摘要
目的:采用凝胶法测定脂肪乳(10%)/氨基酸(15)/葡萄糖(20%)注射液中的细菌内毒素。方法:依据2015年版《中国药典》(四部)"细菌内毒素检查法"项下凝胶法,通过干扰试验确定样品最大有效稀释倍数,并进行方法学验证;将检测结果与显色基质法比较。结果:凝胶法中供试品溶液稀释24倍或以下时对鲎试剂与细菌内毒素的凝集反应无干扰作用,而显色基质法则为稀释76倍或以下。结论:凝胶法可用于脂肪乳(10%)/氨基酸(15)/葡萄糖(20%)注射液的细菌内毒素检查。
OBJECTIVE： To adopt gel method for the determination of bacterial endotoxin in Fat emulsion （10%）/amino acid （15）/glucose （20%） injection. METHODS： According to the gel method in term of ＂bacterial endotoxin test method＂ in Chinese Pharmacopeia（2015 edition）, the maximal valid dilution （MVD） of samples were determined through interference test and the validated. The results were compared with chromogenic method. RESULTS： In gel method, the interference to agglutination reaction of TAL and bacterial endotoxin can be excluded when samples were diluted 24 times or less. In chromogenic method, the samples should be diluted 76 times or less. CONCLUSIONS： Gel method can be used for bacterial endotoxin test of Fat emulsion （10%）/ amino acid （ 15 ）/glucose （20 % ） injection.
出处
《中国药房》
CAS
北大核心
2017年第18期2576-2578,共3页
China Pharmacy
