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尼莫地平注射液在进行兔法热原实验时,经常引起试验兔体温异常下降现象,从而导致试验必须一再重试,消耗了大量人力和物力。细菌内毒素检查试验比热原试验灵敏度高,且试验迅速,用样量少,经济可靠,操作简单,工作量少,每天可进行多批样品检测。美国药典24版对大部分的注射剂均由细菌内毒素法代替了热原试验,中国药典2000年版也增订了若干品种的细菌内毒素检查试验,同时删除了相应品种的热原试验,可见用细菌内毒素检查试验代替热原试验已成为必然规律。本文通过一系列的试验发现,尼莫地平注射液经有效稀释后在细菌内毒素检查试验中,无干扰作用,故认为可以用细菌内毒素法代替兔法热原试验。
Nimodipine injection in rabbits during the pyrogen test, often caused abnormal temperature drop test rabbits, which led to the test must be repeated retry, consuming a lot of manpower and material resources. Bacterial endotoxin test than the pyrogen test sensitivity, and the test quickly, with less sample, economic and reliable, simple operation, less workload, multiple batches of samples can be tested daily. The United States Pharmacopoeia 24 version of the majority of injections by the bacterial endotoxin method instead of the pyrogen test, the Chinese Pharmacopoeia 2000 edition also updated a number of species of bacterial endotoxin test, while removing the corresponding varieties of pyrogen test, showing the use of bacteria Endotoxin test instead of pyrogen test has become a necessary law. This article through a series of experiments found that nimodipine injection after effective dilution in the bacterial endotoxin test without interference, it is considered that the bacterial endotoxin method can replace the rabbit pyrogen test.