长春西汀注射液细菌内毒素检查法的改进  

Improvement of the Bacterial Endotoxins Testing Method for Vinpocetine Injection

作　　者：刘建辉[1] 唐先明[1] 宋丽阳[1] 王姝 Liu Jianhui(Harbin Food and Drug Inspection Center,Heilongjiang(Harbin 150525,China))

机构地区：[1]哈尔滨市食品药品检验检测中心

出　　处：《黑龙江医药》2019年第4期763-765,共3页Heilongjiang Medicine journal

摘　　要：目的:对现有长春西汀注射液细菌内毒素检查法进行改进,建立更加切实可行的检查方法。方法:按《中国药典》2015年版四部进行长春西汀注射液细菌内毒检查。结果:发现长春西汀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水进行样品稀释50倍以上时可排除干扰。结论:所建立的细菌内毒素检查法可用于长春西汀注射液的细菌内毒素检查。Objective: To improvement of the Bacterial Endotoxins Testing Method for Vinpocetine Injection. Methods: The experiment was carried on and the results were judged according to Chinese Pharmacopeia 2015 edition Vol Ⅳ. Results: 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 over 50-fold dilution had no interference on the bacterial endotoxin test. Conclusion: The established bacterial endotoxin test may be applicable for bacterial endotoxin test of Vinpocetine Injection.

关 键 词：长春西汀注射液 细菌内毒素 干扰实验 稀释剂Ⅰ 

分 类 号：R927.1[医药卫生—药学]