摘要
目的:开展干扰试验研究,确定丙泊酚中/长链脂肪乳注射液细菌内毒素的检查方法。方法:按中国药典2015年版细菌内毒素检查法第一法(凝胶法),对3批产品进行细菌内毒素干扰试验。结果:丙泊酚中/长链脂肪乳注射液稀释至105.6倍时,对细菌内毒素检查法无干扰作用。经检测,3批产品的细菌内毒素均符合要求。结论:凝胶法可用于丙泊酚中/长链脂肪乳注射液的细菌内毒素检查,并可为细菌内毒素检查的干扰试验提供数据支持。
Objective: To study the interference of bacterial endotoxin test in propofol medium and long chain fat emulsion injection and establish a method for bacterial endotoxin test.Methods: The inference of bacterial endotoxin test in 3 batches of products were determined based on the Chinese Pharmacopoeia(2015 edition).Results: Propofol medium and long chain fat emulsion injection did not interfere with the bacterial endotoxin test when it was diluted to 105.6 folds with bacterial endotoxin water.The bacterial endotoxin in the 3 batches of products met the requirements after determination.Conclusion: Gelation assay can be used for detecting the bacterial endotoxin in propofol medium and long chain fat emulsion injection and can provide data support for interference tests of bacterial endotoxin inspection.
作者
丁丽燕
DING Liyan(Shanghai Joy Biopharm CO.,LTD.,Shanghai Engineering Research Center of Lipid Emulsion,Shanghai 201203,China)
出处
《上海医药》
CAS
2020年第1期70-73,共4页
Shanghai Medical & Pharmaceutical Journal
关键词
丙泊酚中/长链脂肪乳注射液
细菌内毒素
干扰试验
propofol medium and long chain fat emulsion injection
bacterial endotoxins
interference test
