精制橄榄油细菌内毒素检查的可行性研究  

Study on the Test Method of Bacterial Endotoxin in Refined Olive Oil

作　　者：潘卫松[1] 肖瑛[2,3] 

机构地区：[1]广州市药品检验所,广东广州510610 [2]暨南大学药学院,广东广州510632 [3]暨南大学中药药效物质基础及创新药物研究广东省高校重点实验室,广东广州510632

出　　处：《中国医药科学》2011年第8期10-11,16,共3页China Medicine And Pharmacy

基　　金：广东省广州市食品药品监督管理局科技计划项目(2010GZFDA006);广东省中医药局科技计划项目(2010124);暨南大学211项目资助

摘　　要：目的对精制橄榄油进行凝胶法干扰试验,建立精制橄榄油细菌内毒素的检查方法。方法按2010年版《中国药典》(二部)"细菌内毒素检查法",用不同厂家的鲎试剂对不同批号的精制橄榄油分别进行干扰试验。结果精制橄榄油稀释至浓度83.4mg/mL或以下稀释浓度的溶液对细菌内毒素检查法无干扰作用。结论精制橄榄油注射液进行细菌内毒素检查是可行的。Objective To establish a bacterial endotoxin test for refined olive oil injection.Methods According to the bacterial endotoxins test in Chinese Pharmacopoeia 2005.Different batches of refined olive oil injection from different TAL manufacturers were underwent the interference tests.Results There was no interference in the bacterial endotoxins test when the concentration of refined olive oil is less than or equal to the detection limit 83.4mg/mL.Conclusion Carrying out the bacterial endotoxin test for refined olive oil injection is feasible.

关 键 词：精制橄榄油 细菌内毒素检查法 干扰试验 药用辅料 质量控制 

分 类 号：R927.11[医药卫生—药学]