动态浊度法测定益气复脉(冻干)中细菌内毒素的含量  

Determination of bacterial endotoxin in Yiqifumai compound freeze-dry powder by kinetic turbidimetric assay

作　　者：王志伟[1] 高钧[1] 胡靖[2] 孙静[2] 

机构地区：[1]天津天士力集团有限公司,天津300402 [2]天津天士力之骄药业有限公司,天津300402

出　　处：《沈阳药科大学学报》2010年第5期409-411,418,共4页Journal of Shenyang Pharmaceutical University

摘　　要：目的建立益气复脉（冻干）细菌内毒素定量分析方法。方法按照2005年版《中华人民共和国药典》二部收载的细菌内毒素检查法的要求,将益气复脉（冻干）作倍比稀释,采用动态浊度法通过干扰试验和验证试验考察其最佳稀释倍数,对益气复脉（冻干）中细菌内毒素进行检测。结果益气复脉（冻干）8倍稀释后对细菌内毒素检查无干扰,平均回收率均在50%-200%。结论该方法可以进行益气复脉（冻干）中细菌内毒素的定量检测。Objective To develop an assay for determining bacterial indotoxin（BET） content in Yiqifumai（traditional Chinese medicines）compound freeze-dry powder.Methods The test was conducted according for the Chinese Pharmacopoeia（Edition 2005）.The dilution ratio of Yiqifumai compound freeze-dry powder was optimized and BET content was determined by turbidimetric kinetic method.Results Dilution ration of Yiqifumai compound freeze-dry powder at 1∶8 did not interfere with the limulus test.The average recovery of BET was between 50% and 200%.Conclusions The method is proved to be accurate,sensitive and suitable for the determination of BET content in Yiqifumai compound freeze-dry powder.

关 键 词：益气复脉(冻干) 动态浊度法 细菌内毒素 

分 类 号：R927.12[医药卫生—药学]