摘要
目的:采用凝胶法测定10%中/长链脂肪乳注射液(C8-24Ve)和30%脂肪乳注射液(C14-24)中的细菌内毒素。方法:根据《中国药典2015年版四部》1143细菌内毒素检查法,先调节供试品pH值,再进行干扰试验,确定10%中/长链脂肪乳注射液8倍稀释液无干扰作用,30%脂肪乳注射液原液无干扰作用。结果:在调节pH值至中性后,10%中/长链脂肪乳注射液8倍稀释液对细菌内毒素试验无干扰,30%脂肪乳注射液原液对细菌内毒素试验无干扰。结论:凝胶法可用于10%中/长链脂肪乳注射液(C8-24Ve)和30%脂肪乳注射液(C14-24)中的细菌内毒素检查。
Objective:To adopt gel method for the determination of bacterial endotoxin in10% Medium/Long Chain Fat Emulsion Injection(C8-24Ve) and 30% Fat Emulsion Injection(C14-24).Methods:According to the "bacterial endotoxin test method" of 1143 in Four Part of Chinese Pharmacopoeia 2015 edition,the PH of the sample was adjusted first,and then the interference test was carried outIt was determined that the dilution of 10% medium/long chain fat emulsion injection 8 times had no interference effect,and the original solution of 30% fat emulsion injection had no interference effect.Results:After adjusting the PH to neutral,the 8 times dilution solution of 10% medium/long chain fat emulsion injection did not interfere with the bacterial endotoxin test,and the original solution of 30% fat emulsion injection did not interfere with the bacterial endotoxin testConclusions:the gel method can be used for bacterial endotoxin test in 10% Medium/Long Chain Fat Emulsion Injection(C8-24Ve) and 30% Fat Emulsion Injection(C14-24).
出处
《科技视界》
2020年第2期163-166,共4页
Science & Technology Vision
