喘可治注射液细菌内毒素检查法研究  

Study on the bacterial endotoxins test method for chuankezhi injection

作　　者：唐先明[1] 刘建辉[1] 宋丽阳[1] 郁玖慧 王姝 TANG Xianming;LIU Jianhui;SONG Liyang;YU Jiuhui;WANG Shu(Harbin Institute for Food and Dnlg Control, Harbin 150525, China)

机构地区：[1]哈尔滨市食品药品检验检测中心,哈尔滨150525

出　　处：《中国药品标准》2018年第1期64-67,共4页Drug Standards of China

摘　　要：目的:建立喘可治注射液的细菌内毒素检查方法。方法:按《中国药典》2015年版四部通则进行实验和结果判断。结果:喘可治注射液稀释50倍时对细菌内毒素检查无干扰,细菌内毒素限值为25 EU·m L^(-1)。对3批喘可治注射液进行常规检查,结果均符合规定。结论:所建立的细菌内毒素检查法可用于喘可治注射液的细菌内毒素检查。Objective： To establish a bacterial endotoxins test method for Chuankezhi Injection. Methods：The ex- periment was carried on and the results were judged according to Chinese Pharmacopeia 2015 Vol IV. Results： There was no interference on bacterial endotoxins test when Chuankezhi Injection was diluted for 50 times. The lim- it value of the bacterial endotoxin was 25 EU ·mL^-1. The test results of bacterial endotoxin in 3 batches of samples met the criteria. Conclusion： The established method can be used for bacterial endotoxin test for Chuankezhi Injection.

关 键 词：喘可治注射液 细菌内毒素 凝胶法 干扰实验 

分 类 号：R921.2[医药卫生—药学]