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从乳糖酸红霉素细菌内毒素检查法的干扰实验入手,确定了方法的可行性。对全国九个主要生产厂各三批制品中的内源性细菌内毒素进行检测,23份样品中细菌内毒素含量低于或等于理论限值,4份样品超过理论限值,而家兔热原检查均视合格。文章表明:为了彻底解决乳糖酸红霉素热原检查中的家兔降温问题,可以采用细菌内毒素检查法,控制药品的热原指标。
Starting from the interference experiment of erythromycin lactobionate bacterial endotoxin test, the feasibility of the method was confirmed. Endogenous bacterial endotoxins were tested in three batches of products at nine major manufacturing facilities across the country. The bacterial endotoxin content in 23 samples was less than or equal to the theoretical limit, 4 samples exceeded the theoretical limit, and rabbit heat The original inspection as qualified. The article shows that: In order to completely solve the problem of rabbits in the pyrogen test of erythromycin lactobionate, the bacterial endotoxin test can be used to control the pyrogen index of the drug.