摘要
目的:采用动态显色基质法测定地佐辛注射液中的细菌内毒素含量。方法:根据《中华人民共和国药典》(2015年版)四部通则1143细菌内毒素检查法,对样品进行干扰预实验和干扰实验,确定样品的最小不干扰浓度。结果:地佐辛注射液可采用稀释200倍的溶液进行定量检测。结论:动态显色基质法可用于检测地佐辛注射液中的细菌内毒素含量。
Objective:To determine the bacterial endotoxin content in dezocine injection by dynamic chromogenic substrate method.Methods:According to the requirements in Bacterial Endotoxin Test in the Chinese Pharmacopoeia(Volume IV,2015 edition),pre-interference and interference tests were perforemd to determine the minimum sample concentration without interference.Results:Dezocine injection may be quantitatively determined after being diluted 200 folds.Conclusion:Dynamic chromogenic substrate method may be used for the determination of bacterial endotoxin content in dezocine injection.
出处
《中国执业药师》
CAS
2017年第2期31-33,62,共4页
China Licensed Pharmacist
关键词
地佐辛注射液
动态显色基质法
细菌内毒素
含量测定
Dezocine Injection
Kinetic Chromogenic Substrate Method
Bacterial Endotoxin
Content Determination
