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自卫生部《药品卫生标准》颁布执行以来,各种药品(除消毒剂、口服抗生素制剂等免检药品外)[1～2],不论品种、剂型均需进行卫生学检查,其中大肠杆菌作为粪便污染指示菌,是非规定灭菌口服药品的控制菌必检项目,需要逐批次检查。但根据微生物生理学特性分析[3～4],大肠杆菌需要在
Since the promulgation and implementation of “Pharmaceutical Hygiene Standards” by the Ministry of Health, all kinds of drugs (except for disinfectants, oral antibiotics and other exemption medicines) [1 ~ 2], regardless of variety and dosage form, are required to undergo hygiene examination. Escherichia coli Indicators of contamination, non-regulated oral administration of sterile drugs will be seized items need to be checked by batches. However, according to the physiological characteristics of microbial analysis [3 ~ 4], Escherichia coli needs