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目前各国药典规定的热原检查法是用家兔升温试验法(简称兔法)。但家兔饲养工作繁杂,试验操作费时,要求一定的条件设备,基层单位用以控制热原具有一定困难,且某些放射性药品及某些抗肿瘤药物,不适于用兔法检测。因此,十多年来国内外对鲎试验方法(鲎法)进行了广泛研究,并已用于革兰氏阴性细菌感染的快速诊断及生物制品、食品的内霉素污染检测。在检查放射性药品、抗肿瘤药、大输液等注射剂热原方面,也积累了大量资料,但对鲎法与兔法的一致性、鲎法的灵敏度及其适用品种,仍有必要进一步探讨。我们用鲎试验的试管法和兔法,对比检查了28个品
Current national pharmacopoeia pyrogen test method is to use rabbit heating test (referred to as rabbit law). However, the rabbit breeding work is complex, time-consuming operation of the trial, require certain conditions and equipment, grass-roots units to control the pyrogen has some difficulties, and some radioactive drugs and some anti-cancer drugs, not suitable for testing by rabbit method. Therefore, more than ten years at home and abroad on the test method 鲎 (鲎 law) conducted a wide range of studies, and has been used for rapid diagnosis of gram-negative bacterial infections and biological products, food endocarditis pollution detection. In the inspection of radiopharmaceuticals, anti-tumor drugs, infusion and other pyrogen pyrogen, but also accumulated a large amount of information, but the law and Rabbit Law, the sensitivity and the applicable varieties, there is still a need to further explore. We used 鲎 test tube method and rabbit method, compared to check 28 items