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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。
Objective: To prepare Sanqing hypoglycemic dispersible tablets and optimize its prescription process. Methods: According to the disintegration time as an index, the types of filler and disintegrant were investigated by single factor and optimized by orthogonal test. The content of baicalin and the dissolution rate of dispersible tablets were determined by high performance liquid chromatography (HPLC) . RESULTS: Optimum prescription was 30% microcrystalline cellulose, 20% pregelatinized starch as filler, 6% crospovidone as disintegrating agent and 2% silica as lubricant. According to the optimization prescription powder prepared directly Sanping hypoglycemic dispersible tablets dispersed within 3 min, 15 min dissolution of more than 90%. Conclusion: Sanqing Hypoglycemic Dispersible Tablets prepared according to the preferred prescription have the advantages of rapid disintegration in water, good dispersion uniformity and controllable quality.