顺铂原料药细菌内毒素检查方法的研究  

Studies on the Test Method of Bacterial Endotoxin of Cisplatin

作　　者：栾春芳[1] 彭娟[1] 李瑞丹[1] 普绍平[1] 刘祝东[1] 

机构地区：[1]昆明贵金属研究所昆明贵研药业有限公司,昆明650221

出　　处：《中国药事》2008年第1期40-42,共3页Chinese Pharmaceutical Affairs

基　　金：国家科技型中小企业技术创新项目(代码05C26215301434);昆明市科技型中小企业技术创新基金项目(编码CJ2005016)

摘　　要：建立顺铂原料药的细菌内毒素的检查方法。方法参照《中国药典》2005年版二部附录进行。本方法选用灵敏度为0.25EU·mL^-1的鲎试剂,供试品浓度在0.25 mg·mL^-1-1.0 mg·mL^-1之间,通过鲎试剂灵敏度复核、预试验、干扰试验和供试品的细菌内毒素检查,结果证明此方法检查顺铂原料药的细菌内毒素可行。A test method of bacterial endotoxin in cisplatin was established according to the principle of Chinese Pharmacopeia 2005 Edition,Second Volume.In this method,Sensitivity of tachypleus amebocyte lysate was 0.25EU·mL^-1 and concentration of samples were 0.25mg·mL^-1 to 1.0mg·mL^-1.By a series of tests,such as tachypleus amebocyte lysate check,trial test,interference test and samples check,the result shows that the present method is feasible for the bacterial endotoxin test of cisplatin.

关 键 词：顺铂 细菌内毒素 干扰试验 鲎试剂 

分 类 号：R916.696[医药卫生—药学] R927.3