注射用头孢菌素类抗生素有关物质检查的稳定性研究

目的通过考察7个临床常用的注射用头孢菌素类抗生素品种的有关物质检查供试品溶液的稳定性,分析实验过程中环境温度及放置的时间对有关物质的影响,为该类药品的规范检验提供参考数据。方法将临床常用的7个注射用头孢菌素类抗生素品种共19批次分别按法定标准配制成有关物质检查的供试溶液,分别在4、25、35℃的条件下放置,依法测定24h内有关物质的量的变化。结果供试溶液的放置时间及实验环境温度直接影响检测结果的准确性,温度越高,放置时间越长,稳定性越差。在4℃中7个品种稳定性均好,可达24h。有些对热敏感的品种,35℃的条件下稳定时间不足2h。结论检查注射用头孢菌素类抗生素有关物质时,应注意供试溶液的稳定性,控制试验温度及放置时间,做到现配现用。

Study on Stability of Related Substances of Cephalosporins for Injection

Objective By examining the seven clinical commonly used cephalosporins for injection of the stability of the sample solutions for related substance tests and the influence of different temperatures and storing times on the stability of related substances;data were collected for standardizing tests for such drugs.Methods In accordance with statutory criteria,the seven varieties of samples,19 batches in total,were prepared into test solutions and the changes in the amount of related substances were tested within 24 hours at 4℃,25℃,35℃.Results The temperature and storing time of the sample solutions directly affect the accuracy of the results.The temperature was higher and the storing time was longer,so that the stability of the solution was worse.The stability of seven varieties was good,up to 24 hours.But to some heat-sensitive species,the stable storing time was less than 2 hours at 35℃.Conclusion It is necessary to control the temperature and storing time of the sample solutions of cephalosporins,and to use the preparation promptly.