甲磺酸多沙唑嗪缓释片的研制

Preparation of Doxazosine Mesylate Sustained-release Tablets

目的研制甲磺酸多沙唑嗪缓释片,评价其与参比制剂体外释放行为的相似性。方法以羟丙甲纤维素为骨架材料,以乙基纤维素水分散体为包衣材料,采用湿法制粒技术制备甲磺酸多沙唑嗪缓释片,考察了粘合剂种类、包衣处方、包衣增重等对药物释放的影响,并进行了处方工艺验证,对中试放大产品进行体外释放度研究并与参比制剂"可多华"进行对比。结果本品与参比制剂具有相同的释放曲线。结论该制剂处方合理,制备方法可行、工艺稳定、简单、重复性好、成本低、生产效率高、缓释效果良好。

OBJECTIVE To prepare doxazosine mesylate sustained-release tablets and evaluate the similarity of release property in vitro compared with reference preparation.METHODS HPMC was employed as matrix material and ethyl cellulose aqueous dispersion was used as coating material.The tablets were prepared by wet granule compression method,and the impacts on the release rates with the types of adhesive,the coating formulation and weight gain were examined.After the optimal formula was verified,the test of dissolution in vitro was also researched compared with the reference preparation CarduraXR.RESULTS The release curve was similar to that reference preparation.CONCLUSION The formula of this preparation is stable and simple in technology,and is good in reproduction quality,low in cost and high in production efficiency.