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本文介绍了鲎试验标准化的研究,建立了细菌内毒素国家标准品和细菌内毒素检查方法。经1745批5种大输液家兔热原试验和细菌内毒素检查比较,结果认为5种大输液制剂的热原检查可以用细茵内毒素检查代替家兔热原检查。
This paper introduces the research on the standardization of test, and establishes the national standard of bacterial endotoxin and the test method of bacterial endotoxin. After 1745 batches of five kinds of large transfusion fever in rabbits and bacterial endotoxin test comparison, the results that the pyrogen test of 5 kinds of large infusion preparations can be fine endotoxin test instead of rabbit pyrogen test.