芪丹颗粒剂成型工艺研究

Study on Formulation Process of Qidan Granules

目的确定芪丹颗粒剂的成型工艺条件。方法采用颗粒成型率、吸湿性为指标筛选颗粒的最佳辅料配比。结果以干浸膏粉与辅料(蔗糖∶糊精=3.32∶1.43)按7.25∶4.75比例混匀,以90%乙醇为润湿剂,制得的颗粒成型率高、吸湿率小。结论该成型工艺条件可为芪丹颗粒制剂处方组成的确定提供依据。

Objective To ascertain the best granulation formulation process of Qidan Granules.Methods By determining granulation and hygroscopicity as the indexes,the optimal excipient and its formula were screened.Results The best excipient and its formula were 7.25 powders and 4.75 excipients which consisted of sucrose and dextrin（3.32 ∶1.43）.The made granules had low hygroscopicity and high granulation.Conclusion The experimental results provide the basis of the ascertainment of formulation process and control of production environment of Qidan Granules.