摘要
目的确定合理的去甲万古霉素注射液的内毒素限值,建立其细菌内毒素检查方法,以替代热原检查。方法按中国药典2000版二部收载的细菌内毒素检查方法进行试验,根据静滴时联合药液的内毒素总限量确定去甲万古霉素注射液的内毒素限值,通过干扰试验,确定其最大无干扰浓度。结果根据临床实际应用情况,将去甲万古霉素注射液的内毒素限值定为0.22 EU.mg-1,最大无干扰浓度为0.5714 mg.ml-1。结论去甲万古霉素注射液的内毒素限值和最大无干扰浓度的确定,为去甲万古霉素注射液静滴时的细菌内毒素检查提供了方法依据。
Objective To set up a reasonable limit of bacterial endotoxin for Norvancomycin hydroehloride and establish a method for examining bacterial endotoxin instead of pyrogen examination. Methods We used the bacterial endotoxin test according to the Chinese Pharmacopoeia, The total limit of the bacterial endotoxin in the combined medicines was used as the limit of the bacterial endotoxin for Norvancomycin hydrochloride. The maximum noninterference concentration was determined through the interference test. Results The most suitable limit of bacterial endotoxin in Norvancomycin hydrochloride was 0.22 EU·mg^-1, The maximum noninterference concentration was 0. 5714 mg·ml^-1. Conclusion The method of examining bacterial endotoxin for Norvancomycin hydrochloride in intravenousdrip is provided.
出处
《苏州大学学报（医学版）》
CAS
北大核心
2005年第6期1004-1006,共3页
Suzhou University Journal of Medical Science
