乳糖酸红霉素细菌内毒素检查法研究

BACTERIAL ENDOTOXIN TEST FOR ERYTHROMYCIN LACTOBIONATE

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。

Tested for inhibition and enhancement, Bacterial Endotoxin Test for Erythromycin lactobionate is validated. We did TAL Test to determine the endogenous endotoxin content of three batches of each finished product, which came from nine main manufacturers of China. Among all 27 samples, bacterial endotoxin contents in 23 samples were less than or equal to endotoxin limit, but 4 were higher.All products were up to standard by Pyrogen Test. In order to control the pyrogen of the drug, Bacterial Endotoxin Test can be used instead of the usual Pyrogen Test by which body temperature of rabbit always drops.