三清降糖分散片的处方优化

目的：制备三清降糖分散片并优化其处方工艺。方法：以崩解时限为指标，对填充剂、崩解剂类型进行单因素考察，并通过正交试验优化；高效液相色谱（HPLC）法测定优选处方所制分散片黄芩苷含量和溶出度。结果：优化处方为30%微晶纤维素、20%预胶化淀粉作为填充剂，6%交联聚维酮作为崩解剂，2%微粉硅胶作为润滑剂。按优化处方粉末直接压片制备的三清降糖分散片3 min内分散均匀，15 min溶出度达到90%以上。结论：按优选处方制得的三清降糖分散片，遇水崩解迅速、分散均匀性好，质量可控。

Preparation and optimization of Sanqingjiangtang dispersible tablets

OBJECTIVE To prepare Sanqingjiangtang dispersible tablets and optimize its formulation technology.METHODS Distribution time was used as the index, single factor test was conducted for the types of filler and disintegrating agent. The indexes were optimized by orthogonal experiment. The tablet quality by optimized formulation was detected, and the content and dissolution rate of baicalin were determined by HPLC.RESULTS The optimized formulation was composed of 30% MCC and 20% α-starch as fillers, 6% PVPP as disintegrants, micro-silica gel 2%. The distribution homogeneity was good at 3 min. The accumulative dissolution rate was more than 90% at 15 min.CONCLUSION Sanqingjiangtang dispersible tablet has a rapid disintegration, a good distribution homogeneity and controllable quality.