2.612(新)微生物限度检测.docVIP

2.6.12.MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS: MICROBIAL ENUMERATION TESTS 2．6.12.非无菌药品的微生物检测：微生物计数试验 1. INTRODUCTION 导言 The tests described hereafter will allow quantitative enumeration of mesophilic bacteria and fungi which may grow under aerobic conditions. 本试验用于检测在有氧条件下生长的嗜温性细菌和真菌总数。 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. 本试验用于检测原料药或制剂是否符合已建立的微生物限度要求，基于这一目的应遵循以下指导原则，包括取样量并且按照下述方法分析试验结果。 The methods are not applicable to products containing viable micro-organisms as active ingredients. 此试验方法不适用于含有活性微生物的药品的检测。 Alternative microbiological procedures, including automated methods, may be used, provided that their equivalence to the Pharmacopoeia method has been demonstrated. 倘若已证明某种方法可产生与药典试验方法同样的效果，此方法也可应用，其中包括自动化方法。 2．GENERAL PROCEDURES 一般程序 Carry out the determination under conditions designed to avoid extrinsic microbial contamination of the product to be examined. The precautions taken to avoid contamination must be such that they do not affect any micro-organisms that are to be revealed in the test. 试验应在供试品不被外来微生物污染的条件下进行，用于防止供试品污染的措施不应影响微生物的检出。 If the product to be examined has antimicrobial activity, this is insofar as possible removed or neutralised. If inactivators are used for this purpose, their efficacy and their absence of toxicity for micro-organisms must be demonstrated. 如果被检测供试品有抗微生物活性，必须进行中和。如果使用灭活剂来消除供试品的抗微生物活性，必须证明其有效性和不会对微生物产生毒性。 If surface-active substances are used for sample preparation, their absence of toxicity for micro-organisms and their compatibility with inactivators used must be demonstrated. 如果在供试品的制备过程中使用了表面活性剂，必须证明其不会对微生物产生毒性并且可与灭活剂兼容。 3.ENUMERATION METHODS 计数方法 Use the membrane filtration method or the plate-count methods, as prescribed. The most-pr