注射用卡铂细菌内毒素检查的方法学评价与应用  

Evaluation of the Applicability of Bacterial Endotoxin Test for Carboplatin Injection

作　　者：宋立中[1] 石庆平[1] 丁峰[1] 

机构地区：[1]安徽省蚌埠医学院附属医院医院药剂科,233004

出　　处：《实用全科医学》2006年第5期600-601,共2页Applied Journal Of General Practice

摘　　要：目的验证注射用卡铂细菌内毒素检查法的可行性。方法参照《中国药典2005年版》二部附录ⅪⅩF试验方法,通过干扰/确证实验来确定注射用卡铂的有效稀释浓度和细菌内毒素检查限值。结果0.125 mg/ml供试品液无干扰作用,其细菌内毒素限值符合规定。结论注射用卡铂可以通过细菌内毒素检查法来控制其细菌内毒素含量。Objective To establish a bacterial endotoxin test for carboplatin injection. Methods Test was carried out according to the guideline of interfering test and producure specified in Chinese Pharmacopeia （published in 2005 ）. Results The injection did not interfere with limulus agent in 0.125 mg/ml diluted concentration. Conclusions Bacterial endotoxin test can used for carboplatin injection.

关 键 词：注射用卡铂 细菌内毒素 鲎试剂 

分 类 号：R927.1[医药卫生—药学]