鲎试法检查硫酸庞大霉素注射液热原的探讨
Study on the pyrogen detection of injection gentamycin sulfate with the method of tachypleus amebocyte lysate test
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摘要: 本文通过稀释40倍后的硫酸庆大霉素注射液对鲎试法凝集反应过程的干扰试验,证明稀释后硫酸庆大霉素注射液对鲎试剂的灵敏度(λ=0.5EU/ml)无干扰作用(未超出±2λ,可以用鲎试法代替传统的家兔法进行热原检查或进行初试筛选。本实验建立的方法大大提高了热原检查的效率和灵敏度,对实际工作特别是药品生产企业具有很大指导意义。Abstract: Through the test of interfere to the process of agglutinate reaction with Injection Gentamycin Sulfate which have been forty times diluted.This experiment proved that there is no interference (not excessed ±2λ) to the sensitive of Tachypleus Amebocyte Lysate for Endotoxin (Purogen) Detection (λ=05EU/ml). On the basis of this experiment.a new method can be established for pyrogen detection or applying to primary screening instead of the traditional rabbit test.This method may raise the efficiency and sensitivety of pyrogen test greatly.There will be particularly for drug production manufactured a important reference significance.
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