银杏叶提取物微丸的制备及其释放度研究

目的:制备银杏叶提取物微丸,并测定其体外释放度。方法:采用3种不同包衣材料(欧巴代Ⅱ、Eudragit L30D-55、Eu-dragit S100)对银杏叶提取物进行包衣,采用离心造粒法制备成相应的包衣微丸;将3种包衣微丸按预设比例混合制成混合包衣微丸;采用pH梯度改变介质方式(0.1mol.L-1盐酸、pH5.8PBS、pH7.2PBS)测定包衣微丸和混合包衣微丸的释放度。结果:3种不同包衣微丸分别在0.1mol.L-1盐酸、pH5.8PBS、pH7.2PBS中可以迅速释放;混合包衣微丸在pH梯度改变介质中持续释放,约8h释放完全。结论:该制备工艺可行,可为工业化生产提供理论依据。

Preparation and in Vitro Yinxingye Extract Pellets

OBJECTIVE： To prepare Yinxingye extract pellets and study its in vitro drug release rate. METHODS： The Yinxingye extract were coated with 3 coating materials（opadry Ⅱ, Eudragit L30D- 55 and Eudragit S 100, respectively） to be prepared into pallets by centrifugalized palletizing method; and the 3 different coated pallets were prepared into mixed pallets in an pre - designed ratio. The in vitro release of the 3 coated pallets and the mixed - coated pallets were determined by changing the pH-gradient of media （0.1 mol·L^1 hydrochloric acid, pH 5.8 PBS, pH 7.2 PBS）. RESULTS： The pallets coated with 3 different coating materials released quickly in 0.1 mol·L^-1 hydrochloric acid, pH 5.8 PBS and pH 7.2 PBS, and the pellets with mixed coating materials had a sustained release until a complete release within about 8 h in pH gradient - changed media. CONCLUSION： The preparation process is feasible and provides theoretic basis for industrial production.