肠安康微丸结肠靶向验证实验  

Verification of colon-targeted release of Changankang Pellets

作　　者：闫惠俊[1] 龙致贤[2] 王玉蓉[1] 郑礼[2] 高卫华 

机构地区：[1]北京中医药大学,北京100102 [2]中国医药研究开发中心,北京102206 [3]山东省青岛市纺织医院,山东青岛266042

出　　处：《中成药》2003年第7期523-526,共4页Chinese Traditional Patent Medicine

摘　　要：目的 :应用体外溶出度测定和体内X 射线造影技术 ,对用Surelease和Eudragit薄膜包衣的肠安康微丸进行结肠靶向验证。方法 :将药物与硫酸钡医用干粉混合后按原制备工艺和包衣方法制备成试验性微丸 ,经体外测定后 ,由志愿者A与B同时服用 ,经医用X 射线造影检测 ,根据各时间段图像显示 ,观察和分析该微丸在健康人体的分布位置与运行状态。结果 :实验表明用本法制成的微丸有能力携带药物通过胃、小肠 ,到达结肠定位释放 ,体内外实验均表明 pH值依赖性与时间相结合的Eudragit薄膜包衣的肠安康微丸效果较好。结论 :建立用硫酸钡医用干粉作造影剂进行X 射线造影的方法 ,实验初步表明肠安康微丸可以达到结肠靶向释放的目的 ,此方法可作为观察结肠释药的检测方法之一。Objective:To determine the in vitro release of two kinds of Changankang Pellets (Radix Astragall, Rhizama coptid) coated with Surelease and Eudragit respectively and verify their colon-targeted release in vivo through X-ray photography. Methods: Changankang Pellets were made by mixing the medical BaSO 4 powder and appropriate drugs together according to original produce and coat methods. After determining their in vitro release, they were tested in vivo by 2 volunteers. X-ray films were taken after appropriate time and analyzed to determine the location and status of these pellets inside healthy objects. Results: Pellets made by this way can carry drugs through stomach, intestine and targeted-release them in colon; the coating combined with pH-dependent and time-dependent Eudragit thin layer has better results. Conclusion: X-ray radiography applying BaSO 4 powder could be taken as a quality control method for colon-targeted release drugs. The preliminary results showed that Changankang Pellets met the requirements of colon-targeted release.

关 键 词：肠安康微丸 结肠靶向 硫酸钡 X-射线造影 

分 类 号：R944.22[医药卫生—药剂学]