卡铂原料药细菌内毒素检查方法的研究  

Study on Bacterial Endotoxin Test for Carboplatin Raw Drug

作　　者：彭娟[1] 栾春芳[1] 普绍平[1] 

机构地区：[1]昆明贵金属研究所昆明贵研药业有限公司,云南昆明650106

出　　处：《贵金属》2009年第2期46-50,共5页Precious Metals

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

摘　　要：参照《中国药典》2005年版二部收载的细菌内毒素检查法中的凝胶法,建立了卡铂细菌内毒素检查方法。5.0mg/mL的卡铂及稀释液对细菌内毒素检查无干扰,对3个批号的供试品进行检查,结果均符合规定。结果表明,卡铂原料药采用细菌内毒素检查法是可行、有效的。Referring to the testing methods which are recorded in 《 Chinese Pharmacopoeia 》 Vol. 2, 2005, a method for detection of bacterial endotoxin in carboplatin was established. The solution containing 5.0 mg/mL carboplatin and its dilute solutions do not interfere with the bacterial endotoxin test. The data of bacterial endotoxin test of three batches conform to the related requirements of carboplatin. The results showed that the bacterial endotoxin test is feasible and effective to detect bacterial endotoxin in carboplatin raw drug.

关 键 词：药物化学 卡铂原料药 细菌内毒素检查法 凝胶法 

分 类 号：R917[医药卫生—药物分析学]