雷公藤多苷分散片的制备工艺研究及质量控制

Preparation and quality investigation of tripterygium glycosides dispersible tablets

目的制备雷公藤多苷分散片。方法筛选崩解剂、润湿剂、制粒方法、颗粒压片条件,并控制其质量。结果崩解剂的最佳比例为MCC:L-HPC=11:3;制粒时选用水为其润湿剂,润湿剂用量为药粉重量的80%(ml/g);20目筛制粒,30目筛整粒。所制备的分散片在3min内崩解完全,含量均匀,稳定性好,符合分散片的各项指标。结论本品达到分散片的要求,制剂稳定。

Objective To prepare Tripterygium Glycosides dispersible tablets. Methods tilt disintegrating agent, wetting agent, granulate method, clip condition of Tripterygium Glycosides dispersible tablets, and control its quality. Results The optimum proportion of disintegrating agent was MCC ： L-HPC = 11 ： 3, moistening agent was water, and its weight as same as 80% weight of medicine powder（ ml/g）. The screen mesh was 20 meshes of granulate, and it was 30 meshes of mend pill. The dispersible tablets all disaggregated in 3 minutes and content well-distributed, stability was well, meeting the requirements of all the indexes of dispersible tablets. Conclusion It has met all the requirements of disapersible tablets.