鲎试剂方法检测胎盘多肽注射液中细菌内毒素  

Detection of bacterial endotoxins in placental peptide injection by tachypleus amebocyte lysate test

作　　者：王宗春[1] 张洪[1] 姜俊勇[1] 

机构地区：[1]武汉大学人民医院药学部,湖北武汉430060

出　　处：《湖北大学学报（自然科学版）》2011年第2期190-192,共3页Journal of Hubei University：Natural Science

基　　金：湖北省科技厅科技攻关项目(2002AA301C13)资助

摘　　要：考察采用鲎试剂方法检测胎盘多肽注射液中细菌内毒素的可行性.参照中国药典2010年版(二部)附录ⅪE细菌内毒素检查法,选择两个厂家生产的鲎试剂(灵敏度为0.5 EU/mL),对不同稀释倍数的胎盘多肽注射液供试品溶液进行细菌内毒素与鲎试剂之间凝集反应的干扰试验.结果显示胎盘多肽注射液经40倍稀释后对鲎试剂与细菌内毒素之间的凝集反应既无抑制作用,也无增强作用.因此,使用鲎试剂方法检测胎盘多肽注射液中细菌内毒素是可行的,具有简便、快捷、可靠等优点.The feasibility for detecting the bacterial endotoxins in placental peptide injections via tachypleus amebocyte lysate test was investigated in this paper.Using the tachypleus amebocyte lysate with the sensitivity of 0.5 EU/mL produced by two manufacturers,the interference test was carried out to study the influence of sample＇s dilution times on the congregating reactivity between tachypleus amebocyte lysate and bacterial endotoxins in accordance with appendix Ⅺ E,volume two,Chinese pharmacopoeia 2010 edition.The results showed that the sample had no inhibitive or enhanced effect on the congregating reactivity when it was diluted 40 times,indicating that the method of tachypleus amebocyte lysate test for detecting the bacterial endotoxins in placental peptide injections was simple,rapid and reliable.

关 键 词：胎盘多肽注射液 鲎试剂 细菌内毒素 干扰试验 

分 类 号：R927.12[医药卫生—药学]