庆大霉素质量标准变迁对庆大霉素质量的影响

庆大霉素为发酵的多组分抗生素，各组分活性和毒性各不相同，含有发酵工艺的活性物质的杂质谱更复杂及难以预测，同时庆大霉素无特征紫外吸收，且极性强，因此，对庆大霉素质量特别是组分、有关物质的控制较为困难。本文通过对庆大霉素质量标准和产品质量变迁的综述，说明了一个有效可行质量标准的建立对产品质量的重要影响。

Gentamicin is a complex mixture produced by fermentation.The activity and toxicity of its components are different,and the impurities from fermentation are more complicated and difficult to predict.Meanwhile,due to its low UV absorptivity and high polarity,it is difficult but important to control the quality of gentamicin,especially its components and the related substances.In this paper,changes in the gentamicin quality standard and gentamicin quality were reviewed,and the notable influence of an effective and feasible drug quality standard on the drug quality was confirmed.