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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 establish a method for quantitative analysis of bacterial endotoxin in Yiqi Fumai (lyophilized) bacteria. Methods According to the bacterial endotoxin test method contained in the 2005 edition of “The People’s Republic of China Pharmacopoeia”, Yiqi Fumai (freeze-dried) was used as the dilution ratio. The dynamic turbidity method The best dilution factor, the Yiqi Fumai (freeze-dried) in the detection of bacterial endotoxin. The results of Yiqi Fumai (freeze-dried) 8-fold dilution of bacterial endotoxin test without interference, the average recovery was 50% to 200%. Conclusion The method can be used for the quantitative detection of bacterial endotoxin in Yiqi Fumai (lyophilized).