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目的:找出大输液生产过程主要污染途径。方法:采用《中国药典》收载的“细菌内毒素检查法”,对注射用水、中间品、管道、输液瓶进行全年细菌内毒素水平检测。鲎试剂灵敏度选0.125EU·ml~(-1),0.25EU·ml~(-1),0.5EU·ml~(-1)。结果:中间品和管道内毒素水平夏季偏高,注射用水内毒素浓度全年小于0.125EU·ml~(-1)。结论:中间品和管道为主要污染途径,注射用水内毒素水平最低。
Objective: To find out the main pollution route of large infusion production process. Methods: The “bacterial endotoxin test” contained in “Chinese Pharmacopoeia” was used to test the bacterial endotoxin level in water, intermediate products, pipeline and infusion bottle for the whole year.鲎 reagent sensitivity selected 0.125EU · ml -1, 0.25EU · ml -1, 0.5EU · ml -1. Results: The levels of endotoxin in intermediate products and pipeline were high in summer, and the concentration of endotoxin in water for injection was less than 0.125EU · ml -1. Conclusion: The intermediate products and pipelines are the main pollutants, and the level of endotoxin in water for injection is the lowest.