荧光素钠注射液细菌内毒素检查法的研究  

Method of Bacterial Endotoxin Test of Fluorescein Sodium Injection

作　　者：潘卫松[1] 肖瑛[2] 潘建明[1] 

机构地区：[1]广州市药品检验所,广州市510610 [2]暨南大学药学院,广州市510632

出　　处：《中国药房》2009年第13期1010-1012,共3页China Pharmacy

基　　金：广州市科技计划资助项目(2007Z3-D0031)

摘　　要：目的:建立荧光素钠注射液的细菌内毒素检查法。方法:按2005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荧光素钠注射液分别进行干扰试验。结果:荧光素钠注射液的检测浓度小于或等于0.75mg.mL-1时对细菌内毒素检查法无干扰。结论:荧光素钠注射液按限值L=0.15EU.mL-1进行细菌内毒素检查是可行的。OBJECTIVE： To establish a bacterial endotoxin test method for fluorescein sodium injection. METHODS： Based on the bacterial endotoxin test method stated in Chinese Pharmacopoeia 2005 edition （second part） , an interference test was conduced on different batches of fluorescein sodium samples using tachypleus amebocyte lysate from different companies. RESULTS： At a concentration of no more than 0.75mg·mL^-1, fluorescein sodium showed no interfere with the bacterial endotoxin test. CONCLUSION： It is feasible for bacterial endotoxin test of fluorescein sodium injection be conducted, in a limit value of 0.15 EU·mL^-1.

关 键 词：荧光素钠注射液 细菌内毒素检查法 鲎试剂 干扰试验 

分 类 号：R927.11[医药卫生—药学]