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目的 考察顺铂注射液进行细菌内毒素检查的可行性。方法 采用凝胶法和动态浊度法鲎试验。结果 6批顺铂注射液稀释至 0 1 4 g·L- 1 时对细菌内毒素检查没有干扰作用 ,而稀释至 0 2 8g·L- 1 时 3批样品有明显的干扰作用 ;所有检测样品的细菌内毒素含量均小于 1 8ZU·g- 1 。结论 动态浊度法鲎试验提供了一个测定顺铂注射液细菌内毒素含量的新方法 ,日常细菌内毒素检查时可将样品稀释至 0 1 4 g·L- 1 以排除其干扰作用
Objective To investigate the feasibility of Cisplatin injection for bacterial endotoxin test. Methods Gel method and dynamic turbidity method 鲎 test. Results 6 batches of cisplatin injection diluted to 0 1 4 g · L -1 did not interfere with the bacterial endotoxin test, and diluted to 0 2 8g · L -1 3 batches of samples had significant interference; all test samples The bacterial endotoxin levels were less than 18ZU · g-1. Conclusions The dynamic nephelometry test provides a new method for the determination of bacterial endotoxin levels in cisplatin injection. Samples can be diluted to 0 1 4 g · L -1 for routine bacterial endotoxin testing to rule out interference