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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。
The relationship between bacterial endotoxin and pyrogen in Astragalus injection was established and the limit of bacterial endotoxin was established. The 16-fold diluted Astragalus injection was used to prepare bacterial endotoxin samples with different concentration gradients. The dynamic turbidity and rabbit methods were used to determine the bacterial endotoxin and rabbit maximum temperature. The results showed that the establishment of bacterial endotoxin method, Astragalus injection 8 to 64 times diluted after the determination of non-interference; bacterial endotoxin concentrations and rabbits elevated body temperature have a correlation equation regression equation Y = 0.448 + e3.221 X (r2 = 0.997); further consider the pyrogen test bias, Astragalus injection of bacterial endotoxin limits should not exceed 2.31EU / mL. Therefore, the dynamic turbidity method can be used to determine the bacterial endotoxin in astragalus injection and establish reliable limits. Bacterial endotoxin determination of traditional Chinese medicine aseptic preparation provides a research idea, at the same time to provide an effective conversion method for the rapid reflection of the pyrogen condition of traditional Chinese medicine sterile preparation, in particular, is conducive to the control of the pyrogen of traditional Chinese medicine sterile preparation intermediates .