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目的通过头孢尼西钠细菌内毒素检查方法的研究,探讨内毒素检查限值的适用性。方法采用《中国药典》2000年版二部附录细菌内毒素检查法[1],动态比浊法和凝胶法进行试验。结果部分头孢尼西钠原料细菌内毒素的量在0.15EU/mg-0.35EU/mg之间。结论有必要统一头孢尼西钠的检测限值。
Objective To investigate the applicability of endotoxin test by Cefonicid sodium bacterial endotoxin test. Methods The bacterial endotoxin test [2] of the appendix of “Chinese Pharmacopoeia” 2000 edition was used, and the turbidimetric method and gel method were used to test. As a result, the amount of bacterial endotoxin of the cefonicid sodium raw material was between 0.15 EU / mg and 0.35 EU / mg. Conclusion It is necessary to unify the detection limit of cefonicid sodium.