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目的研究鲎试剂法与家兔法检测重组人干扰素α2b内毒素结果的相关性,并参照家兔热原试验的阈值量,来确定本制品质量标准中内毒素的限量标准。方法分别用不同浓度的内毒素溶液和含不同浓度内毒素的供试品溶液进行家兔热原质试验,确定供试品内毒素限值,并在此限值下进行内毒素检测,方法均参照2000年版《中国药典》和2000年版《中国生物制品规程》进行。结果在含不同浓度内毒素溶液的家兔热原质试验中,致热阈值小于5.0EUml。在含不同浓度内毒素供试品溶液的家兔热原质试验中,致热阈值小于1.25EUml。以此确定本品内毒素限值,检测该制品的内毒素含量,结果均符合规定。结论本品在内毒素含量小于3.5EU500万单位dose的范围内,根据具体的对照实验及制品的用途来规定细菌内毒素限值,可用鲎试剂法代替家兔法检测注射用重组人干扰素α2b冻干制剂的热原质。
Objective To study the correlation between the limulus amebocyte lysate reagent method and the rabbit method for the detection of recombinant human interferon α2b endotoxin and to determine the limit of endotoxin content in the quality standard of the product by referring to the threshold amount of the pyrogen test in rabbits. Methods Different concentrations of endotoxin solution and test solution containing different concentrations of endotoxin were used to test the pyrogen test of rabbits to determine the limits of endotoxin in the test sample. Reference to the 2000 edition of “Chinese Pharmacopoeia” and the 2000 edition of “China Biological Products Regulations”. Results In the pyrogen test of rabbits containing different concentrations of endotoxin solution, the pyrogen threshold was less than 5.0EUml. In the pyrogen test of rabbits containing different concentrations of endotoxin for the test solution, the thermal threshold is less than 1.25EUml. In order to determine the limits of the endotoxin of the product, testing the endotoxin content of the product, the results are in line with the provisions. Conclusion This product in the endotoxin content of less than 3.5EU500 million dose within the range, according to the specific control experiments and the use of products to regulate the bacterial endotoxin limits, available 鲎 reagent instead of rabbit method for the detection of recombinant human interferon α 2b Lyophilized preparations of pyrogen.