摘要
目的:建立ω-3脂肪酸甘油三酯细菌内毒素检查方法。方法:将ω-3脂肪酸甘油三酯溶解于三氯甲烷,再加水漩涡振荡混匀,取上层制备供试品溶液;进行方法干扰试验的同时考察内毒素的回收率。结果:采用三氯甲烷溶解ω-3脂肪酸甘油三酯,再用水振荡萃取的方法制备供试品溶液,对细菌内毒素检查法无干扰作用。该方法的回收率在70%～84%之间,符合检测要求。结论:用三氯甲烷溶解脂溶性的该样品,然后加水制备细菌内毒素检查用供试品溶液是可行的,方法重复性和可操作性较好。其限度拟订为0.1 EU·mg^(-1)。
Objective:To develop a bacterial endotoxin test(BET)method for omega-3-acid-triglycerides.Methods:Water was added after an aliquot of drug substance dissolved in chloroform and then the mixture was vortexed for 30 seconds,the upper layer was used as sample solutions.The interference test and the recovery test were conducted.Results:There was no interference to bacterial endo to xin test for omega-3-acid-triglycerides by water extraction after chloroform dissolving.The recovery rate of spiked endotoxin was between 70% and 84%.Conclusion:Chloroform may be as a feasible solvent for drug substances with slightly soluble in water for BET test.For omega-3-acid-triglycerides,the endotoxin limit is specified in 0.1 EU·mg-1.
作者
张婷婷
鹿麟
窦佳
刘进朋
孙经宽
ZHANG Ting-ting;LU Lin;DOU Jia;LIU Jin-peng;SUN Jing-kuan(Dalian Institute for Drug Control,Dalian 116021,China;The Second Hospital of Dalian Medical University,Dalian 116027,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2019年第2期341-345,共5页
Chinese Journal of Pharmaceutical Analysis
关键词
ω-3脂肪酸甘油三酯
细菌内毒素
干扰试验
萃取
回收率
omega-3-acid-triglycerides
bacterial endotoxin
interference test
extraction
recovery rate
