摘要
建立了黄芪注射液细菌内毒素与热原之间的关系,并确定其细菌内毒素的限度。用稀释16倍的黄芪注射液配成含不同浓度梯度的细菌内毒素系列样品,分别用动态浊度法和家兔法测定细菌内毒素和家兔最大升温值。结果表明,细菌内毒素方法建立中,黄芪注射液在稀释8～64倍后测定无干扰;细菌内毒素浓度与家兔体温升高值有相关性,回归方程为Y=0.448+e3.221 X(r2=0.997);进一步考虑热原检查法的偏差,黄芪注射液的细菌内毒素限度应不超过2.31EU/mL。因此,采用动态浊度法可对黄芪注射液中细菌内毒素进行测定并建立可靠的限度标准。对中药无菌制剂采用细菌内毒素测定法提供一种研究思路,同时为快速反映中药无菌制剂的热原情况提供一种有效的转换方法,尤其有利于中药无菌制剂中间体热原的控制。
To establish the relationship between bacterial endotoxin and pyrogen in Astragalus Injection,and also determine the limits of bacterial endotoxin.To confect different thicknesses gradients of bacterial endotoxin samples by diluting the Astragalus injection with 16 times water for injection to determine bacterial endotoxin and max rabbits temperature-rising value by using Kinetic Turbidimetric Limulus Rabbits Test methods separately.Results showed that in the establishment of bacterial endotoxin method,no interference in the determination of bacterial endotoxin was found when the Astragalus injection was diluted with 8 to 64 times water for injection,there is correlation between the Thicknesses of bacterial endotoxin and rabbits temperature-rising values,the regression equation is Y=0.448＋e3.221X（r2=0.997）.Taking differences of Pyrogen Test Method into consideration,the bacterial endotoxin limit of Astragalus injection should be not more than 2.31 EU/mL.Therefore,bacterial endotoxin in Astragalus injection can be tested by Kinetic Turbidimetric Limulus Method,and furthermore a reliable limit is established.This method provides another approach for applying bacterial endotoxin test method in TCM sterile injection,as well as an effective conversion method for manifesting the pyrogen conditions in TCM sterile injection,which facilitate the control of pyrogen in TCM intermediate injection most.
出处
《河北化工》
2012年第5期17-19,共3页
Hebei Chemical Industry
关键词
黄芪注射液
细菌内毒素
热原
相关性
限度
Astragalus injection
bacterial endotoxin
pyrogen
correlation
limit
