薄膜包衣工艺制备苦参总碱控释微丸的研究.pdfVIP

呻毒材 Journal of Chinese Medicinal Materials 第30卷第12期2007年12月 薄膜包衣工艺制备苦参总碱控释微丸的研究 时 军，程 怡 ，李学涛 (广州中医药大学中药学院，广东广州510045) 摘要 目的：薄膜包衣工艺制备苦参总碱控释微丸。方法：采用GPCG一1型流化床包衣设备和乙基纤维素水分 散体对苦参总碱液投入包衣，进行药物体外释放度研究和外观考察。结果：包衣微丸外观光洁，成膜均匀，体外释 放符合零级动力学方程。结论：薄膜包衣工艺制备苦参总碱控释微丸方法可行，控释效果良好。 关键词 薄膜包衣工艺；苦参总碱；控释微丸 中图分类号：R284．2 文献标识码：A 文章编号：1001 54(2007)12—1601-03 Preparation of Total Matrine Controlled Release Micropellet Capsules SHI Jun，CHENG Yi，LI Xue—tao (Department of Pharmarcy，Guangzhou University of Chinese Medicine，Guangzhou 5 10045，China) Abstract Objective：To prepare total matrine controlled release micropellet capsules．Methods：The capsules were prepared by the technology of film—coating with surelease as matrix，and judged by the release behavior．Results：The drug had completely been coated into a homogeneous and continuous film，and the results repeated in three batches showed that the release behavior of the pellet capsules followed zero—equation．Conclusion：The capsules have good sustained release effect and the process of the preparation is a— vailable． Key words Film—coating technology；Total matrine；Controlled release micropellet 苦参总碱(TM)系从中药苦参中提取的总生物 2 方法和结果 碱，主要含苦参碱和氧化苦参碱，总生物碱含量超过 2．1 苦参总碱控释微丸的制备工艺 50％。其具有抗病原体、免疫和抗肿瘤作用，能抑制 2．1．1 速释部分(A)的制备：取丸芯500 g，置于 乙肝病毒的增殖，促进乙肝病毒标志物转阴；并能增 GPCG．1流化床内流化，包衣液处方为TM、辅料适 强白细胞的吞噬能力，防止放、化疗所致的白细胞减 量用水溶解成的速释包衣液。 少，明显升高白细胞数量…。由于苦参总碱的消除 2．1．2 缓释部分(B)的制备：因Surelease中含有 半衰期较短 ，为提高其生物利用度，将其制成控 增塑剂、稳定剂和致孔剂，无需额外添加。取A 500 释微丸。 g流化，包衣液处方为TM、Surelease、辅料适量用水 聚合物水性包衣工艺是近年来发展迅速的薄膜