多西他赛脂质体热原和细菌内毒素检查方法的研究  

Study on theinspection method of pyrogen and bacterial endotoxin in docetaxel liposomes

作　　者：潘卫松[1] 周永标[1] 张讷敏[1] 肖瑛[2,3] 

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

出　　处：《药物分析杂志》2013年第2期326-330,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：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)

摘　　要：目的:对注射用多西他赛脂质体进行热原检查和细菌内毒素检查试验,建立注射用多西他赛脂质体的热原控制方法。方法:按2010年版中国药典(二部)"热原检查"和"细菌内毒素检查法",用家兔法对注射用多西他赛脂质体进行热原检查,并用不同厂家的鲎试剂对不同批号的注射用多西他赛脂质体分别进行细菌内毒素检查试验,并对结果进行比较。结果:注射用多西他赛脂质体以60%乙醇溶解后,稀释到640倍时(0.03 mg.mL-1)对细菌内毒素检查法无干扰作用。结论:对注射用多西他赛脂质体进行细菌内毒素检查是可行的,优于使用家兔法的热原检查对该项目的质量控制。Objective：To establish a bacterial endotoxin test method to control pyrogen of docetaxel liposome. Methods：According to the pyrogen test and bacterial endotoxins test in Chinese Pharmacopoeia 2010, interference tests were performed on different batches of docetaxel liposome from different TAL manufacturers. Results：There was no interference in the bacterial endotoxins test when docetaxel liposome was diluted by 640 times in 60% alco- hol solution, and the concentration was less than or equal to the detection limit 0.03 mg· mL^-l. Conclusion：The bacterial endotoxin test for doeetaxel liposome is feasible, which can be used for quality control of the pyrogen test.

关 键 词：注射用多西他赛脂质体 热原检查 细菌内毒素检查法 鲎试剂 干扰试验 

分 类 号：R917[医药卫生—药物分析学]