氧化苦参碱微丸的制备及其性质考察

目的:制备氧化苦参碱微丸并考察其性质。方法:用实验型低温挤出滚圆制粒机制备氧化苦参碱微丸;采用L9(34)正交设计优化工艺条件;考察不同含药量的微丸的粉体学性质及体外溶出度。结果:用挤出滚圆法制备的氧化苦参碱微丸圆整度好,大小均匀;最佳工艺为水∶微晶纤维素=0.90∶1,滚圆速度为35Hz,滚圆时间为5min,挤出速度为40Hz;体外溶出度在30min内达到75%以上。结论:挤出滚圆法制备氧化苦参碱微丸的工艺简便易行,制得的微丸质量好。

Preparation and Properties of Oxymatrine Pellets

OBJECTIVE： To prepare oxymatrine pellets and study the pellets＇ properties.METHODS： Oxymatrine pellets were prepared using an experimental low- temperature extrusion- spheronization granulator.L0（34） orthogonal design was used to obtain optimal formulation.The micromeritie properties and in vitro dissolution of the pellets at different dosage were determined. RESULTS： Oxymatrine pellets prepared by extrusion - spheronization were round and smooth and well - distributed. The optimal technical conditions were as follows ： water ： MCC = 0.90 ： 1; spheronization velocity - 35 Hz; spheronization time -- 5 min; extrusion velocity = 40 Hz.The in vitro dissolution was more than 75% within 30 minutes.CONCLUSION： The process of preparing pellets by extrusion - spheronization was simple and feasible and the quality of pellets was excellent.