盐酸布比卡因注射液细菌内毒素检查方法的研究  

The Study for Bacteria Eendotoxin Test of Bupivacaine Hydrochloride Injection

作　　者：于婷[1] 蔡彤[1] 张国来[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国药事》2009年第8期807-809,共3页Chinese Pharmaceutical Affairs

摘　　要：目的建立盐酸布比卡因注射液的细菌内毒素检查方法。方法根据《中国药典》2005年版二部附录细菌内毒素检查法,采用2个不同生产厂家的鲎试剂对盐酸布比卡因注射液进行研究。结果盐酸布比卡因注射液最大不干扰浓度为1.34mg.mL-1,细菌内毒素限值为0.096EU.mg-1。结论采用细菌内毒素检查法控制盐酸布比卡因注射液的质量是可行的。Objective To establish the bacterial endotoxin test for Bupivacaine Hydrochloride Injection. Methods The experiment was carried out according to the appendix of Chinese Pharmacopeia in 2005 Edition （Vol Ⅱ）. Results The reactions with two Tachyploue Amebocyte Lysate manufacturers were not disturbed in 1.34mg·mL^-1 for Bupivacaine Hydrochloride Injection, which was the maximum nondisturbing concentration. The endotoxin limit of Bupivacaine Hydroehloride Injection was 0. 096EU·mg^-1. Conclusions It is feasible to control quality of Bupivacaine Hydrochloride Injection by bacterial endotoxin test.

关 键 词：盐酸布比卡因注射液 细菌内毒素检查法 干扰试验 

分 类 号：R927.12[医药卫生—药学]