挤出滚圆法和空气悬浮包衣法制备丹七有效部位肠溶微丸

目的研制丹七有效部位肠溶微丸。方法采用挤出滚圆法制备丹七有效部位丸芯,再以雅克宜93F肠溶包衣材料对载药丸芯进行包衣,以粉体学指标与体外释药性能相结合的方法综合评价微丸质量和包衣效率。结果制得的丹七有效部位肠溶微丸圆整度佳、收率高,在0.1 mol/L HCl中2 h内累积释放度小于5%,在磷酸盐缓冲液中(pH=6.8)2 h内累积释放85%以上。结论该制备工艺简单易行,重现性好。制得的丹七有效部位肠溶微丸抗酸性好,具备较理想的肠溶特征,避免了丹酚酸和三七总皂苷类成分在胃液中的降解。

Preparation of enteric-coated Danqi pellets by extrusion-spheronization and airsuspension coating technology

Objective To prepare enteric-coated pellets containing active fractions of Danqi.Methods Danqi pellets were prepared by extrusion spheronization method,and coated by Acryl-EZE 93F with air-suspension coating technology.The release of the pellets in vitro was determined.Results Enteric-coated Danqi pellets had perfect sphericity and high yield.The drug release of enteric-coated pellets would be lower than 5% within 2 h in 0.1 mol/L HCl solution,but reach above 85% in 2 h in PBS(pH=6.8).Conclusion The preparation technology is feasible and replicable.The enteric-coated pellets have good dissolution property and acid residence to avoid the degradation of salvianolic acid and panax notoginseng saponins in gastric juice.