银杏内酯组分固体分散体微丸释药单元的制备

Study on preparation of ginkgolides component solid dispersions micro pill drug release unit

将微晶纤维素和壳聚糖联合应用于银杏内酯组分固体分散体(GKS)微丸的制备,考察银杏内酯组分微丸的溶出性。以微晶纤维素-壳聚糖为复合载体,采用溶剂法制备银杏内酯组分固体分散体,借助差示扫描量热(DSC)对其进行制剂表征,进一步采用挤出滚圆法制备银杏内酯组分微丸释药单元,考察比较不同类型、不同剂量的黏合剂、载药量和崩解剂对制备银杏内酯组分微丸释药单元影响,采用正交设计试验优化制备工艺。微晶纤维素和壳聚糖按1∶3制备的GKS固体分散体,60 min时药物的体外累积溶出率达到80%以上,银杏内酯组分微丸释药单元能显著改善GKS的溶出,具有实际应用价值。

Microcrystalline cellulose and chitosan were applied to prepare ginkgolides component solid dispersions micro pill drug release unit and study the dissolution of GKS. Microcrystalline cellulose, chitosan as composite carrier, solvent method was used to prepare ginkgolides component solid dispersions. Differential scanning calorimetry was used to Characterization of ginkgolides component solid dispersions. Ginkgolides component solid dispersions as principle agent were prepared for micro-pellet. Comparison of different types, different doses of the adhesive, drug-polymer interactions, and disintegrating agent for the preparation of ginkgolides components of micro-pellet drug release unit, the optimum preparation ginkgolides components of micro-pellet drug release unit was screened by orthogonal design experiment. Preparation of ginkgolides components solid dispersions with microcrystalline cellulose and chitosan at ratio 1：3. Drug cumulative dissolution was more than 80% in 60 min. Solid dispersion-micro-pellet drug release unit can significantly improve the dissolution of ginkgolides components, it has practical application value.