关键词: font-size:medium, ">头孢拉定颗粒剂；稳定性；杂质

Abstract: 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.

Key words: Cefradine Granules, Stability, Impurities