王志伟;高钧;胡靖;孙静;
WANG Zhi-wei1,GAO Jun1,HU Jing2,SUN Jing2(1.Tianjin Tasly Group Co.Ltd.,Tianjin 300402,China;2.Tianjin Tasly Pride Pharmaceutical Co.Ltd.,Tianjin 300402,China)

• 1:天津天士力集团有限公司
• 2:天津天士力之骄药业有限公司

摘要(Abstract)：

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(KeyWords)： 益气复脉(冻干);动态浊度法;细菌内毒素
Yiqifumai compound freeze-dry powder;kinetic turbidimetric assay;bacterial endotoxin

Abstract:

Keywords:

基金项目(Foundation):

作者(Authors): 王志伟;高钧;胡靖;孙静;
WANG Zhi-wei1,GAO Jun1,HU Jing2,SUN Jing2(1.Tianjin Tasly Group Co.Ltd.,Tianjin 300402,China;2.Tianjin Tasly Pride Pharmaceutical Co.Ltd.,Tianjin 300402,China)

DOI: 10.14066/j.cnki.cn21-1349/r.2010.05.014

参考文献(References)：

• [1]单亚.细菌内毒素定量检查法的发展概况及方法简介[J].安徽医药,2008,12(4):361-363.
• [2]国家药典委员会.中华人民共和国药典:二部[M].北京:化学工业出版社,2005:附录XIE.