATCC No.6538).The viable microorganisms used in the test must not be more than five passages removed from the
original ATCC culture. For purposes of the test, one passage is defined as the transfer of organisms from an established
culture to fresh medium. All transfers are counted. In the case of organisms maintained by seed-lot techniques, each cycle
of freezing, thawing, and revival in fresh medium is taken as one transfer.
使用以下微生物的培养菌：白念珠菌（ATCC NO.10231）,黑曲霉（ATCC NO.16404）,大肠杆菌（ATCC NO.8739）,假单胞菌 aeruginosa(ATCC no.9027),和葡萄球菌aureus ( ATCC NO.6538). 在测试中里使用的活的微生物从原始的ATCC 培养菌移除必须不超过五个通道。由于测试的目的，从一个确定的培养菌到新鲜的媒介，一个通道被定义为有机体的转移。所有的转移是被计数的。一旦有机体被通过seed-lot 技术培养，每个在新鲜媒介里冰冻的，融化的和再生的周期被认为一个转移。
A seed-stock technique should be used for long-term storage of cultures. Cultures received from the ATCC should be
resuscitated according to directions. If grown in broth, the cells are pelleted by centrifugation. Resuspend in 1/20th the
volume of fresh maintenance broth, and add an equal volume of 20%(v/v in water)sterile glycerol. Cells grown on agar may
