微生物计数检查法USP61中英对照版

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

<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 used for such purposes, 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。

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 used, 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 used for this purpose, their efficacy and their absence 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 used for sample preparation, their absence of toxicity for microorganisms and their compatibility with any inactivators used 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

Use 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 based on factors such as the nature of the product and the required limit of microorganisms. The method chosen must allow testing of a sufficient sample size to judge compliance with the specification. The suitability of the chosen 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 Use of Test Microorganisms

表1. 供试微生物的制备和使用

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