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1980年,美国食品药品管理局(FDA)就曾发布了LAL试验可行性指南的草案,该指南制定了检测注射制剂中内毒素的LAL试验程序,为此,所使用的LAL试剂必须经FDA批准,其灵敏度应当是标定的,并不得含有对LAL有抑制或增强作用的物质。在我国,对注射制剂用鲎试验法与常规的家兔热原试验法进行比较的研究已广泛开展。在总共1800批试验中,有130批鲎试验阳性,只有20批发现与家兔法结果不符,所有那些家兔试验通不过(阳性)的批号,在鲎试验中皆为阳性反应。这足以证明,体外鲎试验法是一种特异性好,远比常规家兔法灵敏度高的试验法。但迄今为止,是否将鲎试验作为一个公认的热原试验法纳入中国药典,还一直存在着争论。
In 1980, the United States Food and Drug Administration (FDA) released a draft guide to the feasibility of LAL testing, which developed a LAL test program to detect endotoxin in injectable preparations, for which LAL reagents used must be approved by the FDA , Its sensitivity should be calibrated and does not contain substances that inhibit or potentiate LAL. In our country, the research on the comparison between the injection preparation and the conventional rabbit pyrogen test method has been carried out widely. Of a total of 1800 batches of tests, 130 batches were positive and only 20 batches were found to be inconsistent with the rabbit test. All batches of rabbits that passed the test (positive) were positive in the 鲎 test. This is sufficient to prove that in vitro 鲎 test is a good specificity, much higher than conventional rabbit test sensitivity. However, there is still controversy over whether to include the test as a recognized pyrogen test in the Chinese Pharmacopoeia.