盐酸克林霉素注射液细菌内毒素检查法的改进  

Improvement of bacterial endotoxins testing method for clindamycin hydrochloride injection

作　　者：刘建辉[1] 唐先明[1] 宋丽阳[1] 王姝 LIU Jian-hui;TANG Xian-ming;SONG Li-yang;WANG Shu(Harbin Food and Drug Inspection Center,Harbin 150525,China)

机构地区：[1]哈尔滨市食品药品检验检测中心

出　　处：《哈尔滨商业大学学报（自然科学版）》2019年第4期388-391,共4页Journal of Harbin University of Commerce：Natural Sciences Edition

摘　　要：按《中国药典》2015年版四部进行盐酸克林霉素注射液细菌内毒检查,发现盐酸克林霉素注射液对细菌内毒素与鲎试剂反应存在抑制干扰作用.用稀释剂Ⅰ代替BET水进行样品的稀释,干扰试验结果表明,样品在15倍以上稀释质量浓度时可排除干扰.对3批盐酸克林霉素注射液进行检查,结果均符合规定.所建立的细菌内毒素检查法可用于盐酸克林霉素注射液的细菌内毒素检查.The experiment was carried on and the results were judged according to Chinese Pharmacopeia 2015 edition VolⅣ.There was interference in the agglutination reaction between tachypleus amebocyte lysatein and endotoxin.The preliminary interference test and interference test revealed that using thinnerⅠas solvent,the sample injection in over15-fold dilution had no interference on the bacterial endotoxin test.According to the established standard,the results of bacterial endotoxin test in 3 batches of samples were conformed to the required stipulation.The established bacterial endotoxin test may be applicable for bacterial endotoxin test of clindamycin hydrochloride injection.

关 键 词：盐酸克林霉素注射液 细菌内毒素 干扰实验 稀释剂Ⅰ 鲎试剂 凝胶法 

分 类 号：R927.1[医药卫生—药学]