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药品中含有致病菌危害极大,患者用后不但不能治病,反而会引起新的祸端,并可能通过药品的流通而传播。国家规定致病菌为药品的重要卫生指标菌,是药品的常规必检项目。目前的检验方法要经过培养、镜检、生化等步骤,需要一周的时间,十分复杂,不能满足生产的需要。本文阐明应用免疫荧光法这一新兴技术检定药品中致病菌的原理、条件、方法,以取代繁锁的细菌培养检定法。
Containing pathogenic bacteria in medicine is extremely harmful. Patients not only can not cure the disease, but will cause new troubles and may spread through the circulation of medicines. Pathogenic bacteria as an important national health indicators of drugs, drugs are routine inspection items. The current test method to go through training, microscopic examination, biochemical and other steps, take a week’s time, is very complicated and can not meet the production needs. This article illustrates the application of the emerging technology of immunofluorescence to the identification of pathogens in pharmaceuticals, the conditions, and methods to replace the cumbersome bacterial culture assay.