胶态二氧化硅固化的银杏黄酮组分磷脂复合物微丸的制备工艺研究

摘要

Objective: To prepare ginkgo flavones solidified powder pellets and to research its preparation technology. Methods: Ginkgo flavones solidified powder as principal agent was prepared for pellets. To select the wetting agent, drug loading dose and disintegrant by single factor test. The forming technology of ginkgo flavones complex was optimized by the orthogonal design Results: Single factor test conformed that 30% ethanol was chosen as wetting agent, drug loading dose is 70% and CMC-Na is chosen as disintegrant. The best conditions were confirmed: spheronization time (4 min), spheronization machine frequency (30Hz), extrusion frequency (30Hz). Conclusion:The prepared pellets are stable and the preparation technology is scientific and rational.%目的：制备胶体二氧化硅固化粉末微丸，并对制备工艺进行研究。方法：首先制备银杏黄酮组分磷脂复合物，并利用胶体二氧化硅进行固化得到固化粉末。以其为主药，通过单因素实验筛选制备微丸的润湿剂、载药量和崩解剂，以微丸的圆整度和收率为评价指标，采用正交实验设计筛选出最佳制备工艺。结果：选择30%乙醇作为润湿剂，确定载药量为70%，选择CMC-Na作为崩解剂。最佳制备工艺确定为滚圆时间为4min，滚圆频率30Hz，挤出频率为30Hz。结论：制备的微丸稳定，验证试验结果表明制备工艺科学合理。