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

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.