头孢拉定颗粒剂稳定性研究  

Study on Stability of Cefradine Granules

作　　者：崇小萌[1] 田冶[1] 王立新[1] 姚尚辰[1] 尹利辉[1] 刘颖[1] CHONG Xiao-meng;TIAN Ye;WANG Li-xin;YAO Shang-chen;YIN Li-hui;LIU ying(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药物评价》2022年第1期22-27,共6页Chinese Journal of Drug Evaluation

摘　　要：目的:考察头孢拉定颗粒剂稳定性,确定生产、储存过程中的关键控制点。方法:确定头孢拉定颗粒剂杂质谱,对原料及制剂进行加热及加热加湿稳定性实验,加热实验温度为65℃,加热加湿实验温度65℃、湿度60%,评估杂质种类及含量的变化;同时利用构效关系理论计算头孢拉定及各有关物质安全性参数。结果:头孢拉定原料及颗粒剂加热、加湿稳定性均较好。头孢拉定颗粒在包装完好的条件下,储存及运输的温度对其稳定性影响较小。结论:头孢拉定颗粒剂生产过程中的湿度为其关键控制点,可通过监控制剂中的主要杂质来考察生产工艺的合理性及制剂的安全性。Objective:To investigate the stability of Cefradine Granules and determine the critical control points during production and storage.Methods:The impurity profile of Cefradine Granules were determined,and the raw materials and preparations were subjected to heating and heating-humidification stability tests at 65℃and 65℃、60%humidity.The changes of impurity types and content were evaluated.Meanwhile,the safety parameters of Cefradine and related substances were calculated by using the theory of structure-activity relationship.Results:Cefradine raw materials and granules had good thermal and humidification stability.The stability of Cefradine granules was less affected by the temperature of storage and transportation under the condition of intact packaging.Conclusion:The humidity in the production process was the key control point.The rationality of the production process and the safety of the preparation could be reflected by monitoring the main impurities in the preparation.

关 键 词：头孢拉定颗粒剂 稳定性 杂质 

分 类 号：R927.1[医药卫生—药学]