药用辅料苯甲醇细菌内毒素检查方法学研究  

Study on Bacterial Endotoxins Test for Pharmaceutical Excipient Benzyl Alcohol

作　　者：陈群英 郑马庆[2] Chen Qunying;Zheng Maqing(Nanjing University of Technology,Jiangsu Provincial Institute of Materia Media,Nanjing 210009,China;School of Pharmaceutical Sciences,Nanjing University of Technology,Nanjing 211816,China)

机构地区：[1]南京工业大学江苏省药物研究所,江苏南京210009 [2]南京工业大学药学院,江苏南京211816

出　　处：《山东化工》2018年第7期68-69,72,共3页Shandong Chemical Industry

摘　　要：建立药用辅料苯甲醇的细菌内毒素检查方法。参照《中国药典》2015年版第四部1143"细菌内毒素检查法"进行干扰试验,同时利用凝胶半定量方法测定苯甲醇细菌内毒素的含量。结果:当鲎试剂灵敏度为0.125EU/m L时,苯甲醇的最低不干扰浓度为4.188 mg/m L,此时苯甲醇稀释了250倍;利用凝胶半定量法测得苯甲醇的细菌内毒素<0.06EU/mg。苯甲醇可以通过直接稀释法进行细菌内毒素检测,且最低不干扰浓度为4.188 mg/m L。Objective To establish a bacterial endotoxin test method for pharmaceutical excipient benzyl alcohol.Methods Interference tests of benzyl alcohol were performed with TAL from 2 manufacturers according to bacterial endotoxin test method in appendix of Chinese Pharmacopoeia(2015 Edition).Results The interference elements could be excluded by diluting benzyl alcohol 250 times when the accuracy of TAL is 0.125EU/mL;The bacterial endotoxin limit of benzyl alcohol is less than 0.06 EU/mg through gel semi-quantitative analysis.Conclution The bacterial endotoxin of benzyl alcohol could be tested through diluting until the densenty is 4.188mg/mL.

关 键 词：苯甲醇 细菌内毒素 干扰试验 凝胶半定量法 

分 类 号：O655[理学—分析化学]