非无菌产品微生物学检查：微生物计数检查法USP61中英对照版
customerrvice<61> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMENRATION TESTS
非无菌产品微生物学检查：微生物计数检查法
INTRODUCTION 导言
The tests described hereafter will allow quantitative enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions.
以下所描述的这些检测将使得对在有氧的条件下生长的嗜温性细菌和真菌进行定量计数成为可能。
The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality. When ud for such purpos, follow the instructions given below, including the number of samples to be taken, and interpret the results as stated below.
这些检测主要设计用于测定一种物质或制备品是否符合已确立的微生物质量标准。当用于此类目的时，需遵照以下所给的说明，包括待取样品的数量，并且按照下面所述解释结果。
化妆品有害成分The methods are not applicable to products containing viable microorganisms as active ingredients.
这些方法不适用于以活菌作为活性成分的产品。
Alternative microbiological procedures, including automated methods, may be ud, provided that their equivalence to the Pharmacopeial method has been demonstrated.
可以使用替代的微生物规程，包括自动化方法，只要已经证明它们与药典方法具同等作用。
GENERAL PROCEDURES 通用规程
Carry out the determination under conditions designed to avoid 12 microbial contamination of the product to be examined. The precautions taken to avoid contamination must be such that they do not affect any microorganisms that are to be revealed in the test.
在经过设计可避免外来微生物污染供试产品的条件下，进行此项测定。用于避免污染的这些预防措施是必须做到，它们不会影响任何试图在此项检验中揭示的微生物。
If the product to be examined has antimicrobial activity, this is, insofar as possible, removed or neutralized. If inactivators are ud for this purpo, their efficacy and their abnce of toxicity for microorganisms must be demonstrated.
如果供试产品具有抗菌活性，则此活性需在尽可能的范围内去除或中和。如果将灭活剂用于这个目的，则必须证实它们的功效和对微生物不具毒性。
If surface-active substances are ud for sample preparation, their abnce of toxicity for microorganisms and their compatibility with any inactivators ud must be demonstrated.
如果表面活性物质用于样品制备，则必须证实它们对微生物不具毒性以及与所使用的任何灭活剂的兼容性。
ENUMERATION METHODS计数法
U the Membrane Filtration methodor one of the Plate-Count Methods, as directed. The Most-Probable-Number (MPN) Method is generally the least accurate method for microbial counts; however, for certain product groups with very low bioburden, it may be the most appropriate method.
按规定，使用膜过滤法或多个平板计数法中的一种。液体稀释法（MPN）通常对微生物计数而言是最不准确的方法；然而，对具备非常低生物载荷的特定产品类型，它可能是最合适的方法。
The choice of a method is bad on factors such as the nature of the product and the req
uired limit of microorganisms. The method chon must allow testing of a sufficient sample size to judge compliance with the specification. The suitability of the chon method must be established.
方法的选择基于某些因素，例如产品的性质和微生物的要求限度。所选的方法必须能够对充足的样本量进行检测，以判断与质量标准的符合性。所选方法的适用性必须被建立。
Table 1. Preparation and U of Test Microorganisms
表1. 供试微生物的制备和使用
| Growth Promotion 生长促进 | Suitability of Counting Method in the Prence of Product 在产品存在的情况下计数方法的适用性 |
Microorganism 微生物 | Preparation of Test Strain 供试菌株的制备 | Total Aerobic Microbial Count 总好氧微生物计数 | Total Yeasts and Molds Count 总酵母菌和霉菌计数 | Total Aerobic Microbial Count 总好氧微生物计数 | Total Yeasts and Molds Count总酵母菌和霉菌计数 |
Staphylococcus aureus such as ATCC 6538, NCIMB 9518, CIP 4.83, or NBRC 13276 崇明中学金黄色葡萄球菌如：ATCC 6538, NCIMB 9518, CIP 4.83, 或 NBRC 13276 | Soybean-Cain Digest Agar or Soybean-Cain Digest Broth 300-350 18-24 hours 大豆酪蛋白消化物琼脂培养基或大豆酪蛋白消化物肉汤培养基300-350 18-24 小时 | Soybean-Cain Digest Agar and Soybean-Cain Digest Broth≤100 cfu 300-350≤3 days加减乘除英文 大豆酪蛋白消化物培养基和大豆酪蛋白消化物肉汤培养基≤100 cfu 300-350 ≤3 天 | | Soybean-Cain Digest Agar/MPN Soybean-Cain Digest Broth≤100 cfu 300-350≤3 days 大豆酪蛋白消化物培养基/MPN（最大几率数）大豆酪蛋白消化物肉汤培养基≤100 cfu 300-350 ≤3 天 | |
