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自1968年用鲎细胞溶出物(LAL,鲎试剂)检测内毒素以来,各种研究均证明鲎试验比美国药典的家兔热源试验法更为灵敏,且能定量测定细菌内毒素。自1980年1月至1983年10月,美国FDA 用鲎试剂共测试2526只药物样品,其中包括333种不同药物产品。本文报道上述检测结果。试验所用的材料事先均应作内毒素检查,器皿用干热灭菌法去除热源,采用USP 灭菌注射用水作稀释剂,个别产品用分散剂Pyrosperse 处理。标明灵敏度的鲎试剂及内毒素标准均由厂商提供,试验前所有样品需按美国药典第20版规定要求作产品验证,以确保产品不增加或抑制鲎试验后再进行产品的内毒素试验。大输液和小针剂按美国药典第20版规定
Since the detection of endotoxin by haematoblast cell lysate (LAL) in 1968, various studies have demonstrated that hay tests are more sensitive than the USP’s rabbit heat source assay and allow for the quantitative determination of bacterial endotoxins. From January 1980 to October 1983, the United States FDA tested a total of 2526 drug samples using 鲎 reagents, including 333 different drug products. This article reports the above test results. The materials used in the test should be checked for endotoxin in advance. The utensils should be heat-sterilized to remove the heat, using USP sterile water for injection as a diluent, and individual products treated with the dispersant Pyrosperse. Indicators of sensitivity 鲎 reagents and endotoxin standards provided by the manufacturer, before testing all samples required by the United States Pharmacopoeia 20th edition for product validation, to ensure that the product does not increase or inhibit the test 再 after the product endotoxin test. Large infusion and small injection by the United States Pharmacopeia 20th edition regulations