头孢噻呋注射液稳定性试验研究

Stability test of ceftiofur injection

为了确定头孢噻呋注射液包装和贮存条件,保证临床用药安全有效,对该制剂进行稳定性试验考察。试验将头孢噻呋注射液样品60℃高温与(4500±500)Lx强光照射放置10 d,分别于5 d、10 d取出,进行性状考察、无菌检验、粒度检查、有关物质检查和含量测定等;同时对3批次头孢噻呋注射液在(30±2)℃的条件下进行6个月加速试验,进行性状考察、无菌检验、注射液粒度检查、有关物质检查和含量测定等。结果表明,在60℃高温与(4500±500)Lx强光照射10 d以及(30±2)℃的加速实验条件下,经过为期6个月的稳定性考察试验,其性状、无菌、粒度、有关物质等重点考察项目变化差异不显著,头孢噻呋含量变化在5%范围内,符合《兽用化合药物稳定性研究指导原则》规定。说明头孢噻呋注射液在密闭、避光条件下贮存稳定性良好。

To determine the packaging and storage conditions of ceftiofur injection and ensure the safety and effectiveness of clinical medication,the stability test of the preparation was investigated.Ceftiofur injection samples were placed under high temperature of 60℃and strong light of(4500±500)Lx for 10 d,and were taken out on 5 d and 10 d respectively,for the inspection of properties,sterility test,particle size test,inspection of related substances and content determination.At the same time,three batches of ceftiofur injection were accelerated for 6 months under the condition of(30±2)℃,and the traits,sterility test,particle size test,related substances test and content determination were carried out.The results showed that under 60℃high temperature and(4500±500)Lx strong light irradiation for 10 d and(30±2)℃accelerated experimental conditions.After 6 months of stability test,the changes of its characters,sterility,particle size,related substances and other key inspection items were not significant,and the content of ceftiofur was within the range of 5%,which was in line with the provisions of the"guiding principles for stability study of veterinary compound drugs".The results indicated that ceftiofur injection had good storage stability under closed and dark conditions.