<62> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS：TESTS FOR SPECIFIED MICROORGANISMS
非无菌产品的微生物学检查：指定微生物检查
INTRODUCTION导言
The tests described hereafter will allow determination of the abnce of, or limited occurrence of, specified microorganisms that may be detected under the conditions described.
以下描述的这些检测将使确定特定微生物不存在或数量在限度内的测定得以进行，这些微生物可以在描述的条件下进行检测。
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.
这些测试主要设计用于测定某种物质或制备品是否符合已确立的微生物质量标准。当用于此目的时，遵循以下所给的说明，包括待取样品的数量，并按照以下所述来解释结果。
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，只要它们与药典方法的同等性得到论证。
GENERAL PROCEDURES 通用规程
The preparation of samples is carried out as described in Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests <61>.
按照在非无菌产品微生物学检查：微生物计数检查法<61>中的描述进行样品制备。
If the product to be examined has antimicrobial activity, this is insofar as possible removed or neutralized as described in Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests <61>.
如果供试品具有抗菌活性，则按照非无菌产品微生物学检查：微生物计数检查法<61>中的描述尽可能将其去除或中和。
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 as described in Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests <61>.
如果表面活性物质被用于样品制备，则必须按照在非无菌产品微生物学检查：微生物计数检查法<61>中的描述来论证其对微生物不具毒性以及其与所使用的任何灭活剂的兼容性，。
GROWTH-PROMOTING AND INHIBITORY PROPERTIES OF THE MEDIA AND SUITABILITY OF THE TEST
培养基的生长促进和抑菌性能以及测试的适用性
The ability of the test to detect microorganisms in the prence of the product to be teste食物怎么画
d must be established. 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.
在存在供试品的情况下，此项测试检测微生物的能力必须得到确立。如果在测试性能或产品中作了变更且这些变更可能影响测试的结果，则其适用性必须得到确认。
Preparation of Test Strains供试菌株的制备
U standardized stable suspensions of test strains 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 five passages removed from the original master ed-lot.
按下面所述，使用标准化的稳定供试菌株悬浮液。使用菌种保存技术（种子批系统），以便用于接种的可萌发微生物从最初的主种子批开始不超过5代。
AEROBIC MICROORGANISMS好氧微生物
Grow each of the bacterial test strains parately in containers containing Soybean-Cain Digest Broth or on Soybean-Cain Digest Agar at 30o to 35o for 18 to 24 hours. Grow the test strain for Candida albicans parately on Sabouraud Dextro Agar or in Sabouraud Dextro Broth at 20o to 25o for 2 to 3 days.
将每个供试细菌菌株单独置于装有大豆酪蛋白消化物肉汤培养基或者大豆酪蛋白消化物琼脂培养基中容器内，在温度30o至35 o之间培养18至24小时。将白色念珠菌的供试菌株单独置于Sabouraud（沙氏）葡萄糖琼脂培养基或者Sabouraud手工青蛙（沙氏）葡萄糖肉汤中，在温度20o披萨皮至25 o之间培养2至3天。
U Buffered Sodium Chloride-Peptone Solution PH 7.0 or Phosphate Buffer Solution PH 7.2 to make test suspensions. U the suspensions within 2 hours or within 24 hours if stored at 2o to 8o.
使用pH值中级会计师报名条件7.0的缓冲氯化钠—蛋白胨溶液或pH值7.2的磷酸盐缓冲液来制备检测供试悬浮液。悬浮液在2小时内使用，或在存放于2o至8 o的情况下，在24小时内使用。
CLOSTRIDIA梭状芽孢杆菌
U Clostridium sporogenes such as ATCC 11437 (NBRC14293, NCIMB 12343, CIP 100651) or ATCC 19404 (NCTC 532 or CIP 79.3). Grow the clostridial test strain under anaerobic conditions in Reinforced Medium for Clostridia at 30o to 35o for 24 to 48 hours. As an alternative to preparing and then diluting down a fresh suspension of vegetative cells of Cl. sporogenes, a stable spore suspension is ud for test inoculation. The stable spore suspension may be maintained at 2o to 8o for a validated period.
使用生孢梭菌如ATCC 11437 (NBRC14293, NCIMB 12343, CIP 100651) 或 ATCC 19404
(NCTC 532或 CIP 79.3)。于温度30o至35 o，厌氧条件下，在梭状芽孢杆菌强化培养基里将梭菌供试菌株培养24至48小时。作为制备然后稀释新鲜的梭状芽孢杆菌体细胞悬浮液的替代方法，一种稳定的孢子悬浮液被用于检测接种。此稳定孢子悬浮液可以在2o至 8o温度内保存，期限需验证。
