中文摘要：

目的 制备三清降糖分散片并建立其质量控制方法。方法 以三清降糖方提取物为模型药物,采用正交试验设计以分散均匀性为指标,对三清降糖分散片处方进行优化;高效液相色谱法测定三清降糖分散片中黄芩苷的量及其溶出度,进行质量控制。结果 优化处方为微晶纤维素、预胶化淀粉作为填充剂,交联聚维酮作为崩解剂,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3min内分散均匀,15min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。

英文摘要：

Objective To prepare Sanqingjiangtang dispersible tablets and establish a method for the quality control of it .Methods Using distribution homogeneity as index ,the index were optimized by orthogonal experiment .The tablet quality by optimized formulation was detected ,the content and dissolution rate of baicalin was done by HPLC .Results The optimized formula was A3B1C2 .The optimized formulation was composed of 30% MCC and 20% α-starch as fillers ,6% PVPP as disintegrants ,micro-silica gel 2% .The products formulated by the optimum techniques were bright and clean .The dispersible tablets prepared in accordance with the optimize formula could disintegrate completely within 3 min ,the accumulative dissolu‐tion rate could reach beyond 90% in 15 min .Conclusion Sanqingjiangtang dispersible tablet has a rapid disintegration and a good distribution homogeneity ,it can reach the design standard .