地氯雷他定口崩片处方及工艺研究

Formulation for the orally disintegrating tablets of desloratadine and its process research

目的 :筛选地氯雷他定口崩片的最佳处方和工艺流程,并进行质量研究。方法 :考察不同种类、不同剂量的填充剂和矫味剂对地氯雷他定口崩片口感及崩解时限的影响,并制定合理的质量标准。结果 :按照筛选出的最佳处方制备的地氯雷他定口崩片口感易于患者接受,平均崩解时限在30 s之内,且适合工业生产。结论 :本法处方合理、工艺简单,生产的片剂可用于临床。

Objective：To optimize the formulation and process for the orally disintegrating tablets of desloratadine and assess its quality. Methods：The effects of the different types and doses of fillers and flavoring agents on the taste and disintegration of the tablets were studied and a reasonable quality standard was developed. Results：The tablets prepared by optimum formulation were well-tasted, the time for their disintegration was within 30 seconds and the formulation was suitable for the industrial production. Conclusion：The formulation is reasonable and the process is simple. The prepared tablets are suitable for clinical use.