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应用鲎试剂检测药品内毒素(细菌内毒素检查法,本文称鲎法),具有灵敏度高,方法简便,正日益受到人们的重视。美国药典X X I版首先将60多种抗生素的热原检查法由家兔法改为细菌内毒素检查法。我国在1991年也将细菌内毒素检查法收入卫生部部颁标准,应用于放射性药品及5种大输液的热原检查。中国药典1995版正式收载该法,但应用的品种不多,共有15种药品,随后广大药学工作者积极探索该鲎法用于药典和收载品种实行的可行性。2000版新版增加了47
Application 鲎 reagent detection of drug endotoxin (bacterial endotoxin test method, this article 鲎 law), with high sensitivity, the method is simple, is increasingly subject to people’s attention. American Pharmacopoeia X X I version of the first more than 60 kinds of antibiotics pyrogen test from the rabbit law to bacterial endotoxin test. In 1991, our country also included the bacterial endotoxin test into the Ministry of Health’s ministerial standards for pyrogen testing of radioactive drugs and five large transfusion fluids. The Chinese Pharmacopoeia 1995 edition formally incorporated the law, but the application of a small variety, a total of 15 kinds of drugs, then the majority of pharmacy workers to actively explore the method for the Pharmacopoeia and the implementation of the feasibility of containing varieties. The new version of 2000 added 47