温度和光照对阿维拉霉素稳定性的影响

试验旨在研究不同剂型阿维拉霉素的稳定性,为其生产、运输及贮存等提供科学依据。试验以高效液相色谱法(HPLC)测定阿维拉霉素相对含量及单组分相对含量,分别通过温度试验和光照试验探讨贮存过程中阿维拉霉素相对含量及单组分相对含量的变化规律,以评价其预混剂及原料药两种剂型的稳定性。温度试验和光照试验结果均显示阿维拉霉素预混剂及阿维拉霉素原料药对温度和光照敏感,光照的影响大于温度的影响;但相同条件下阿维拉霉素原料药较阿维拉霉素预混剂稳定,阿维拉霉素A组分较B组分稳定。结果表明阿维拉霉素在运输及贮存时需确保避光,其贮存温度应低于20 ℃,以保证产品质量,提高稳定性。

Effect of Temperature and Light on the Stability of Avilamycin

The research was aimed to study the stability of avilamycin with different formulations.The relative contents of avilamycin and two main components were determined by high performance liquid chromatography (HPLC).Temperature and light tests were used to study the change rule of the relative content of avilamycin and two main components, so that the stability of avilamycin could be evaluated.The results showed that the formulation of avilamycin premix and avilamycin active pharmaceutical ingredients (API) were sensitive when stored in the conditions of different temperature and light conditions.And avilamycin API and avilamycin A component were more stable than avilamycin premix and avilamycin B component, respectively.So avilamycin should be stored at blow 20 ℃ and no light sealing, which could effectively improve the stability and quality of the product.