倒装句英语结构【最新整理，下载后即可编辑】
51 ANTIMICROBIAL EFFECTIVENESS TESTING 抗菌的效力测试
Antimicrobial prervatives are substances added to nonsterile dosage forms to protect them from microbiological growth or from microorganisms that are introduced inadvertently during or subquent to the manufacturing process. In the ca of sterile articles packaged in multiple-do containers, antimicrobial prervatives are added to inhibit the growth of microorganisms that may be introduced from repeatedly withdrawing individual dos.
抗菌防腐剂是实际被添加到有菌的剂量配方里的物质，使他们不受微生物滋长或是被无意中引进到生产过程中的微生物侵害。在无菌包装多剂量配方的容器里，抗菌防腐剂被添加用来抑制由重复添加单剂量所引进的微生物的滋长。
Antimicrobial prervatives should not be ud 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 multido formulations during manufacturing. Antimi
crobial prervatives in compendial dosage forms meet the requirements for Added Substancesunder Ingredients and Processin the General Notices.
抗菌防腐剂不应被作为在良好生产操作中的替代方式使用，或仅是用来减少一个有菌产品的微生物群数量，或是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必需符合规定。
豁达的诗句
All uful antimicrobial agents are toxic substances. For maximum protection of patients, the concentration of the prervative 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 prervative can be kept at a minimum if the active ingredients of the formulation posss an intrinsic antimicrobial activity. Antimicrobial effectiveness, whether inherent in the product or whether produced becau of the addition of an antimicrobial prervative, must be demonstrated for all injections packaged in multiple-do containers or for other products containing antimicrobial prervatives. Antimicrobial effectiveness must be demonstrated for multiple-do topical and oral dosage forms and
for other dosage forms such as ophthalmic, otic, nasal, irrigation, and dialysis fluids (e Pharmaceutical Dosage Forms (1151).
所有有用的抗菌药剂都是有毒物质。为了最大的保护使用者，防腐剂的含量应被有效地显示在产品的最终包装上，并应会处在一个可能对人体有毒的水平线下。添加的抗菌防腐剂含量能够被保持在一个最小的浓度，如果配方的活性成分具有一个固定的抗菌力。抗菌的效力，不管是产品里固有的或者是生产中添加的抗菌防腐剂，都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量型和给其它剂量型，如眼药，耳药，鼻药，冲洗的和透析液。(看 Pharmaceutical Dosage Forms(a1151).
This chapter provides tests to demonstrate the effectiveness of antimicrobial protection. Added antimicrobial prervatives 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.
本章提供的测试用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。测试的
效力和标准适用于一个产品在原有的、未打开过的经由制造商销售的容器里。
PRODUCT CATEGORIES 产品分类
For the purpo of testing, compendial articles have been divided into four categories (e Table 1).The criteria of antimicrobial effectiveness for the products are a function of the route of administration.
为了测试的目的，配制产品分开为四个分类（看表1）。抗菌效力的标准对于这些产品是一个管理的作用。
Table 1.Compendial Product Categories 表1: 配制药品分类
Category 类 别 | Product Description 产鹦鹉的英文 品 概 述 |
1 | 含山店梦觉作Injections, other parenterals including emulsions, otic products, sterile nasalproducts, and ophthalmic products made with aqueous bas or vehicles. 针剂，其它非肠胃药剂，包括乳剂、无菌耳用剂、鼻用剂和眼用剂含水的或其它介质的。 |
2 | Topically ud products made with aqueous bas or vehicles, nonsterile nasal products, and emulsions, including tho applied to mucous membranes. 局部使用产品，含水的或其它介质，如未灭菌耳用剂产品、软膏，包括那些涂在黏膜上的。 |
3 | Oral products other than antacids, made with aqueous bas or vehicles. 口服产品，除了以水为基底或其它的介质的解酸剂。蔡伦竹海 |
4 | Antacids made with an aqueous ba. 含水解酸剂。 |
| 抑郁的表现和症状 | |
TEST ORGANISMS 测试生物体
U cultures of the following microorganisms1:Candida albicans ( ATCC No.10231), Aspergillus niger(ATCC No.16404),中国历史朝代顺序Escherichia coli(ATCC No.8739),Pudomonas aeruginosa ( ATCC No.9027),and Staphylococcus aureus ( ATCC No.6538).The viable microorganisms ud in the test must not be more than five passages removed from the original ATCC culture. For purpos 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 ca of organisms maintained by ed-lot techniques, each cycle of freezing, thawing, and revival in fresh medium is taken as one transfer.
