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目的建立L-鸟氨酸盐酸盐的细菌内毒素检查方法。方法确定L-鸟氨酸盐酸盐的细菌内毒素限值,按《中国药典》2010年版二部的规定,通过干扰试验,确定其最大不干扰浓度。结果 L-鸟氨酸盐酸盐的细菌内毒素限值为5 EU/g,最大不干扰浓度为12.5 mg/ml。结论 L-鸟氨酸盐酸盐采用细菌内毒素检查法(鲎试剂法)是可行的。
Objective To establish a bacterial endotoxin test method of L-ornithine hydrochloride. Methods To determine the bacterial endotoxin limit of L-ornithine hydrochloride, according to the Chinese Pharmacopoeia 2010 edition two provisions, through the interference test to determine the maximum non-interference concentration. Results L-ornithine hydrochloride had a bacterial endotoxin limit of 5 EU / g and a maximum non-interfering concentration of 12.5 mg / ml. Conclusions L-Ornithine hydrochloride is feasible using bacterial endotoxin test (鲎 reagent method).