Pudomonas aeruginosa such as ATCC 9027, NCIMB 8626,CIP 82.118, or NBRC 13275 绿脓杆菌如ATCC 9027, NCIMB 8626,CIP 82.118, 或 NBRC 13275 | Soybean-Cain Digest Agar or Soybean-Cain Digest Broth 300-350 18-24 hours 大豆酪蛋白消化物琼脂培养基或大豆酪蛋白消化物肉汤培养基300-350 18-24 小时 | Soybean-Cain Digest Agar and Soybean-Cain Digest Broth≤100 cfu 300-35兵马俑侠0≤3 days 大豆酪蛋白消化物琼脂培养基和大豆酪蛋白消化物肉汤培养基≤100 cfu 300-350≤3 天 | | Soybean-Cain Digest Agar/MPN Soybean-Cain Digest Broth≤100 cfu 300-350≤3 days 网贴翻译大豆酪蛋白消化物琼脂培养基/MPN（最大几率数）大豆酪蛋白消化物肉汤培养基≤100 cfu 300-350≤3 天 | |
Bacillus subtilis such as ATCC 6633, NCIMB 8054, CIP 52.62, or NBRC 3134 枯草芽孢杆菌 如ATCC 6633, NCIMB 8054, CIP 52.62, 或 NBRC 3134 | Soybean-Cain Digest Agar or Soybean-Cain Digest Broth 300-350 18-24 hours 大豆酪蛋白消化物琼脂培养基或大豆酪蛋白消化物肉汤培养基300-350 18-24 小时 | Soybean-Cain Digest Agar and Soybean-Cain Digest Broth≤100 cfu 300-350≤3 days 大豆酪蛋白消化物琼脂培养基和大豆酪蛋白消化物肉汤培养基≤100 cfu 300-350≤3 天 | | Soybean-Cain Digest Agar/MPN Soybean-Cain Digest Broth≤100 cfu 300-350≤3 days 大豆酪蛋白消化物琼脂培养基/MPN（最大几率数）大豆酪蛋白消化物肉汤培养基≤100 cfu 300-350≤3 天 | |
Candida albicans such as ATCC 10231, NCPF 3179, IP 48.72, or NBRC 1594 白色念珠菌 如ATCC 10231, NCPF 3179, IP 48.72, 或 NBRC 1594 | Sabouraud Dextro Agar or Sabouraud Dextro Broth 200-250 2-3 days Sabouraud（沙氏）葡萄糖琼脂培养基或Sabouraud（沙氏）葡萄糖肉汤培养基 | Soybean-Cain Digest Agar ≤100 cfu 300-350≤5 days大豆酪蛋白消化物琼脂培养基≤100 cfu 300-350≤5 天 | Sabouraud Dextro Agar ≤100 cfu 200-250≤5 days Sabouraud（沙氏）葡萄糖琼脂培养基≤100 cfu 200-250≤5 天 | Soybean-Cain Digest Agar≤100 cfu 300-350≤5 days MPN: not applicable 大豆酪蛋白消化物琼脂培养基≤100 cfu 300-350≤5 天 MPN(最大几率数)：不适用 | Sabouraud Dextro Agar≤100 cfu 200-250≤5 days Sabouraud（沙氏）葡萄糖琼脂培养基≤100 cfu 200-250≤5 天 |
Aspergillus niger such as ATCC 16404, IMI 149007, IP 1431.83, or NBRC 9455 黑曲霉如ATCC 16404, IMI 149007, IP 1431.83, 或NBRC 9455 | Sabouraud Dextro Agar or Potato-Dextro Agar 200-250 5-7 days, or until good sporulation is achieved Sabouraud（沙氏）葡萄糖琼脂培养基或马铃薯葡萄糖琼脂培养基 200-250 5-7天,或直到实现良好的产孢 | Soybean-Cain Digest Agar≤100 cfu 300-350≤5 days 大豆酪蛋白消化物琼脂培养基≤100 cfu 300-35nasty nasty0≤5 天 | Sabouraud Dextro Agar ≤100 cfu 200-250≤5 days Sabouraud（沙氏）葡萄糖琼脂培养基≤100 cfu 200tendering-250≤5 天 | Soybean-Cain Digest Agar≤100 cfu 30强调英文>英语培训找弋果美语0-350≤5 days MPN: not applicable 大豆酪蛋白消化物琼脂培养基≤100 cfu 300-350≤5 天MPN(最大几率数)：不适用 | Sabouraud Dextro Agar≤100 cfu 200-250≤5 days Sabouraud（沙氏）葡萄糖琼脂培养基≤100 cfu 200-250≤5 天 |
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GROWTH PROMOTION TEST AND SUITABILITY OF THE COUNTING METHOD 生长促进试验和计数方法的适用性
General Considerations通用考虑因素
The ability of the test to detect microorganisms in the prence of product to be tested must be established.
在供试产品存在的情况下，必须确立检测微生物的试验能力。
Suitability must be confirmed if a change in testing performance or a change in the product that may affect the outcome of the test, is introduced.
如果引入了可能影响试验结果的在测试性能或产品方面的变更，则必须确认其适用性。
Preparation of Test Strains
供试菌株的制备
U standardized stable suspensions of test strains or prepare as stated below. Seed-lot culture maintenance techniques (ed-lot systems) are ud so that the viable microorganisms ud for inoculation are not more than 5 passages removed from the original master ed-lot. Grow each of bacterial and fungal test strains parately as described in Table 1.
