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美国生物制品检定所对领有生产执照厂商所出品的5和25％正常人血清白蛋白(NSA)和纯制蛋白组份(PPF)负有检定和批准发放的责任。规定每批制品应不含或含极少热原物质,从而用于输注人体不得发生热原反应。直至最近,传统的家兔检定热原法是保证这类制品安全的唯一方法。当前,美国生物制品检定所由于人力、试验室以及实验动物场所的限制,只能对送检制品的一小部分进行抽检。 但是,在过去18个多月里,随着鲎变形
The National Institutes of Biological Products are responsible for the verification and approval of the release of 5 and 25% of normal human serum albumin (NSA) and pure protein fractions (PPF) produced by licensed manufacturing licensee manufacturers. Provisions for each batch of products should be free or contain very little pyrogen, so as to be used for infusion of the human body may not pyrogen reaction. Until recently, the traditional method for detecting fever in rabbits was the only way to ensure the safety of such products. At present, the United States Biological Products Limited due to human, laboratory and laboratory animal restrictions, only a small part of the inspection of products sampling. However, in the past 18 months or so, as 鲎 deformed