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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。
Objective To prepare Sanqing Hypoglycemic Dispersible Tablets and establish its quality control method. Methods Sanqang Hypoglycemic extract as a model drug, orthogonal design was used to disperse the uniformity as an indicator to optimize the Sanqiang Hypoglycemic Dispersible tablets prescription; HPLC determination of Sanqiang Hypoglycemic Dispersible Scutellariae Glycosides and their dissolution, quality control. Results The optimized formulation was microcrystalline cellulose, pregelatinized starch as filler, crospovidone as disintegrant and silica powder as lubricant. According to the optimization prescription powder prepared directly Sanping Hypoglycemic dispersible tablets dispersed within 3min, 15min dissolution of more than 90%. Conclusions Sanqing Hypoglycemic Dispersible Tablets prepared according to the preferred prescription have rapid disintegration in water, good dispersion and good quality control.