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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

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【作者】 王志伟高钧胡靖孙静

【Author】 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)

【机构】 天津天士力集团有限公司天津天士力之骄药业有限公司

【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。

【Abstract】 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.

  • 【文献出处】 沈阳药科大学学报 ,Journal of Shenyang Pharmaceutical University , 编辑部邮箱 ,2010年05期
  • 【分类号】R927.12
  • 【被引频次】4
  • 【下载频次】166
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