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抑制/增强系数鲎试验法是用于检查注射液中细菌内毒素的新方法。结果是不同的注射液抑制/增强系数不同,但每一种注射液的抑制/增强系数又是恒定的。本文测定了6种注射液及其1→2和1→4稀释液的抑制/增强系数和其细菌内毒素限量校正值。其抑制/增强系数:复方氯化钠注射液(及其稀释液)1;20%甘露醇注射液(及其稀释液)1.2;葡萄糖氟化钠注射液(及其稀释液)1.4;50%葡萄糖注射液130,(其1→2和1→4稀释液均为5);25%葡萄糖注射液45,(其1→2和1→4稀释液均为5);甲硝唑注射液8,(其1→2和1→4稀释液分别为2.5)。本法与经典的家兔法试验结果一致,两方法间无显著差异(p>0.05)。我们认为本法可以用于注射液细菌内毒素的检查。
Inhibition / enhancement factor 鲎 Test method is a new method for examining bacterial endotoxins in injection. The result is a different injection inhibition / enhancement factor, but the inhibition / enhancement factor for each injection is again constant. In this paper, the inhibition / enhancement coefficient and the bacterial endotoxin limit correction values of 6 kinds of injection and its 1 → 2 and 1 → 4 dilutions were determined. The inhibition / enhancement factor: compound sodium chloride injection (and its dilution) 1; 20% mannitol injection (and its dilution) 1.2; glucose sodium fluoride injection (and its dilution) 4; 50% glucose injection 130, (1 → 2 and 1 → 4 dilutions were 5); 25% glucose injection 45, (1 → 2 and 1 → 4 dilutions were 5) Azole injection 8, (the 1 → 2 and 1 → 4 dilutions were 2.5). This method is consistent with the classic rabbit test results, there was no significant difference between the two methods (p> 0.05). We think this method can be used for the examination of bacterial endotoxins in injection.